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Pharmaceutical Patents Patents Statutory Interpretation

McDermott Will & Emery

No Article III Appellate Standing Under the Sun

McDermott Will & Emery 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

McDonnell Boehnen Hulbert & Berghoff LLP

Recor Medical, Inc. v. Medtronic Ireland Mfg. (Fed. Cir. 2025)

The inter partes review provisions of the Leahy-Smith America Invents Act have been criticized for the propensity of the Patent Trial and Appeal Board (PTAB) to find invalid all or at least some of the challenged claims,...more

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

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

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

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

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 - Minding Your Business

Generic Competition for Withdrawn Drug Products

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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2019 #3

PATENT CASE OF THE WEEK - Blackbird Tech LLC v. Health in Motion LLC, Appeal No. 2018-2393 (Fed. Cir. Dec. 16, 2019) - In this week’s Case of the Week, the Federal Circuit affirmed a fee award against prevailing...more

McDermott Will & Emery

“Equal to” Means “Not Exceed” when Determining Patent Term Adjustment

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit found that the US Patent and Trademark Office (PTO) erred in calculating a patent term adjustment (PTA) for a patent covering an oral osmotic form of an antihypertensive drug,...more

Mintz - Intellectual Property Viewpoints

Time-Barred IPR Petitioners Have Separate Standing to Appeal PTAB Decisions

In the February 1, 2019 decision of Mylan Pharms. Inc. v. Research Corp. Techs., 2019 U.S. App. LEXIS 3282, __ F.3d __, 2019 WL 405682, the Federal Circuit affirmed a PTAB final written decision (FWD) holding claims of U.S....more

Mintz - Intellectual Property Viewpoints

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

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

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