Momenta Pharmaceuticals v. Amphastar Pharmaceuticals ( 2012 )


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  •   United States Court of Appeals
          for the Federal Circuit
                   __________________________
    
          MOMENTA PHARMACEUTICALS, INC.,
                  Plaintiff-Appellee,
                               and
                        SANDOZ, INC.,
                        Plaintiff-Appellee,
                                v.
        AMPHASTAR PHARMACEUTICALS, INC.,
     INTERNATIONAL MEDICATION SYSTEMS, LTD.,
          WATSON PHARMACEUTICALS, INC.,
             AND WATSON PHARMA, INC.,
                 Defendants-Appellants.
                   __________________________
    
                     2012-1062, -1103, -1104
                   __________________________
    
        Appeals from the United States District Court for the
    District of Massachusetts in case no. 11-CV-11681, Judge
    Nathaniel M. Gorton.
                   __________________________
    
                    Decided: August 3, 2012
                  ___________________________
    
        ROBERT S. FRANK, JR., Choate Hall & Stewart LLP, of
    Boston, Massachusetts, argued for both plaintiffs-
    appellees. With him on the brief was ERIC J. MARANDETT.
    Of counsel on the brief for plaintiff-appellee for Sandoz,
    MOMENTA PHARMA   v. AMPHASTAR PHARMA                     2
    
    
    Inc., was THOMAS P. STEINDLER, McDermott, Will &
    Emery LLP, of Washington, DC.
    
        PATRICIA A. MILLETT, Akin Gump Strauss Hauer &
    Feld LLP, of Washington, DC, argued for plaintiffs-
    appellants. With her on the brief were ANTHONY T.
    PIERCE, MARK MANSOUR, EMILY C. JOHNSON and JAMES E.
    TYSSE; and L. RACHEL LERMAN, of Los Angeles, California.
                   __________________________
    
      Before RADER, Chief Judge, DYK and MOORE, Circuit
                           Judges.
       Opinion for the court filed by Circuit Judge MOORE.
        Dissenting opinion filed by Chief Judge RADER.
    MOORE, Circuit Judge.
        Amphastar Pharmaceuticals, Inc., International
    Medication Systems, Ltd., Watson Pharmaceuticals, Inc.,
    and Watson Pharma, Inc. (collectively, Amphastar) appeal
    the district court’s order denying the Emergency Motion
    to Dissolve or Stay the preliminary injunction entered in
    this case. Because the district court applied an unduly
    narrow interpretation of the Hatch-Waxman safe harbor,
    35 U.S.C. § 271(e)(1), we vacate the grant of a preliminary
    injunction and remand for further proceedings consistent
    with this opinion.
                          BACKGROUND
        This case is a patent litigation involving a generic
    version of Lovenox (enoxaparin), a drug that prevents
    blood clots. Enoxaparin is a low molecular weight version
    of heparin, a naturally occurring molecule. Heparin is a
    polymer, known as a polysaccharide, made up of long
    chains of sugar molecules. Heparin is not a single defined
    molecule. Instead, heparin molecules have considerable
    3                   MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
    diversity in (1) the length of the polysaccharide chain and
    (2) in the component disaccharide units and the corre-
    sponding distribution of disaccharide unit sequences in
    the polysaccharide chains. FDA Letter to Aventis Phar-
    maceuticals, Inc., July 23, 2010, FDA Docket No. FDA-
    2003-P-0273 (FDA Letter), J.A. 291. For example, the
    molecular weight of heparin molecules varies between
    5,000 and 40,000 daltons. Id. Likewise, the disaccharide
    units can vary between two different uronic acid compo-
    nents, and each of four positions on the disaccharide unit
    can be modified. Id., J.A. 291-92. The natural diversity
    inherent to heparin stems from the biosynthetic pathway
    used to produce the molecule. Id., J.A. 292.
        Enoxaparin is produced by breaking the heparin poly-
    saccharide into smaller pieces, called oligosaccharides.
    Because the heparin starting material is a diverse set of
    molecules, enoxaparin is also made up of different chain
    lengths and disaccharide units corresponding to the
    diversity in the original mix of heparin molecules. Id.
    Additional diversity is introduced based on the way in
    which the heparin molecule is broken down into the low
    molecular weight heparin product. Id., JA 292-93. Thus,
    unlike a typical small molecule drug like penicillin, enoxa-
    parin is made up of a range of different molecules.
        This molecular diversity raises a potential problem in
    light of the Food and Drug Administration’s (FDA’s)
    abbreviated new drug application (ANDA) approval
    process. ANDAs are typically used by generic companies
    to obtain approval to market a generic version of an
    existing drug. Unlike a new drug application (NDA), an
    ANDA applicant is not required to submit the same
    extensive clinical studies typically needed to prove the
    drug’s safety and efficacy. Instead, the ANDA applicant
    must submit studies to establish that its drug is bio-
    equivalent to the reference drug. The ANDA must also
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                       4
    
    
    include sufficient information to establish that the generic
    drug has the same active ingredients as the reference
    drug.
        The obvious complication with using an ANDA appli-
    cation to gain approval for enoxaparin is that it is a
    mixture of a number of different low molecular weight
    heparin molecules. In fact, Aventis, which marketed
    Lovenox, asked the FDA to deny approval for a generic
    version of enoxaparin via an ANDA unless the applicant
    either (1) completely characterized enoxaparin by isolat-
    ing, purifying, and sequencing each of its unique polysac-
    charide chains, which Aventis claimed was impossible;
    (2) used Aventis’s manufacturing process; or (3) conducted
    clinical trials to prove safety and efficacy (the very type of
    duplicative studies the ANDA approval process was
    designed to avoid). FDA Letter, J.A. 286. The FDA
    rejected Aventis’s arguments, and instead explained that
    the ANDA “statutory provisions do not describe the type
    or amount of information that an ANDA applicant must
    submit to demonstrate that the active ingredient in the
    generic drug product is the same as the active ingredient
    in the [reference drug].” Id., J.A. 294. As a result, the
    FDA concluded that Congress recognized that the FDA
    has “broad discretion with respect to the information [it]
    may consider in making a finding on the ‘sameness’ of an
    active ingredient.” Id.
        Consistent with this discretion, the FDA identified
    five criteria, or “standards for identity,” that “together
    provide sufficient information to conclude that generic
    enoxaparin has the ‘same’ active ingredient as Lovenox.”
    Id., J.A. 295.      These criteria included, inter alia,
    “[e]quivalence in disaccharide building blocks, fragment
    mapping, and sequence of oligosaccharide species.” Id.
    The FDA explained that such equivalence is proven by
    “exhaustive digestion of enoxaparin with purified heparin
    5                   MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
    digesting enzymes (heparinases I, II, III) and nitrous acid,
    among other means, to yield the constituent disaccharide
    building blocks comprising enoxaparin.” Id., J.A. 300.
    These disaccharides can then potentially be “separated
    and quantified” by a number of techniques, including
    capillary electrophoresis (CE), reverse phase high per-
    formance liquid chromatography (RP-HPLC), and strong
    anion exchange high performance liquid chromatography
    (SAX-HPLC). Id.
         The FDA also suggested the identity of the disaccha-
    rides could be determined via standard techniques, in-
    cluding mass spectroscopy, NMR spectroscopy, modifying
    reagents, or modifying enzymes. These techniques iden-
    tify the nature of the constituent sugars and their substi-
    tution patterns, including the sulfation and acetylation
    patterns, as well as “whether the disaccharide possesses,
    among other structures, a . . . 1,6 anhydro ring” structure.
    Id., J.A. 300-01. Detecting the presence of a 1,6 anhydro
    ring structure is particularly important for proving
    equivalence because “[e]quivalence in disaccharide build-
    ing blocks together with equivalence in molecular weight
    distribution shows that generic enoxaparin contains the
    1,6 anhydro ring structure at the reducing ends of be-
    tween     15    percent    and      25   percent    of   its
    poly(oligo)saccharide chains.” Id. n.68, J.A. 301.
        Amphastar was the first company to file an ANDA for
    a generic version of enoxaparin. It submitted its ANDA to
    the FDA in March 2003, and subsequently engaged in a
    lengthy patent litigation with Sanofi-Aventis. Amphastar
    received FDA approval to market its generic enoxaparin
    on September 19, 2011. Despite the fact that Amphastar
    was the first company to file an ANDA, Momenta Phar-
    maceuticals, Inc. and Sandoz, Inc. (collectively Momenta),
    who collaborated to develop a generic enoxaparin product,
    were the first to bring generic enoxaparin to the market-
    MOMENTA PHARMA   v. AMPHASTAR PHARMA                     6
    
    
    place. Momenta received FDA approval to market enoxa-
    parin in July 2010, more than a year before Amphastar’s
    approval. Being the only generic version of enoxaparin
    has it benefits: its sales generated revenues of $260
    million per quarter. J.A. 189. The approval of Amphas-
    tar’s version of enoxaparin, and the resultant ruinous
    competition of another generic version of the drug, threat-
    ened this unique market position. Understandably un-
    willing to give up a billion dollars in yearly revenue,
    Momenta initiated the present litigation two days after
    Amphastar received final FDA approval to market its
    generic enoxaparin.
         Momenta is the assignee of United States Patent No.
    7,575,886 (’886 patent). The ’886 patent generally relates
    “to methods for analyzing heterogeneous populations of
    sulfated polysaccharides, e.g. heparin [and] . . . LMWH
    [e.g., enoxaparin.]” ’886 patent col.4 ll.53-55. Claim 6 is
    typical. It is a method for analyzing an enoxaparin sam-
    ple “for the presence or amount of a non naturally occur-
    ring sugar . . . that results from a method of making
    enoxaparin that included β-eliminative cleavage with a
    benzyl ester and depolymerization.” Id. col.64 ll.35-39.
    Momenta also asserted independent claims 15, which
    assesses the level of non-naturally occurring sugar, and
    53, which allows selection of an appropriate batch. These
    claims are similar to claim 6. The asserted claims gener-
    ally require digestion of an enoxaparin sample with a
    heparin degrading enzyme, followed by the use of a sepa-
    ration method to detect the presence of the non-naturally
    occurring sugar resulting from the β-eliminative cleavage.
    The signal corresponding to the non-naturally occurring
    sugar can then be used to analyze the test sample based
    on a comparison with a reference standard. Id. col.64
    ll.40-57.
    7                   MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
          Momenta alleged that Amphastar infringed the ’886
    patent by “manufacturing generic enoxaparin for com-
    mercial sale” using the claimed methods. J.A. 58. Mo-
    menta asserted that Amphastar “included in their process
    for manufacturing batches of enoxaparin sodium . . . a
    method for determining that a defined percentage of the
    oligosaccharide chains that make up enoxaparin include
    . . . a non-naturally occurring sugar that includes a 1,6-
    anhydro ring structure, which method infringes the ’886
    patent.” J.A. 57. Momenta also alleged that this infring-
    ing testing was necessary because the “FDA requires a
    generic manufacture to include in its manufacturing
    process the analysis of each batch of its enoxaparin drug
    substance to confirm that . . . [it] includes a 1,6-anhydro
    ring structure.” J.A. 56. Momenta moved for and re-
    ceived a temporary restraining order to prevent the
    irreparable harm of additional generic entry from Am-
    phastar. J.A. 4. The district court subsequently granted
    Momenta a preliminary injunction based on its belief that
    Amphastar’s quality control batch testing infringed the
    ’886 patent. J.A. 30. Amphastar later filed two emer-
    gency motions for relief from the preliminary injunction,
    which the district court denied.
        Amphastar sequentially appealed the preliminary in-
    junction and the two denials for relief from the prelimi-
    nary injunction. These three appeals were consolidated.
    We have jurisdiction to hear these appeals pursuant to 28
    U.S.C. § 1292. After hearing oral argument in this case,
    we stayed the preliminary injunction. This stay, however,
    was not a final decision on the merits of Amphastar’s
    appeal. We now explain why the district court incorrectly
    concluded that Momenta was likely to succeed on the
    merits of its infringement claim, and conclude that the
    preliminary injunction must be vacated.
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                       8
    
