Source: http://www.pharmapatentsblog.com/supreme-court-decisions/
Timestamp: 2013-05-21 20:58:02
Document Index: 444023779

Matched Legal Cases: ['§ 1338', '§ 355', '§ 145', '§ 101', '§ 145', '§ 101', '§ 102', '§ 271', '§ 282']

Category Archives: Supreme Court Decisions	Supreme Court Finds For Monsanto In Seed Harvesting Case
Email	Supreme Court Holds A Gunn To Exclusive Federal Court Jurisdiction Over Patent Malpractice Claims
Posted by Courtenay Brinckerhoff on 28 February 2013
Posted in Supreme Court Decisions In Gunn v. Minton, the Supreme Court held that federal courts do not have exclusive jurisdiction over patent malpractice claims. Under 28 USC § 1338(a), federal courts have exclusive jurisdiction over cases “arising under any Act of Congress relating to patents,” but the Court determined that patent malpractice claims do not arise under the patent laws. Continue reading this entry
Tags: Jurisdiction, Malpractice Comment
Email	Supreme Court To Hear AndroGel Reverse Payment Case
Posted by Courtenay Brinckerhoff on 10 January 2013
Posted in Supreme Court Decisions The Supreme Court granted certiorari in Federal Trade Commission v. Watson Pharmaceuticals, Inc., to address whether and when “reverse payment” agreements made to settle ANDA litigation violate antitrust laws. The Supreme Court may decide whether such reverse payments should be evaluated under the “scope of the patent” test (which upholds most agreements) or the “quick look rule of reason” test (which is more likely to find an antitrust violation). Oral arguments are scheduled for March 25, 2013. Continue reading this entry
Tags: ANDA, ANDA Litigation, AndroGel, Certiorari, Hatch-Waxman, Reverse Payments, Reverse Settlement Payment, Watson Comment
Email	Supreme Court Reverses Caraco, Finds Right To Challenge Orange Book Use Code
Posted by Courtenay Brinckerhoff on 24 April 2012
Posted in Supreme Court Decisions On April 17, 2012 the Supreme Court issued a unanimous decision in Caraco Pharmaceutical Labs., Ltd. v. Novo Nordisk A/S, reversing the Federal Circuit decision and finding that 21 USC § 355(j)(5)(C)(ii)(I) provides a mechanism for a generic drug manufacturer to challenge the accuracy of a use code associated with an Orange Book listed patent. This decision may permit generic manufacturers to obtain earlier FDA approval for certain generic drugs, but may not solve all of the problems that can arise from an overly broad use code. Continue reading this entry
Tags: ANDA, Caraco, Carve-Out, Hatch-Waxman, Novo-Nordisk, Orange Book, Prandin Comment
Email	Supreme Court Affirms Hyatt, Confirms Availability Of New Evidence, De Novo Review In Section 145 Actions
Posted by Courtenay Brinckerhoff on 18 April 2012
Posted in Supreme Court Decisions On April 18, 2012, the U.S. Supreme Court decided Kappos v. Hyatt, which raised questions regarding the ability to introduce new evidence and the applicable standard of review when a patent applicant challenges the USPTO’s refusal to grant a patent in a district court proceeding under 35 USC § 145 (“Civil Action to Obtain a Patent”). The Supreme Court affirmed the decision of the en banc Federal Circuit, holding that “there are no evidentiary restrictions beyond those already imposed by the Federal Rules of Evidence and the Federal Rules of Civil Procedure,” and that “when new evidence is presented on a disputed question of fact,” the district court must “make a de novo finding.” The Court agreed with the Federal Circuit that the district court may “consider whether the applicant had an opportunity to present the evidence to the PTO” when deciding how much weight the new evidence should be given. This decision will be welcomed by patent applicants who have received negative USPTO decisions on patentability, and reflects the realities — and difficulties — of marshalling evidence during patent prosecution.Continue reading this entry
Tags: Evidence, Hyatt, Kappos, Section 145, Standard Of Review Comment
Email	Supreme Court Sends Myriad Back to the Federal Circuit
Posted by Courtenay Brinckerhoff on 26 March 2012
Posted in Myriad; Supreme Court Decisions The Supreme Court has issued a “GVR” in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), granting certiorari only to vacate the Federal Circuit decision that upheld the patent-eligibility of Myriad’s “isolated DNA” claims, and remanding the case to the Federal Circuit for rehearing in view of the Supreme Court’s unanimous decision in Prometheus. While Myriad’s isolated DNA claims raise a different question under 35 § USC 101 than Prometheus’ method claims, this action by the Supreme Court indicates that the Court thinks that the “product of nature” and “law of nature” questions are close enough that the Federal Circuit should revisit its decision in Myriad in view of the analysis the Supreme Court provided in Prometheus.
