Posts Tagged: "SCOTUS"

SCOTUS Takes on Scope of Enablement Inquiry in Amgen v. Sanofi: Implications for Pharma/ Biotech and Beyond

On November 4, the U.S. Supreme Court granted Amgen’s petition for certiorari against the advice of the U.S. government – taking up Amgen’s challenge to the Federal Circuit’s enablement review of its PCSK9 antibody patents covering evolocumab (Repatha®). In its petition, Amgen asserts that the Federal Circuit has gone too far in invalidating its PCSK9 antibody patents by imposing a disclosure burden beyond the requirements of 35 U.S.C. § 112. Notably, the Supreme Court, albeit with a different composition, recently declined to hear several other similar cases raising issues with the Federal Circuit’s enablement precedent.

Tillis Bill Would Restore Needed Clarity and Predictability in Patent Eligibility Law

Over the last 15 years, the United States Supreme Court has mutated patent eligibility into an impossibly complex and confusing mess. The Court’s current eligibility test strays far from Congress’s original intent, erodes trust in predictability, and has left many remarking that innovation in the United States is falling behind due to uncertainty of patent eligibility law. Even more troubling, the resulting uncertainty of patent ineligibility for large swaths of innovation in critical technology areas, including artificial intelligence, poses significant risks to U.S. competitiveness, economic growth and national security. The Court has had opportunities to rectify its patent sinkhole but recently declined another chance to mend the chaos. When the Court denied certiorari in American Axle v. Neapco—despite the Solicitor General’s plea to hear the case—it became clear that Congress must step in to rescue U.S. innovation.

Supreme Court’s Denial of Juno Therapeutics is Another Blow to the Life Science Patent Industry

On November 7, the U.S. Supreme Court issued an order list showing that it had denied the petition for writ of certiorari filed in Juno Therapeutics, Inc. v. Kite Pharma, Inc. In denying the petition, the Court refused yet again to clarify the Federal Circuit’s questionable interpretation of U.S. patent code, this time within the context of the written description requirement of 35 U.S.C. § 112, and leaves in place an appellate court ruling that many believe will be very damaging to the United States’ life sciences innovation sector.

Supreme Court Grants Two IP Cases, Including Amgen v. Sanofi on Enablement

The U.S. Supreme Court granted petitions for certiorari in two intellectual property cases Friday, one dealing with the limits of extraterritorial application of the Lanham Act and another asking the High Court to weigh in on whether “enablement” means a specification must enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation.

Jim Jordan Letter to Vidal on West Virginia v. EPA Could Implicate USPTO’s Section 101 Subject Matter Eligibility Guidelines

On November 1, Representative Jim Jordan (R-OH) sent letters to several federal agency heads, including Kathi Vidal, Director of the U.S. Patent and Trademark Office (USPTO), asking those officials what their agencies had done to respond to the U.S. Supreme Court’s mandate in West Virginia v. Environmental Protection Agency decided this June. While Jordan’s letter is clearly responding to political developments during the Biden Administration, West Virginia has garnered interest among some patent industry stakeholders responding to recent USPTO rulemaking surrounding subject matter eligibility under 35 U.S.C. § 101.

Amici Back Jump Rope Company in Supreme Court Case

Three amici filed briefs last week in Jump Rope System’s petition asking the U.S. Supreme Court to review a U.S. Court of Appeals for the Federal Circuit (CAFC) decision upholding a Patent Trial and Appeal Board (PTAB) finding of unpatentability. Eagle Forum Education and Legal Defense Fund and the Fair Inventing Fund filed briefs in support of the jump rope company while DivX filed in support of neither party .

Jump Rope Systems, the inventor of a novel jump rope system, is petitioning the Supreme Court to clarify “whether, as a matter of federal patent law, a determination of unpatentability by the Patent Trial and Appeal Board in an inter partes review proceeding, affirmed by the Federal Circuit, has a collateral estoppel effect on patent validity in a patent infringement lawsuit in federal district court.”

Interactive Wearables is Not the 101 Case That You’ve Been Waiting For

On October 3, the U.S. Supreme Court once again requested the views of the Solicitor General (SG) in a Section 101 case, Interactive Wearables v. Polar Electric Oy. Last summer, there was excitement in the patent community when the SG, whose advice the Court usually follows, recommended granting review in American Axle v. Neapco. Although that petition was ultimately denied, this new case purports to fit the mold of American Axle. This has led some to hope that Interactive Wearables will also get the nod from the SG—and perhaps High Court review. To those eager for a Supreme Court decision that reins in patent eligibility jurisprudence, however, I regret to inform you that Interactive Wearables will not be that case. This case is quite unlike American Axle—and its claimed invention is in the heartland of what should be ineligible subject matter.

Presenting the Evidence for Patent Eligibility Reform: Part III – Case Studies and Litigation Data Highlight Additional Evidence of Harm

Systemic-level studies and data regarding impact on investment and innovation, as detailed in Part II of this series, are not the only way to demonstrate the substantial harm that the current state of patent eligibility has inflicted on the U.S. innovation ecosystem. Other robust evidence shows that current Section 101 law has harmed innovation by removing the incentives to develop and commercialize particular inventions of public importance. As another form of harm, the vagueness and breadth of the Alice/Mayo framework have also enabled accused infringers to transmogrify Section 101 into a litigation weapon in inappropriate cases that has created unnecessary burdens and costs on innovators and the courts.

