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Patent Infringement Petition for Writ of Certiorari Pharmaceutical Patents

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

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions: Mylan Labs. Ltd v. Janssen Pharmaceutica, N.V.,...

Mylan appealed from a Patent Trial and Appeal Board (Board) discretionary denial of institution of an inter partes review (IPR) proceeding. The Board declined to institute Mylan’s IPR under NHK-Fintiv, a multi-factor analysis...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions

[co-author: Jamie Dohopolski] Last year, the continued global COVID-19 pandemic forced American courts to largely continue the procedures set in place in 2020. The U.S. Court of Appeals for the Federal Circuit was no...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

Haug Partners LLP

Are Biopharma Genus Patent Claims Dead?

Haug Partners LLP on

A recent Supreme Court petition for certiorari alleges that genus claims are no longer viable under the Federal Circuit’s recent application of enablement and written description law.The petition has huge ramifications not...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - November 2020 #3

C.R. Bard Inc. v. AngioDynamics, Inc., Appeal No. 2019-1756, -1934 (Fed. Cir. Nov. 10, 2020) - Our Case of the Week is one of two cases decided this week in which the Federal Circuit finds that a district court jumped the...more

McDonnell Boehnen Hulbert & Berghoff LLP

DOE Infringers Petition for Certiorari over PHE "Tangential Relationship" Test

Recently, the Federal Circuit has taken up issues relating to infringement under the doctrine of equivalents (DOE) and a related doctrine, prosecution history estoppel (PHE), that limits the scope of equivalents that can be...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

Goodwin

Supreme Court Declines to Review Scope of Section 271(e)(1) Safe-Harbor

Goodwin on

Earlier this week, the United States Supreme Court denied Amphastar Pharmaceutical’s petition for certiorari regarding the scope of the safe-harbor of 35 U.S.C. § 271(e)(1), a provision that generic drug and biosimilar makers...more

Patterson Belknap Webb & Tyler LLP

Apotex Prevails in Neulasta Biosimilar Litigation, Files for Cert on 180-Day Issue

Among the first generation of biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA) is a dispute between Amgen and Apotex over Apotex’s proposed biosimilar versions of Amgen’s Neupogen...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

Federal Circuit Denies En Banc Petition in Amgen v. Sandoz

The Federal Circuit today denied the petitions for rehearing by the panel and rehearing by the en banc Court filed by both parties in Amgen v. Sandoz. Amgen had petitioned for rehearing on the panel's decision that the...more

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