IP News

Caraco's position is also supported by Amici including the Generic Pharmaceutical Association, the United States of America, Rep. Henry A. Waxman, and fellow generic drug maker Mylan Pharmaceuticals Inc. Novo's position is supported by Amici including the Pharmaceutical Research and Manufacturers of America and the Washington Legal Foundation.

Supreme Court Hears First Patentable Subject Matter Case Post-Bilski

On Dec. 7, the Supreme Court heard oral arguments in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150. The issue presented is whether 35 U.S.C. ' 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively pre-empts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve transformations of body chemistry.

The Federal Circuit held that the claims in Prometheus' patents were valid under ' 101 because they recite “a patent-eligible application of naturally occurring correlations between metabolite levels and efficacy or toxicity, and thus do not wholly preempt all uses of the recited correlations.” Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347, 1355 (Fed. Cir. 2010).

Oral arguments focused on Mayo's argument that Prometheus' patent pre-empts the use of a law of nature, with Justice Anthony Kennedy asking whether a system of measurements that you take every half-hour which “constantly monitor how a drug is being retained in the tissues, and that there is a protocol for the admission of some two or three different drugs to get the balance right” is patentable.

Amici supporting Mayo include Verizon Communications, Hewlett Packard Company, the ACLU, the CATO Institute, and the American College of Medical Genetics, among others. Amici supporting Prometheus include SAP America, the Pharmaceutical Research and Manufacturers of America, the National Venture Capital Association, Novartis Corporation, and the American Intellectual Property Law Association, among others.

Re-examination Allowed to Proceed After Final Judgment From Federal Circuit

In an opinion issued on Dec. 8, 2010, the Federal Circuit panel of Judges Sharon Prost, Pauline Newman, and Kathleen M. O'Malley upheld a decision of the USPTO that claims directed toward an assembly for screening rocks and debris were obvious over the prior art. The patent at issue had previously been asserted by Construction Equipment Company against Powerscreen International Distribution Ltd., and during the litigation Powerscreen had failed to prove that the claims were obvious. Powerscreen then instituted an ex parte re-examination at the USPTO, adding additional prior art references and new combinations to the obviousness argument. The USPTO held the claims were obvious, and the Federal Circuit in In re Construction Equipment Company, No. 2010-1507, upheld the USPTO's decision in the re-examination.

In a footnote of the majority opinion written by Judge Prost, the court notes that the re-examination was not unlawful or barred by res judicata or issue preclusion for three reasons: 1) the notion that the re-examination may have been unlawful was never briefed or argued by any party; 2) there was no claim or issue preclusion because the district court's judgment that the accused infringer had failed to carry his burden to prove the patent invalid is different from the Examiner's conclusion regarding the per se validity of the patent; and 3) a rule holding that a finding that a patent is not invalid in one proceeding being able to preclude any other validity challenge would be “a dramatic expansion of the concept of non-mutual offensive collateral estoppel.” Slip Op. at 5, footnote 3.

Judge Newman filed a dissent, arguing that the USPTO's decision is “the same issue that we finally adjudicated eleven years ago.” Judge Newman argued that the final disposition of the issue of validity in Article III courts raises constitutional separation of powers issues if it is allowed to be revisited by a non-Article III tribunal. Slip Op. at 4 (Newman, J., dissenting). She also argued that because Powerscreen could not have re-litigated the issue of validity in any court, res judicata bars the USPTO from also reconsidering validity.

Howard J. Shire is a partner and Joseph Mercadante is an associate in the New York office of Kenyon & Kenyon LLP.

Supreme Court to Determine Interpretation of Use Code Counterclaims

On Dec. 5, 2011, the Supreme Court heard oral arguments in Caraco Pharmaceutical Labs. v. Novo Nordisk A/S, No. 10-844. The Federal Circuit previously held that Caraco's counterclaim under 21 U.S.C. ' 355(j)(5)(C)(ii) that requested an order requiring Novo to change the allegedly overbroad use code for the patent-in-suit was improper. Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., No. 2010-1001 (Fed. Cir. 2010). The Federal Circuit held that because the use code contains “an approved method of using the drug” covered by the patent-in-suit, the counterclaim seeking a change of the use code was improper.

