News & Analysis as of

Pharmaceutical Industry › Prior Art › Written Descriptions

A&O Shearman

Court of Appeal upholds invalidity of AstraZeneca's compound patent and clarifies the standard of plausibility

A&O Shearman on

On July 16 2025, the Court of Appeal dismissed AstraZeneca’s appeal and upheld the first instance decision, finding that AstraZeneca’s compound patent for dapagliflozin, an SGLT2 inhibitor used to treat diabetes, was invalid...more

Snell & Wilmer

Federal Circuit Upholds a Silent Written Description

Snell & Wilmer on

In a precedential opinion this week, the Federal Circuit affirmed a district court judgment in favor of Novartis Pharmaceuticals, in an appeal brought by HEC Pharm challenging the written description in Novartis’s 9,187,405...more

McDonnell Boehnen Hulbert & Berghoff LLP

Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)

McDonnell Boehnen Hulbert & Berghoff LLP on

When does the absence of evidence turn into evidence of absence, and when does such absence amount to an adequate written description of the absence of a step of a method claim?  This is a question that comes readily to mind...more

Haug Partners LLP

No Clear Error to Find Lack of Written Description for a Method of Treatment Patent Despite Separate Disclosures of the Drug,...

Haug Partners LLP on

Biogen International GMBH, Biogen MA, Inc., v. Mylan Pharmaceuticals Inc. marks the Federal Circuit’s most recent interpretation of the 35 U.S.C. § 112 written description requirement in the Hatch-Waxman context. No....more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Denies Certiorari in Actavis Laboratories v. Nalproprion Pharmaceuticals

McDonnell Boehnen Hulbert & Berghoff LLP on

In the Supreme Court's recent clarifying campaign through the Federal Circuit's U.S. patent law jurisprudence, one section of the statute, 35 U.S.C. §112(a) has been noticeably left unscathed. Indeed, avoidance of this...more

McDermott Will & Schulte

Equivalent Disclosure Used to Satisfy Written Description Requirement

McDermott Will & Schulte on

Invoking a newly minted equivalent disclosure doctrine, a panel of the US Court of Appeals for the Federal Circuit found that the written description requirement of § 112 was satisfied in the interest of arriving at a...more

Bradley Arant Boult Cummings LLP

A Federal Circuit Prescription to Take Away the Pain for Generics - Intellectual Property News

Bradley Arant Boult Cummings LLP on

The Federal Circuit recently reversed a lower court’s ruling of validity under the § 112 written description requirement effectively opening the door for a number of generic drug manufacturers to enter the market with a...more

Foley & Lardner LLP

Lumigan Patents Upheld by Unexpected Results

Foley & Lardner LLP on

In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit affirmed the district court decision that upheld the validity of the Allergan patents relating to Lumigan® 0.01% glaucoma eye drops. This decision shows that it is still...more

Robins Kaplan LLP

GENERICally Speaking - Vol. 4, No. 1

Robins Kaplan LLP on

The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more

9 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