Patents Hatch-Waxman

News & Analysis as of

First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains

The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch...more

Contract Manufacturing Is a Commercial Transaction for Purpose of “On-Sale” Bar - The Medicines Company v. Hospira, Inc.

Addressing the application of the on-sale bar under § 102(b), the U.S. Court of Appeals for the Federal Circuit found that the claims of an asserted patent were invalid based on an agreement, dated more than one year prior to...more

Purdue Pharma L.P. v. Amneal Pharms., LLC

Case Name: Purdue Pharma L.P. v. Amneal Pharms., LLC, Civ. Nos. 04-Md-1603 (SHS); 13-cv-3372 (SHS), 2015 U.S. Dist. LEXIS 45967 (S.D.N.Y. Apr. 8, 2015) (Stein, J.) - Drug Product and Patent(s)-in-Suit: OxyContin®...more

Otsuka Pharm. Co., Ltd. v. Torrent Pharms. Ltd., Inc.

Case Name: Otsuka Pharm. Co., Ltd. v. Torrent Pharms. Ltd., Inc., Civ. No. 14-1078 (JBS/KMW), 2015 U.S. Dist. LEXIS 50082 (D.N.J. Apr. 16, 2015) (Simandle, C.J.) - Drug Product and Patent(s)-in-Suit: Abilify®...more

Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more

Bayer Intellectual Property GmbH v. Warner Chilcott Co.

Case Name: Bayer Intellectual Property GmbH v. Warner Chilcott Co., LLC, 12-1032-GMS, 2015 U.S. Dist. LEXIS 52061 (D. Del. Apr. 21, 2015) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Lo Loestrin® Fe (norethindrone...more

GlaxoSmithKline LLC. v. Glenmark Generics Inc.

Case Name: GlaxoSmithKline LLC. v. Glenmark Generics Inc., USA, Civ. Nos. 14-877-LPS-CJB; 14-878-LPS-CJB, 2015 U.S. Dist. LEXIS 52525 (D. Del. Apr. 22, 2015) (Burke, J.) - Drug Product and Patent(s)-in-Suit: Coreg®...more

In re Bendamustine Consolidated Cases

Case Name: In re Bendamustine Consolidated Cases, Civ. No. 13-2046-GMS, 2015 U.S. Dist. LEXIS 55963 (D. Del. Apr. 29, 2015) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Treanda® (bendamustine HCl); U.S. Patents Nos....more

Otsuka Pharmaceutical Co., Ltd. v. Burwell

Case Name: Otsuka Pharmaceutical Co., Ltd. v. Burwell, Civ. No. GJH-15-852, 2015 U.S. Dist. LEXIS 68230 (D. Md., May 27, 2015) (Hazel, J.) - Drug Product and Patent(s)-in-Suit: Abilify® (aripiprazole); N/A - Nature...more

Amarin Pharms. Ireland Ltd v. FDA

Case Name: Amarin Pharms. Ireland Ltd v. FDA, Case No. 14-cv-00324 (RDM), 2015 U.S. Dist. LEXIS 68723 (D.D.C. May 28, 2015) (Moss, J.) - Drug Product and Patent(s)-in-Suit: Vascepa® Capsules (icosapent ethyl); N/A...more

Representatives Seek Protections for Hatch-Waxman and BPCIA in Innovation Act

Last month, in a letter to Congressional leadership, 79 Members of Congress expressed their support for the Innovation Act (H.R. 9) but sought inclusion of language in the bill "to preserve the integrity of the Drug Price...more

Sowing Uncertainty: Navigating Patent Disputes and Antitrust Scrutiny Post King Drug

On June 26, 2015, the Third Circuit issued an opinion in King Drug Co. of Florence, Inc. v. Smithkline Beecham Corp., (Case No. 14-1243). King Drug. The opinion, which already has been extensively commented on and...more

Braintree Labs., Inc. v. Novel Labs., Inc.

