NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
PHIGENIX, INC.,
Plaintiff-Appellant
v.
GENENTECH, INC.,
Defendant-Cross-Appellant
______________________
2017-2617, 2018-1042
______________________
Appeals from the United States District Court for the
Northern District of California in No. 5:15-cv-01238-BLF,
Judge Beth Labson Freeman.
______________________
Decided: September 5, 2019
______________________
BENJAMIN THOMPSON, Fish & Richardson, P.C., At-
lanta, GA, argued for plaintiff-appellant. Also represented
by AHMED JAMAL DAVIS, Washington, DC; MATTHEW C.
BERNTSEN, Boston, MA; ALANA CANFIELD MANNIGE, Red-
wood City, CA; SARAH CORK, Proskauer Rose, Los Angeles,
CA.
DEANNE MAYNARD, Morrison & Foerster LLP, Wash-
ington, DC, argued for defendant-cross-appellant. Also
represented by SETH W. LLOYD, BRIAN ROBERT MATSUI;
2 PHIGENIX, INC. v. GENENTECH, INC.
MATTHEW A. CHIVVIS, MICHAEL ALLEN JACOBS, MATTHEW
IAN KREEGER, San Francisco, CA.
______________________
Before REYNA, BRYSON, and STOLL, Circuit Judges.
STOLL, Circuit Judge.
Phigenix, Inc. sued Genentech, Inc. for induced in-
fringement of various claims of
U.S. Patent No. 8,080,534.
After striking the infringement opinion of Phigenix’s ex-
pert, the district court granted summary judgment of non-
infringement based on a lack of evidence of both direct
infringement and intent to induce infringement. The dis-
trict court also denied summary judgment of invalidity
based on various utility, enablement, and written descrip-
tion challenges advanced by Genentech.
Phigenix appeals the order striking its expert report
and the grant of summary judgment of noninfringement.
Genentech conditionally cross-appeals the denial of sum-
mary judgment of invalidity. Because the district court did
not abuse its discretion, we affirm its order striking the in-
fringement opinion of Phigenix’s expert. We further affirm
the district court’s grant of summary judgment of nonin-
fringement based on a lack of evidence of direct infringe-
ment. Because we affirm the district court’s judgment of
noninfringement, we do not address Genentech’s condi-
tional cross-appeal.
BACKGROUND
I
The ’534 patent is titled “Targeting PAX2 for the Treat-
ment of Breast Cancer.” It is a continuation-in-part of a
prior application that issued as
U.S. Patent No. 7,964,577,
and it claims priority to a provisional application filed on
October 14, 2005. The specification of the ’534 patent de-
scribes preventing or treating breast conditions (including
breast cancer) by administering a composition that inhibits
PHIGENIX, INC. v. GENENTECH, INC. 3
and/or enhances the expression of certain genes (PAX2 and
DEFB1, respectively). See, e.g., ’534 patent col. 1 l. 51–
col. 2 l. 39, col. 6 l. 22–col. 8 l. 37. 1 Claim 1 recites “[a]
method for treating a breast condition” by administering a
composition that inhibits PAX2 expression or activity,
and/or expresses DEFB1.
Id. at col. 109 ll. 2–6.
II
In January 2014, Phigenix sued Genentech for in-
fringement of the ’534 patent based on Genentech’s product
Kadcyla, a pharmaceutical indicated for treating drug-re-
sistant breast cancer. In its complaint, Phigenix alleged
that Genentech induced infringement of the ’534 patent by
encouraging health care professionals to prescribe and ad-
minister Kadcyla to breast cancer patients who had previ-
ously received the chemotherapy drugs “trastuzumab and
a taxane, separately or in combination.” J.A. 531–32. Phi-
genix’s infringement contentions, last supplemented in Oc-
tober 2014, similarly identified the relevant population as
Kadcyla patients who had “previously received
trastuzumab and a taxane.” J.A. 1168–74.
In February 2017, the district court issued a summary
judgment order holding that the asserted claims of the
’534 patent are not entitled to the priority date of the 2005
provisional application. Phigenix did not move to amend
its infringement contentions in response. Several months
later—after fact discovery had closed and expert reports
had been exchanged—Phigenix narrowed the relevant pop-
ulation to Kadcyla patients who were pretreated exclu-
sively with trastuzumab and a taxane—i.e., trastuzumab,
a taxane, and “and nothing else.” J.A. 317–19. Phigenix
did not do so by affirmatively moving for leave to amend its
infringement contentions. Instead, Phigenix first revealed
1 We take no position on the content or adequacy of
the disclosure of the ’534 patent.
