Category Archives: Supreme Court Decisions

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Supreme Court Will Judge Biosimilar Patent Dance

The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz, where the Federal Circuit decided that the biosimilar patent dance provisions are optional, but pre-marketing notice always is required.… Continue reading this entry

Supreme Court Adopts More Flexible Standard For Enhanced Damages For Willful Infringement

In Halo Electronics, Inc. v. Pulse Electronics, Inc., the Supreme Court rejected the Federal Circuit’s two-part Seagate test for awarding enhanced damages under 35 USC § 284, finding that both the substantive requirement for “objective recklessness” and the “clear and convincing” burden of proof were inconsistent with the intent of the statute. In particular, the … Continue reading this entry

Sequenom Throws Diagnositc Method Patents At The Mercy Of The Supreme Court

It comes as no surprise that Sequenom has filed a petition for certiorari to the Supreme Court, asking the Court to review the Federal Circuit decision that upheld the district court decision that held its diagnostic method claims invalid for failing to satisfy the patent eligibility requirements of 35 USC § 101. With no relief from Congress … Continue reading this entry

Sandoz Asks Supreme Court To Reverse Biosimilar Decision

On February 16, 2016, Sandoz, Inc. filed a petition for writ of certiorari to the Supreme Court, asking the Court to overturn the Federal Circuit decision that interpreted the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA) as requiring the biosimilar applicant to give 180 days’ pre-marketing notice that cannot be given until … Continue reading this entry

Why Did The Supreme Court GVR The Shire Lialda Case?

On January 26, 2015, the Supreme Court granted certiorari, vacated, and remanded Shire Development LLC v. Watson Pharmaceuticals, Inc., to the Federal Circuit “for further consideration in light of Teva Pharmaceuticals USA, Inc., v. Sandoz, Inc.” But, if Teva v. Sandoz still calls for de novo review when the claim construction was based only on intrinsic evidence, … Continue reading this entry

Supreme Court Calls For Some Deference In Claim Construction Standard Of Review

On January 20, 2015, the Supreme Court issued its decision in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., finding that the Federal Rules of Civil Procedure call for some deference in the claim construction standard of review. In particular, the Court held that when claim construction is based on external evidence, a district court’s findings of … Continue reading this entry

How The Supreme Court Decision In Alice Corp. v. CLS Bank Undermines The USPTO Subject Matter Eligibility Guidance

On June 19, 2014, the Supreme Court issued its decision in Alice Corp. v. CLS Bank International, finding that patents directed to “a computer-implemented scheme for mitigating ‘settlement risk'” were invalid as being drawn to a patent-ineligible abstract idea. Although the Court did not address patent claims relating to laws of nature or natural phenomena, … Continue reading this entry

Supreme Court Adopts Reasonable Certainty Test For Definiteness

On June 2, 2014, the Supreme Court issued a unanimous decision in Nautilus, Inc. v. Biosig Instruments, Inc., rejecting the Federal Circuit’s “insolubly ambiguous” test for patent claim indefiniteness under 35 USC § 112, and instead adopting a “reasonable certainty test.” The Court vacated the Federal Circuit decision rendered under the “insolubly ambiguous” test, and remanded for … Continue reading this entry

Supreme Court Reverses Federal Circuit On Induced Infringement In Limelight Networks, Inc. v. Akamai

On June 2, 2014, the Supreme Court issued a unanimous decision in Limelight Networks, Inc. v. Akamai Technologies, Inc., reversing the en banc Federal Circuit decision and holding that there can be no liability for induced infringement under 35 USC § 271(b) when there has been no direct infringement under 35 USC § 271(a). The Court did not dig … Continue reading this entry

Supreme Court Lays Burden Of Proof On Patentee, Even In Declaratory Judgment Action

In Medtronic, Inc. v. Mirowski Family Ventures, LLC, a unanimous Supreme Court held that the patent holder bears the burden of proving infringement, even in a declaratory judgment action brought by a licensee. In reaching its decision, the Court dismissed concerns that it would skew the balance of power between patent holder and licensee, noting … Continue reading this entry

Supreme Court Applies Antitrust Scrutiny To ANDA Reverse Payment Settlement Agreements

In Federal Trade Commission v. Actavis, Inc., the Supreme Court held that reverse payment (“pay-for-delay”) settlement agreements made in the context of settling Hatch-Waxman ANDA litigation should be evaluated for antitrust violations under a “rule of reason” analysis. In so doing, the Court rejected both the “scope of the patent” test urged by the patent … Continue reading this entry

A Look At The Myriad Gene Patent Claims And The USPTO Memo To Examiners On Myriad

Now that the Supreme Court has issued its decision in the “ACLU/Myriad” gene patents case (Association For Molecular Pathology v. Myriad Genetics, Inc.), people are wondering what the decision means for the Myriad patents and BRCA1/BRCA2 genetic testing. If you missed it, this article provides an overview of the Supreme Court Myriad decision. Here, I review … Continue reading this entry

Supreme Court Decides Myriad Gene Patents Case, Holds Isolated Human Genes May Not Be Patented

On June 13, 2013, the Supreme Court issued its long-awaited decision in the “ACLU/Myriad” gene patents case (Association For Molecular Pathology v. Myriad Genetics, Inc.). In a unanimous opinion authored by Justice Thomas, the Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has … Continue reading this entry

Supreme Court Finds For Monsanto In Seed Harvesting Case

In Bowman v. Monsanto Co., the Supreme Court held that the doctrine of patent exhaustion does not give a farmer who has bought patented seeds the right to “reproduce” them through planting and harvesting without the patent holder’s permission. This decision presents a straight-forward application of the patent exhaustion doctrine, and is refreshing in its recognition … Continue reading this entry

Supreme Court Oral Arguments in ACLU Myriad Gene Patent Case

On April 15, 2013, the Supreme Court heard oral arguments in one of the most controversial and publicized biotech patent cases–the “ACLU/Myriad” gene patent case (e.g., The Association For Molecular Pathology v. USPTO). While it is always risky to predict the outcome of a Supreme Court case from the oral arguments, the Justices seemed to have … Continue reading this entry

Briefing The Supreme Court In Myriad

March 15, 2013 was a big deadline for patent applicants seeking to secure first-to-invent filing dates for U.S. patent applications, but April 15 will be a big day for the biotechnology industry, when the Supreme Court hears oral arguments in The Association of Molecular Pathology v. Myriad Genetics, Inc. (also known as the ACLU/Myriad “gene … Continue reading this entry

Supreme Court Holds A Gunn To Exclusive Federal Court Jurisdiction Over Patent Malpractice Claims

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 … Continue reading this entry

Supreme Court To Hear AndroGel Reverse Payment Case

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 … Continue reading this entry

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