    
                              ANALYSIS
         “The issuance of a preliminary injunction . . . is a mat-
    ter of discretion for a district court. That discretion,
    however, is not absolute and must be reviewed in light of
    the equitable standards governing the issuance of injunc-
    tions.” Intel Corp. v. ULSI Sys. Tech., Inc., 
    995 F.2d 1566
    ,
    1568 (Fed. Cir. 1993). To determine whether a prelimi-
    nary injunction is appropriate, the district court weighs
    factors including “(1) whether the movant has sufficiently
    established a reasonable likelihood of success on the
    merits; (2) whether the movant would suffer irreparable
    harm if the injunction were not granted; (3) whether the
    balance of hardships tips in the movant's favor; and (4)
    the impact, if any, of the injunction on the public inter-
    est.” Id. The grant of a preliminary injunction can be
    overturned “by showing that the court made a clear error
    of judgment in weighing relevant factors or exercised its
    discretion based upon an error of law or clearly erroneous
    factual findings.” Genentech, Inc. v. Novo Nordisk A/S,
    
    108 F.3d 1361
    , 1364 (Fed. Cir. 1997). As the party seek-
    ing the injunction, the burden is on Momenta to establish
    it is entitled to this extraordinary relief. Id. In order to
    prove a likelihood of success on the merits, Momenta must
    prove that Amphastar likely infringes its patent. Id.
    Conversely, if Amphastar establishes that Momenta is
    unlikely to succeed on its claim of infringement, a pre-
    liminary injunction is likely not appropriate. Id.
        In its opposition to the preliminary injunction, Am-
    phastar argued, among other things, that its testing falls
    within the scope of the Hatch-Waxman safe harbor, 35
    U.S.C. § 271(e)(1). Section 271(e)(1) indicates that “[i]t
    shall not be an act of infringement to . . . use . . . a pat-
    ented invention . . . solely for uses reasonably related to
    the development and submission of information under a
    Federal law which regulates the manufacture, use, or sale
    9                   MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
    of drugs . . . .” The district court found that “the alleged
    infringing activity involves the use of plaintiffs’ patented
    quality control testing methods on each commercial batch
    of enoxaparin that will be sold after FDA approval.” J.A.
    31; see also J.A. 56 (Momenta’s complaint alleging that
    the “FDA requires” the testing). While acknowledging
    that Amphastar’s use of the patented method was for the
    purpose of developing information to submit to the FDA,
    the district court nevertheless concluded that the safe
    harbor does not apply to Amphastar’s testing: “although
    the safe harbor provision permits otherwise infringing
    activity that is conducted to obtain regulatory approval of
    a product, it does not permit a generic manufacturer to
    continue in that otherwise infringing activity after obtain-
    ing such approval.” J.A. 23. In reaching this conclusion,
    the district court focused primarily on the legislative
    history of the safe harbor, as quoted in one of our prior
    cases, Classen Immunotherapies, Inc. v. Biogen IDEC, 
    659 F.3d 1057
     (Fed. Cir. 2011). J.A. 23.
        On appeal, Amphastar argues that the district court
    took an unduly restrictive view of the safe harbor, and
    that its activities fall within the plain language of 35
    U.S.C. § 271(e)(1). Momenta counters that the district
    court correctly held that the safe harbor does not apply to
    Amphastar’s testing for two reasons. First, Momenta
    argues that that the safe harbor does not apply to post-
    approval activity: “In Classen, this court squarely held
    that ‘[t]he [safe harbor] does not apply to information that
    may be routinely reported to the FDA long after market-
    ing approval has been obtained.’” Appellee’s Br. at 43
    (quoting Classen, 659 F.3d at 1070, alterations made by
    Momenta)). Because Amphastar’s batch testing is carried
    out as a condition for the post-FDA approval sale of
    enoxaparin, Momenta argues it falls outside the scope of
    the safe harbor.
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                    10
    
    
        Second, despite its allegations and concessions, Mo-
    menta asserts the safe harbor does not apply because “the
    FDA does not require the use of the particular procedure
    that is claimed in the ’886 patent.” Id. at 41. Instead,
    Momenta claims that the FDA’s interpretation of its
    statutory mandate in its letter response to Aventis’s
    petition, J.A. 300-01, allows a variety of testing methods
    to be used to establish equivalence, both for the submis-
    sion of an ANDA and for the undisputedly required batch
    testing. Appellee’s Br. at 41. Momenta argues that the
    availability of other acceptable testing methods means
    that Amphastar’s alleged use of the patented method is
    not required by the FDA, and is therefore outside of the
    safe harbor provision.
        The parties thus present us with conflicting views
    about the scope of the safe harbor. If Amphastar is cor-
    rect that its post-approval activities actually fall within
    the scope of 35 U.S.C. § 271(e)(1), Momenta is unlikely to
    succeed on its claim of infringement and the preliminary
    injunction is likely inappropriate. Genentech, 108 F.3d at
    1364. In order to determine whether the preliminary
    injunction was appropriate in this case, we must first
    ascertain the scope of the Hatch-Waxman safe harbor
    provision, 35 U.S.C. § 271(e)(1).
                                 I.
        “[A]ll statutory construction cases . . . begin with the
    language of the statute.” Barnhart v. Sigmon Coal Co.,
    
    534 U.S. 438
    , 450 (2002). The “first step in interpreting a
    statute is to determine whether the language at issue has
    a plain and unambiguous meaning with regard to the
    particular dispute in the case.” Robinson v. Shell Oil Co.,
    
    519 U.S. 337
    , 340 (1997). If the language of the statute is
    unambiguous, there is no second step: “Our inquiry must
    cease if the statutory language is unambiguous and ‘the
    11                   MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
    statutory scheme is coherent and consistent.’” Id. (quot-
    ing United States v. Ron Pair Enters., Inc., 
    489 U.S. 235
    ,
    240 (1989)). Whether the text of a statute is plain or
    ambiguous “is determined by reference to the language
    itself, the specific context in which the language is used,
    and the broader context of the statute as a whole.” Id. at
    341.
        The Drug Price Competition and Patent Term Resto-
    ration Act (Hatch-Waxman Act), Public Law No. 98-417
    (1984) (codified in relevant part at 35 U.S.C. § 271(e)) set
    up a statutory system to “balance the need to stimulate
    innovation against the goal of furthering the public inter-
    est.” H.R. Rep. 98-857, pt. 2, at 2714 (Aug. 1, 1984). This
    balance is embodied, in part, in the “safe harbor” provi-
    sion of 35 U.S.C. § 271(e)(1), which provides (with empha-
    sis added) that:
         It shall not be an act of infringement to make, use,
         offer to sell, or sell within the United States or
         import into the United States a patented inven-
         tion (other than a new animal drug or veterinary
         biological product (as those terms are used in the
         Federal Food, Drug, and Cosmetic Act and the Act
         of March 4, 1913) which is primarily manufac-
         tured using recombinant DNA, recombinant RNA,
         hybridoma technology, or other processes involv-
         ing site specific genetic manipulation techniques)
         solely for uses reasonably related to the develop-
         ment and submission of information under a Fed-
         eral law which regulates the manufacture, use, or
         sale of drugs or veterinary biological products.
    Congress could not have been clearer in its choice of
    words: as long as the use of the patented invention is
    solely for uses “reasonably related” to developing and
    submitting information pursuant to “a Federal law”
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                    12
    
    
    regulating the manufacture, use, or sale of drugs, it is not
    “an act of infringement.”
        Although the Hatch-Waxman safe harbor provision
    was enacted in the context of the then-novel ANDA ap-
    proval process, 35 U.S.C. § 271(e)(1) does not reference
    the portion of the Federal Food, Drug, and Cosmetic Act
    describing the ANDA requirements, e.g., 21 U.S.C.
    § 355(j). Instead, Congress used more flexible and expan-
    sive language to define the scope of § 271(e)(1), referring
    generally to “the development and submission of informa-
    tion under a Federal law which regulates the manufac-
    ture, use, or sale of drugs.”        This broad language
    unambiguously applies to submissions under any federal
    law, providing that the law “regulates the manufacture,
    use, or sale of drugs.” Limiting the scope of 35 U.S.C.
    § 271(e)(1) to just the submission of information pursuant
    to the Federal Food, Drug, and Cosmetic Act generally, or
    to the ANDA provision of the Federal Food, Drug, and
    Cosmetic Act in specific, would read words into the stat-
    ute in violation of the express language chosen by Con-
    gress.
        This interpretation is also consistent with the rest of
    the statutory scheme. When Congress wanted to impose
    a limitation based on the Federal Food, Drug, and Cos-
    metic Act, it expressly referenced the Act. For example,
    in the safe harbor provision, Congress excluded “a new
    animal drug or veterinary biological product (as those
    terms are used in the Federal Food, Drug, and Cosmetic
    Act and the Act of March 4, 1913)” made using certain
    genetic techniques.      35 U.S.C. § 271(e)(1) (emphasis
    added). Likewise, when Congress wanted to limit the
    statute to just a certain kind of submission, for example
    the submission of an ANDA application under 21 U.S.C.
    § 355(j), it specifically referenced the statutory section
    governing those submissions. For example, in the subsec-
    13                  MOMENTA PHARMA     v. AMPHASTAR PHARMA
    
    
    tion immediately following the safe harbor, Congress
    defined as an act of infringement the submission of “an
    application under section 505(j) of the Federal Food,
    Drug, and Cosmetic Act [codified at 21 U.S.C. § 355(j)] or
    described in section 505(b)(2) of such Act for a drug
    claimed in a patent or the use of which is claimed in a
    patent.” 35 U.S.C. § 271(e)(2)(A).
         Unlike the closely related infringement provision, 35
    U.S.C. § 271(e)(2), Congress did not link the safe harbor
    to the submission of an application for approval under the
    Federal Food, Drug, and Cosmetic Act. Compare 35
    U.S.C. § 271(e)(1) (not an act of infringement when used
    for “the development and submission of information under
    a Federal law”) with 35 U.S.C. § 271(e)(2)(A) (it is an act
    of infringement to submit “an application under section
    505(j) of the Federal Food, Drug, and Cosmetic Act or
    described in section 505(b)(2) of such Act”). We cannot
    change the statutory language. We will not import the
    limitation of § 271(e)(2) into § 271(e)(1). “[O]ur obligation
    is to take statutes as we find them.” Diamond v. Chakra-
    barty, 
    447 U.S. 303
    , 315 (1980); see also, e.g., Reiter v.
    Sonotone Corp., 
    442 U.S. 330
    , 344 (1978) (“We must take
    the statute as we find it.”). The statute here applies to
    any use of a patented invention as long as the use is
    “reasonably related to the development and submission of
    information under a Federal law which regulates the
    manufacture, use, or sale of drugs . . . .” 35 U.S.C.
    § 271(e)(1).
        In light of these provisions, the only coherent and
    consistent interpretation of “a Federal law which regu-
    lates the manufacture, use, or sale of drugs” is that it
    must be broad enough to encompass submissions made
    pursuant to the Federal Food, Drug, and Cosmetic Act.
    Since there is no ambiguity in the language used by
    Congress in 35 U.S.C. § 271(e)(1), our inquiry into the
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                     14
    