Case Name: Braintree Labs., Inc. v. Novel Labs., Inc., Case No. 3:11-cv-01341-PGS-LHG, 2015 U.S. Dist. LEXIS 70993 (D.N.J. June 2, 2015) (Sheridan, J.) - Drug Product and Patent(s)-in-Suit: Suprep® Bowel Prep Kit (sodium...more

Spectrum Pharms., Inc. v. Burwell

Case Name: Spectrum Pharms., Inc. v. Burwell, Civ. No. 15-631 (RCL), 2015 U.S. Dist. LEXIS 73218 (D.D.C. May 27, 2015) (Lamberth, J.) - Drug Product and Patent(s)-in-Suit: Fusilev® (levoleucovorin); N/A - Nature of...more

Veloxis Pharmaceuticals, Inc. v. FDA

Case Name: Veloxis Pharmaceuticals, Inc. v. FDA, Civ. No. 14-2126 (RBW), 2015 U.S. Dist. LEXIS 77559 (D.D.C. June 12, 2015) (Walton, J.) - Drug Product and Patent(s)-in-Suit: Astagraf XL® (tacrolimus); N/A...more

AstraZeneca AB v. Apotex Corp.

Case Name: AstraZeneca AB v. Apotex Corp., 2014-1221, 2015 U.S. App. LEXIS 5543 (Fed. Cir. Apr. 7, 2015) (Circuit Judges O’Malley, Clevenger, and Bryson presiding; Opinion by Bryson, J.) (Appeal from S.D.N.Y., Cote, J.)...more

Third Circuit Says Actavis Not Limited to Cash

In the first decision by a federal appeals court interpreting the U.S. Supreme Court’s landmark ruling in FTC v. Actavis, the Third Circuit recently held in King Drug Co. of Florence v. SmithKline Beecham Corp. that so-called...more

Insite Vision Inc. v. Sandoz, Inc.

Case Name: Insite Vision Inc. v. Sandoz, Inc., 783 F.3d 853 (Fed. Cir. Apr. 9, 2015) (Circuit Judges Prost, Newman, and Linn presiding; Opinion by Linn, J.) (Appeal from D.N.J., Cooper, J.) - Drug Product and...more

ANDA Update - July 2015

Supreme Court Holds Good Faith Belief of Patent Invalidity Is Not a Defense to Induced Infringement - Commil USA, LLC v. Cisco Systems, Inc. (Supr. Ct. May 26, 2015): Pharmaceutical patents commonly include...more

Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp.

Case Name: Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp., 785 F.3d 625 (Fed. Cir. May 6, 2015) (Circuit Judges Newman, Dyk, and Hughes presiding; Opinion by Dyk, J.; Dissent by Newman, J.) (Appeal from D. Del.,...more

Classen Immunotherapies, Inc. v. Elan Pharms., Inc.

Case Name: Classen Immunotherapies, Inc. v. Elan Pharms., Inc., 786 F.3d 892 (Fed. Cir. May 13, 2015) (Circuit Judges Prost and Lourie, and District Judge Gilstrap presiding; Opinion by Lourie, J.) (Appeal from D. Md.,...more

Novartis Pharms. Corp. v. Watson Labs., Inc.

Case Name: Novartis Pharms. Corp. v. Watson Labs., Inc., Fed. Cir. Nos. 2014-1799, -1800, 2015-1061, -1062, -1120, -1121, -1141, 2015 U.S. App. LEXIS 8374 (Fed. Cir. May 21, 2015) (Circuit Judges Lourie, Taranto, and Hughes...more

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

Case Name: Shire Development, LLC v. Watson Pharms., Inc., 787 F.3d 1359 (Fed. Cir. June 3, 2015) (Circuit Judges Prost, Chen, and Hughes presiding; Opinion by Hughes, J.) (Appeal from S.D. Fla., Middlebrooks, J.) - Drug...more

Teva Pharms. USA, Inc., v. Sandoz, Inc.

Case Name: Teva Pharms. USA, Inc., v. Sandoz, Inc., Fed. Cir. Nos. 2012-1567, -1568, -1569, -1570, 2015 U.S. App. LEXIS 10229 (Fed. Cir. June 18, 2015) (Circuit Judges Moore, Mayer, and Wallach presiding; Opinion by Moore,...more

IPR Broader Review Standard Upheld by Narrow Federal Circuit Majority

On July 8, 2015, the full Federal Circuit decided not to reconsider en banc (before all the judges) the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board’s (PTAB) standard to construe patents broadly for inter...more

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