Author Info for Proskauer - The Patent Playbook

Isaiah Anderson

Eyes Open to the Past: Federal Circuit Holds Prosecution History Is Claim Construction Evidence

The Federal Circuit’s decision in Eye Therapies, LLC v. Slayback Pharma, LLC provides further insight into the tools available for patent claim construction. The Federal Circuit had previously held that a patent’s specification… more

CAFC, Claim Construction, Generic Drugs, Inter Partes Review (IPR) Proceeding, Obviousness

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James Anderson

U.S. Medical Device Manufacturers Should Take Note of New European Medical Device Regulations

The European Union has been a leader in recent years when it comes to regulatory reform intended to protect individuals’ privacy, safety, and health. As Europe leads the way, regulators in the United States often follow suit on… more

Cybersecurity, EU, Life Sciences, Manufacturers, Medical Devices

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Colin Cabral

"Commercially Reasonable Efforts” Clauses in Drug Development Deals: What Level of Protection Do They Really Provide?

Pharmaceutical drug development is expensive. One recent study estimates that the median cost to develop a new drug is $985 million, while the average is $1.3 billion. And those figures appear to be on the low end of a broad… more

Commercially Reasonable Efforts, Contract Terms, Drug Design, Funding Arrangements, IP License

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Robert Cantone

BridgeBio Transaction Reflects Healthy Market for FDA Priority Review Vouchers

BridgeBio’s recently announced sale of an FDA Priority Review Voucher for $110 million reflects a robust secondary market for these regulatory fast passes. Prices for Priority Review Voucher (“PRVs”) reflect the high stakes… more

Biologics, Expedited FDA Approval, Food & Drug Regulations, Food and Drug Administration (FDA), Healthcare

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Fangli Chen Ph.D.

Novo Nordisk v. Mylan: Method of Treatment Claims Must Be Aligned with Label

Method-of-treatment (“MoT”) claims can be powerful tools for pharmaceutical companies seeking to extend market exclusivity for their products after the original composition-of-matter patents expire. However, the District of… more

Abbreviated New Drug Application (ANDA), Food and Drug Administration (FDA), Hatch-Waxman, Induced Infringement, Method Claims

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Sarah Cork Ph.D.

In the Orphan Drug Approval Race, Winner Takes All? Ramifications of Catalyst Pharms. v. Becerra

How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for? By way of background, a sponsor can obtain orphan drug… more

Biopharmaceutical, FDA Approval, Food and Drug Administration (FDA), Generic Drugs, Life Sciences

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Joseph Drayton

AI, Algorithms and Abstract Ideas: Federal Circuit Reinforces Limits in Recentive v. Fox

In April, the Federal Circuit issued a significant patent law ruling involving artificial intelligence. In Recentive Analytics, Inc. v. Fox Corp, the Court addressed a core question facing many AI-driven businesses: When are… more

Algorithms, Appeals, Artificial Intelligence, CAFC, Innovative Technology

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Christine Espino, PhD

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s perceived… more

Biden Administration, Biosimilars, Biotechnology, Competition, Drug Pricing

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Lawrence Frank Ph.D.

The Supreme Court Kept the Door Open to Genus Claims

The U.S. Supreme Court on May 18, 2023 delivered its decision on the scope of the patent enablement requirement, set forth in 35 U.S.C. § 112, in the antibody dispute Amgen, Inc. v. Sanofi. While the parties obtained finality,… more

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Russell Gorkin

"Commercially Reasonable Efforts” Clauses in Drug Development Deals: What Level of Protection Do They Really Provide?

Pharmaceutical drug development is expensive. One recent study estimates that the median cost to develop a new drug is $985 million, while the average is $1.3 billion. And those figures appear to be on the low end of a broad… more

Commercially Reasonable Efforts, Contract Terms, Drug Design, Funding Arrangements, IP License

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Siegmund Gutman

The Seventh Circuit Asks, “What’s Wrong With Having Lots of Patents?”

The answer? Not much, in itself. If one patent is good, 132 is probably fine too. That was Judge Easterbrook’s reasoning in a recent decision addressing indirect purchasers’ antitrust challenge to AbbVie’s so-called “patent… more

Patents, Pharmaceutical Patents, Sherman Act

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Erik Milch

Federal Circuit Lifts § 101 Barrier on Smart Dumbbells

On August 11, 2025, the Federal Circuit reversed the District of Utah’s ruling that all but one of the claims in PowerBlock Holdings, Inc.’s U.S. Patent No. 7,578,771 were invalid under 35 U.S.C. § 101. PowerBlock Holdings,… more

Abstract Ideas, Appeals, Appellate Courts, CAFC, Intellectual Property Litigation

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David Munkittrick

The Seventh Circuit Asks, “What’s Wrong With Having Lots of Patents?”

The answer? Not much, in itself. If one patent is good, 132 is probably fine too. That was Judge Easterbrook’s reasoning in a recent decision addressing indirect purchasers’ antitrust challenge to AbbVie’s so-called “patent… more

Patents, Pharmaceutical Patents, Sherman Act

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Christopher Ondeck

The Seventh Circuit Asks, “What’s Wrong With Having Lots of Patents?”

