University of Rochester v. G.D. Searle & Co., Inc., 03-1304.

• Decision Date: 02 July 2004
• Docket Number: No. 03-1304.,03-1304.
• Citation: 375 F.3d 1303
• Parties: UNIVERSITY OF ROCHESTER, Plaintiff-Appellant, v. G.D. SEARLE & CO., INC., Monsanto Company, Pharmacia Corporation, and Pfizer Inc., Defendants-Appellees.
• Court: U.S. Court of Appeals — Federal Circuit

375 F.3d 1303

UNIVERSITY OF ROCHESTER, Plaintiff-Appellant, v. G.D. SEARLE & CO., INC., Monsanto Company, Pharmacia Corporation, and Pfizer Inc., Defendants-Appellees.

No. 03-1304.

United States Court of Appeals, Federal Circuit.

July 2, 2004.

Gerald P. Dodson, Morrison & Foerster, LLP, of Palo Alto, California, filed a petition for rehearing en banc for plaintiff-appellant. With him on the petition were Emily A. Evans, Erica D. Wilson and Erik J. Olson.

Gerald Sobel, Kaye Scholer LLP, of New York, NY, filed an opposition to the petition for defendants-appellees. With him on the opposition were Richard G. Greco, Sylvia M. Becker and Daniel L. Reisner. Of counsel on the opposition was Robert L. Baechtold, Fitzpatrick, Cella, Harper & Scinto, of New York, NY.

Daniel J. Furniss, Townsend and Townsend and Crew LLP, of Palo Alto, CA, filed an amici curiae brief for the Regents of the University of California, et al. With him on the brief were Susan M. Spaeth and Madison C. Jellins.

ORDER

LARIMER, Judge.

A petition for rehearing en banc was filed by the Appellant, and a response thereto was invited by the court and filed by the Appellees.¹

This matter was referred first as a petition for rehearing to the merits panel that heard this appeal. Thereafter, the petition for rehearing en banc, response, and the amici curiae brief were referred to the circuit judges who are authorized to request a poll whether to rehear the appeal en banc. A poll was requested, taken, and failed.

Upon consideration thereof,

IT IS ORDERED THAT:

(1) The petition for rehearing is denied.

(2) The petition for rehearing en banc is denied.

NEWMAN, Circuit Judge, dissents in a separate opinion.

LOURIE, Circuit Judge, concurs in a separate opinion.

RADER, Circuit Judge, with whom GAJARSA and LINN, Circuit Judges, join, dissents in a separate opinion.

LINN, Circuit Judge, with whom RADER and GAJARSA, Circuit Judges, join, dissents in a separate opinion.

DYK, Circuit Judge, concurs in a separate opinion.

The mandate of the court will issue on July 9, 2004.

NEWMAN, Circuit Judge, dissenting from the denial of rehearing en banc.

I respectfully dissent from the court's decision not to resolve en banc the burgeoning conflict in pronouncements of this court concerning the written description and enablement requirements of the Patent Act. This question has been promoted from simple semantics into a fundamental conflict concerning patent scope and the support needed to claim biological products. The appropriate forum is now the en banc tribunal, not continuing debate in panel opinions applying divergent law.

I fully share Judge Lourie's understanding of the law. The continuing attack on well-established and heretofore unchallenged decisions such as Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed.Cir. 1991) ("we hereby reaffirm, that 35 U.S.C. § 112, first paragraph, requires a `written description of the invention' which is separate and distinct from the enablement requirement") and earlier cases such as In re Ruschig, 54 C.C.P.A. 1551, 379 F.2d 990 (CCPA 1967) (written description is one of three distinct requirements under 35 U.S.C. § 112) is not only unwarranted, but is disruptive of the stability with which this court is charged. If precedent has become obsolete or inapplicable, we should resolve the matter as a court and again speak with one voice.

The new biology has indeed raised new and important questions, with implications for policy as well as law. However, the answer is not the simplistic one espoused by some commentators; it is simply incorrect to say that there is not now and never has been a "written description" requirement in the patent law. It has always been necessary to disclose and describe what is patented. It has never been the law that one can claim what is not made known and set forth in the patent.