The Supreme Court granted certiorari on June 27, 2011, on the question of whether an ANDA applicant may assert a counterclaim under ' 355(j)(5)(C)(ii)(I) by alleging that the brand-name manufacturer's patent information does not accurately and precisely describe the method of use claimed by its parent. During oral arguments, Justice Antonin Scalia mentioned that Caraco's reading of the statute contained “oddities,” while Caraco's counsel argued that under Novo's reading of the statute, the only corrections that could be made using the counterclaim provision are typos in the patent numbers listed in the Orange Book.

Caraco's position is also supported by Amici including the Generic Pharmaceutical Association, the United States of America, Rep. Henry A. Waxman, and fellow generic drug maker Mylan Pharmaceuticals Inc. Novo's position is supported by Amici including the Pharmaceutical Research and Manufacturers of America and the Washington Legal Foundation.

Supreme Court Hears First Patentable Subject Matter Case Post-Bilski

On Dec. 7, the Supreme Court heard oral arguments in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150. The issue presented is whether 35 U.S.C. ' 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively pre-empts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve transformations of body chemistry.

The Federal Circuit held that the claims in Prometheus' patents were valid under ' 101 because they recite “a patent-eligible application of naturally occurring correlations between metabolite levels and efficacy or toxicity, and thus do not wholly preempt all uses of the recited correlations.” Prometheus Laboratories, Inc. v. Mayo Collaborative Services , 628 F.3d 1347, 1355 (Fed. Cir. 2010).

Oral arguments focused on Mayo's argument that Prometheus' patent pre-empts the use of a law of nature, with Justice Anthony Kennedy asking whether a system of measurements that you take every half-hour which “constantly monitor how a drug is being retained in the tissues, and that there is a protocol for the admission of some two or three different drugs to get the balance right” is patentable.

Amici supporting Mayo include Verizon Communications, Hewlett Packard Company, the ACLU, the CATO Institute, and the American College of Medical Genetics, among others. Amici supporting Prometheus include SAP America, the Pharmaceutical Research and Manufacturers of America, the National Venture Capital Association, Novartis Corporation, and the American Intellectual Property Law Association, among others.

Re-examination Allowed to Proceed After Final Judgment From Federal Circuit

In an opinion issued on Dec. 8, 2010, the Federal Circuit panel of Judges Sharon Prost, Pauline Newman, and Kathleen M. O'Malley upheld a decision of the USPTO that claims directed toward an assembly for screening rocks and debris were obvious over the prior art. The patent at issue had previously been asserted by Construction Equipment Company against Powerscreen International Distribution Ltd., and during the litigation Powerscreen had failed to prove that the claims were obvious. Powerscreen then instituted an ex parte re-examination at the USPTO, adding additional prior art references and new combinations to the obviousness argument. The USPTO held the claims were obvious, and the Federal Circuit in In re Construction Equipment Company, No. 2010-1507, upheld the USPTO's decision in the re-examination.

In a footnote of the majority opinion written by Judge Prost, the court notes that the re-examination was not unlawful or barred by res judicata or issue preclusion for three reasons: 1) the notion that the re-examination may have been unlawful was never briefed or argued by any party; 2) there was no claim or issue preclusion because the district court's judgment that the accused infringer had failed to carry his burden to prove the patent invalid is different from the Examiner's conclusion regarding the per se validity of the patent; and 3) a rule holding that a finding that a patent is not invalid in one proceeding being able to preclude any other validity challenge would be “a dramatic expansion of the concept of non-mutual offensive collateral estoppel.” Slip Op. at 5, footnote 3.

Judge Newman filed a dissent, arguing that the USPTO's decision is “the same issue that we finally adjudicated eleven years ago.” Judge Newman argued that the final disposition of the issue of validity in Article III courts raises constitutional separation of powers issues if it is allowed to be revisited by a non-Article III tribunal. Slip Op. at 4 (Newman, J., dissenting). She also argued that because Powerscreen could not have re-litigated the issue of validity in any court, res judicata bars the USPTO from also reconsidering validity.

Howard J. Shire is a partner and Joseph Mercadante is an associate in the New York office of Kenyon & Kenyon LLP.