Release to a Court of Trade Secret Information Protected Under the Federal Food, Drug, and Cosmetic Act ( 1978 )

September 1, 1978
78-48 MEMORANDUM OPINION FOR THE CHIEF,
TORTS SECTION, CIVIL DIVISION
Trade Secrets— Federal Food, Drug, and Cosmetic Act
(21 U .S.C . § 331)— Disclosure— Swine Influenza
Immunization Program (42 U .S.C . § 2746)
This responds to your request for our opinion whether the Department may
release to a court trade secret information entitled to protection under § 301 of
the Federal Food, Drug, arid Cosmetic Act, 21 U.S.C. § 331 (j), where the
manufacturers owning the trade secrets consent to such release. The Depart­
ment is defending certain personal injury and wrongful death actions arising out
of the National Swine Influenza Immunization Program of 1976. See 90 Stat.
1114, 42 U.S.C. § 247b(k)(l)(A)(ii), which provides that the exclusive remedy
under this program shall be against the United States. These actions have been
consolidated for pretrial discovery purposes and are pending in the United
States District Court of the District of Columbia. A relevant issue in the
litigation will be the ingredients and manufacturing processes of the vaccine.
The vaccine manufacturers claim that some of this information involves trade
secrets.
The court has issued a protective order requiring that documents involved in
this iitigation be used for no other purpose. The order further provides that the
documents or any information contained therein shall not be disclosed to
anyone other than the attorneys and persons assisting them in litigation. Subject
to the conditions in the protective order, the vaccine manufacturers have
consented to use of the. information in the litigation.
You ask whether the Department may, in light of § 301 (j), release in
discovery proceedings documents containing trade secret information acquired
under the authority of the Federal Food, Drug, and Cosmetic Act. Section
301(j), 21 U.S.C. § 33l(j), reads, in pertinent part, as follows:
The following acts and the causing thereof are hereby prohibited:
*****
(j) The using by any person to his own advantage, or revealing,
other than to the Secretary or officers or employees of [the Depart­
ment of Health, Education and Welfare] when relevant in any judicial
proceeding under this Act, any information acquired under authority
193
of sections 404, 409, 505, 506, 507, 510, 512, 513, 514, 515, 516,
518, 519, 520, 704, 706, or 708 of this title concerning any method
or process which as a trade secret is entitled to protection.
It is conceded that the pending judicial proceeding is not one under the Federal
Food, Drug, and Cosmetic Act. However, we believe that the Department may
release the documents in question in the pending litigation.
The intention of § 301 (j) is solely to protect the manufacturers’ interests in
their trade secrets and it is tied to their interest of maintaining the protection to
which the trade secrets are entitled. A manufacturer can waive his right to this
protection. The legislative history of § 301(j) shows that it was designed as a
“ safeguard to the property rights of manufacturers by making [a crime] the
unauthorized use or disclosure of any information. . .concerning any method or
process which is entitled to protection in equity as a trade secret.” S. Rept. No.
493, 73d Cong., 2d sess. 18, 21 (1934). This is consistent with the terms of
§ 301 (j) barring disclosure of only the information relating to trade secrets that
is “ entitled to protection.” Other than protecting the manufacturers’ proprie­
tary interest, there is no general societal value in keeping this information
confidential.
As mentioned above, § 301(j) only bars disclosure of such trade secrets
information as is “ entitled to protection.” This entitlement runs to the owner of
the trade secret who may waive it entirely or in part. See, Kewanee Oil Co. v.
Bicron Corp., 416 U.S. 470 (1974); Underwater Storage, Inc. v. United
States Rubber C o., 371 F. (2d) 950 (D.C. Cir. 1966), cert, denied, 386 U.S.
911 (1967). Thus, the “ entitled to protection” element of § 301 (j) is deter­
mined by the intent and legitimate interests of the owner of a covered trade
secret. Accordingly, the owner may consent to a limited waiver in the pending
litigation, thereby permitting the disclosure of the information to be used
therein. Cf., Plastic & M etal Fabrications, Inc. v. Roy, 163 Conn. 257, 303 A.
2d 725 (1972). This comports with the literal language and the spirit of
§ 3010).
For these reasons the Department may properly release the above-described
documents in the pending litigation.
M ary C . Law ton
Deputy Assistant Attorney General
Office o f Legal Counsel
194