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Appeals Patents Biologics

Cooley LLP

End of the Road for Jepson Format Claims in the Life Sciences?

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In In re: Xencor, Inc., the US Court of Appeals for the Federal Circuit confirmed that the limiting preamble of a Jepson claim must be supported by the specification with “sufficient written description.” In its decision, the...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025) Our Case of the Week is a 31-page decision that touches on a variety of issues, including...more

Smart & Biggar

Federal Court of Appeal and Federal Court release three decisions relating to macitentan (Janssen’s OPSUMIT)

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Federal Court of Appeal (FCA) dismisses appeal on finding of inducement: Apotex Inc v Janssen Inc, 2023 FCA 220 - Apotex appealed the trial decision, finding that Apo-Macitentan would infringe Canadian Patent No. 2,659,770...more

Smart & Biggar

Federal Court of Appeal dismisses appeal, upholds strict interpretation of patent listing deadline for KEYTRUDA formulation patent

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The Federal Court of Appeal (FCA) dismissed an appeal by Merck from a decision of the Federal Court... dismissing Merck’s application for judicial review of Health Canada’s refusal to add Canadian Patent No. 2,830,806 (806...more

Fish & Richardson

2020 Post-Grant Report

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In a year of extraordinary change, the Patent Trial and Appeal Board (PTAB) rose to the challenge - Given the challenges of 2020 – a global pandemic, a deep economic recession, and a turbulent presidential election, among...more

King & Spalding

The Federal Circuit’s Ball Metal Decision Raises Important Considerations for Pharma and Biologics Patents

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The U.S. Court of Appeals for the Federal Circuit’s New Year’s eve opinion in Ball Metal v. Crown Packaging, though nonprecedential, raises important considerations for pharmaceutical and biologics patents – where patent...more

Knobbe Martens

Safe Harbor Defense Under 35 U.S.C. §271(e)(1) Requires That the Accused Activity Is Solely for Uses Reasonably Related to...

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AMGEN INC. v. HOSPIRA, INC. Before Moore, Bryson, and Chen.  Appeal from the United States District Court for the District of Delaware. Summary: Biological engineering activity that would otherwise constitute patent...more

Smart & Biggar

Rx IP Update - February 2019

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Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more

Knobbe Martens

Protecting Your Claimed Ranges

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Assertions of obviousness based on prior art references in combination with “routine optimization” by one skilled in the art are common in the chemical and biological fields. The Federal Circuit recently addressed this issue...more

Troutman Pepper Locke

Attorney General’s Office May Weigh In on Constitutionality of IPRs involving Pre-AIA Patents

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The 2011 America Invents Act (AIA) provided a variety of new ways to administratively challenge patents, including the now widely used inter partes review (“IPR”) procedure. In two recent appeals of IPR decisions, Genentech...more

Jones Day

Federal Circuit Clarifies Probative Value of Patent Dance Statements

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The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more

Snell & Wilmer

Supreme Court Permits Biosimilar Drugs to Be Marketed Sooner

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On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more

Jones Day

Supreme Court Hears Oral Arguments in Sandoz Inc. v. Amgen

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On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more

Knobbe Martens

Supreme Court Grants Certiorari in Amgen v. Sandoz

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On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

Knobbe Martens

Inherent Anticipation for Biotechnology Inventions

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Anticipation by inherent disclosure requires that a single prior art reference necessarily includes the unstated limitation. The unpredictable nature of biological processes means that winning summary judgment of invalidity...more

Patterson Belknap Webb & Tyler LLP

Amgen’s Federal Circuit Appeal: the Importance of Manufacturing Information to Biosimilar Litigation

Amgen has filed its appeal brief in Amgen v. Hospira, following the Federal Circuit’s denial of Hospira’s motion to dismiss the appeal for lack of jurisdiction. The appeal presents an important question for biosimilar...more

McDermott Will & Emery

BPCIA 180-Day Notice of Intent to Market a Biosimilar Is Required, Enforceable by Injunction

In an opinion that details many intricacies of both the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and related portions of the Patent Act, the US Court of Appeals for the Federal Circuit affirmed a...more

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

Federal Circuit Backs Amgen on Key Provision of Biosimilars Statute

The Federal Circuit on Tuesday ruled that the 180-day notice of commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is a requirement for all biosimilar applicants regardless of whether...more

Knobbe Martens

Federal Circuit Rules on Biosimilar Notice Requirement

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Biosimilar Applicants Must Provide Notice of Commercial Launch: What You Need To Know - Case Background - In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who...more

BakerHostetler

A Split Decision Remains Split; No en banc Review of Amgen v. Sandoz

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On October 16, 2015, the Court of Appeals for the Federal Circuit (“Federal Circuit”) opted not to rehear its previously issued split decision in the court’s first analysis of the Biologics Price Competition and Innovation...more

Troutman Pepper

Post-Grant Challenges in Life Sciences: A Midyear Assessment

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The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

Patterson Belknap Webb & Tyler LLP

Both Parties Seek En Banc Intervention in Amgen v. Sandoz

Last month, a divided panel of the Federal Circuit issued a split decision in Amgen v. Sandoz (summary; opinion). Amgen (in which Patterson Belknap represented one of the amici supporting Amgen) is the court’s first decision...more

K&L Gates LLP

BPCIA Statute: Patent Dance Is Optional, But Opting Out Has Consequences

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The Federal Circuit issued a ruling on July 21, 2015 in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499, appeal after hearing oral arguments on June 3, 2015. See BPCIA: A “Choose Your Own Adventure” Statute?...more

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