SCOTUS Justices Lob Tough Questions at Both Sides in Prince-Photo Fair Use Fight

The Supreme Court today heard oral arguments in The Andy Warhol Foundation v. Lynn Goldsmith, a case asking the nation’s highest court to determine whether Warhol’s unlicensed use of Goldsmith’s photographs of pop superstar Prince was a fair use of that copyright-protected photo. Many of the Supreme Court’s questions focused on the scope of the use at issue in the case, as well as the extent of the new meaning or message that a purportedly derivative work must take on before it is considered transformative under factor one of the four-factor fair use test.

Presenting the Evidence for Patent Eligibility Reform: Part II – Harm to R&D Investment, Innovation and U.S. Interests

The muddled state of patent eligibility law has direct and significant negative consequences for U.S. R&D investment, and for innovation in key fields of medical, economic, and strategic importance to the United States and its citizens. Uncertainty reduces R&D investment, as has been well-documented, and reliable patent protection mitigates uncertainty and generates increased R&D investment. As we explained in Part I of this series, the experts overwhelmingly agree on these points.

Amgen Says Solicitor General’s ‘Disagreement With Everyone’ Further Supports SCOTUS Review of Legal Standard for Enablement

On October 5, American biopharmaceutical firm Amgen filed a supplemental brief at the U.S. Supreme Court, which comes about two weeks after the U.S. Solicitor General’s office filed a brief urging the Court to deny certiorari on Amgen’s petition for writ. Amgen’s petition seeks Supreme Court review of rulings in the lower courts invalidating Amgen’s patent claims for lack of enablement. Amgen’s latest brief argues that Solicitor General’s own arguments further support Supreme Court review to clarify the proper standard for reviewing questions of enablement under 35 U.S.C. § 112.

SCOTUS Week in Review: Cert Denied in Cases Challenging Fairness of IPR Institutions, Application of Alice/Mayo; SG Briefing Requested in Teva’s ‘Skinny Label’ Case

On October 3, the U.S. Supreme Court entered an order list in which it denied petitions for writ of certiorari in several cases involving questions under U.S. patent law. In rejecting these appeals, the Supreme Court declined to clarify aspects of the written description requirement under 35 U.S.C. § 112, the patent eligibility standard under the Court’s two-step framework for 35 U.S.C. § 101 subject matter eligibility, and whether institution decisions at the Patent Trial and Appeal Board (PTAB) violate constitutional due process. The Supreme Court did, however, invite the U.S. Solicitor General to file a brief on Teva’s petition challenging the Federal Circuit’s induced infringement ruling over Teva’s “skinny label,” and the Court granted cert in a case that questions whether online platforms face liability for aiding and abetting terrorist acts if they offer services that are used by terrorist organizations.

Presenting the Evidence for Patent Eligibility Reform: Part I – Consensus from Patent Law Experts

Patent eligibility law in the United States is in a state of disarray that has led to inconsistent case decisions, deep uncertainty in the innovative, investment and legal communities, and unpredictable outcomes in patent prosecution and litigation. These facts have been extensively documented in multiple sources, including: the statements of all 12 active judges of the nation’s only patent court, the U.S. Court of Appeals for the Federal Circuit (confirmed prior to October 2021); the findings and reports of the Executive branch across all recent Administrations; the bi-partisan conclusions of Congressional committees; a robust body of academic studies; and at least forty separate witness statements at the 2019 hearings on this issue before the Senate Committee on the Judiciary Subcommittee on IP, including statements from advocates that oppose Section 101 reforms.

Life Sciences Patents After American Axle — Grave Danger or Temporary Uncertainty?

The Federal Circuit’s denial of en banc rehearing and the Supreme Court’s denial of certiorari review mean the decision in American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, 967 F.3d 1285 (Fed. Cir. 2020), is the latest word on subject-matter eligibility under 35 U.S.C. § 101. In American Axle, the Federal Circuit applied the Supreme Court’s two-part Alice/Mayo test to hold a method for manufacturing driveline propeller shafts with liners designed to attenuate vibrations invalid as directed to a use of a natural law. The Federal Circuit characterized the claims as simply “[c]laiming a result” without “limiting the claim to particular methods of achieving the result. . . .”  Id. at 1295. The method claims were directed to nonpatentable subject matter because, even though neither the claims nor the specification explicitly referenced a natural law, the method steps required the application of a natural law, “and nothing more.”  Id. at 1297. Although the panel in American Axle stressed its decision was consistent with Supreme Court and Federal Circuit precedent, see 967 F.3d 1295, 1296 (“Our cases as well have consistently rejected such claims as unpatentable.”), its rationale, literally applied, jeopardizes broad categories of patent claims that have traditionally been considered patent-eligible subject matter.

Hip-Hop Producer’s SCOTUS Petition Argues Ninth Circuit was Improperly Indifferent to ‘Unique, Paramount Issue’ of Subject Matter Jurisdiction

This week, the U.S. Supreme Court docketed a petition for certiorari filed on September 17 by hip-hop producer Gary Frisby, who performs under the name G-Money, asking the Court to revive his musical composition copyright case that alleged infringement of Frisby’s 2013 beat track “Shawty So Cold.” Frisby’s appeal challenges the U.S. Court of Appeals for the Ninth Circuit’s ruling that the appellate court lacked subject matter jurisdiction over Frisby’s appeal from U.S. district court because he failed to file a notice of appeal, despite the fact that the court failed to inform Frisby that the ruling on summary judgment was filed.