    
    scope of the safe harbor is complete. Robinson, 519 U.S.
    at 340. When the intent of Congress is expressed so
    clearly and consistently throughout the statute, there is
    neither the need nor the occasion to refer to the legislative
    history. Id. The scope of the Hatch-Waxman safe harbor
    does not stop at activities reasonably related to develop-
    ment of information submitted in an ANDA. Instead, the
    safe harbor applies “to the development and submission of
    information under a Federal law which regulates the
    manufacture, use, or sale of drugs or veterinary biological
    products.” As long as the allegedly infringing use is “for
    uses reasonably related” to the development and submis-
    sion of that information it is not an act of infringement,
    regardless of where that requirement resides in the law.
        This analysis is not groundbreaking: the Supreme
    Court came to essentially the same conclusion in 1990. In
    Eli Lilly & Co. v. Medtronic, Inc., the Court explained
    that “the phrase ‘a Federal law which regulates the
    manufacture, use, or sale of drugs’ more naturally sum-
    mons up the image of an entire statutory scheme of regula-
    tion,” and not just a particular provision of the law. 
    496 U.S. 661
    , 666 (1990) (emphasis added). Although the
    legislative history of the safe harbor only mentioned
    drugs, id. at 669 n.2, the Court nevertheless concluded
    that the safe harbor also extended to medical devices,
    which were also part of “a Federal law which regulates
    the manufacture, use or sale of drugs,” namely the Fed-
    eral Food, Drug, and Cosmetic Act, id. at 674.
         The Court later reaffirmed this expansive view, ex-
    plaining: “we think it apparent from the statutory text
    that § 271(e)(1)’s exemption from infringement extends to
    all uses of patented inventions that are reasonably related
    to the development and submission of any information
    under the FDCA [(Food, Drug, and Cosmetic Act)].”
    Merck KGaA v. Integra Lifesciences I, Ltd., 
    545 U.S. 193
    ,
    15                  MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
    202 (2005) (citing Eli Lilly, 496 U.S. at 665-69). Merck
    KGaA expressly rejected the notion that the safe harbor
    only applies to information developed during a clinical
    trial. 545 U.S. at 202 n.6. Instead, “the statutory text
    makes clear that it provides a wide berth for the use of
    patented drugs in activities related to the federal regula-
    tory process.” Id. at 202 (emphasis added). In light of the
    unqualified exemption for uses reasonably related to the
    development and submission of information, “[t]here is
    simply no room in the statute for excluding certain infor-
    mation from the exemption on the basis of the phase of
    research in which it is developed or the particular submis-
    sion in which it could be included.” Id. (emphasis added).
    The use of the word “under” in the statute is expansive.
    Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 
    566 U.S.
    __, 
    132 S. Ct. 1670
    , 1683-84 (2012). “Under a federal law”
    extends beyond just the “most barebones information”
    required by the FDA, and instead encompasses all “mate-
    rials the FDA demands in the regulatory process.” Id.
        While it is clear that the safe harbor applies to a
    broad set of “activities related to the federal regulatory
    process,” Merck KGaA, 545 U.S. at 202, there is an impor-
    tant limitation: the use must be “for uses reasonably
    related to the development and submission of informa-
    tion,” 35 U.S.C. § 271(e)(1). “Reasonably related,” how-
    ever, does not mean that the use of the patented invention
    must necessarily result in submission of information to
    the FDA: “Congress did not limit § 271(e)(1)’s safe harbor
    to the development of information for inclusion in a
    submission to the FDA; nor did it create an exemption
    applicable only to the research relevant to filing an ANDA
    for approval of a generic drug.” Merck KGaA, 545 U.S. at
    206. Instead, the Court explained that the safe harbor
    “exempted from infringement all uses of patented com-
    pounds ‘reasonably related’ to the process of developing
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                     16
    
    
    information for submission under any federal law regulat-
    ing the manufacture, use, or distribution of drugs.” Id.
    (emphasis in original). Thus, the Court explicitly rejected
    the notion that § 271(e)(1) was limited “to the activities
    necessary to seek approval of a generic drug.” Id. As long
    as the accused infringer “has a reasonable basis for believ-
    ing” that use of the patented invention might yield infor-
    mation that “would be appropriate to include in a
    submission to the FDA, that use is ‘reasonably related’ to
    the ‘development and submission of information under . . .
    Federal law.’” Id. at 207.
                                 II.
         At the outset we are met with the contention that the
    information in question was not “submitted” to the FDA,
    see 35 U.S.C. § 271(e)(1) (“. . . solely for uses reasonably
    related to the development and submission of information
    . . .”), but rather was retained by the ANDA holder. We
    do not agree. Amphastar, as a generic drug manufacturer
    under an ANDA, cannot sell a batch of enoxaparin unless
    it has established that its strength and quality is consis-
    tent with the standards set forth in the relevant official
    compendium. See 21 U.S.C. §§ 331(a), 351(b). FDA
    regulations require that all records associated with a
    produced batch of drugs, including these batch records,
    “be retained for at least 1 year after the expiration date of
    the batch.” 21 C.F.R. § 211.180(a). These records “shall
    be readily available for authorized inspection” by the FDA
    at any time. 21 C.F.R. § 211.180(c). We think that the
    requirement to maintain records for FDA inspection
    satisfies the requirement that the uses be reasonably
    related to the development and submission of information
    to the FDA. It is not disputed by the parties that these
    records are produced in order to develop and submit to the
    FDA proof that the Amphastar products comply with a
    Federal law. The fact that the FDA does not in most
    17                   MOMENTA PHARMA   v. AMPHASTAR PHARMA
    
    
    cases actually inspect the records does not change the fact
    that they are for the “development and submission of
    information under a Federal law.” 35 U.S.C. § 271(e)(1);
    cf. Merck KGaA, 545 U.S. at 207 (holding that uses which
    are not ultimately included in a submission to the FDA
    are nonetheless exempted by the safe harbor). Thus, we
    consider this information “submitted” for purposes of the
    statute. We turn then to the question of whether these
    submissions are within the safe harbor.
        In Merck KGaA v. Integra Lifesciences I, Ltd., 
    545 U.S. 193
     (2005), the Supreme Court held that uses of
    patented inventions in preclinical research, the results of
    which are not ultimately included in a submission to the
    FDA, are nevertheless exempted from infringement by the
    safe harbor provision. Id. at 208. The Court explained
    that
         Congress did not limit §271(e)(1)’s safe harbor to
         the development of information for inclusion in a
         submission to the FDA; nor did it create an ex-
         emption applicable only to the research relevant
         to filing an ANDA for approval of a generic drug.
         Rather, it exempted from infringement all uses of
         patented compounds “reasonably related” to the
         process of developing information for submission
         under any federal law regulating the manufac-
         ture, use, or distribution of drugs.
    Id. at 206. Thus, it was not an act of infringement to use
    patented compounds in preclinical studies which were not
    ultimately submitted to the FDA where “there [was] a
    reasonable basis for believing that the experiments
    [would] produce the types of information that are relevant
    to an IND or NDA.” Id. at 208.
       However, in Classen Immunotherapies, Inc. v. Biogen
    IDEC, 
    659 F.3d 1057
    , 1070 (Fed. Cir. 2011), we held that
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                    18
    
    
    § 271(e)(1) “does not apply to information that may be
    routinely reported to the FDA, long after marketing
    approval has been obtained.” At issue in Classen were
    studies to evaluate the association between the timing of
    childhood vaccinations and the risk of developing certain
    immune-mediated disorders. The studies themselves
    were not mandated by the FDA, but any vaccine license
    holder was required to report to the FDA “adverse experi-
    ence information,” such as adverse side effects, it acquired
    as a result of vaccine studies. See 21 C.F.R. § 600.80. We
    found that the studies conducted by the vaccine license
    holder according to patented methods were not insulated
    by the safe harbor because the studies did not facilitate
    marketing a generic drug by “expedit[ing] development of
    information for regulatory approval.” Classen, 659 F.3d
    at 1070. We, of course, are bound by the Classen decision
    unless it is overruled en banc or by the Supreme Court.
    Accordingly, the scope of the safe harbor provision does
    not extend to “information that may be routinely reported
    to the FDA, long after marketing approval has been
    obtained.”
        This case, however, fits well within Classen because
    the information submitted is necessary both to the con-
    tinued approval of the ANDA and to the ability to market
    the generic drug. Here, the submissions are not “routine
    submissions” to the FDA, but instead are submissions
    that are required to maintain FDA approval. Amphastar
    is required to conduct a laboratory determination of
    identity and strength of the active ingredient for each
    batch of enoxaparin. See 21 C.F.R. § 211.165(a). This test
    must be done according to the patented methods de-
    scribed in an official compendium, in this case the United
    States Pharmacopeia (USP). See 21 U.S.C. § 351(b) (Any
    “determination as to strength, quality, or purity shall be
    made in accordance with the tests or methods of assay set
    19                  MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
    forth in such compendium.”). Moreover, as described
    above, FDA regulations require that all such batch re-
    cords “be retained for at least 1 year after the expiration
    date of the batch,” 21 C.F.R. § 211.180(a), and that such
    records “shall be readily available for authorized inspec-
    tion” by the FDA at any time, 21 C.F.R. § 211.180(c); see
    also 21 C.F.R. §§ 211.186, 211.188, 211.194 (requiring
    “master production and control records,” “batch produc-
    tion and control records,” and “laboratory records”).
    Failure to comply with these requirements could result in
    suspension or revocation of Amphastar’s ANDA approval
    to market the drug. See 21 U.S.C. §§ 335a(g), 355(e).
    Furthermore, such testing is “a condition for [the drug’s]
    approval and release” into commerce, 21 C.F.R.
    § 211.165(d), thus acting as a predicate to the ability to
    market the ANDA-approved drug to the public.
         The submissions to the FDA in this case are anything
    but “routine”—they implicate Amphastar’s very ability to
    continue its FDA approval for its ANDA and to continue
    manufacturing and marketing enoxaparin under its
    ANDA. We also note that, unlike in Classen where the
    patented studies performed were not mandated by the
    FDA, the information here is not generated voluntarily by
    the manufacturer but is generated by FDA requirements
    the manufacturer is obligated under penalty of law to
    follow. Under such circumstances, the information can be
    said to have been gathered solely for submission to the
    FDA and not, as in Classen, primarily for non-FDA pur-
    poses. While Momenta urges us to adopt the pre-/post-
    approval distinction used by the district court, we cannot:
    Classen did not turn on this artificial distinction, and the
    plain language of the statute is not restricted to pre-
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                     20
    
    
    approval activities. 1 We therefore hold that post-approval
    studies that are “reasonably related to the development
    and submission of information under a Federal law which
    regulates the manufacture, use, or sale of drugs” fall
    within the scope of the § 271(e)(1) safe harbor.
         In this case, Momenta concedes that Amphastar’s
    tests “are conducted in order to satisfy the FDA’s require-
    ments that each batch of enoxaparin that is sold commer-
    cially after FDA approval is actually the same as the
    brand name drug.” Appellee’s Br. at 40-41 (emphasis
    added); see also J.A. 56 (allegation that the “FDA re-
    quires” the accused testing). Under a proper construction
    of 35 U.S.C. § 271(e)(1), the fact that Amphastar’s testing
    is carried out to “satisfy the FDA’s requirements” means
    it falls within the scope of the safe harbor, even though
    the activity is carried out after approval. Unlike Classen,
    where the allegedly infringing activity “may” have even-
    tually led to an FDA submission, there is no dispute in
    this case that Amphastar’s allegedly infringing activities
    are carried out to “satisfy the FDA’s requirements.” The
    district court’s interpretation of § 271(e)(1) was erroneous.
    Under the correct construction, Momenta cannot establish
    a likelihood of success on infringement and the prelimi-
    nary injunction must be vacated. Genentech, Inc., 108
    F.3d at 1364.
    