4 PHIGENIX, INC. v. GENENTECH, INC.
its narrowed definition during the deposition of its expert
on May 23, 2017, and only in response to questioning by
Genentech. Phigenix does not dispute that the narrowed
population of relevant patients comprises only about 4% of
the total population of Kadcyla patients. Oral Arg. at 2:23–
3:01, http://oralarguments.cafc.uscourts.gov/de-
fault.aspx?fl=2017-2617.mp3. Yet at no point did Phigenix
move to amend its infringement contentions to reflect this
narrower population.
After learning about the narrowed patient population,
Genentech moved to strike the infringement opinion of Phi-
genix’s expert. Agreeing that Phigenix had failed to pro-
vide adequate notice of its narrowed infringement theory,
the district court struck Phigenix’s expert infringement
opinion and granted summary judgment of noninfringe-
ment based on the resulting lack of direct infringement ev-
idence. The district court specifically noted that if its
determination regarding the 2005 priority date was the im-
petus for Phigenix’s narrowed infringement theory, then
“Phigenix could have moved soon thereafter to amend its
infringement contentions and to notify Genentech of this
change in position.” J.A. 16. Phigenix’s failure to do so
“deprived Genentech [of] a timely disclosure of this new
theory, as well as any potential accommodation in the case
schedule the Court would entertain.”
Id.
The district court also granted summary judgment of
noninfringement based on a lack of evidence of specific in-
tent to induce infringement under Phigenix’s narrowed
theory. The district court further denied summary judg-
ment of invalidity based on various utility, enablement,
and written description challenges advanced by Genen-
tech. Phigenix timely appealed the grant of summary judg-
ment of noninfringement, and Genentech conditionally
cross-appealed the denial of summary judgment of invalid-
ity. We have jurisdiction under
28 U.S.C. § 1295(a)(1).
PHIGENIX, INC. v. GENENTECH, INC. 5
DISCUSSION
I
Like many district courts, the U.S. District Court for
the Northern District of California has established local
rules of practice specifically for patent cases. See N.D. Cal.
Patent L.R. 1-1, 1-2. We review the validity and interpre-
tation of these patent local rules under Federal Circuit law,
applying an abuse of discretion standard. See O2 Micro
Int’l Ltd. v. Monolithic Power Sys., Inc.,
467 F.3d 1355,
1364, 1366–67 (Fed. Cir. 2006). This court grants “broad
deference” to district courts in the enforcement of their pa-
tent local rules. SanDisk Corp. v. Memorex Prods., Inc.,
415 F.3d 1278, 1292 (Fed. Cir. 2005) (citing Genentech, Inc.
v. Amgen, Inc.,
289 F.3d 761, 774 (Fed. Cir. 2002)). “Deci-
sions enforcing local rules in patent cases will be affirmed
unless clearly unreasonable, arbitrary, or fanciful; based
on erroneous conclusions of law; clearly erroneous; or un-
supported by any evidence.” O2 Micro, 467 F.3d at 1366–
67 (citing Genentech,
289 F.3d at 774). Because patent lo-
cal rules “are essentially a series of case management or-
ders,” a district court “may impose any ‘just’ sanction for
the failure to obey” them, including “refusing to allow the
disobedient party to support or oppose designated claims
or defenses, or prohibiting that party from introducing des-
ignated matters in evidence.” Id. at 1363 (quoting Fed. R.
Civ. P. 37(b)(2)(B) (2000)).
This court has observed that some patent local rules
serve an objective that “has been difficult to achieve
through traditional discovery mechanisms such as conten-
tion interrogatories,” namely, to provide the parties with
early notice of their opponent’s theories of liability. Id.
at 1365–66. In doing so, these patent local rules “seek to
balance the right to develop new information in discovery
with the need for certainty as to the legal theories.” Id.
at 1366. They accordingly require the parties to provide
“early notice of their infringement and invalidity
6 PHIGENIX, INC. v. GENENTECH, INC.
contentions, and to proceed with diligence in amending
those contentions when new information comes to light in
the course of discovery.” Id. at 1365–66.
