Posts Tagged: "enablement"

Amici Filings in Amgen Encourage the Supreme Court to Correct the Federal Circuit’s ‘Unworkable’ Enablement Standard

On January 3, a total of 14 amicus briefs and one motion for leave to participate in oral argument were filed with the U.S. Supreme Court on the question presented by Amgen Inc. v. Sanofi, on which the Supreme Court granted certiorari this past November. While organizations representing the most powerful interests in the technology industry supported the Federal Circuit’s holding that Amgen’s patent claims were invalid for lack of enablement, a wide swath of patent stakeholders are urging the Supreme Court to correct the enablement standard to continue the encouragement of genus patent claims. Below is a collection of arguments raised by several of the recent amicus filings from earlier this week.

Juno v. Kite: A Rare Opportunity for the Supreme Court to Grant Rehearing

The patent world is trained on the upcoming Supreme Court Amgen v. Sanofi case. That case is the first time in over 75 years that the Supreme Court is evaluating the meaning and scope of the enablement requirement of 35 U.S.C. § 112. The case offers the Court an opportunity to correct a negative trend in enablement law that has made it more difficult to protect groundbreaking, pioneering inventions. Waiting in the wings, however, is an equally important Section 112 case: . There, the petitioner sought review on whether “the ‘written description of the invention’ [is] to be measured by the statutory standard of ‘in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the same.’” As is apparent, Juno’s written description issue is highly intertwined with the Section 112 enablement issue in Amgen v. Sanofi.

Juno Asks Supreme Court to Reconsider Denial of Petition on Section 112 Question in Light of Amgen Review

Following the denial of Juno Therapeutics’ petition to the U.S. Supreme Court earlier this month, Juno last week petitioned the High Court for rehearing, arguing that the grant of certiorari in Amgen v. Sanofi warrants reconsideration. Juno explained that the issues presented in the Amgen case “are tightly related, and the outcome in Amgen is likely to at least affect, if not be outcome-determinative of, this case.” Juno is asking that the Court grant the petition for rehearing, vacate the denial of certiorari, and hold the case pending the outcome in Amgen.

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.

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.