- conclusive evidence of Roche's understanding years before the Bolar case was decided that such activity was unauthorized and that it amounted to infringement. The quotation in Mr. Engelberg's letter of one sentence from a 20 page transcript of an argument in the Zenith case on June 14, 1976 is taken out of context. One of the issues in that litigation was the effect of 28 U.S.C. § 1498 (a), a statute which provides that when a patented invention is used by or for the United States, the patentee's only remedy is to bring an action against the government in the Claims Court. Since this statutory protection extends to contractors and subcontractors of the government, Zenith claimed its protection, by alleging that it was engaged in steps necessary to supply diazepam under a government contract, asserting that 28 U.S.C. S 1498 (a) barred Roche's suit. Answer, Fourth Affirmative Defense. (Zenith's assertion that its activities fell within the protection of § 1498 (a) is quoted in the margin in full.) As Zenith's then-counsel argued to the court, "We will sell only to the government, " and "We have admitted that we intend to apply to the FDA for approval for purposes of selling to the government. Transcript, pp. 6, 8. (Emphasis supplied). Although Roche does not concede the legal soundness of Zenith's theory that Section 1498 (a) shields such activity, the sentence quoted by Mr. Engelberg in his letter was intended to make the point that Roche was not engaged in challenging activities that were within the legitimate scope of 28 U.S.C. $ 1498 (a). References in the transcript to 28 U.S.C. $ 1498 (a) and to Roche's desire not to enjoin Zenith from doing work for "bidding for United States government contracts" makes it clear that Roche desired to avoid any possible conflict with that statute. The Zenith case was terminated by a Consent Judgment in 1979 which did not sanction continued testing to obtain FDA approval for the marketing of diazepam products commercially. Paragraph 9 of the Consent Judgment allowed Zenith to use diazepam "for the limited purpose of such experimentation as fairly falls within permissible experimentation under the patent laws of the United States." But, here too, the intent was to avoid any possible conflict with Section 1498 (a), and to allow the traditional types of experimental use under the established doctrine. As the very next sentence in that paragraph recites, "Nothing herein shall prejudice Zenith from taking advantage of those rights, if any, under Title 28 U.S.C. § 1498 (a)." */ Roche certainly did not understand the Consent Judgment to permit unlimited testing of its patented product for FDA approval. It is doubtful that Zenith ever understood it differently since, as Zenith conceded in open court this week, Zenith did not proceed with experimentation for the purpose of gaining FDA premarketing approval in the years immediately following entry of that Judgment. * In the same vein, the Consent Judgment also states in paragraph 4: "That nothing herein shall be construed as In 1984, it came to the attention of Roche Products, Inc. that Zenith was conducting infringing tests of diazepam to obtain data for FDA premarketing clearance. Accordingly, Roche Products filed a new infringement suit in the Northern District of New Jersey on July 13, 1984. The case has been assigned to Judge Lacey, the same judge who had responsibility over the earlier Zenith case. Last week Zenith moved to vacate Judge Lacey's order granting Roche the right to expedited discovery. In support of its motion, Zenith relied on the same quotation from the 1976 transcript that appears in Mr. Engelberg's letter to you. In essence, Zenith argued that Roche Products had conceded (through its predecessor in interest, Hoffmann-La Roche Inc.) that Zenith could engage in such testing. We are informed that on July 23, 1984, Judge Lacey denied Zenith's motion after hearing argument in open court. The same argument is entitled to no greater weight when it is made to the Subcommittee. In conclusion, we submit that none of the arguments in Mr. Engelberg's letter displaces the rationale of Roche v. Bolar. In effect, his letter seeks to relitigate Bolar by having this Subcommittee displace the Court of Appeals. However, the law which the court applied is well established and, as Commissioner Mossinghoff testified, the doctrine is a sound one. The "new information" in his letter is not at all "new." More importantly, they establish that Roche has long relied on the doctrine expounded in the Bolar decision to enforce its patent rights. AMERICAN HOME PRODUCTS CORPORATION 685 THIRD AVENUE NEW YORK, N. Y. 10017 JOHN R. STAFFORD PRESIDENT June 22, 1984 The Honorable Robert W. Kastenmeier Room 2232 Independence and S. Capitol Street, S.W. Dear Mr. Kastenmeier: Thank you for meeting with us yesterday concerning the Patent Term/ANDA bill (H.R.3605) which will be before your subcommittee next week. As I mentioned, we have serious concerns with some provisions of this measure. Your willingness to hear from constitutional, law and patent experts is encouraging to our research coalition as we continue to press for changes in H.R.3605. Time constraints prevented me from elaborating on Finally, on a more personal note, enclosed is a We look forward to working with you and your staff on this important piece of legislation. If you have any questions, feel free to contact Enclosures (5) Very truly yours, John 1. Haplord John R. Stafford POSITION PAPER on S 2748 and HR 3605 June 16, 1984 .. DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT OF 1984. The undersigned are among the nation's leading research-based pharmaceutical companies and contribute approximately 50% of the pharmaceutical research dollars spent in the United States by private industry. We favor a patent term restoration abbreviated new drug application bill which: (1) Restores patent life lost to regulatory review for innovative drug products; and (2) Accelerates the availability of safe and effective generic drug products. We are prepared to support a bill that addresses the following issues: LIMITS ON FDA AUTHORITY TO ASSURE SAFETY AND EFFICACY Background Unlike current ANDA regulations for drugs approved before 1962, the bill precludes FDA from requesting information |