monopoly period and generic drug manufacturers were assured of obtaining the necessary approval to engage in competition immediately after that well-defined monopoly period ended. The parties recognized that it was essential to this compromise that generic companies engage in the necessary steps required to obtain ANDA approval prior to the patent expiration date so that they could commence marketing immediately after the patent expired rather than 2 or 3 years later. The agreement to accomplish that result was reached without controversy because it was consistent with common industry practice extending back over many years and therefore did not infringe on any vested economic interest of drug patent owners. The Commissioner's disregard for the fairness of the compromise is demonstrated by the fact that he is anxious to provide patent owners with relief (in the form of patent extension) for the time which they lose in getting to market because of regulatory delay but is unwilling to give generic companies the same relief from the same problem at the end of the patent monopoly period. Finally, it should be noted that throughout the course of the many hearings which have been held on the subject of patent term extension, the Commissioner has not come forward with any data whatsoever which would suggest that the commercial life of patented inventions in any field remotely approaches 17 years; that the commercial life of drug patents is materially shorter than the commercial life of patents in other fields; or that extending patent life in any field for any reason would stimulate investment in research or development. Rather, the Commissioner has consistently supported whatever proposal would lead to longer patents without regard for any demonstrated need for such a change in the patent law or the impact of such a change on the competitive environment or on consumers. an institutional bias is not surprising but it is disappointing that the Patent Office is unable to make a more constructive contribution to this compromise effort. Respectfully submitted, Such AMSTER, ROTHSTEIN & ENGELBERG ABE:11k Alfred B.Engelberg JEngelbe holder and is authorized to submit this application for extension of the above-identified patent pursuant to 35 U.S.C. $156. A copy of the patent for which extension is sought is enclosed. I hereby declare the following with respect to this application: 1. The patent for which this extension is sought claims a product (method of using a product) which was subject to a regulatory review period under the Food, Drug and Cosmetic Act prior to its comercial marketing. The relevant dates of that regulatory review period are set forth above. 2. The patent for which this extension is sought has never been extended. 3. 4. 5. The patent for which this extension is sought does not claim a product (method of using a product) which received permission for commercial marketing under the Food, Drug and Cosmetic Act before the NDA Approval Date set forth above. The active ingredient(s) in the approved product, including any salt or ester thereof, as a single entity or in combination with another active ingredient has never received permission for commercial marketing under the Food, Drug and Cosmetic Act before the NDA Approval Date set forth above. The following patents have been identified in the application under Section 505(b) of the Food, Drug and Cosmetic Act for the above-identified approved product as patents for which a claim of patent infringement might reasonably be asserted in the event of the unlicensed manufacture, use or sale of the approved product: 6a. To the best of my knowledge, the approved product (method of using the product) is not claimed in another patent having an earlier issuance date or which was previously extended. 6b. The approved product is claimed in U.S. Patent No. but it is not identically disclosed or described never be held by the patent holder herein and the never be held by the holder of U.S. Patent No. 7. To the best of my knowledge, the approved product and the use approved for the approved product are not identically disclosed or described in another patent having an earlier issuance date or which was previously extended. An extension of [Date] is sought based upon the following calculation: months and days until years, The extension does not exceed five years and will not extend the expiration date of the patent for more than fourteen years from the NDA Approval Date. I acknowledge the duty to disclose information which is material to the examination of this application in accordance with Title 37, Code of Federal Regulations, $1.56(a). I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and belief are believed to be true: and further that these statements were made with the knowledge that willful false statuments and the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the application or any patent extension issued thereon. APPLICANT'S SIGNATURE POST OFFICE ADDRESS DATE Honorable Robert W. Kastenmeier Chairman, Subcommittee on Courts, Civil Liberties and the Administration of Justice Committee on the Judiciary House of Representatives Washington, D.C. 20515 Re: H.R. 3605 Drug Price Competition and Dear Mr. Chairman: I am patent counsel to the Generic Pharmeceutical Industry Association (GPIA) and am writing this letter to provide the Committee with important new information bearing on the alleged constitutional law issue which the dissident pharmeceutical companies have raised. This new information establishes, that the decision in Roche V. Bolar made completely new law and was contrary to industry practices and expectations. Accordingly, Section 202 cannot possibly upset any reasonable investment-back expectations. On December 23, 1975, Hoffman-LaRoche Inc. commenced a Civil Action (Civil Action No. 75-2221) in the United States District Court for the District of New Jersey charging Zenith Laboratories, a generic manufacturer, with infringement of Roche's patent covering valium. In an Answer (copy enclosed) filed by Zenith on March 26, 1976, Zenith asserted that it was not liable for patent infringement because the only activity in which it had engaged was experimental studies for the purpose of seeking F.D.A. approval. Accordingly, Zenith filed a counterclaim seeking a declaratory judgment that experimental use did not constitute patent infringement. In early June 1976, Roche sought to have Zenith's counterclaim dismissed on the ground that there was no case or controversy. In support of that motion, Roche made the following statement: "It has been clear from the outset of this for diazepam. Nor has Roche done anything to "Roche does not seek to enjoin Zenith from On June 14, 1976, a hearing was held on Roche's motion before the Honorable Frederick B. Lacey. At that hearing, Roche's attorney stated: we've taken the position that attempts to secure NDAS in the proper On August 2, 1979, Zenith and Roche entered into an Agreement which led to a Consent Judgment in the foregoing Civil Action. A copy of that Consent Judgment is enclosed. The Consent Judgment clearly states that Zenith was engaged in FDA related experimental activities and wished to continue with such activities. Paragraph 9 of the Consent Judgment permitted Zenith to retain 5 kilograms of diazepam so that it could engage in such experimentation. It is respectfully submitted that the foregoing facts establish beyond question that until the recent decision in Roche v. Bolar, no one in the industry believed that F.D.A. experimental activity constituted patent infringement. Certainly, there is no other reasonable explanation for Roche's statements with regard to experimental activity involving the most important drug in Roche's recent history. The foregoing facts cast serious doubt on the testimony of both Professor Dorsen and Commissioner Mossinghoff in stating that the decision in Roche v. Bolar was a mere reaffirmation of a 200 year old principle of patent law. In actual fact, the decision is a total departure from past industry practice. Accordingly, the enactment of Section 202 will clearly not upset any reasonable investment-backed expectations and is not unconstitutional. Respectfully submitted, AMSTER, ROTHSTEIN & ENGELBERG ABE/jm Alfred B. Engelberg Defendant, Zenith Laboratories, Inc., with offices at 140 Le Grand Avenue, Northvale, New Jersey, by way of Answer to the Complaint herein, says: AS TO COUNT ONE 1. Defendant denies that this Court has jurisdiction under the Patent Laws of the United States or under 28 U.S.C. Sec. 1338 in that no case or controversy is stated sufficient to invoke the jurisdiction of this Court either under the above-listed sections or under 28 U.S.C. Sec. 2201 (the Declaratory Judgment Act). 2. Defendant admits the allegations of Paragraph 2. 3. Defendant admits the allegations of Paragraph 3. 4. Defendant, Zenith Laboratories, Inc., denies knowledge or information sufficient to form a belief as to the truth of the allegations contained in Paragraph 4. 5. Defendant denies knowledge or information sufficient to form a belief as to the truth of the allegations contained in Paragraph 5. 6. Defendant denies knowledge or information sufficient to form a belief as to the truth of the allegations contained in Paragraph 6. |