The answer? Not much, in itself. If one patent is good, 132 is probably fine too. That was Judge Easterbrook’s reasoning in a recent decision addressing indirect purchasers’ antitrust challenge to AbbVie’s so-called “patent… more

Patents, Pharmaceutical Patents, Sherman Act

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Michelle Ovanesian

Value and Risk of Overlapping Intellectual Property Protections

A well-orchestrated intellectual property strategy requires carefully and thoughtfully leveraging copyright, trademark, and patent laws, as highlighted by a recent decision handed down by the United Sates Court of Appeals for… more

Appeals, Functionality, Intellectual Property Litigation, Litigation Strategies, Patent Litigation

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Marc Palmer

Navigating Parallel Proceedings: Lessons Learned As Time Runs Out for AliveCor in its Apple Smartwatch Patent Dispute

On March 7, 2025, the Federal Circuit issued a decision resolving the ongoing patent litigation between AliveCor and Apple concerning methods of cardiac monitoring purportedly employed in certain of Apple’s Watches. The Court’s… more

Appeals, Discovery Disputes, Inter Partes Review (IPR) Proceeding, International Trade Commission (ITC), Medical Devices

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Nicholas Prairie

Novo Nordisk v. Mylan: Method of Treatment Claims Must Be Aligned with Label

Method-of-treatment (“MoT”) claims can be powerful tools for pharmaceutical companies seeking to extend market exclusivity for their products after the original composition-of-matter patents expire. However, the District of… more

Abbreviated New Drug Application (ANDA), Food and Drug Administration (FDA), Hatch-Waxman, Induced Infringement, Method Claims

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William Rose

Skinny Labels May Not Be Dead: Delaware District Court Distinguishes GSK, Dismisses Induced Infringement Claim

In one of the first district court opinions applying the Federal Circuit’s recent GSK decision on induced infringement in the context of label carve-outs, Judge Richard Andrews in the District of Delaware held that plaintiff… more

Amarin, Generic Drugs, GlaxoSmithKline, Induced Infringement, JMOL

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Elizabeth Shrieves

PTO Defends its Recent Policy Changes Regarding Discretionary Denials

In the past few months, the U.S. Patent and Trademark Office (“PTO”) Acting Director has made substantial changes to the process for, and factors considered in, exercising discretion to deny institution of an inter partes review… more

Administrative Authority, Administrative Procedure, Appeals, Appellate Courts, Due Process

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Gourdin Sirles

“Negative” Patent Claim Limitations—May They be Adequately Described by Omission?

Patent claim limitations that are “negative”—that is, claim limitations specifying the absence of a particular element from the patent claim—can pose a dilemma in the written description context. How much of the specification… more

Intellectual Property Protection, Life Sciences, Novartis, Patent Infringement, Patent Litigation

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Alan Teran Ph.D.

Crypto Unlocked: New Patent Eligibility Guidance on Blockchain Technology

The U.S. gave crypto one of its biggest regulatory jolts in years. With the signing of the Guiding and Establishing National Innovation for U.S. Stablecoins (“GENIUS”) Act stablecoins now have a legal framework. The GENIUS Act… more

Abstract Ideas, Alice/Mayo, Blockchain, Cryptocurrency, Emerging Technologies

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Margaret Ukwu

The Crucial Role of Patent Due Diligence in Mergers & Acquisitions: Spotting Patent Litigation Risks Before Closing a Deal

In today’s rapidly evolving business landscape, mergers and acquisitions (“M&A”) remain a common strategic priority for companies aiming to grow, innovate, or strengthen their market position. However, the complexity of these… more

Acquisitions, Contract Terms, Due Diligence, Intellectual Property Litigation, Mergers

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Connor Villar

Federal Circuit Lifts § 101 Barrier on Smart Dumbbells

On August 11, 2025, the Federal Circuit reversed the District of Utah’s ruling that all but one of the claims in PowerBlock Holdings, Inc.’s U.S. Patent No. 7,578,771 were invalid under 35 U.S.C. § 101. PowerBlock Holdings,… more

Abstract Ideas, Appeals, Appellate Courts, CAFC, Intellectual Property Litigation

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Baldassare Vinti

Crypto Unlocked: New Patent Eligibility Guidance on Blockchain Technology

The U.S. gave crypto one of its biggest regulatory jolts in years. With the signing of the Guiding and Establishing National Innovation for U.S. Stablecoins (“GENIUS”) Act stablecoins now have a legal framework. The GENIUS Act… more

Abstract Ideas, Alice/Mayo, Blockchain, Cryptocurrency, Emerging Technologies

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Edward Wang

Federal Circuit Reverses $4.7M Verdict in Labcorp v. QIAGEN: Claim Scope and Doctrine of Equivalents in the Crosshairs

The Federal Circuit recently reversed a $4.7M verdict in a patent lawsuit involving two patents concerning next-generation sequencing methods—U.S. Patent Nos. 10,017,810 and 10,450,597. Both patents concern DNA preparation using… more

Appeals, Appellate Courts, Biotechnology, CAFC, Claim Construction

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