    
        1   We are puzzled by the dissent’s claim that the use
    of the words “solely” and “submitted” require us to limit
    the statute to pre-approval activities. This is not the
    plain meaning of those words. For example, if the FDA
    required post-approval testing with subsequent submis-
    sion of those test results, those test results were clearly
    generated “solely” for an FDA submission and equally
    clearly were “submitted” to the agency. “Solely” and
    “submitted” in no manner limit § 271(e)(1) to “pre-
    approval testing.”
    21                  MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
        Momenta also argues that even if 35 U.S.C.
    § 271(e)(1) extends to post-approval activities, Amphas-
    tar’s testing is not protected because there are FDA
    endorsed non-infringing alternatives available. The safe
    harbor, however, does not mandate the use of a non-
    infringing alternative when one exists. The only limita-
    tion in the safe harbor is that the use must be “reasonably
    related to the development and submission of informa-
    tion” pursuant to a federal law regulating the “manufac-
    ture, use, or sale of drugs or veterinary biological
    products.” 35 U.S.C. § 271(e)(1). The safe harbor’s pro-
    tection is not limited to the dire situation where the
    patented invention is the only way to develop and submit
    the information. Instead, the safe harbor expressly allows
    the submitter the freedom to use an otherwise patented
    means to develop the necessary information demanded by
    the “Federal law.” This makes good sense because it
    eliminates liability for infringement when that act of
    infringement is, in effect, required by the federal govern-
    ment as part of the continuing safety and efficacy moni-
    toring of an approved drug. It also avoids the situation
    here, where a drug has received approval, but is neverthe-
    less kept from the market based on an FDA mandated
    testing requirement.
        Momenta’s interpretation is predicated upon the in-
    correct assumption that “solely” in the context of 35
    U.S.C. § 271(e)(1) means that the patented invention
    must be the “sole” means of providing the information for
    the safe harbor to apply. This is not the language of the
    statute: under 35 U.S.C. § 271(e)(1), as long as the use is
    “reasonably related to the development and submission of
    information” under a relevant statute, it is not an act of
    infringement. “Solely” modifies “uses reasonably related
    to the development and submission of information,” but
    does not place any other restriction on when the patented
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                    22
    
    
    invention may be used without infringing. As long as the
    use of the patented invention is done to generate informa-
    tion that will be submitted pursuant to a relevant federal
    law, that use falls within the safe harbor. Merck KGaA,
    545 U.S. at 205-206. Momenta is therefore incorrect that
    the possibility that the FDA would accept the use of other,
    non-patented, testing methods for the development and
    submission of information precludes Amphastar from
    relying on the safe harbor in this case. 2
        Even if Momenta’s strained reading of the statute was
    supportable, Amphastar’s allegedly infringing activities
    are clearly carried out according to the dictates of the
    Federal Food, Drug, and Cosmetic Act. Under the Act,
    Amphastar is prohibited from selling a drug if it is adul-
    
       2     Although the parties do not argue that FDA-
    mandated quality control testing during manufacturing is
    not done “solely” for purposes of developing and submit-
    ting information to the FDA, the dissent suggests that
    because Amphastar uses the patented method while
    manufacturing a product to sell in commerce its infring-
    ing activity does not meet the “solely” limitation in the
    statute. This is not a tenable reading of the statute, and
    is indeed contrary to precedent. The Supreme Court cases
    interpreting the safe harbor make clear that the safe
    harbor is not limited to acts which only produce informa-
    tion for the FDA but protects all acts, even interim re-
    search steps and acts that might produce other useful
    data, “as long as there is a reasonable basis for believing
    that the [act] will produce the types of information that
    are relevant to [a submission to the FDA].” Merck, 545
    U.S. at 208. We have interpreted this language of the
    safe harbor to allow alleged infringers to use “data from
    tests for more than FDA approval,” such as for fund
    raising and other business purposes. Abtox, Inc. v.
    Exitron Corp., 
    122 F.3d 1019
    , 1030 (Fed. Cir. 1997) (hold-
    ing that the alleged infringer’s “intent or alternate uses
    [of test data] are irrelevant to its qualification to invoke
    the section 271(e)(1) shield”).
    23                  MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
    terated. 21 U.S.C. § 331(a). A drug is adulterated if it
    purports to be a drug listed in an official compendium, for
    example the USP, but in actuality differs in composition.
    21 U.S.C. § 351(b); see also 21 U.S.C. § 321(j) (defining
    “official compendium”). In order to demonstrate that a
    drug is not adulterated, testing must be carried out
    pursuant to the methods articulated in the compendium,
    in this case the USP. See 21 U.S.C. § 351(b) (Any “deter-
    mination as to strength, quality, or purity shall be made
    in accordance with the tests or methods of assay set forth
    in such compendium.”). “For each batch of drug product,
    there shall be appropriate laboratory determination of . . .
    the identity and strength of each active ingredient . . . .”
    21 C.F.R. § 21.165(a). FDA regulations characterize this
    testing as “a condition for [the drug’s] approval and
    release” into commerce. 21 C.F.R. § 211.165(d). The FDA
    also mandates maintenance of appropriate records related
    to this type of testing. See 21 C.F.R. § 211.180(a) (produc-
    tion, control, and distribution records associated with a
    batch of drug must be retained for at least one year after
    the expiration date of the batch); see also 21 C.F.R.
    §§ 211.186, 211.188, 211.194 (requiring “master produc-
    tion and control records,” “batch production and control
    records,” and “laboratory records”).
         The USP entry for enoxaparin, the drug at issue in
    this litigation, states: “About 20 percent of the materials
    contain a 1,6-anhydro derivative on the reducing end of
    the chain, the range being between 15 and 25 percent.”
    J.A. 365 (USP Revision Bulletin, Official December 1,
    2008). Thus, in order to be “enoxaparin” as defined in the
    USP entry, the marketed drug product must contain
    between 15 and 25 percent of the 1,6-anhydro derivative.
    Id.; see also 21 U.S.C. § 351(b) (drug adulterated if pur-
    ports to be a drug in an official compendium but its
    strength, quality, or purity differs from the standard set
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                    24
    
    
    forth in the compendium). The USP also includes a
    specific test for the 1,6-anhydro derivative, which “in-
    volves HPLC analysis of a depolymerized enoxaparin
    sodium solution by a mixture of heparinases.” J.A. 369
    (USP Method <207>). As the district court explained:
    “Claims 6, 16, and 53 of the ’886 patent describe how to
    analyze a sample of enoxaparin to ensure its conformity to
    the USP Monograph standard.” J.A. 8. Amphastar is
    required by the FDA to use this test in order to ensure its
    enoxaparin is not adulterated. 21 U.S.C. § 351(b). This
    testing, which generates information for submission
    pursuant to the Food, Drug, and Cosmetic Act, therefore
    falls squarely within the scope of the safe harbor.
        Finally, the dissent suggests that we must reject any
    disequilibrium between sections 201 and 202 of the
    Hatch-Waxman Act, that is, the safe harbor should not be
    available unless a patent term extension is also available.
    Dissenting Op. at 19-20. This is not correct. The Su-
    preme Court in Eli Lilly noted that equilibrium was not
    always achieved. See Eli Lilly, 496 U.S. at 671-72. We
    too have rejected this strict interpretation of the safe
    harbor, explaining that “statutory symmetry is preferable
    but not required.” Abtox, 122 F.3d at 1029 (holding that
    Class II medical devices, which are not subject to a “rigor-
    ous premarket approval process” and thus cannot receive
    patent term extensions, are nonetheless covered by the
    safe harbor).
                                III.
        Under the correct interpretation of 35 U.S.C.
    § 271(e)(1), Momenta’s admission that Amphastar’s
    testing is carried out to “satisfy the FDA’s requirements,”
    Appellee’s Brief at 40-41, makes it unlikely that Momenta
    will succeed on the merits of its infringement claim. The
    district court’s findings with respect to the irreparable
    25                     MOMENTA PHARMA   v. AMPHASTAR PHARMA
    
    
    harm, balance of the hardships, and public interest fac-
    tors were all, to some extent, predicated on its erroneous
    conclusion that Momenta’s patent was likely infringed by
    Amphastar’s product. See J.A. 24 (applying a presump-
    tion of irreparable harm in view of Momenta’s “showing of
    infringement and validity”); J.A. 29 (explaining that in
    light of the “showing of likelihood of success on the merits,
    the balance of hardship tips in [Momenta’s] favor”); J.A.
    30 (public interest favors protection of patent rights
    secured by valid patents). Because Momenta has not
    established a likelihood of success on its claim of in-
    fringement, the preliminary injunction must be vacated.
        On remand, the district court may want to consider
    whether Momenta’s admission that Amphastar’s use of
    the patented invention is to “satisfy the FDA’s require-
    ments” makes this case amenable to summary judgment
    of non-infringement in favor of Amphastar. Because the
    safe harbor issue is dispositive, we need not reach the
    other arguments on appeal.
                 VACATED AND REMANDED
                               COSTS
    Costs to Appellants.
      United States Court of Appeals
          for the Federal Circuit
                   __________________________
    
           MOMENTA PHARMACEUTICALS, INC.,
                   Plaintiff-Appellee,
                               and
                         SANDOZ, INC.,
                        Plaintiff-Appellee,
                                 v.
        AMPHASTAR PHARMACEUTICALS, INC.,
     INTERNATIONAL MEDICATION SYSTEMS, LTD.,
          WATSON PHARMACEUTICALS, INC.,
             AND WATSON PHARMA, INC.,
                 Defendants-Appellants.
                   __________________________
    
                     2012-1062, -1103, -1104
                   __________________________
    
        Appeals from the United States District Court for the
    District of Massachusetts in Case No. 11-CV-11681, Judge
    Nathaniel M. Gorton.
                   __________________________
    