Consistent with that objective, the patent local rules of
the Northern District of California require a party claiming
patent infringement to serve infringement contentions on
all parties within 14 days of the initial case management
conference. N.D. Cal. Patent L.R. 3-1. In relevant part,
the infringement contentions must separately identify, for
each asserted claim:
[E]ach accused apparatus, product, device, pro-
cess, method, act, or other instrumentality . . . of
each opposing party of which the party is aware.
This identification shall be as specific as possible.
Each product, device, and apparatus shall be iden-
tified by name or model number, if known. Each
method or process shall be identified by name, if
known, or by any product, device, or apparatus
which, when used, allegedly results in the practice
of the claimed method or process[.]
Id. at 3-1(b). Infringement contentions may only be
amended by order of the district court upon a timely show-
ing of good cause—such as an adverse claim construction,
a recent discovery of prior art, or a recent discovery of non-
public information about the accused instrumentalities.
Id. at 3-6. The duty to supplement discovery responses un-
der the Federal Rules, moreover, “does not excuse the need
to obtain leave of court to amend contentions.” Id.; see also
Fed. R. Civ. P. 26(e) (describing duty to supplement discov-
ery responses).
II
A
We hold that the district court was within its discretion
to exclude the infringement opinion of Phigenix’s expert in
response to Phigenix’s failure to timely disclose its
PHIGENIX, INC. v. GENENTECH, INC. 7
narrowed infringement theory. Phigenix narrowed the rel-
evant patient population from “Kadcyla patients who were
pretreated with trastuzumab and a taxane” to “Kadcyla pa-
tients who were pretreated with trastuzumab and a taxane
and nothing else.” Phigenix did so not in response to new
evidence or a claim construction, but instead following the
district court’s February 2017 rejection of a 2005 priority
date for the ’534 patent. Regardless of the source of Phige-
nix’s motivation to narrow the relevant patient population,
it is clear that Phigenix did not take any deliberate action
to proactively put Genentech on notice that it had done so.
Instead, Phigenix first disclosed the narrowed scope
through the deposition of its expert in May 2017, after fact
discovery had closed.
Phigenix does not dispute that the narrowed patient
group is only about 4% of the full Kadcyla patient popula-
tion. Oral Arg. at 2:23–3:01. We agree with the district
court that such a dramatic narrowing at such a late stage
in the litigation prejudiced Genentech because it “mark-
edly transformed the nature of the infringement theory,
and consequently, impacted Genentech’s ability to prepare
a defense.” J.A. 15–16. As counsel made clear at oral ar-
gument, Genentech relied on Phigenix’s early disclosure of
its original infringement theory to develop noninfringe-
ment and invalidity theories that would need to be sub-
stantially revised under Phigenix’s narrowed infringement
theory. See generally Oral Arg. at 12:40–19:55. With re-
gard to noninfringement, Genentech had already commis-
sioned laboratory experiments and prepared an expert
report—efforts that would need to be repeated under the
new infringement theory. See id. at 15:41–16:52. Genen-
tech would also likely require additional discovery to un-
derstand the basis for Phigenix’s new infringement
theory—i.e., what aspect of the narrowed patient popula-
tion causes it to infringe even as the rest of the Kadcyla
population does not infringe. Id. With regard to invalidity,
Genentech and its expert had already developed and
8 PHIGENIX, INC. v. GENENTECH, INC.
advanced a theory that the Kadcyla clinical trials antici-
pate the asserted claims. Oral Arg. at 17:54–18:52; see also
J.A. 190–93 (Genentech expert opinion regarding Kadcyla
clinical trials). By effectively adding a negative limitation
to the invalidity analysis, Phigenix would send Genentech
back to the drawing board on invalidity quite late in the
litigation. 2
We agree with Phigenix that narrowing the scope of ac-
cused infringement will not always result in a failure to ad-
equately disclose infringement contentions. But, here,
where the relevant patient population was narrowed after
the close of fact discovery to a small percentage of its orig-
inal size, and where Genentech convincingly explained the
prejudicial consequences of the narrowing on its case, we
discern no abuse of discretion by the district court in strik-
ing Phigenix’s expert opinion on infringement. Accord-
ingly, we affirm the district court on this issue.
