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DNA Genotek Inc. v. Spectrum Solutions LLC (Fed. Cir. 2025)

Sometimes important contributions to innovation can come from the mundane rather than the extraordinary. One (perhaps apocryphal) example comes from the story of the early development of television by Philo Farnsworth (the...more

Immunogen, Inc. v. Stewart (Fed. Cir. 2025)

After creating something of a frisson due to the apprehension that the Federal Circuit might be convinced to re-evaluate whether it was a necessary element for establishing obviousness for the skilled artisan to have had a...more

USPTO Challenges Reasonable Expectation of Success Prong of Obviousness Law Precedent in Immunogen v. Vidal

The U.S. Patent and Trademark Office has a history of attempting to challenge judicial decisions that the Office, usually for its own policy reasons, takes issue with.[1]  Recently, the Office decided to challenge the...more

FTC Warns Pharma Companies It Means Business with Its Orange Book Listing Policy

Policy differences are endemic in politics, and the phrase "causing more heat than light" regarding federal drug policy comes readily to mind listening to the rhetoric coming from the Federal Trade Commission in this regard. ...more

Blue Whale Genome Determined: Implications

The "genome revolution" over the past 30 years has resulted in the elucidation of several species, both domesticated (see, e.g., "The Genetic Basis of Coat Variation in Dogs"; "Further and More Detailed Study of Domestic Cat...more

Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. (Fed. Cir. 2024)

A fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor...more

Cardiovalve Ltd. v. Edwards Lifesciences Corp. (Fed. Cir. 2024)

Last week, the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings. This post concerns the decision in Cardiovalve Ltd....more

Medtronic, Inc. v. Teleflex Life Sciences Ltd. (Fed. Cir. 2024)

Last week the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings.  This post concerns the decision in Medtronic, Inc....more

United Therapeutics Corp. v. Liquidia Technologies, Inc. (Fed. Cir. 2023)

In earlier times, the Federal Circuit, responding to efforts by the U.S. Patent and Trademark Office to reject patent applications directed to biotechnology-related inventions, held (In re Brana) that utility of such...more

Amici Support Reversal of PTAB Decision in CRISPR Interference

Two amici have filed briefs in support of the appeal by Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") of the decision by the Patent Trial and...more

Broad Files Opening Brief and Cross-Appeal in CRISPR Interference

The decision by the Patent Trial and Appeal Board (PTAB) in favor of Senior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") and against Junior Party the University of California/Berkeley, the...more

CVC Appeals PTAB Decision in CRISPR Interference

The decision by the Patent Trial and Appeal Board (PTAB) in favor of Senior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") and against Junior Party the University of California/Berkeley, the...more

Medytox, Inc. v. Galderma S.A. (Fed. Cir. 2023)

It is not surprising that the Federal Circuit has taken the opportunity to apply the Supreme Court's recent precedent in Amgen v. Sanofi regarding the sufficiency of disclosure needed to satisfy the statutory enablement...more

Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2023)

In its recent review of a district court decision the Federal Circuit characterized as "a thorough opinion," the Federal Circuit affirmed invalidation for obviousness of four claims from four different Orange Book-listed...more

Supreme Court Renders Decision in Amgen v. Sanofi: Three Takeaways

The Supreme Court handed down its decision in Amgen v. Sanofi today. In Justice Gorsuch’s unanimous opinion, the Court held that the scope of the claims at issue were much broader than the 26 expressly disclosed antibodies....more

Supreme Court Decides Amgen v. Sanofi; Status Quo Extended

The Supreme Court handed down its decision in Amgen v. Sanofi today. In Justice Gorsuch’s unanimous opinion, the Court held that the scope of the claims at issue were much broader than the 26 expressly disclosed antibodies....more

Senate Once Again Tries to Address Drug Pricing

Over the past several years Congress has tried to address high drug prices, with variable success  (see "FTC to the Rescue Regarding High Drug Prices and Patents"; "Even More Ill-Conceived Remedies from Congress Regarding...more

Amicus Briefing in Amgen v. Sanofi: The Rest of the Story - Part III

The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. § 112(a) has been occasioned for the first time in over a century by the Court's granting certiorari in Amgen v....more

Amicus Briefing in Amgen v. Sanofi: The Rest of the Story - Part II

The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. § 112(a) has been occasioned for the first time in over a century by the Court's granting certiorari in Amgen v....more

Amicus Briefing in Amgen v. Sanofi: The Rest of the Story

The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. 112(a) has been occasioned for the first time in over a century by the Court's granting certiorari in Amgen v. Sanofi. ...more

Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2023)

An appellant's burden on appeal is never easy but it is particularly difficult when the questions at issue are based on factual evidence.  The appellate judiciary is loathe (generally) to second guess a district court judge...more

The Supreme Court Grapples with Patent Enablement - April 2023

The Supreme Court heard oral argument in Amgen v. Sanofi last week in an extended session with argument from the parties and the U.S. government.  Petitioner was represented by Jeffrey Lamken, Respondents by Paul Clement, and...more

Esteemed Scientists File Amicus Brief in Amgen v. Sanofi on Respondents' Behalf

During oral argument before the Supreme Court on Monday in Amgen v. Sanofi, all three advocates (Jeff Lamken for Amgen, Paul Clement for Sanofi, and Colleen Sindzak for the United States) had reason to reference and discuss...more

The Supreme Court grapples with patent enablement

The Supreme Court heard oral arguments in Amgen v. Sanofi yesterday in an extended session with arguments from the parties and the U.S. government. The Justices showed a great deal of interest, albeit with some difficulty,...more

Another Group of Law Professors File Amicus Brief in Amgen v. Sanofi

The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35...more

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