Stakeholders and practitioners in the fields of personalized medicine, biologics, and pharmaceuticals will be watching closely to see what happens next.
Will the divided panel of Federal Circuit judges who originally decided Myriad be swayed to reach a different conclusion?
Will the Federal Circuit take up the case en banc?
Will the court distinguish Prometheus or decide that the unanimous Supreme Court decision reaches beyond its facts to different patent-eligibilty issues?
Will the court dodge the whole § 101 issue and dismiss for lack of jurisdiction because no plaintiff has standing?
Email	Supreme Court Hears Oral Arguments In Section 145 Case (Kappos v. Hyatt)
Posted by Courtenay Brinckerhoff on 11 January 2012
Posted in Supreme Court Decisions On January 9, 2012, the Supreme Court heard oral arguments in Kappos v. Hyatt. The issues before the Court relate to the scope of new evidence that a patent applicant can introduce against the USPTO in a district court action under 35 USC § 145 (“Civil Action to Obtain a Patent”) and the degree of deference the reviewing court must give to the USPTO’s decision not to grant a patent. Continue reading this entry
Tags: Board, Board of Appeals, Deference, District Court, Evidence, Hyatt, Section 145, Standard Of Review Comment
Email	Who’s On First? The Supreme Court Struggles With The Patent-Eligibility Of Personalized Medicine Claims
Posted by Courtenay Brinckerhoff on 07 December 2011
Posted in 101; Prometheus; Supreme Court Decisions On December 7, 2011, the Supreme Court heard oral arguments in Mayo Collaborative Services v. Prometheus Laboratories, Inc. While the issue before the Court is patent-eligibility under 35 USC § 101, the arguments veered into the topic of patentability under 35 USC §§ 102 and 103, whether the Court intended to raise that issue or not. Continue reading this entry
Tags: Eligibility, Mayo, Personalized Medicine, Prometheus Comment
Email	Supreme Court To Hear Oral Arguments In Two Important Cases This Week
Posted by Courtenay Brinckerhoff on 05 December 2011
Posted in Supreme Court Decisions This week the Supreme Court will hear oral arguments in two cases that are important to the pharmaceutical industry: (i) Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S and (ii) Mayo Collaborative Services v. Prometheus Laboratories, Inc. Continue reading this entry
Tags: Caraco, Mayo, Novo-Nordisk, Orange Book, Personalized Medicine, Prometheus Comment
Email	Supreme Court Says Bayh-Dole Act Does Not Trump Inventor Rights
Posted by Courtenay Brinckerhoff on 12 July 2011
Posted in Supreme Court Decisions In Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc., the Supreme Court upheld the basic principle of U.S. patent law that rights to an invention vest initially in the inventor(s), and affirmed the Federal Circuit’s determination that the Bayh-Dole Act does not upset the rule of inventor ownership.
Tags: Assignment, Bayh-Dole Act, Inventor, Ownership, PCR, Roche, Stanford 1 Comment
Email	Supreme Court Grants Certiorari in Hyatt v. Kappos Section 145 Case
Posted by Courtenay Brinckerhoff on 30 June 2011
Email	Supreme Court To Hear Orange Book Listing Case
Posted by Courtenay Brinckerhoff on 26 June 2011
Posted in Supreme Court Decisions On June 27, 2011, the Supreme Court granted certiorari in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S. This means that the Court will review the Federal Circuit decision which held that the ANDA litigation counterclaim provision of the Hatch-Waxman Act does not permit a counterclaim to challenge a method patent listing when the listed patent claims at least one approved method of using the drug, and does not permit a challenge of a use code narrative on the basis that it is broader than the relevant patent claims.