    RADER, Chief Judge, dissenting.
        By definition, a patent defines a right to exclude.
    Consistent with property principles, an infringer of a
    valid patent is an unlawful trespasser. The remedy for
    trespassing, in this area of property law as well as others,
    is removal of the trespasser. Indeed even the Constitu-
    tion acknowledges the patent owner’s right to exclude
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                      2
    
    
    trespassers. U.S. Const. art. I, § 8, cl. 8. Thus, exceptions
    to the traditional property remedy amount to a get-out-of-
    jail-free card for the trespasser. Accordingly, such excep-
    tions must occur only sparingly with awareness that this
    license allows the wrongdoer free reign to continue tres-
    passing.
        The public readily applauds the role of patents in the
    development and delivery to the marketplace of life-
    saving drugs or modern technology products like smart-
    phones. At the same time, many incremental advances
    contribute to these monumental advances or, as in this
    case, enhance their delivery to the public. These incre-
    mental inventions also represent difficult and expensive
    advances in technology. For example, in this case, Am-
    phastar had a strong incentive to invent this patented
    manufacturing method. As the first-filer, it would have
    obtained 180 days of market exclusivity as the only seller
    of the generic drug — a right worth $260 million per
    quarter. Nevertheless, Amphastar could not make that
    invention. Instead, the patentee Momenta made the
    investment, did the research, and engineered the new
    method disclosed in the '886 patent.
        At that point, Amphastar stepped in and took Mo-
    menta’s patented invention without permission and used
    it to manufacture each commercial batch it sells on the
    market. Indeed Amphastar continues to trespass and
    promises to trespass for years to come. In fact, as the
    court repeatedly acknowledges, Amphastar is only able to
    compete with Momenta by taking its patented invention.
    Amphastar has not developed its own method, but instead
    delights in trespassing and refuses to pay a reasonable
    royalty to make the trespass lawful.
       This court would allow this arrogance to continue by
    expanding the limited reach of 35 U.S.C. § 271(e)(1). This
    3                   MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
    expansion of the law circumvents the purpose of the law
    and ignores the binding precedent of Classen Immuno-
    therapies, Inc. v. Biogen IDEC, 
    659 F.3d 1057
     (Fed. Cir.
    2011). Sadly this result will render worthless manufac-
    turing test method patents. Accordingly, I must respect-
    fully dissent.
                                 I.
        The Supreme Court has observed that the text alone
    of § 271(e)(1) can be “not plainly comprehensible.” Eli
    Lilly & Co. v. Medtronic, Inc., 
    496 U.S. 661
    , 669 (1990).
    The purpose of this text, which ought to inform its appli-
    cation, however, is evident from the legislative history.
    The legislative history of § 271(e)(1) includes more than 2
    House reports, 25 statements and letters, and many pages
    of Congressional testimony. A review of this extensive
    material shows that section 202 of the Hatch-Waxman
    Act, enacted as § 271(e)(1), had the sole purpose of over-
    ruling this court’s holding in Roche Products, Inc. v. Bolar
    Pharmaceutical Co., 
    733 F.2d 858
     (Fed. Cir. 1984). In
    particular, § 271(e)(1) applied only in limited situations,
    namely pre-approval experiments to obtain FDA ap-
    proval:
        The purpose of 271(e)(1) and (2) is to establish
        that experimentation with a patented drug
        product, when the purpose is to prepare for com-
        mercial activity which will begin after a valid pat-
        ent expires, is not a patent infringement. Since
        the Committee’s Subcommittee on Health and the
        Environment began consideration of this bill, the
        Court of Appeals for the Federal Circuit held that
        this type of experimentation is infringement. In
        Roche Products, Inc. v. Bolar Pharmaceutical Co.,
        
    733 F.2d 858
     (Fed. Cir. 1984), the Court of Ap-
        peals for the Federal Circuit held that the ex-
    MOMENTA PHARMA   v. AMPHASTAR PHARMA                      4
    
    
       perimental use of a drug product prior to the ex-
       piration date of a patent claiming that drug prod-
       uct constitutes patent infringement, even though
       the only purpose of the experiments is to
       seek FDA approval for the commercial sale of
       the drug after the patent expires. It is the Com-
       mittee’s view that experimental activity does
       not have any adverse economic impact on the pat-
       ent owner’s exclusivity during the life of a patent,
       but prevention of such activity would extend the
       patent owner’s commercial exclusivity beyond the
       patent expiration date.
    H.R. REP. NO. 98-857, pt. 1, at 45-46 (1984) (emphases
    added).
       The provisions of section 202 of the bill have the
       net effect of reversing the holding of the court in
       Roche Products, Inc. v. Bolar Pharmaceutical Co.,
       
    733 F.2d 858
     (Fed. Cir. 1984).
    H.R. REP. NO. 98-857, pt. 2, at 27 (1984). See also Innova-
    tion and Patent Law Reform: Hearing on H.R. 3605 Before
    the Subcomm. on Courts, Civil Liberties and the Admin. of
    Justice of the H. Comm. on the Judiciary, 98th Cong. 742
    (1984) (statement of Laurence H. Tribe, Professor of Law,
    Harvard Law School) (“Section 202, the thrust of which is
    to overturn Roche v. Bolar legislatively”); Innovation and
    Patent Law Reform: Hearing on H.R. 3605 Before the
    Subcomm. on Courts, Civil Liberties and the Admin. of
    Justice of the H. Comm. on the Judiciary, 98th Cong. 826
    (1984) (letter from Bernarr R. Pravel, President, Ameri-
    can Intellectual Property Law Association) (“Section 202
    is intended to reverse the April 23, 1984, decision of the
    Court of Appeals for the Federal Circuit in Roche Prod-
    ucts, Inc. v. Bolar Pharmaceutical Co., 
    733 F.2d 858
     (Fed.
    Cir. 1984).”); Memorandum from Congressional Research
    5                   MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
    Service, The Library of Congress, American Law Division
    to House Judiciary Committee, located at H.R. REP. NO.
    98-857, pt. 2, at 27 n.18 (1984).
         Roche v. Bolar held that the limited pre-approval ex-
    periments to obtain FDA approval still infringed a valid
    patent. See 733 F.2d at 861 (“The district court correctly
    recognized that the issue in this case is narrow: does the
    limited use of a patented drug for testing and investi-
    gation strictly related to FDA drug approval re-
    quirements during the last 6 months of the term of
    the patent constitute a use which, unless licensed, the
    patent statute makes actionable?” (emphasis added)). In
    overturning Roche v. Bolar, § 271(e)(1) allowed pharma-
    ceutical companies to conduct such experiments to obtain
    FDA approval. The new section enabled those companies
    to begin the approval process while the patent is still in
    force, so that they can obtain FDA approval and begin
    selling immediately after the patent’s life. Otherwise, the
    safety testing processes would have to wait until after the
    patent’s life ends thus creating a lag in time when the
    patent would not be in force yet the companies could not
    enter the market pending FDA approval:
            In order to complete this application the
        generic manufacturer must conduct certain drug
        tests. In order to facilitate this type of testing,
        section 202 of the bill creates general exception to
        the rules of patent infringement. Thus, a generic
        manufacturer may obtain a supply of a patented
        drug product during the life of the patent and
        conduct tests using that product if the purpose
        of those tests is to submit an application to
        FDA for approval.
    130 CONG. REC. 23060 (1984) (statement of Rep. Robert
    W. Kastenmeier, Chairman of the Subcommittee on
    MOMENTA PHARMA   v. AMPHASTAR PHARMA                     6
    
    
    Courts, Civil Liberties and the Administration of Justice,
    Committee on the Judiciary) (emphases added).
        The Pharmaceutical Manufacturers Association ech-
    oed the Chairman’s analysis of the purpose of the bill:
       The sponsors and supporters of the legislation
       have agreed from the beginning that generic
       products should not be approved for marketing
       prior to the expiration of a valid patent as ex-
       tended under the legislation. In return, there has
       been a compromise agreement that preapproval
       testing could be conducted prior to the expiration
       of the patent, as extended, so that marketing
       could begin immediately thereafter. Therefore,
       the bill reverses the Roche v. Bolar decision to
       permit a generic company to “use” a patented
       product for the limited purpose of completing
       the testing necessary for FDA approval.
    Innovation and Patent Law Reform: Hearing on H.R. 3605
    Before the Subcomm. on Courts, Civil Liberties and the
    Admin. of Justice of the H. Comm. on the Judiciary, 98th
    Cong. 696 (1984) (letter from Pharmaceutical Manufac-
    turers Association) (emphases added).
        On the other side of the industry, the Generic Phar-
    maceutical Industry Association agreed that section 202
    is only for limited pre-approval experiments:
       The purpose of the foregoing provision is to permit
       a generic drug manufacturer to engage in the
       limited experimental activities which are
       necessary to obtain FDA pre-marketing ap-
       proval before a patent expires so that actual
       competition between the generic drug and the
       original drug can begin immediately after the pat-
       ent covering the original drug expires. Section
    7                   MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
        202 does not authorize any activity which
        would deprive the patent owner of the sale
        of a single tablet during the life of a valid
        patent. In fact, the limited testing activity
        required to obtain FDA approval of a ge-
        neric drug would not normally result in the
        use of even a single generic tablet for its
        therapeutic purpose during the life of a
        valid patent.
    Innovation and Patent Law Reform: Hearing on H.R. 3605
    Before the Subcomm. on Courts, Civil Liberties and the
    Admin. of Justice of the H. Comm. on the Judiciary, 98th
    Cong. 926 (1984) (memorandum of Alfred B. Engleberg,
    Patent Counsel, Generic Pharmaceutical Industry Asso-
    ciation) (emphases added).
        The executive branch favored an even more limited
    exception than the one proposed in section 202 and en-
    acted as § 271(e)(1). Nevertheless, it clearly understood
    the boundaries of section 202 to be pre-approval experi-
    mental use.
        This letter sets forth the Administration’s views
        on H.R. 3605 … First, section 202 of title II should
        be amended to permit experimental use of a drug
        by a non-patentee only during the period in which
        the affected patent is in restoration period. Exist-
        ing patentees have relied upon accepted doctrine
        indicating that use of a patented invention for
        the purpose of obtaining regulatory ap-
        proval infringes that patent. Upsetting expecta-
        tions of this sort could only inhibit future
        innovation and investment, which depend upon
        the integrity of the patent laws.
    Innovation and Patent Law Reform: Hearing on H.R. 3605
    Before the Subcomm. on Courts, Civil Liberties and the
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                       8
    
    
    Admin. of Justice of the H. Comm. on the Judiciary, 98th
    Cong. 812 (1984) (letter from David A. Stockman, Direc-
    tor, Office of Management and Budget, to Rep. Edward R.
    Madigan, Subcomm. on Health and the Environment, H.
    Comm. on Energy and Commerce) (emphasis added).
        The pharmaceutical industry expressed concern about
    permitting trespass on exclusive rights, but this concern
    dissipated with promises that § 271(e)(1) only allowed
    “limited testing of drugs.” See H.R. REP. NO. 98-857, pt. 2,
    at 29 (1984).
       In this case the generic manufacturer is not per-
       mitted to market the patented drug during the life
       of the patent; all that the generic can do is test the
       drug for purposes of submitting data to the
       FDA for approval. Thus, the nature of the in-
       terference is de minimis.
    Id. at 30 (emphases added).
        Specifically, § 271(e)(1) won approval because it was
    limited in time, quantity, and type. First, as to time,
    § 271(e)(1) only applies to pre-marketing approval. 130
    CONG. REC. 23060 (1984) (statement of Rep. Robert W.
    Kastenmeier, Chairman of the Subcommittee on Courts,
    Civil Liberties and the Administration of Justice, Com-
    mittee on the Judiciary) (see block quote above); Innova-
    tion and Patent Law Reform: Hearing on H.R. 3605 Before
    the Subcomm. on Courts, Civil Liberties and the Admin. of
    Justice of the H. Comm. on the Judiciary, 98th Cong. 696
    (1984) (letter from Pharmaceutical Manufacturers Asso-
    ciation) (see block quote above); Innovation and Patent
    Law Reform: Hearing on H.R. 3605 Before the Subcomm.
    on Courts, Civil Liberties and the Admin. of Justice of the
    H. Comm. on the Judiciary, 98th Cong. 742 (1984) (state-
    ment of Laurence H. Tribe, Professor of Law, Harvard
    Law School) (“Section 202, the thrust of which is to over-
    9                    MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
    turn Roche v. Bolar legislatively, so as to provide that it is
    not an infringement to make, use, or sell a patented
    invention for purposes ‘reasonably related’ to the devel-
    opment and submission of information to obtain FDA’s
    premarketing approval to engage in the commercial
    manufacture, use, or sale of the drug after patent expira-
    tion”) (emphasis added); Innovation and Patent Law
    Reform: Hearing on H.R. 3605 Before the Subcomm. on
    Courts, Civil Liberties and the Admin. of Justice of the H.
    Comm. on the Judiciary, 98th Cong. 926 (1984) (memo-
    randum of Alfred B. Engleberg, Patent Counsel, Generic
    Pharmaceutical Industry Association) (see block quote
    above); Memorandum from Congressional Research
    Service, The Library of Congress, American Law Division
    to House Judiciary Committee, located at H.R. REP. NO.
    98-857, pt. 2, at 27 n.18 (1984) (“In § 202, Congress would
    provide that it is not an infringement to make, use, or sell
    a patented invention solely for uses reasonably related to
    the development and submission of information for the
    purpose of obtaining FDA premarketing approval
    of a drug.”).
         Second, as to quantity and type, § 271(e)(1) only ap-
    plies to experimentation — and therefore would have
    limited impact on the patentee’s exclusivity during the
    life of the patent. H.R. REP. NO. 98-857, pt. 1, at 45-46
    (1984) (see block quote above); Innovation and Patent Law
    Reform: Hearing on H.R. 3605 Before the Subcomm. on
    Courts, Civil Liberties and the Admin. of Justice of the H.
    Comm. on the Judiciary, 98th Cong. 696 (1984) (letter
    from Pharmaceutical Manufacturers Association) (see
    block quote above); Innovation and Patent Law Reform:
    Hearing on H.R. 3605 Before the Subcomm. on Courts,
    Civil Liberties and the Admin. of Justice of the H. Comm.
    on the Judiciary, 98th Cong. 742 (1984) (statement of
    Laurence H. Tribe, Professor of Law, Harvard Law
    MOMENTA PHARMA   v. AMPHASTAR PHARMA                    10
    
