Category Archives: Supreme Court Decisions

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Supreme Court Grants Cert In Myriad To Decide If Human Genes Can Be Patented

On November 30, 2012, the Supreme Court granted certiorari in the “ACLU/Myriad” gene patenting case (Association for Molecular Pathology v. Genetics, Inc.), guaranteeing that the debate over the patent-eligibility of human genes will continue for another round. The Court will review the August 16, 2012 Federal Circuit decision that held for the second time that … Continue reading this entry

Myriad Marches Towards The Supreme Court (Again)

The Association for Molecular Pathology (represented by the ACLU) has filed a petition for certiorari to the Supreme Court, seeking review of the Federal Circuit’s August 16, 2012 decision that upheld the patent-eligibility of Myriad’s “isolated DNA” claims. The petition raises three questions for Supreme Court review: Are human genes patentable? Did the court of … Continue reading this entry

Smoke Signals or Smokescreen: The Ultramercial GVR

After the Supreme Court decided that the personalized medicine method claims at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc. did not satisfy the patent eligibility requirements of 35 USC § 101, it was not surprising that the Court asked the U.S. Court of Appeals for the Federal Circuit to take a second look … Continue reading this entry

Supreme Court Reverses Caraco, Finds Right To Challenge Orange Book Use Code

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 … Continue reading this entry

Supreme Court Affirms Hyatt, Confirms Availability Of New Evidence, De Novo Review In Section 145 Actions

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 … Continue reading this entry

Supreme Court Sends Myriad Back to the Federal Circuit

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 … Continue reading this entry

My Myriad Nightmare

Now that the Supreme Court has issued its unanimous decision reversing the Federal Circuit decision in Prometheus, it is expected to decide the petition for certiorari in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCAI case), as early as Monday (March 26). Many are predicting that the Court will issue a “GVR” to … Continue reading this entry

Justice Breyer Gets The Last Word And Invalidates Prometheus Personalized Medicine Claims

On March 20, 2012, Justice Breyer issued the unanimous decision for the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., holding that Prometheus’ claims directed to methods of optimizing the dose of specific drugs used in the treatment of specific conditions are invalid under 35 USC § 101 because they impermissibly claim laws … Continue reading this entry

Supreme Court Hears Oral Arguments In Section 145 Case (Kappos v. Hyatt)

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 … Continue reading this entry

Who's On First? The Supreme Court Struggles With The Patent-Eligibility Of Personalized Medicine Claims

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 … Continue reading this entry

Supreme Court To Hear Oral Arguments In Two Important Cases This Week

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

Supreme Court Says Bayh-Dole Act Does Not Trump Inventor Rights

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. The … Continue reading this entry

Supreme Court Grants Certiorari in Hyatt v. Kappos Section 145 Case

On June 27, 2011, the Supreme Court granted certiorari in Hyatt v. Kappos. This means that the Court will review the en banc Federal Circuit decision which held that there are virtually no limits on the new evidence that a patent applicant can introduce in a district court action under 35 USC § 145 (“Civil Action to Obtain a Patent”). … Continue reading this entry

Supreme Court To Hear Orange Book Listing Case

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 … Continue reading this entry

Supreme Court Grants Cert In Mayo v. Prometheus

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 … Continue reading this entry

Supreme Court Says Willful Blindness Can Satisfy Knowledge Requirement For Induced Infringment

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, … Continue reading this entry

Justice Breyer Resurrects Metabolite

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 … Continue reading this entry

Supreme Court Stands By Clear & Convincing Evidence

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 … Continue reading this entry

Supreme Court Ponders Burden Of Proof in Microsoft v. i4i

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 … Continue reading this entry

How Hard Should It Be To Invalidate A Patent?

On Monday, November 29, 2010, the U.S. Supreme Court granted certiorari in Microsoft Corp. v. i4i Limited Partnership. Microsoft’s petition for certiorari asked the Court to consider whether it requires “clear and convincing evidence” or only “a preponderance of the evidence” to invalidate a patent. The Court’s willingness to hear this case suggests that it … Continue reading this entry

Catching A Breath After Bilksi

On Monday, June 28, 2010, the last day of its 2009 term, the Supreme Court finally issued its decision in Bilski v. Kappos. While the case directly addresses the patent-eligibility of “business method patents,” many in the biotech and pharmaceutical industries were concerned that the Court might take this opportunity to limit the circumstances under … Continue reading this entry