Tags: ANDA, Caraco, Carve-Out, Certiorari, Hatch-Waxman, Novo-Nordisk, Orange Book 1 Comment
Email	Supreme Court Grants Cert In Mayo v. Prometheus
Posted by Courtenay Brinckerhoff on 18 June 2011
Posted in 101; Prometheus; Supreme Court Decisions Today (June 20, 2011), the Supreme Court granted Mayo’s petition for certiorari in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, which means that the Supreme Court will review the Federal Circuit decision that upheld the patent-eligibility of Prometheus’ personalized medicine claims against a Bilski-type challenge. As I wrote last week, it will be interesting to see if Justice Breyer will be able to use this case to resurrect the anti-patent views he expressed in his opinion dissenting from the GVR in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc.
You can read my summary of the Federal Circuit’s Prometheus decision here and my separate discussion of the court’s treatment of Justice Breyer’s Metabolite opinion here.
Tags: 101, Eligibility, Mayo, Personalized Medicine, Prometheus Comment
Email	Supreme Court Says Willfull Blindness Can Satisfy Knowledge Requirement For Induced Infringment
Posted by Courtenay Brinckerhoff on 16 June 2011
Posted in Supreme Court Decisions The Supreme Court provided additional guidance on the doctrine of induced infringement when it decided Global-Tech Appliances, Inc. v. SEB S.A., but it still affirmed the Federal Circuit’s judgment that the defendant was liable for inducing infringement of SEB’s patent. The Court held that 35 USC § 271(b) requires “knowledge” for liability for induced infringement, but found that “willful blindness” can satisfy that requirement.
Tags: 271(b), 271(c), Contributory Infringement, Induced Infringement, Inducement, Pentalpha, SEB, Sunbeam 1 Comment
Email	Justice Breyer Resurrects Metabolite
Posted by Courtenay Brinckerhoff on 14 June 2011
Posted in Supreme Court Decisions Justice Breyer’s dissenting opinion in Board of Trustees of Leland Stanford Junior University v. Roche Molecular Systems, Inc. is interesting for more than his views on inventor rights and the Bayh-Dole Act. As I was reviewing it, I was struck by his negative comments about patents and his citation of his own 2006 opinion dissenting from the dismissal of the grant of certiorari in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc.
Tags: 101, Eligibility, Metabolite, Personalized Medicine Comment
Email	Supreme Court Stands By Clear & Convincing Evidence
Posted by Courtenay Brinckerhoff on 09 June 2011
Posted in Supreme Court Decisions In a unanimous decision issued June 9, 2011, the Supreme Court rejected Microsoft’s arguments that a granted U.S. patent can be invalidated based on a mere preponderance of evidence, rather than clear and convincing evidence, as long has been required. The Federal Circuit had interpreted 35 USC § 282 as embodying a clear and convincing standard, and the Supreme Court agreed.
Tags: 282, burden, clear and convincing, i4i, Microsoft, Patent, preponderance 1 Comment
Email	Supreme Court Ponders Burden Of Proof in Microsoft v. i4i
Posted by Courtenay Brinckerhoff on 19 April 2011
Posted in Supreme Court Decisions On April 18, 2011, the U.S. Supreme Court heard oral arguments in Microsoft Corp. v. i4i Limited Partnership. Microsoft wants the Court to reconsider the “clear and convincing evidence” standard usually required to invalidate a patent, and hold that only “a preponderance of the evidence” is required when the prior art at issue was not considered by the USPTO. The Justices asked similar questions on both sides of the issue, and did not seem to telegraph their views. With Justice Roberts’ recusal, a 4-4 split decision could leave the Federal Circuit’s decision in tact without a decisive proclamation from the Supreme Court.
Tags: 282, burden, clear and convincing, i4i, Microsoft, preponderance, presumption of validity 1 Comment