    
    School) (quoted above); Innovation and Patent Law Re-
    form: Hearing on H.R. 3605 Before the Subcomm. on
    Courts, Civil Liberties and the Admin. of Justice of the H.
    Comm. on the Judiciary, 98th Cong. 926 (1984) (memo-
    randum of Alfred B. Engleberg, Patent Counsel, Generic
    Pharmaceutical Industry Association) (see block quote
    above).
        In particular, the authors made clear that section
    271(e)(1) would not apply to commercial sales, i.e., the
    “infringing” product would not enter the market until
    after the patent’s life. H.R. REP. NO. 98-857, pt. 1, at 45
    (1984) (“This section does not permit the commercial
    sale of a patented drug by the party using the drug to
    develop such information, but it does permit the commer-
    cial sale of research quantities of active ingredients to
    such party.”) (emphasis added); Innovation and Patent
    Law Reform: Hearing on H.R. 3605 Before the Subcomm.
    on Courts, Civil Liberties and the Admin. of Justice of the
    H. Comm. on the Judiciary, 98th Cong. 932 (1984)
    (memorandum of Alfred B. Engleberg, Patent Counsel,
    Generic Pharmaceutical Industry Association) (“The
    limited ‘experimental use’ permitted by Section 202
    does not, in any way, impinge on the exclusive right of the
    patent owner to make, use and sell the patented invention
    for all commercial purposes during the life of the patent.
    The permitted experimental use would not result in
    competitive commercial activity until all valid
    patents expired.”) (emphases added).
        The authors of this section (and I hesitate to add that
    I was present through this legislative process) did not
    imagine that § 271(e)(1) would allow continuous, commer-
    cial infringing sales during any portion of the life of the
    patent. As discussed below, Amphastar has already
    obtained FDA regulatory approval, and today this court
    rewrites the law to allow Amphastar to infringe Mo-
    11                  MOMENTA PHARMA     v. AMPHASTAR PHARMA
    
    
    menta’s patent throughout the entire life of Momenta’s
    patent and for the purpose of obtaining profits on commer-
    cial sales of a product that competes with the patentee.
        Nowhere in the legislative history can this court find
    any suggestion that § 271(e)(1) would apply other than in
    the limited scenario of conducting de minimis experi-
    ments pre-approval (i.e., to obtain FDA approval). No-
    where in the legislative history can this court find a hint
    that an “infringer” could continue to use its competitor's
    patented method in manufacture of each commercial
    batch for contemporaneous sale. Nowhere in the legisla-
    tive history can this court find any mention of the post-
    approval, continuous, commercial sales allowed by this
    decision. Nowhere in the legislative history can this court
    find any suggestion that the mere maintenance or reten-
    tion of information as part of a company’s records is
    considered a submission that would trigger § 271(e)(1). In
    fact, this court makes no attempt to examine the legisla-
    tive history of this section at all — a very telling silence.
        Of course, this court proclaims that it finds no ambi-
    guity requiring it to find out the purpose of the section it
    distorts. To the contrary, the Supreme Court found the
    statute can be ambiguous and “not plainly comprehensi-
    ble.” See Eli Lilly, 496 U.S. at 669. Moreover the court
    strains to avoid ambiguity by discounting critical statu-
    tory phrases, namely “solely” and “submission.”
        To facilitate a post-approval, continuous, commercial
    use, the court discounts the word “solely.” Indeed,
    throughout its opinion, the court cites the language of the
    statute yet omits the word “solely.” See Majority Op. 13,
    14, 15, 16, 20, 21. If one properly reads “solely” as the
    statute says, the result must be that Amphastar’s activity
    is not within the statute. Its infringing activity is not
    solely for developing and submitting information to the
    MOMENTA PHARMA   v. AMPHASTAR PHARMA                    12
    
    
    FDA. Instead, Amphastar uses this method for the pur-
    pose of manufacturing a product to sell on the market in
    commerce.
        Second, the court claims that the mere retention of re-
    cords can satisfy the “submission” requirement in
    § 271(e)(1). By essentially stating that “submission” can
    mean not really submitting, this new interpretation reads
    this requirement out of the statute as well.
         Specifically, despite the plain meaning of “submission
    of information” to mean the company actually submitting
    information to the FDA, the court interprets “submission
    of information” to mean the mere retention of information
    as part of a company’s records. Majority Op. 16 (“We
    think that the requirement to maintain records for FDA
    inspection satisfies the requirement that the uses be
    reasonably related to the development and submission of
    information to the FDA. Thus, we consider this informa-
    tion ‘submitted’ for purposes of the statute.” (emphasis
    added)), 19. Maintaining or keeping a document has the
    exact opposite meaning of submitting a document. In
    other words, “submission” means not really submitting
    anything — a strange construction of an “unambiguous”
    term.
        This new interpretation would allow almost all activ-
    ity by pharmaceutical companies to constitute “submis-
    sion” and therefore justify a free license to trespass. The
    FDA can inspect records of any drug manufacturer and
    seller. See 21 U.S.C. § 374. Thus, the drug manufacturer
    need only make a record, which could potentially be
    inspected by the FDA, and then any activity could satisfy
    this new meaning of “submission.”
        Therefore, a reading of all the words in the statute
    and a reading of those words in light of their legislative
    history shows that § 271(e)(1) only permits a limited
    13                   MOMENTA PHARMA   v. AMPHASTAR PHARMA
    
    
    amount of pre-approval experiments to obtain FDA ap-
    proval. Thus, the statute limits the exception to “solely
    for uses reasonably related to the development and sub-
    mission of information under a Federal law which regu-
    lates the manufacture, use, or sale of drugs or veterinary
    biological products.”
                                II.
        This court has already decided the meaning of this
    statute in Classen. The Classen majority held Ҥ 271(e)(1)
    provides an exception to the law of infringement in order
    to expedite development of information for regula-
    tory approval of generic counterparts of patented prod-
    ucts. The statute does not apply to information that may
    be routinely reported to the FDA, long after marketing
    approval has been obtained.” 659 F.3d at 1070 (emphasis
    added). As support, Classen looked to the legislative
    history: “The Report is replete with statements that the
    legislation concerns premarketing approval of generic
    drugs. The Report emphasizes that ‘The information
    which can be developed under this provision is the type
    which is required to obtain approval of the drug.’” Id.
    at 1071 (emphases added).
        Classen also looked to Supreme Court precedent, such
    as Eli Lilly & Co. v. Medtronic, Inc., 
    496 U.S. 1047
     (1990)
    and Merck KGaA v. Integra Lifesciences I, Ltd., 
    545 U.S. 193
     (2005): “Every decision examining the statute has
    appreciated that § 271(e)(1) is directed to premarketing
    approval of generic counterparts before patent expira-
    tion.” Id. at 1071 (emphasis added). In particular, Clas-
    sen stated:
         Our colleague in dissent strays from statute and
         precedent, in arguing that any activity by any en-
         tity concerning any adversely patented product or
         method is exempted from infringement by
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                     14
    
    
       § 271(e)(1), provided only that the information ob-
       tained is ‘reasonably related to submitting any in-
       formation under the FDCA,’ [659 F.3d at 1083
       (Moore, J., dissenting)] (emphasis in dissent), ‘in-
       cluding information regarding post-approval
       uses.’ Id. Such a massive enlargement of the
       statutory exemption is incorrect.
    Id. at 1072 n.4 (bold emphasis added).
        Here, Amphastar uses Momenta’s patented method in
    the manufacture of each commercial batch it sells. By
    definition, its use is not to obtain FDA approval. One can
    only market a drug that the FDA has already approved.
    Amphastar is not using Momenta’s patented method for
    pre-approval, limited experimental use. It is not pre-
    approval because Amphastar has already obtained ap-
    proval. See Appellant Br. 7 (Amphastar received FDA
    approval on September 19, 2011.); Majority Op. 21 (“It
    also avoids the situation here, where a drug has received
    approval …”). Thus, its activity is post-approval. It is not
    limited because Amphastar uses Momenta’s invention on
    a continuous basis in the manufacture of each commercial
    batch and during the life of Momenta’s patent. It is not
    experimental because Amphastar uses Momenta’s inven-
    tion in manufacturing each commercial batch of its prod-
    uct for contemporaneous sale on the market (in
    commerce) to obtain profits and to compete with Mo-
    menta. This is a commercial use of an invention by a
    competitor to compete and trespass on the inventor’s
    exclusive right. Amphastar’s use is not for premarketing
    FDA approval and therefore Classen definitively holds
    that § 271(e)(1) does not apply here.
        To come out the exact opposite way, the court first
    claims Classen did not turn on the pre-/post-approval
    distinction. Majority Op. 19. Second, the court claims
    15                  MOMENTA PHARMA     v. AMPHASTAR PHARMA
    