B
Phigenix advances several arguments in support of its
claim that the district court abused its discretion, but they
are insufficient to cure Phigenix’s untimely disclosure of its
narrowed infringement theory.
1
Phigenix first argues that its revised infringement the-
ory is not newly propounded because it falls wholly within
the scope of its original infringement contentions. While
technically accurate, this argument fails to acknowledge
the notice function served by infringement contentions.
2 We further note an adverse consequence for judi-
cial efficiency: such a dramatic narrowing of the relevant
patient population could have increased Genentech’s will-
ingness to settle the litigation early on, thereby conserving
limited judicial resources.
PHIGENIX, INC. v. GENENTECH, INC. 9
Patent local rules bolster discovery under the Federal
Rules because they “allow the defendant to pin down the
plaintiff’s theories of liability . . . thus confining discovery
and trial preparation to information that is pertinent to the
theories of the case.” O2 Micro, 467 F.3d at 1365 (first cit-
ing Hickman v. Taylor,
329 U.S. 495, 501 (1947); then cit-
ing CHARLES ALAN WRIGHT, ARTHUR R. MILLER & RICHARD
L. MARCUS, FEDERAL PRACTICE AND PROCEDURE § 2001
(2d ed. 1994); and then citing Fed. R. Civ. P. 33, advisory
committee’s note to 1970 amendment of subsection (b)).
The Northern District’s patent local rules, furthermore, ex-
pressly require that the identification of the accused meth-
ods in infringement contentions “shall be as specific as
possible.” N.D. Cal. Patent L.R. 3-1(b). We agree with the
district court that the broader theory disclosed in Phige-
nix’s infringement contentions is not sufficiently specific to
disclose its narrowed theory. If, as Phigenix suggests,
plaintiffs could include broadly scoped infringement theo-
ries in their contentions only to unilaterally narrow them
after the close of fact discovery, infringement contentions
would provide little relief to defendants.
2
Next, Phigenix seizes on a brief statement at a Janu-
ary 2017 hearing to assert that it did in fact put Genentech
on notice of its narrowed infringement theory. See Appel-
lant’s Br. 8–9 (quoting J.A. 429–30). This argument is in-
effective. The brief statement identified by Phigenix—
made in the course of challenging the prior art status of a
particular clinical trial—is far from clear notice of a nar-
rowed infringement theory:
The prescribing data that’s been approved and
that’s the subject of this lawsuit is previously re-
ceived trastuzumab and a taxane, which is a subset
of the population that they’re looking at in here of
compositions. The patients in this Exhibit H clini-
cal trial are being given a much different cocktail
10 PHIGENIX, INC. v. GENENTECH, INC.
here. . . . [I]n addition to a taxane and the
trastuzumab, they’re providing three other chemo-
therapy agents [anthracycline, lapatinib, and cape-
citabine] as either prior or co-therapy with this. So
we would disagree that this is actually describing
the same patient population. It’s not the same clin-
ical trial we believe led to the approval [of Kadcyla],
which is the EMILIA trial, which we don’t see in-
formation on that.
J.A. 429–30 (emphases added); see also J.A. 1706–08 (ref-
erenced clinical trial exhibit). This statement does not
identify any changed position, much less suggest that the
relevant patient population had changed.
3
Phigenix’s reliance on case law is similarly unavailing.
Phigenix asserts that the opinions cited by the district
court are inapposite because they only address “ambush”
tactics. Appellant’s Br. at 33–36. 3 Phigenix also points to
various district court opinions purportedly allowing plain-
tiffs to narrow their infringement theories after propound-
ing broader infringement contentions. Appellant’s Reply
at 8–10. 4 We are not persuaded by these decisions
3 Adobe Sys. Inc. v. WowzaMedia Sys., No. 11-02243-
JST,
2014 WL 709865, at *13–15 (N.D. Cal. Feb. 23, 2014);
Genentech Inc. v. Trustees of Univ. of Pa., No. 10-2037-
LHK-PSG,
2012 U.S. Dist. LEXIS 16959, at *6 (N.D. Cal.
Feb. 9, 2012); Oracle Am., Inc. v. Google Inc., No. 10-03561-
WHA,
2011 WL 4802535, at *2 (N.D. Cal. Oct. 11, 2011);
Linex Techs., Inc. v. Belkin Int’l, Inc.,
628 F. Supp. 2d 703,
707 (E.D. Tex. 2008).
