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
way? .
Can we [dismiss the appeal]
without allowing that the legislature
may prescribe rules of decision to the
Judicial Department of the government
in cases pending before it?" Supra at
146.

The Court answered these questions with a
It declined to enforce the

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 againṣṭ 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
By Section 202 of the Proposed Abbreviated New
Drug Application and Patent Term Restoration Act

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

of the Constitution, the Government is barred from passing laws which impair such rights of contract.

Patent rights are also recognized as property rights. The retroactive deprivation of one of these rights, 1.g., the exclusive right to develop information for FDA submissions, constitutes an uncompensated "taking" in violation of the Fifth Amendment of the Constitution, as well as a violation of the Due Process Clause of that Amendment.

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Section 202 also violates the Constitutional principles concerning the Separation of Powers, in that it would reverse the decision of the Federal Circuit Court of Appeals in Roche Products Inc. v. Bolar Pharmaceutical Company, Inc., even though that case is still pending. Section 202 intrudes Congress into the District Court proceedings where that case has been remanded to deny the relief to the patentee to which the Federal Circuit has ruled it is entitled.