ANDA

News & Analysis as of

Full Federal Circuit Denies En Banc Review of Jurisdictional Decision with Important Implications for BPCIA Litigation

On June 20, 2016, the full Federal Circuit denied Mylan’s petitions for rehearing en banc in Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016), leaving intact the panel’s decision affirming two...more

Post-Trial Rulings Issue In Bandamustine Case

Sleet, J. Post-trial opinion issues with respect to four patents-in-suit in ANDA trial relating to Bendamustine. Trial took place December 1 through 8, 2015....more

ANDA Filing Alone Suffices For Specific Personal Jurisdiction Over ANDA Filer; Related Canadian Entity With No Contacts To...

Sleet, J. Defendant PSI’s motion to dismiss the complaint for lack of personal jurisdiction is denied. Defendant PSL’s motion to dismiss the complaint for lack of personal jurisdiction and for failure to state a claim is...more

Trial Opinion Issues In Suboxone® ANDA Case

Andrews, J. Trial opinion finding the asserted claims in one patent invalid and certain products would infringe if valid; the asserted claims of a second patent are valid and infringed; the asserted claims of a third patent...more

ANDA Filing May Subject a Pharmaceutical Company to Personal Jurisdiction in Patent Infringement Suits Anywhere in the U.S.

On March 18, 2016, the Federal Circuit held that filing an abbreviated new drug application (“ANDA”) with the FDA for a generic drug product, and thus indicating an intention to sell that product in every state (including...more

Court Report - June 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Orexo AB et al. v. Actavis Elizabeth LLC et al. 1:16-cv-00397; filed May 27, 2016 in the District Court of Delaware...more

Court Decides that ANDA Approved Before Patent Issued Cannot Infringe 35 U.S.C. § 271(e)(2)(A)

Although the Hatch-Waxman Act was passed by Congress decades ago, it still produces new questions. Despite vigorous argument by the patent owner, a district court dismissed a count alleging that the ANDA-filer infringed under...more

On Sale Bar Invalidates Safyral, Beyaz Folate Patent

In Merck & CIE v. Watson Laboratories, Inc., the Federal Circuit found communications between Merck and a potential joint venture partner amounted to a commercial offer to sell that invalidated the Orange Book-listed folate...more

Post-Grant Review Roils Patent Litigation Waters

The America Invents Act (AIA) has had a profound impact on patent litigation, particularly surrounding inter partes and other post-grant proceedings. Below, Manish K. Mehta, who handles patent litigation across an array of...more

Court Report - May 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Ventana Medical Systems, Inc. v. Hologic, Inc. 3:16-cv-02703; filed May 18, 2016 in the Northern District of...more

FTC Maintains Aggressive Stance Against Pay-for-Delay Deals

A recent complaint filed by the Federal Trade Commission (FTC) indicates that the agency is continuing its aggressive pursuit of agreements between drug manufacturers that delay the entry of generic pharmaceuticals into the...more

CAFC Affirms Finacea Gel Infringement Under Doctrine of Equivalents

In Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA, the Federal Circuit affirmed the district court decision that found infringement under the doctrine of equivalents. This case shows that the doctrine of equivalents...more

AGG Food and Drug Newsletter - May 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA (Fed. Cir. 2016)

The Federal Circuit and the Supreme Court spent an inordinate amount of time wrestling with each of their conceptions of the scope and application of the doctrine of equivalents a dozen years ago, coming to an accommodation...more

Merck & Cie v. Watson Laboratories, Inc. (Fed. Cir. 2016)

The Federal Circuit had the occasion to revisit the proper application of the on-sale bar under 35 U.S.C. § 102(b) in ANDA litigation over claim 4 of U.S. Patent No. 6,441,168, which reads...more

Judgment Issues For Plaintiffs In ANDA Case

Sleet, J. The court issues findings of fact and conclusions of law and rules on post-trial motions. A 4-day trial took place between November 9-13, 2015. The disputed product is generic forms of plerixafor, which is...more

Patents-In Suit In ANDA Trial Are Non-Obvious

A 6-day bench trial was held from April 6-14, 2015. After trial, the court entered stipulations and orders regarding infringement of certain claims of the ‘178 and ‘206 patents. The court rejected defendant’s claim that the...more

Judge Griesa Grants Endo an Injunction Against Generic Manufacturers of Opioid Opana ER

On April 29, 2016, S.D.N.Y. District Judge Thomas P. Griesa granted Defendants Actavis, Inc., Actavis South Atlantic LLC (together “Actavis”) and Roxane Laboratories, Inc.’s motion to correct the court’s August 14, 2015...more

Apotex, Inc. v. Daiichi Sankyo, Inc.

Case Name: Apotex, Inc. v. Daiichi Sankyo, Inc., C.A. Nos. 12-cv-9295, 15-cv-3695, 2016 U.S. Dist. LEXIS 2126 (N.D. Ill. Jan. 8, 2016) (Coleman, J.)... Drug Product and Patent(s)-in-Suit: Benicar® and Benicar® HCT...more

Amarin Pharma, Inc. v. Apotex, Inc.

Case Name: Amarin Pharma, Inc. v. Apotex, Inc., Civil Action No. 14-2250 (MLC), 2016 U.S. Dist. LEXIS 7555 (D.N.J. Jan 22, 2016) (Cooper, J.)... Drug Product and Patent(s)-in-Suit: Vascepa® (icosapent ethyl); U.S....more

Supernus Pharms., Inc. v. Actavis Inc.

Case Name: Supernus Pharms., Inc. v. Actavis Inc., Civil Nos. 13-4740 (RMB/JS), 14-1981 (RMB/JS), 2016 U.S. Dist. LEXIS 14111 (D.N.J. Feb 5, 2016) (Bumb, J.)... Drug Product and Patent(s)-in-Suit: Oxtellar XR®...more

Helsinn Healthcare, S.A. v. Dr. Reddy’s Labs. Ltd.

Case Name: Helsinn Healthcare, S.A. v. Dr. Reddy’s Labs. Ltd., Civ. No. 11-3962 (MLC), 2016 U.S. Dist. LEXIS 27477 (D.N.J. Mar. 3, 2016) (Cooper, J.)... Drug Product and Patent(s)-in-Suit: Aloxi® (palonosetron); U.S....more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more

Braintree Labs. Inc. v. Breckenridge Pharm., Inc.

Case Name: Braintree Labs. Inc. v. Breckenridge Pharm., Inc., C.A. No 12-cv-6851 (AJN), 2016 U.S. Dist. LEXIS 33336 (S.D.N.Y. Mar. 15, 2016) (Nathan, J.)... Drug Product and Patent(s)-in-Suit: Suprep® (sodium sulfate /...more

Shire Development, LLC v. Watson Pharms., Inc.

Case Name: Shire Development, LLC v. Watson Pharms., Inc., Civ. No. 12-60862-CIV-MIDDLEBROOKS/BRANNON, 2016 U.S. Dist. LEXIS 40360 (S.D. Fla. Mar. 25, 2016) (Middlebrooks, J.)... Drug Product and Patent(s)-in-Suit:...more

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