4 Trading Techs. Int’l, Inc. v. CQG, Inc., No. 05-cv-
4811,
2014 U.S. Dist. LEXIS 127615, at *12 (N.D. Ill.
Sep. 10, 2014); Dig. Reg of Tex., LLC v. Adobe Sys., No. CV
PHIGENIX, INC. v. GENENTECH, INC. 11
considering the broad deference that this court grants to
district courts in the enforcement of their patent local
rules. See SanDisk,
415 F.3d at 1292. And on the merits,
these cases are readily distinguishable because the moving
party in each demonstrated early notice, diligence, new ev-
idence, and/or leave obtained from the district court—none
of which apply here.
The only controlling authority cited by Phigenix, Ke-
min Foods L.C. v. Pigmentos Vegetales Del Centro S.A. de
C.V., does not compel a different result.
464 F.3d 1339
(Fed. Cir. 2006). Kemin Foods is inapposite because it ad-
dresses the scope of asserted claims and does not apply pa-
tent local rules. See generally
id. Furthermore, in Kemin
Foods, this court relied on the fact that the plaintiff—who
had been diligent in giving notice and pursuing evidence to
support its infringement claim—could have done “nothing
more” to keep the disputed claim in the case.
Id. at 1351–
52. In contrast, Phigenix plainly could have done more to
put Genentech on notice about the change in the scope of
its infringement allegations.
4
Finally, Phigenix argues that striking Phigenix’s entire
expert infringement opinion is an abuse of discretion be-
cause it is (at least in Phigenix’s view) heavy-handed. In
support, Phigenix avers that Genentech has not adequately
explained how it was prejudiced. Phigenix further argues
that Genentech fails to explain why a less severe sanction
would not address any concern the district court had. Phi-
genix even boldly asserts that Genentech was obligated to
seek clarification if it was confused by the scope of Phige-
nix’s infringement contentions.
12-01971-CW (KAW),
2014 U.S. Dist. LEXIS 58113, at *7
(N.D. Cal. Apr. 24, 2014).
12 PHIGENIX, INC. v. GENENTECH, INC.
As a threshold matter, we need not consider the preju-
dice to Genentech in evaluating whether the court abused
its discretion. See O2 Micro, 467 F.3d at 1368 (“Having
concluded that the district court could properly conclude
that [the plaintiff] did not act diligently in moving to
amend its infringement contentions, we see no need to con-
sider the question of prejudice to [the defendant].”). In any
event, Genentech adequately explained how it was preju-
diced by Phigenix’s untimely narrowing of its infringement
theory.
The consequences imposed on Phigenix, furthermore,
are not beyond the discretion of the district court. Both the
Ninth Circuit and this court have concluded that the exclu-
sion of evidence is often an appropriate sanction for a
party’s failure to comply with the patent local rules. O2
Micro, 467 F.3d at 1369 (first citing SanDisk,
415 F.3d
at 1292; then citing Wong v. Regents of Univ. of Cal.,
410 F.3d 1052, 1060 (9th Cir. 2005)). Thus, even if other
courts might have chosen a less potent remedy in these cir-
cumstances, we assess only whether the district court
abused its discretion in prescribing a harsher one. On
these facts, we conclude that it did not.
III
Without its expert report, Phigenix’s direct infringe-
ment case fails, so we affirm the district court’s grant of
summary judgment of noninfringement on that basis. Be-
cause we affirm the district court’s determination of no di-
rect infringement, we do not address the district court’s
summary judgment of no induced infringement, as there
can be no inducement liability without direct infringement.
Limelight Networks, Inc. v. Akamai Techs., Inc.,
572 U.S.
915, 921 (2014) (citing Aro Mfg. Co. v. Convertible Top Re-
placement Co.,
365 U.S. 336, 341 (1961)). At oral argu-
ment, Genentech’s counsel indicated that its cross-appeal
is conditional on non-affirmance of the district court’s
PHIGENIX, INC. v. GENENTECH, INC. 13
judgment. Oral Arg. at 30:06–30:21. Having affirmed the
district court’s judgment, we do not address the cross-ap-
peal.
CONCLUSION
For the foregoing reasons, we affirm the district court’s
order striking Phigenix’s expert infringement opinion and
its grant of summary judgment of noninfringement.
AFFIRMED