    
    Classen merely held that § 271(e)(1) does not apply to
    “routine” submissions. Therefore, this court opines: “This
    case, however, fits well within Classen because the infor-
    mation submitted is necessary both to the continued
    approval of the ANDA and to the ability to market the
    generic drug. Here, the submissions are not ‘routine
    submissions’ to the FDA, but instead are submissions that
    are required to maintain FDA approval.” Majority Op. 18.
         At the outset, this court must stretch too far to claim
    Classen did not turn on a pre-/post-approval distinction.
    The dissent actually helps identify the holding in Classen.
    The Classen dissent stated: “The majority concludes that
    the district court incorrectly interpreted the safe harbor of
    § 271(e)(1) because, according to the majority, § 271(e)(1)
    is limited to pre-approval activities. … Accordingly, I
    conclude that the safe harbor extends to all uses that are
    reasonably related to submitting any information under
    the FDCA, including information regarding post-
    approval uses. …” 659 F.3d at 1083 (emphases added).
         Further, the parties and the amici certainly thought
    Classen turned on a pre-/post-approval distinction. See,
    e.g., Classen’s Opposition to Petition for Rehearing En
    Banc, at *1 (“Plaintiff-Appellant agrees with Hatch-
    Waxman, The United States Supreme Court and the
    Federal Circuit: 35 USC §271(e)(1) applies only to pre-
    market development activities, there is no safe harbor
    after the commencement of commercial sales of a drug. An
    extension of 271(e)(1) into the post-approval/post-
    commercialization period is outside the scope of the
    Drug Price Competition and Patent Term Restoration Act
    and would present unworkable difficulties in its applica-
    tion.”) (emphases added).
        Moreover, this court in Classen did not at any point
    state that § 271(e)(1) applies to information “necessary
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                    16
    
    
    both to the continued approval of the ANDA and to the
    ability to market the generic drug.” Majority Op. 18.
    Indeed, this post-approval, continuous, commercial use is
    the exact opposite of the Classen rule. Classen rested its
    holding on “premarketing approval,” 659 F.3d at 1070,
    1071, “limited amount of testing,” id. at 1071, and “ex-
    perimentation,” id.
        This decision (“post-approval studies”; “after ap-
    proval”; “not restricted to pre-approval activities”) cannot
    be genuinely reconciled with Classen (“pre-marketing
    approval”). Instead, the court in this decision uses the
    same language as the dissent in Classen (“post-approval”;
    “I conclude that the safe harbor extends to all uses that
    are reasonably related to submitting any information
    under the FDCA, including information regarding post-
    approval uses”). This decision should instead request the
    entire court to resolve the issue en banc.
         The court distinguishes Classen by characterizing the
    activities in that case as not “mandated by the FDA,”
    while the activities here are. Some context is in order.
    The patented method here is “mandated” only in that
    Momenta thus far has created and developed the only
    successful method by which one can show the FDA’s
    requirement has been met. Amphastar is free to invent
    its own method to satisfy these requirements. Instead it
    chooses to trespass. Because it has not ventured to find
    another way to perform these tests, it is unfair to suggest
    that Amphastar’s hands are tied. Indeed, to the extent
    the court is creating a new expansion of the statute that
    covers anything “mandated” by the FDA, this would
    unfairly attack inventors of the newest and most success-
    ful method. Such a method would be adopted or “man-
    dated” by the FDA and then trigger the court’s new
    infringement exception. Needless to say, that would be
    17                  MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
    the exact opposite from a system that incentivizes crea-
    tion and improvement.
                                III.
         This court’s interpretation of § 271(e)(1) would essen-
    tially render manufacturing method patents worthless.
    This court repeatedly states that the FDA’s adoption of
    Momenta’s patented method as a standard means that
    § 271(e)(1) should apply. Majority Op. 19 (“the informa-
    tion here is not generated voluntarily by the manufac-
    turer but is generated by FDA requirements the
    manufacturer is obligated under penalty of law to follow”),
    21 (“that act of infringement is, in effect, required by the
    federal government as part of the continuing safety and
    efficacy monitoring of an approved drug”), id. (“where a
    drug has received approval, but is nevertheless kept from
    the market based on an FDA mandated testing require-
    ment”), 20 (“the fact that Amphastar’s testing is carried
    out to ‘satisfy the FDA’s requirements’ means it falls
    within the scope of the safe harbor, even though the
    activity is carried out after approval”), 22 (“Amphastar’s
    allegedly infringing activities are clearly carried out
    according to the dictates of the Federal Food, Drug, and
    Cosmetic Act”).
        In essence, this reasoning repeals the incentives and
    protections of the patent act in this area. A patentee
    invents the first and (at the time) best method. Because
    of the success and utility of the inventive method, the
    FDA adopts that method as a standard. Because that
    method is “required by the FDA,” this court would permit
    copiers to infringe. What incentive remains to invest in
    inventing a better test? Imagine a teacher who rewards
    the top student by allowing her peers to copy her exam
    answers. Needless to say, this approach does violence to
    patent law and future research incentives in this field.
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                    18
    
    
        And what happens if a second, less effective (pat-
    ented) method appears? Will copiers be allowed to in-
    fringe that method, too? Or, instead, because it is not as
    good and the FDA does not adopt it as the standard, then
    the court’s new interpretation of § 271(e)(1) does not apply
    and copiers can infringe the first, best method but not the
    second, less effective method?
                                IV.
        The Supreme Court cases Eli Lilly & Co. v. Medtronic,
    Inc., 
    496 U.S. 1047
     (1990) and Merck KGaA v. Integra
    Lifesciences I, Ltd., 
    545 U.S. 193
     (2005) support the
    holding in Classen and do not support this decision. Both
    holdings in Eli Lilly and Merck dealt with pre-approval
    activity and submissions, meaning before obtaining FDA
    approval. Further, neither even suggested that the mere
    maintenance or retention of information as part of a
    company’s records could be a “submission” to the FDA.
    Nevertheless, the court takes phrases from those opinions
    out of context to allege that its new interpretation of
    § 271(e)(1) is consistent with those cases.
        In Eli Lilly, the Supreme Court addressed whether
    § 271(e)(1) applies to medical devices in addition to drugs.
    496 U.S. at 663-64 (“This case presents the question
    whether 35 U.S.C. § 271(e)(1) renders activities that
    would otherwise constitute patent infringement nonin-
    fringing if they are undertaken for the purpose of develop-
    ing and submitting to the Food and Drug Administration
    (FDA) information necessary to obtain marketing ap-
    proval for a medical device under § 515 of the Federal
    Food, Drug, and Cosmetic Act (FDCA), 90 Stat. 552, 21
    U.S.C. § 360e.”).
        The Supreme Court described how §§ 201 and 202
    should be read together. Section 201 concerns activity in
    the early years of a patent’s life. Section 202 concerns the
    19                   MOMENTA PHARMA     v. AMPHASTAR PHARMA
    
    
    latter years. Each section is a reciprocal counter to the
    other. Importantly, Congress intended the sections to
    deal with “premarket regulatory approval”:
         The parties agree that the 1984 Act was designed
         to respond to two unintended distortions of the 17-
         year patent term produced by the requirement
         that certain products must receive premarket
         regulatory approval. First, the holder of a pat-
         ent relating to such products would as a practical
         matter not be able to reap any financial rewards
         during the early years of the term. … Thus, if the
         discovery relates to a product that cannot be mar-
         keted without substantial testing and regulatory
         approval, the “clock” on his patent term will be
         running even though he is not yet able to derive
         any profit from the invention. The second distor-
         tion occurred at the other end of the patent term.
         In 1984, the Court of Appeals for the Federal Cir-
         cuit decided that the manufacture, use, or sale of
         a patented invention during the term of the pat-
         ent constituted an act of infringement, see
         § 271(a), even if it was for the sole purpose of con-
         ducting tests and developing information neces-
         sary to apply for regulatory approval. See
         Roche Products, Inc. v. Bolar Pharmaceutical Co.,
         
    733 F.2d 858
     (Fed. Cir. 1984). Since that activity
         could not be commenced by those who planned to
         compete with the patentee until expiration of the
         entire patent term, the patentee’s de facto monop-
         oly would continue for an often substantial period
         until regulatory approval was obtained. In other
         words, the combined effect of the patent law and
         the premarket regulatory approval require-
         ment was to create an effective extension of the
         patent term.
    MOMENTA PHARMA   v. AMPHASTAR PHARMA                      20
    
    
    496 U.S. at 669-670 (emphases added). Therefore:
       The 1984 Act sought to eliminate this distortion
       from both ends of the patent period. Section 201
       of the Act established a patent-term extension for
       patents relating to certain products that were sub-
       ject to lengthy regulatory delays and could not be
       marketed prior to regulatory approval. … Section
       201 provides that patents relating to these prod-
       ucts can be extended up to five years … The dis-
       tortion at the other end of the patent period was
       addressed by § 202 of the Act. … This allows
       competitors, prior to the expiration of a patent, to
       engage in otherwise infringing activities neces-
       sary to obtain regulatory approval.”
    Id. at 670-71 (emphasis added).
        The 1984 Act enacted the two sections to create a bal-
    ance. The Supreme Court rejected the party’s attempt to
    create a “disequilibrium” between the two sections. Id. at
    672.
         This court’s new interpretation in this case would ap-
    ply the disadvantage of § 202 to a patentee who would not
    be able to obtain the benefits of § 201. The patentee of a
    manufacturing patent does not obtain the patent exten-
    sion created in § 201, yet this court’s new expansion of
    § 202 would allow its competitors to infringe during the
    life of its patent. The Supreme Court rejected this sort of
    disequilibrium. See Proveris Scientific Corp. v. Innovasys-
    tems, Inc., 
    536 F.3d 1256
     (Fed. Cir. 2008) (relying on
    Merck to hold that § 271(e)(1) does not apply to infringe-
    ment of patented product not eligible to obtain patent
    extension).
        This court’s new interpretation does not reserve § 202
    for the “end of the patent term.” Instead, its interpreta-
    21                  MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
    tion allows infringing activity continuously throughout
    the life of the patent, including the “early years” reserved
    for § 201. If, as the court claims, § 202 was meant to
    cover the continuous, commercial use throughout the life
    of the patent, there would be no balance between § 201
    and § 202. This decision improperly cuts short the life of
    Momenta’s patent.
        And, as already discussed, this new interpretation ex-
    pands beyond “premarket regulatory approval.” See 496
    U.S. at 669-670. Its interpretation allows infringing
    activity after the product has already been approved for
    sale on the market.
        Surprisingly, the court claims that its “analysis is not
    groundbreaking: the Supreme Court came to essentially
    the same conclusion in 1990” and cites Eli Lilly. Majority
    Op. 14. It has been quoted that “Words are easy, like the
    wind.” Saying that something “is not groundbreaking”
    does not make it so.
         Nowhere in Eli Lilly does the Supreme Court come to
    “essentially the same conclusion” as the majority here.
    The Supreme Court does not say that the mere mainte-
    nance or retention of records — with no intention to
    submit to the FDA but that only could potentially be
    viewed by the FDA if the FDA requested it — would
    satisfy as a “submission” to the FDA. The Supreme Court
    does not sanction post-approval activity. The Supreme
    Court does not read the word “solely” out from the stat-
    ute.
        It is more telling what the court’s reasoning omits
    than what it cites. The court only relies on a single
    sentence from Eli Lilly, which it quotes out of context.
    496 U.S. at 666 (“But the phrase ‘a Federal law which
    regulates the manufacture, use, or sale of drugs’ more
    naturally summons up the image of an entire statutory
    MOMENTA PHARMA   v. AMPHASTAR PHARMA                    22
    
    
    scheme of regulation.”). The Supreme Court was not even
    referencing the same phrase that is at issue here: “a
    Federal law,” not “submission.” In fact, that sentence is
    not even in the section in the Supreme Court’s opinion
    that discusses the basis on which the Court decided the
    case. Instead, that sentence is in a prior section discuss-
    ing the text of the statute, which the Supreme Court
    found “somewhat more naturally reads as the Court of
    Appeals determined, but that is not plainly comprehensi-
    ble on anyone’s view.” Id.
         The sentence cited by this court is not even a defini-
    tive holding of the Supreme Court but instead a discus-
    sion of the parties’ arguments.         In looking at the
    paragraphs following the one cited by this decision, the
    Supreme Court states the case for the opposing side: “On
    the other side of the ledger, however, one must admit that
    while the provision more naturally means what respon-
    dent suggests, it is somewhat difficult to understand why
    anyone would want it to mean that. Why should the
    touchstone of noninfringement be whether the use is
    related to the development and submission of information
    under a provision that happens to be included within an
    Act that, in any of its provisions, not necessarily the one
    at issue, regulates drugs?” Id. at 668. On other occasions,
    the Federal Circuit advises against this type of slanted
    wordsmithing.
        In Merck, the Supreme Court addressed whether
    § 271(e)(1) applies to research intended for submission for
    FDA approval but ultimately not submitted to the FDA.
    545 U.S. at 195 (“This case presents the question whether
    uses of patented inventions in preclinical research, the
    results of which are not ultimately included in a submis-
    sion to the Food and Drug Administration (FDA), are
    exempted from infringement by 35 U.S.C. § 271(e)(1).”).
    In other words, the case presented an instance of limited
    23                   MOMENTA PHARMA     v. AMPHASTAR PHARMA
    
