News & Analysis as of

Endo Pharmaceuticals Inc. v. Actavis, Inc. & Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2014)

The Federal Circuit's decision in the consolidated appeals of Endo Pharmaceuticals Inc. v. Actavis, Inc. and Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. amply demonstrates the concept that you should be careful...more

Federal Circuit Finds Barr Does Not Infringe But Rejects Enablement and Written Description Defenses

The recent appeal of Alcon Research Ltd. v. Barr Labs., Inc., No. 2012-1340 (Fed. Cir. Mar. 18, 2014) touched on several of the patent-law issues you will encounter in ANDA cases: infringement, written description, and...more

FDA's Guidance for Industry Concerning Receipt Dates

The U.S. Food and Drug Administration (FDA) on February 10, 2014, published its Guidance for Industry on the receipt date for regulatory submissions. The Guidance applies to submissions that are in electronic or paper format,...more

Court Report - Part II: February 03, 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Noven Pharmaceuticals Inc. et al. 1:14-cv-00111; filed January 30, 2014 in the...more

Court Report - February 02, 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Eli Lilly and Company v. Glenmark Generics Inc., USA. 1:14-cv-00104; filed January 23, 2013 in the Southern District of...more

The District of Delaware Stops Exela’s Bid To Market Generic Orimev

In the District of Delaware, Judge Leonard Stark recently issued a final judgment and permanent injunction in Cadence Pharms., Inc. v. Exela Pharma. Scis., LLC, No 11-733, 2013 U.S. Dist. LEXIS 166097 (D. Del. Nov. 14, 2013),...more

A Short-Lived Victory for Generic Manufacturers? – Part 2

In our prior blog post of the same title on July 5, 2013, we predicted that the protection from product liability/failure to warn litigation for generic manufacturers as a result of the Supreme Court decision in Mutual...more

Court Report - December 29, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Pharmaceuticals Inc. et al. v. Alkem Laboratories Limited 1:13-cv-09227; filed December 26, 2013 in the Northern...more

Federal Circuit Invalidates Galderma Differin Patents

In Galderma Laboratories v. Tolmar, Inc., the Federal Circuit reversed the district court’s findings that the Orange Book-listed patents for Galderma’s Differin® 0.3% gel product were not invalid as obvious. In so doing, the...more

Court Report -- November 24, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Shire LLC et al. v. Apotex Corp. et al. 1:13-cv-24236; filed November 21, 2013 in the Southern District of...more

New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers

Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more

Federal Circuit Finds LUNESTA Patent Infringement Based on ANDA Product Description Not Avoided by Other Certifications

In Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reversed the district’s holding of no Lunesta® patent infringement that was based on a certification submitted to the court, and found...more

Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2013)

Saying "But I won't do it" is not sufficient to avoid infringement in a Hatch-Waxman litigation, according to the Federal Circuit in the recently decided Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. The...more

Pronova Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc. (Fed Cir. 2013)

Last week, the Federal Circuit in a non-precedential opinion, invalidated claims to Orange Book-listed patents on omega-three fatty acid formulations in Pronova Biopharma Norge v. Teva Pharmaceuticals USA. The grounds for...more

Court Report - September 15, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Roche Palo Alto LLC et al. v. Mylan Pharmaceuticals Inc. 1:13-cv-01532; filed September 4, 2013 in the District Court of...more

Court Report - September 9, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Senju Pharmaceutical Co., Ltd. et al. v. Akorn, Inc. 1:13-cv-06080; filed August 28, 2013 in the Southern District of...more

Quickly Take Your Medicine: FDA's Secure Supply Chain Pilot Program Presents Opportunity for Expedited Imports of API and Finished...

Taking a page from an established Customs program, importers of active pharmaceutical ingredients (APIs) and finished drug products may now have the opportunity to become eligible for expedited entry into the United States. ...more

Court Report -- August 11, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Exela Pharma Sciences, LLC v. EKR Therapeutics, LLC et al. - 5:13-cv-00111; filed August 8, 2013 in the Western...more

Research Foundation of State University of New York v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2013)

When assessing the validity of a patent, you cannot ignore the dependent claims. That was the main takeaway from the recent Federal Circuit case, Research Foundation of State University of New York v. Mylan Pharmaceuticals...more

Federal Circuit Finds “Molecular Weight” to Be Insolubly Ambiguous

In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the Federal Circuit invalidated a number of claims directed to a polymer defined by its “molecular weight” because the term was ambiguous, and Applicants’ conflicting...more

Court Report -- August 04, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. UCB, Inc. et al. v. Sun Pharma Global FZE et al. 1:13-cv-05514; filed August 1, 2013 in the Northern District of...more

IP Update, Vol. 16, No. 7, July 2013

“Reverse Payment” Settlements Face Greater Antitrust Scrutiny Following U.S. Supreme Court Ruling in FTC v. Actavis: Federal Trade Commission v. Actavis, Inc. - Resolving a split among the U.S. Courts of Appeals, the...more

Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. (Fed. Cir. 2013)

A claim term that can have different meanings or values depending on the method used to measure it renders the claim indefinite because it is impossible for a potential infringer to discern the boundaries of the claim. This...more

Court Report -- July 28, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cornerstone Therapeutics Inc. et al. v. Exela Pharma Sciences LLC et al. 1:13-cv-01275; filed July 24, 2013 in the...more

IMS Study Shows Pro-Competitive Effects of Reverse Payment Settlement Agreements in ANDA Litigation

Earlier this month, the Generic Pharmaceutical Association (GPhA) held a press conference to announce the release of a study of the effects of reverse settlement payment agreements in ANDA litigation. ...more

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