Author Info for Proskauer - Life Sciences

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

Michelle Ovanesian

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

See all updates »

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

See all updates »

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

See all updates »

Anisha Shenai-Khatkhate

Update on Artificial Intelligence: USPTO Urges Federal Circuit to Affirm Decision That AI Cannot Qualify as an “Inventor”

In three previous blog posts, we have discussed recent inventorship issues surrounding Artificial Intelligence (“AI”) and its implications for life sciences innovations – focusing specifically on scientist Stephen Thaler’s…more

Artificial Intelligence, Innovative Technology, Intellectual Property Protection, Inventions, Inventors

See all updates »

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

See all updates »

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

See all updates »

Proskauer - Life Sciences

"My best business intelligence, in one easy email…"

"My best business intelligence,
in one easy email…"