    
    experiments performed in the pre-approval stage of drug
    development.
        Nowhere does Merck suggest that post-approval,
    commercial, continuous infringing use would be permit-
    ted. Indeed, Merck clearly lays out that § 271(e)(1) is
    intended for pre-approval, experimental, limited use.
         Basic scientific research on a particular com-
         pound, performed without the intent to develop a
         particular drug or a reasonable belief that the
         compound will cause the sort of physiological ef-
         fect the researcher intends to induce, is surely not
         ‘reasonably related to the development and sub-
         mission of information’ to the FDA. It does not fol-
         low from this, however, that § 271(e)(1)’s
         exemption from infringement categorically ex-
         cludes either (1) experimentation on drugs that
         are not ultimately the subject of an FDA submis-
         sion or (2) use of patented compounds in experi-
         ments that are not ultimately submitted to the
         FDA. Under certain conditions, we think the ex-
         emption is sufficiently broad to protect the use of
         patented compounds in both situations.” [205-06
         (emphasis added)] “Moreover, many of the uncer-
         tainties that exist with respect to the selection
         of a specific drug exist as well with respect to
         the decision of what research to include in an
         IND or NDA. As a District Court has observed,
         ‘[I]t will not always be clear to parties setting out
         to seek FDA approval for their new product ex-
         actly which kinds of information, and in what
         quantities, it will take to win that agency’s ap-
         proval.’ Intermedics, Inc. v. Ventritex, Inc., 
    775 F. Supp. 1269
    , 1280 (N.D.Cal. 1991), aff’d, 
    991 F.2d 808
     (Fed. Cir. 1993). This is especially true
         at the preclinical stage of drug approval.”
    MOMENTA PHARMA   v. AMPHASTAR PHARMA                     24
    
    
    545 U.S. at 207 (emphases added).
         This court relies on some text from Merck that ap-
    pears superficially to suggest an expansive interpretation
    of § 271(e)(1). But, read in context, that language has
    another meaning entirely. This language appears to
    suggest that § 271(e)(1) covers any sort of information or
    submission. But, this language actually appears in the
    context of the issue in Merck of whether information
    intended for submission to the FDA for approval should be
    covered when the information was ultimately not submit-
    ted because the drug candidate in that case lacked poten-
    tial. This context is apparent in the sentences next to the
    sentence quoted by the majority, which state:
       We decline to read the “reasonable relation” re-
       quirement so narrowly as to render § 271(e)(1)’s
       stated protection of activities leading to
       FDA approval for all drugs illusory. Properly
       construed, § 271(e)(1) leaves adequate space
       for experimentation and failure on the road
       to regulatory approval: At least where a drug-
       maker has a reasonable basis for believing that a
       patented compound may work, through a particu-
       lar biological process, to produce a particular
       physiological effect, and uses the compound in re-
       search that, if successful, would be appropriate to
       include in a submission to the FDA, that use is
       “reasonably related” to the “development and
       submission of information under ... Federal law.”
       § 271(e)(1).
    Id. at 207 (emphases added).
        Merck does not reduce the importance of the limita-
    tion that § 271(e)(1) is reserved “solely for uses reasona-
    bly related to the development and submission of
    information.” Holding that preclinical research reasona-
    25                  MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
    bly expected to generate information for regulatory ap-
    proval does not fall outside § 271(e)(1) simply because the
    research fails and does not result in a regulatory applica-
    tion, id. at 206-07, is a far cry from permitting infringe-
    ment during manufacture of a commercial product merely
    because the infringing act also generates information that
    might someday be submitted to the FDA, long after
    marketing approval is granted. Here, Amphastar’s use of
    the patented method is primarily for production of a
    commercial product; it is not “solely for uses reasonably
    related to” development of information.
         As another point, this court claims that “the Court
    explicitly rejected the notion that § 271(e)(1) was limited
    ‘to the activities necessary to seek approval of a generic
    drug.’” Majority Op. 16. But, it is important to under-
    stand what Merck was trying to distinguish. Read in
    context, that phrase is referring to allowing § 271(e)(1) to
    include pre-approval activities for a branded drug. It was
    not stating that § 271(e)(1) included post-approval activi-
    ties for a generic drug. In other words, the Supreme
    Court was emphasizing the words “generic drug,” not the
    words “necessary to seek approval.” Imagine ordering a
    computer and stating that “I do not want it delivered to
    my house on Wednesday.” Then, the post office delivered
    it to your neighbor’s house on Thursday. Obviously, you
    meant to emphasize “Wednesday,” not “my house.” Simi-
    larly, this court must read the Supreme Court’s cases as a
    whole and in context.
        Just because Merck held that § 271(e)(1) could cover
    pre-approval activities for not only the ANDA but also the
    NDA and IND, does not mean that the mere retention of
    documents as part of a company’s records could be consid-
    ered a “submission” to the FDA. In other words, if a
    house owner allows a hired painter to paint his house any
    MOMENTA PHARMA    v. AMPHASTAR PHARMA                    26
    
    
    and all shades of brown, that is not permission to choose
    neon orange or turquoise.
        Thus, while Merck said that as long as an activity was
    intended for submission to obtain approval, then
    § 271(e)(1) applies even if the information is not actually
    submitted (because it is difficult to predict which drug
    candidates ultimately will be successful), it did not say
    that § 271(e)(1) applies even if the activity was never
    intended to obtain approval at all. Or if the information
    was not even intended for submission to the FDA. This
    court’s interpretation (that the mere retention of informa-
    tion as part of a company’s records can be a “submission”
    to the FDA) is indeed “groundbreaking” and the Supreme
    Court did not “come to essentially the same conclusion.”
                                V.
        The safe harbor provision at issue in this case, due to
    its origin and purpose in reversing Roche v. Bolar, re-
    ceives attention as an exception that permits experimen-
    tation. This link to experimentation and its role in
    advancing the progress of technology requires some
    commentary as well. Too often patent law is misunder-
    stood as impeding more than promoting innovation. This
    academic proposition, called the tragedy of the Anti-
    commons in some scholarly presentations, suggests that
    exclusive rights impede the flow of information and limit
    experimentation that might lead to the next generation of
    technological advance. Michael A. Heller & Rebecca S.
    Eisenberg, Can Patents Deter Innovation? The Anticom-
    mons in Biomedical Research, 280 SCIENCE 698 (1998).
        In the first place, in an era of empirical research, one
    might ask the reason that this academic notion has never
    actually been verified. Although studied, no research has
    substantiated this alleged attack on the patent system.
    In fact, “the effects predicted by the anti-commons hy-
    27                   MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
    pothesis are not borne out in the available data.” Timothy
    Caulfield, Human Gene Patents: Proof of Problems?, 84
    Chi.-Kent L. Rev. 133, 137 (2009); see also American
    Association     for    the    Advancement     of   Science,
    INTERNATIONAL INTELLECTUAL PROPERTY EXPERIENCES: A
    REPORT OF FOUR COUNTRIES 12 (2007) (finding the results
    of a 2006 survey of U.S. and Japanese researchers “offer
    very little evidence of an ‘anticommons problem’” and that
    “IP-protected technologies remain relatively accessible to
    the broad scientific community”). Surveys of academic
    researchers have revealed that “only 1 percent . . . report
    having to delay a project, and none abandoned a project
    due to others’ patents.” Wesley M. Cohen & John P.
    Walsh, Real Impediments to Academic Biomedical Re-
    search, in 8 INNOVATION POLICY AND THE ECONOMY 1, 10-
    11 (Adam B. Jaffe, Josh Lerner, & Scott Stern eds. 2008),
    available                                                at
    http://www.nber.org/~marschke/mice/Papers/cohenwalsh.
    pdf (citing John P. Walsh et al., The View from the Bench:
    Patents, Material Transfers and Biomedical Research,
    309 SCIENCE 2002 (2005)). In other words, patents on
    research tools and biomedical innovations do not signifi-
    cantly slow the pace of research and do not deter re-
    searchers from pursuing promising projects.
        The reason that patents have not been proven to im-
    pede more than stimulate technological advance is simple:
    it does not happen. It does not happen for several rea-
    sons. First, experiments advancing technology rarely, if
    ever, generate commercial value. Thus patent owners
    have little, if any, incentive to license or inhibit research.
    Stated otherwise, even if a patent owner wanted to sue or
    license potential researchers, experiments do not produce
    income or a source of damages. See id. at 12.
        Second, in the modern age of technology, the charac-
    ter of technological advance has changed. The era when
    MOMENTA PHARMA   v. AMPHASTAR PHARMA                    28
    
    
    the Bell Labs or some other tech center could hire the
    most promising engineers and essentially invent every-
    thing for the world has passed. With the vast specializa-
    tion of all fields of research, advances in technology
    require great cooperation. A new product or a new direc-
    tion in biotechnology or electronics will be produced by
    cooperation between a professor in Chengdu, China, a
    young programmer in Bangaluru, India, an engineer at a
    large corporation in Munich, Germany, a graduate stu-
    dent at Tokyo University, and a team at a small start-up
    company in Silicon Valley. The patent system can help
    inform each of them of the other and bring together their
    incremental advances to achieve the next generation of
    progress in some tiny corner of human progress.
         Thus, patents properly remain a tool for research and
    experimentation because the system encourages publica-
    tion and sharing of research results. Disclosure of how to
    make and use the invention is the “quid pro quo” of the
    patent grant. See JEM Ag Supply, Inc. v. Pioneer Hi-Bred
    Int’l, Inc., 
    534 U.S. 124
    , 142 (2001). In exchange for
    disclosure, the inventor receives a limited term of exclu-
    sivity to benefit from commercialization of his invention.
    Without this promise of exclusivity, researchers at corpo-
    rations would be forced to turn to secrecy as the best
    protection for their inventions. Even academic research-
    ers may delay publication of results in order to maintain
    an edge over the competition, Cohen & Walsh, supra at
    14, and the race to the patent office helps counteract this
    tendency toward secrecy by rewarding earlier disclosure.
    “The information in patents is added to the store of
    knowledge with the publication/issuance of the pat-
    ent. . . . [It] is not insulated from analysis, study, and
    experimentation for the twenty years until patent expira-
    tion.” Classen, 659 F.3d at 1072. Rather, information
    shared through patent applications is immediately avail-
    29                  MOMENTA PHARMA    v. AMPHASTAR PHARMA
    
    
    able for others to build upon. It speeds the progress of
    scientific endeavor. In other words, the patent system’s
    modern benefits facilitate experimentation far more than
    any hypothetical inhibition.
                                VI.
        Every day, Amphastar, a competitor of Momenta, is
    infringing Momenta’s patent. This decision allows that
    trespass. Moreover, to reach that result, this court must
    ignore its own prior decision in Classen and the purpose of
    the statute explained in the legislative history. Sadly this
    decision abrogates Momenta’s hard-achieved property
    right and reallocates that entitlement to its competitors –
    a sad day for property owners and an undeserved victory
    for those who decline to invest in the expense and diffi-
    culty of discovery and invention.