on the record of this legislation. However, even if such a transfer could be construed to constitute a public use, the Fifth Amendment still requires that there must be "just compensation" for which the bill makes no provision. Today, a patent owner has the right to sue for injunctive relief and damages under Bolar if his patent was infringed in any way, even if the purpose of the infringement was to secure government approvals for marketing the substance later on. Under Section 202, that right will be lost without compensation. As the Supreme Court observed this term in Hawaii Housing Authority v. Midkiff, 52 U.S.L.W. 4673 (U.S. May 30, 1984), even where property is taken for a public use, there must be a provision for just compensation, citing Thompson v. Consolidated Gas Crop., 300 U.S. 55 (1973). See also United States Trust Co. v. New Jersey, supra, 431 U.S. 19 n.16 (a "taking" of contract rights for a public purpose is taking of property and requires just compensation). In short, the bill suffers from a basic infirmity under the Fifth Amendment. 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 would 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 for the decision of a cause in a particular The Court answered these questions with a resounding negative. It declined to enforce the 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 Supra 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 The constitutional issues raised by Section 202 are significant. All of them stem from the retroactive nature of Section 202, on which we have focused our attention 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. Substantial Constitutional Questions Raised As set forth in the attached Memorandum of Law; Section 202 of the above-noted legislation raises serious Constitutional issues that have not yet been addressed by the Congress. These issues are in addition to the other public policy issues raised by the proposed legislation. Proposed Section 202 permits parties other than the patent owner to use a drug subject to an existing patent to develop data to submit to the FDA for purposes of obtaining an Approved New Drug Application, without permission of the patentee and without infringement of the patent. The courts expressly recognize that this right to develop data is an exclusive right granted by the patent to the patentee. Accordingly, as proposed Section 202 retrospectively deprives the patent holder of valuable rights in violation of the Constitution. A patent grant is recognized as a contract between the patentee and the U.S. Government, under which in exchange for the public disclosure of the invention, the Government grants the patentee exclusive rights provided by the patent law. Under the Contracts Clause |