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Pharmaceutical Patents Petition for Writ of Certiorari Pharmaceutical Industry

Jones Day

U.S. Supreme Court Invites Solicitor General to Submit Briefing on "Skinny Labels"

Jones Day on

On June 23, 2025, the Supreme Court invited the Solicitor General to submit a brief expressing the views of the United States—dramatically increasing the likelihood that the Court will eventually grant review—in Hikma...more

McDonnell Boehnen Hulbert & Berghoff LLP

In re Cellect in View of Supreme Court's "Long Conference" – Part II

In view of the Supreme Court's "long conference" on September 30th, it seems timely to review the arguments, pro, con, and amicus briefs submitted to the Court asking for certiorari over the Federal Circuit's In re...more

Foley Hoag LLP

Previewing Generic’s Skinny Label: Supreme Court to Rule on Teva’s Certiorari Petition

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The Supreme Court is expected to consider Teva’s pending petition for certiorari in the highly anticipated GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. on May 11, 2023, a case that could carry enormous implications for the...more

BakerHostetler

Juno Therapeutics Requests That the Supreme Court Wait to Make a Decision on Its Written Description Question Until Amgen’s...

BakerHostetler on

Juno Therapeutics (Juno) has filed a Petition for Rehearing with the Supreme Court, requesting that the Court vacate its previous order denying Juno’s petition for certiorari and hold the case in abeyance pending the...more

Knobbe Martens

Medical Device Patentee Petitions Supreme Court Regarding On-Sale Bar and Price Quotes

Knobbe Martens on

A medical device patentee has asked the U.S. Supreme Court to save his design patent, related to an introducer sheath handle, from invalidity based on application of the “on-sale” bar, which prohibits patenting an invention...more

Rothwell, Figg, Ernst & Manbeck, P.C.

A Potential Pivot in Patent Procedure – Will the Supreme Court Hear Amgen’s Challenge to the Standard of Review for Enablement?

As we have previously discussed, on February 11, 2021, the Federal Circuit decided Amgen Inc. et al. v. Sanofi, Aventisub LLC, et al. The Federal Circuit affirmed the district court’s grant of JMOL that Amgen’s Repatha®...more

Kilpatrick

Balancing Hatch Waxman and the Sham Litigation Exception

Kilpatrick on

As previously reported on March 31, 2021, AbbVie Inc. has petitioned the U.S. Supreme Court for a writ of certiorari to review the Third Circuit’s ruling determining the biopharma company’s patent infringement suit was a sham...more

Foley & Lardner LLP

Unpacking The Solicitor General’s Brief In Vanda

Foley & Lardner LLP on

Responding to the invitation from the Supreme Court, the Solicitor General for the United States has filed an amicus brief for the United States in Hikma Pharmaceuticals USC Inc. v. Vanda Pharmaceuticals Inc. Stakeholders...more

McDonnell Boehnen Hulbert & Berghoff LLP

Solicitor General Recommends That Supreme Court Deny Certiorari in Hikma Pharmaceuticals v. Vanda Pharmaceuticals

On Friday, December 6, 2019, the United States filed its brief in response to the March 18, 2019 order of the Supreme Court inviting the Solicitor General to express the views of the United States on the petition for...more

Jones Day

PTAB Denies Stay Pending Sovereign Immunity Cert Petition

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In Microsoft Corp. v. Saint Regis Mohawk Tribe, the PTAB refused to stay ten IPRs filed by Microsoft while Patent Owner St. Regis appeals a Federal Circuit decision that tribal sovereign immunity cannot be asserted in an IPR...more

Herbert Smith Freehills Kramer

Supreme Court Issues Highly Anticipated Decision Interpreting the Biologics Price Competition and Innovation Act

On June 12, the Supreme Court decided Sandoz Inc. v. Amgen Inc., the first case under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) to reach the high court. The BPCIA establishes a regulatory pathway for...more

Herbert Smith Freehills Kramer

Supreme Court to Consider Biologics Price Competition and Innovation Act

On Friday, Jan. 13, the Supreme Court granted the appellant’s petition and the respondent’s cross-petition for a writ of certiorari in Sandoz Inc. v. Amgen Inc. This is the first time the Court will construe the Biologics...more

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Releases Memorandum on Subject Matter Eligibility

On May 4th the U.S. Patent and Trademark Office issued its latest Guidance on how Examiners are to apply recent U.S. Supreme Court and Federal Circuit precedent related to subject matter eligibility (see "USPTO Issues Update...more

Foley & Lardner LLP

Federal Circuit Requires 180 Day Notice For All Biosimilars, Even After Patent Dance

Foley & Lardner LLP on

In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics...more

McDonnell Boehnen Hulbert & Berghoff LLP

Guest Post: Coalition for 21st Century Medicine Comments on Expected Ariosa Cert Petition

The collective experience of the Members of the Coalition for 21st Century Medicine in trying to obtain much needed patent protection for their novel, life-saving technologies has led to one inescapable conclusion: It is...more

BakerHostetler

Sandoz Requests Supreme Court Review of the Federal Circuit’s Interpretation of Biosimilar Law

BakerHostetler on

On February 16, 2016, Sandoz Inc. filed a petition for a writ of certiorari with the U.S. Supreme Court, asking the Court to review the Federal Circuit’s interpretation of the Biologics Price Competition and Innovation Act...more

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