not be affected by this repeal." Act of July 19, 1952, c. 950, 5, 66 Stat. 815. (A current patent bill under consideration, H.R. 4526, does not raise such considerations since it does not impair existing rights of patent holders.) Section 202 Violates the Section 202 has been drafted with the Bolar facts in mind, and it is equally clear that its retrospective reach would reverse the rule of decision in that still pending litigation. By substituting a legislative fiat for the present judicial determination of the Court of Appeals, the bill woul@violate the policy of Congress to refrain from legislating in pending cases and would contravene the fundamental separation between the judicial and legislative branches that the framers wrote into the Constitution. As Chief Justice Marshall stated in Marbury v. Madison, 5 U.S. (1 Cranch) 137, 177 (1803), "It is emphatically the province and duty of the judicial department to say what the law is." See Ogden v. Blackledge, 6 U.S. (2 Cranch) 272 (1804). This very issue was conclusively decided more than a century ago in United States v. Klein, 80 U.S. (13 Wall) 128 (1871). In that case, plantiff claimed a right to the proceeds of property that had been seized and sold by federal authorities during the Civil War. Plaintiff sued in the Court of Claims and recovered on making proof of his loyalty as a result of a presidential pardon, a procedure which had been upheld by the Supreme Court. However, while the case was on appeal, the Congress passed an act which altered that rule, and which provided that a pardon would not be admissible to prove loyalty. In questioning the constitutionality of that Act the Supreme Court asked: "What is this but to prescribe a rule The Court answered these questions with a resounding negative. legislation, and observed: "We must think that Congress has inadvertently passed the limit which separates the legislative from the judicial power. "It is of vital importance that these powers be kept distinct." Supra at 147. The Klein decision remains an authoritative guide in upholding the separation of powers principle. Pacemaker Diagnostic Clinic of America v. Instromedix, Inc., 725 F.2d 537, 544 (9th Cir. 1984). This limit against congressional intrusion on judicial power is plainly applicable here because Section 202 would repudiate the Court of Appeals' holding of infringement and would deny Roche the very relief to which the court said it was entitled. CONCLUSION We have focused attention to the constitutional issues in this memorandum In this document we do not address the additional and serious patent law and public policy issues raised by Section 202, including its possible adverse impact on future incentives to innovation. These issues raised by Section 202 are significant. However, they can be cured by giving the Section prospective effect only. QUESTIONS AND ANSWERS ABOUT DRUG PRICE COMPETITION/PATENT TERM EXTENSION ACT A coalition of the nation's leading research-based pharmaceutical companies is seeking amendments to H.R. 3605 and S. 2748, the Drug Price Competition/Patent Term Extension Act, which will maintain incentives for continuing research and help ensure the safety of generic drugs. The coalition supports the goals of the legislation but favors seven specific amendments that, if enacted, would help encourage pharmaceutical research in the U.S. as well as accelerate the marketing of safe generic drugs. Following are questions and answers about the legislation: Q. Q. Q. Q. What are the bill's purposes? A. There are two: 1. To restore patent rights to drugs approved by FDA, 2. To make it easier for generic versions of drugs What is the status of the legislation? A. H.R. 3605 was reported by the Energy & Commerce Committee June 12, the same day it was introduced and without any opportunity for review or for the public, federal agencies or industry to present their views on this complex legislation. What committees have jurisdiction? A. Because the bill combines health issues and patents, the Senate and House Judiciary Committees and the Senate Labor and Human Resources Committee have jurisdiction, in addition to the House Energy and Commerce Committee. What companies form the coalition? A. American Home Products, Bristol-Myers, Hoffmann-La Roche, Johnson & Johnson, Merck & Co., Procter & Gamble, ScheringPlough, Squibb Corp., and Carter-Wallace. These companies sponsor a significant percentage of U.S. pharmaceutical research. ICI/Stuart has just joined the coalition and other companies are opposing the legislation and considering joining the coalition. Q. Q. Q. Q. Q. Why do these companies favor amending the bill, when other PMA firms favor it as is? A. The bill combines two concepts, on patent restoration and on generic drug approvals. The companies believe that the combined legislation fails to achieve a proper balance between the two issues and would not adequately accomplish either of its stated objectives. What would be accomplished by the coalition's proposed amendments? A. They would provide appropriate incentives for pharmaceutical innovation. They would provide FDA added authority to assure the safety and effectiveness of generic drugs. They would protect certain trade secret data of commercial value to foreign competitors. The coalition also favors changes in the patent section of the bill. As drafted, the current bill in effect encourages patent litigation as well as patent infringement. It also raises serious constitutional questions about elimination of patent rights for already-patented products. Does the coalition oppose the entire legislation? A. It supports the legislation with the seven amendments that would stimulate continued research investment. Has the coalition established priorities among its seven amendments? A. No. The coalition believes that all are critical for the legislation to accomplish its stated objectives. Have the coalition's views been expressed at Congressional hearings? A. No. There have been no hearings, in either the House or Senate, on the current bill. A hearing was held in July 1983 on a one-page bill; the current bill is 52 pages long and deals with many other issues. How was the legislation developed? A. It was developed by staffs from three groups: the House Health Subcommittee, the Pharmaceutical Manufacturers Association and the Generic Pharmaceutical Industry Association. The companies in the coalition oppose PMA support of the bill. |