Various past decisions have been offered to support the exotic proposition that it is not necessary for the inventor to describe the patented invention, but that enablement alone suffices under the statute. These cases concern traditional issues of generic disclosures and specific examples, and questions of support and predictability for scientific concepts and their embodiments. Such traditional law was applied in Regents of the University of California v. Eli Lilly & Co. 119 F.3d 1559 (Fed.Cir. 1997), a case that is misdescribed in this debate, for Lilly does not depart from precedent in its holding that the written description requirement can be fulfilled by "a precise definition, such as by structure, formula, chemical name, or physical properties." Id. at 1565, quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed.Cir.1993).

If the nature of the subject matter is not amenable to precise description, some alternative mode of disclosure is required, such as deposit in a public depository. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956 (Fed.Cir.2002). However, the public purpose of patents is seriously disserved by eliminating the description requirement entirely. Federal Circuit law of written description has become encumbered with inconsistent pronouncements, leading me to remark that "[c]laims to an invention that is not described in the specification are an anachronism." Housey Pharms., Inc. v. Astrazeneca UK Ltd., 366 F.3d 1348, 1357 (Fed.Cir.2004) (Newman, J., dissenting). If the majority of this court is nonetheless sympathetic to that position, there should be careful consideration of the implications of precedent, for the law is that "Section 112 requires that the application describe, enable, and set forth the best mode of carrying out the invention." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 724, 122 S.Ct. 1831, 152 L.Ed.2d 944 (2002).

The issue of whether patent law contains a separate written description requirement has percolated through various panels of this court, on a variety of facts. The differences of opinion among the judges of the Federal Circuit, are, in microcosm, the "percolation" that scholars feared would be lost by a national court at the circuit level. Percolation is the great justifier of conflict among the regional circuits. In the words of the Supreme Court:

We have in many instances recognized that when frontier legal problems are presented, periods of "percolation" in, and diverse opinions from, state and federal appellate courts may yield a better informed and more enduring final pronouncement by this Court.

Arizona v. Evans, 514 U.S. 1, 24 n. 1, 115 S.Ct. 1185, 131 L.Ed.2d 34 (1995). This question has percolated enough; it is ripe for en banc resolution.

LOURIE, Circuit Judge, concurring.

I concur in the decision of the court not to rehear this case en banc, just as previously the court also declined to hear a written description case en banc. See Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 970-75 (Fed.Cir.2002). That is because this case was properly decided based on one of the grounds relied on by the district court in invalidating the Rochester patent, see Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed.Cir.2004), the analysis of which will not be repeated here.

Contrary to the assertions of the appellant, certain amici, and some of the dissenters, there is and always has been a separate written description requirement in the patent law. The requirement to describe one's invention is basic to the patent law, and every patent draftsman knows that he or she must describe a client's invention independently of the need to enable one skilled in the relevant art to make and use the invention. The specification then must also describe how to make and use the invention (i.e., enable it), but that is a different task.

The requirements of the statute cannot be swept away by claiming that it relates only to priority issues or that the prohibition on introduction of new matter takes care of the need for a written description. The statute does not contain a limitation that it pertains only to priority issues. Moreover, the prohibition on introduction of new matter (35 U.S.C. § 132) is not a substitute for the written description requirement. Section 282 of the Patent Act lists as a defense to an infringement action invalidity arising from a failure to comply with a requirement of section 112 of the Act, which includes written description. In contrast, the new matter provision, section 132, appears in a provision entitled "Notice of rejection; reexamination." Failure to comply with that section is not expressly listed in the statute as an invalidity defense to infringement, although we have held that the unsupported claims are invalid. See, e.g., Quantum Corp. v. Rodime, PLC, 65 F.3d 1577 (Fed.Cir.1995) (invalidating claims that were broadened in scope during reexamination in violation of 35 U.S.C. § 305, which is analogous to section 132).

The separate written description requirement poses no conflict with the role of the claims. It is well established that the specification teaches an invention, whereas the claims define the right to exclude. SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 n. 14 (Fed.Cir.1985). While claims must be supported by the written description, the latter contains much material that is not in the claims. The written description contains an elucidation of various aspects of an invention as well as material that is necessary for enablement. Moreover, the written description often contains material that an applicant intended to claim that has been rejected in examination. Thus, the written description and the claims do not duplicate each other.

The fact, if it is a fact, that written description has only been relied upon in recent years as a ground of invalidity does not remove that requirement from the statute. Legal holdings arise when they do because litigants raise them and courts have to decide them. Contrary to what has been asserted, the interpretation of the statute as...