News & Analysis as of

Pharmaceutical Industry › Statutory Interpretation › Patents

Robins Kaplan LLP

Liquidia Techs., Inc. v. FDA - Updated 5.2.25

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: FDA refused to approve Liquidia’s drug product, Yutrepia because another company, UTC, maintained marketing exclusivity. Liquidia sued FDA, and UTC intervened. The court granted...more

McDermott Will & Schulte

Prosecution history primacy: “Consisting essentially of” means what applicant said it meant

McDermott Will & Schulte on

In a decision that underscores the primacy of prosecution history to determine claim scope, the US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s interpretation of the transitional phrase...more

McDermott Will & Schulte

No Article III Appellate Standing Under the Sun

McDermott Will & Schulte on

The US Court of Appeals for the Federal Circuit dismissed Incyte’s appeal of a Patent Trial & Appeal Board decision, holding that a disappointed validity challenger lacked appellate standing to challenge the Board’s final...more

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

Hatch-Waxman Requires Patent Term Extension for Reissued Patents To Be Based on Original Patent

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

The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent,...more

Irwin IP LLP

Federal Circuit Finds Against Generics Where Hatch-Waxman's Full Five-Year Extension Fixes Delay For Pharmaceutical FDA-Review  

Irwin IP LLP on

Merck Sharp & Dohm B.V. v. Aurobindo Pharma USA, Inc. et al (Fed. Cir. March 13, 2025) - The Hatch-Waxman Act seeks to strike a balance in the pharmaceutical industry by incentivizing drugs makers to develop innovative...more

McDonnell Boehnen Hulbert & Berghoff LLP

Aurobindo v. Merck Sharp and Dohme -- Oral Argument

McDonnell Boehnen Hulbert & Berghoff LLP on

The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme). The issue...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit: Patent Must Claim Active Ingredient for Orange Book Listing

Rothwell, Figg, Ernst & Manbeck, P.C. on

On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more

Proskauer - The Patent Playbook

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

Proskauer - The Patent Playbook on

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

Proskauer - Minding Your Business

Generic Competition for Withdrawn Drug Products

Proskauer - Minding Your Business on

When a pharmaceutical company withdraws a product from the market, the basis for the withdrawal can affect whether a competitor can commercialize a generic version of that product. A generic cannot be approved if, in the...more

Mintz - Intellectual Property Viewpoints

Written Description in Amgen v. Sanofi: Is the Federal Circuit Possessed? Will SCOTUS Grant Certiorari?

Mintz - Intellectual Property Viewpoints on

In the continuing Amgen v. Sanofi saga, Amgen has asked SCOTUS to take up the issue of written description, which is currently established by showing “whether the disclosure…reasonably conveys…that the inventor had possession...more

10 Results
 / 
View per page
Page: of 1

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

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide