ANDA

News & Analysis as of

API Manufacturers Are Not Proper Defendants In Hatch-Waxman Actions

A district court judge in New Jersey recently granted an API supplier’s motion to dismiss claims filed against the supplier in an ANDA suit, raising questions about whether an API supplier belongs as a defendant in these...more

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

FDA is Soliciting Comments on Improving the Quality of ANDA Submissions

The Food and Drug Administration (FDA) announced the establishment of a public docket for comments regarding Abbreviated New Drug Application (ANDA) submissions to the agency. FDA is specifically looking for input regarding...more

Orange Book Listing On Its Own Does Not Create A Barrier to Entry

In the Northern District of Illinois, Judge Sharon Coleman recently dismissed for lack of subject matter jurisdiction Apotex’s declaratory judgment action alleging invalidity or non-infringement of U.S. Patent 6,878,703...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

FDA Issues Draft Guidance on Bioequivalence Studies Specifically for ANDAs

The U.S. Food and Drug Administration (FDA) on December 4, 2013 issued new draft guidance on bioequivalence studies for drugs submitted under an Abbreviated New Drug Application (ANDA). In light of the relatively few...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

Recent Federal Circuit decision leaves certain composition claims vulnerable

Last week, in a ruling that could be a boon to generic drug makers, the Federal Circuit invalidated claims covering the 0.3% concentration of Differin® (adapalene) acne gel as obvious. Galderma Labs. v. Tolmar, Inc. (Fed....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

FDA Publishes Draft Guidance on Refuse-to-Receive Standards for ANDA’s in Federal Register for Public Comment

The FDA recently issued draft guidance in the Federal Register setting forth the circumstances in which the FDA will refuse to receive an ANDA. [Guidance for Industry ANDA Submissions] The draft guidance is subject to a...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

Capital Thinking: Health Care

LEGISLATIVE ACTIVITY - The House will take another turn this week on hearings related to health care reform implementation with a focus on the Healthcare.gov website troubles. The House is also planning a vote on H.R....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

The FTC Is at It Again

In a move that will surprise almost no one (except perhaps members of the Supreme Court majority in FTC v. Actavis), the Federal Trade Commission has filed an amicus curiae brief with the District Court of New Jersey in In re...more

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