Author Info for Proskauer - The Patent Playbook

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.

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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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

Federal Circuit Affirms Stem Cell Product-by-Process Claims: Lessons in Claim Construction and Inherency from Restem LLV v. Jadi Cell LLC

The Federal Circuit issued a precedential opinion on March 4, 2025, that serves as valuable guidance for product-by-process claims, particularly in the context of inherency in claim construction. In Restem, LLC v. Jadi Cell,…more

Appeals, Biotechnology, Claim Construction, Inherency, Inter Partes Review (IPR) Proceeding

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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 Affirms Stem Cell Product-by-Process Claims: Lessons in Claim Construction and Inherency from Restem LLV v. Jadi Cell LLC

The Federal Circuit issued a precedential opinion on March 4, 2025, that serves as valuable guidance for product-by-process claims, particularly in the context of inherency in claim construction. In Restem, LLC v. Jadi Cell,…more

Appeals, Biotechnology, Claim Construction, Inherency, Inter Partes Review (IPR) Proceeding

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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

Litigating Patents in the ITC: When and Why Companies Take the Section 337 Route

Formerly a niche venue for trade-related matters, the International Trade Commission (“ITC”) has emerged as a battleground for many high stakes intellectual property disputes, particularly in the technology, life sciences, and…more

International Trade, International Trade Commission (ITC), Jurisdiction, Life Sciences, Litigation Strategies

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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

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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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

Further Shifts in Patent Office Guidance for Discretionary Denials Signal Uphill Battles for Patent Challengers

On the heels of the rescission of the Fintiv guidance memorandum, the U.S. Patent and Trademark Office has again reshaped the PTAB’s approach to discretionary denials. On March 26, 2025, the Acting Director issued a new…more

Corporate Counsel, Filing Deadlines, Intellectual Property Litigation, Inter Partes Review (IPR) Proceeding, New Guidance

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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.

Patent Litigation and the Rise of Quantum Computing: What to Watch for in the Next Decade

A recent Patent Trial and Appeal Board decision related to hybrid quantum computing paves the way for more quantum computing-related patents, and potential litigation…more

Algorithms, Corporate Counsel, Innovative Technology, Intellectual Property Litigation, Intellectual Property Protection

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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 Affirms Stem Cell Product-by-Process Claims: Lessons in Claim Construction and Inherency from Restem LLV v. Jadi Cell LLC

The Federal Circuit issued a precedential opinion on March 4, 2025, that serves as valuable guidance for product-by-process claims, particularly in the context of inherency in claim construction. In Restem, LLC v. Jadi Cell,…more

Appeals, Biotechnology, Claim Construction, Inherency, Inter Partes Review (IPR) Proceeding

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Baldassare Vinti

Alleged Theft of Drug Pricing Trade Secrets Could Cost Both Victim and Thief

Life Sciences is an area ripe for trade secrets misappropriation litigation. In recent news, Merz Pharmaceuticals, LLC filed a lawsuit under the North Carolina Uniform Trade Secrets Act alleging that its former director of…more

Commercial Litigation, Confidentiality Agreements, Customer Lists, Drug Pricing, Employment Contract

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Proskauer - The Patent Playbook

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