ANDA

News & Analysis as of

Purdue OxyContin Patents Invalid Despite Stemming From Discovery Of Source Of Toxic Impurity

In Purdue Pharma L.P. v. Epic Pharma LLC, the Federal Circuit affirmed the district court decision holding four OxyContin patents invalid as obvious. In so doing, the court rejected Purdue’s arguments that its discovery of...more

Court Report - January 2016 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC 1:15-cv-00831; filed September 17, 2015 in the District Court of...more

Otsuka Pharm. Co., Ltd. v. Zydus Pharms. USA,

Case Name: Otsuka Pharm. Co., Ltd. v. Zydus Pharms. USA, C.A. Nos. 14-3168 (JBS/KMW),14-4671 (JBS/KMW),14-5878 (JBS/KMW),14-6398 (JBS/KMW),14-7252 (JBS/KMW), 2015 U.S. Dist. LEXIS 138853 (D.N.J. Oct. 13, 2015) (Simandle,...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, 2015 U.S. Dist. LEXIS 167048 (D.N.J. Nov. 13, 2015) (Cooper, J.)... Drug Product and Patent(s)-in-Suit: Aloxi® (palonosetron); U.S. Patents...more

Spectrum Pharms., Inc. v. Sandoz, Inc.

Case Name: Spectrum Pharms., Inc. v. Sandoz, Inc., 2015-1407, 2015 U.S. App. LEXIS 17313 (Fed. Cir. Oct. 2, 2015) (Circuit Judges Lourie, Wallach, and Hughes presiding; Opinion by Lourie, J.) (Appeal from D. Nev., Navarro,...more

Prometheus Labs., Inc. v. Roxane Labs., Inc.

Case Name: Prometheus Labs., Inc. v. Roxane Labs., Inc., 2014-1634, -1635, 2015 U.S. App. LEXIS 19556 (Fed. Cir. Nov. 10, 2015) (Circuit Judges Dyk, Taranto, and Hughes presiding; Opinion by Dyk, J.) (Appeal from D.N.J.,...more

Court Report - January 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Merck Sharp & Dohme B.V. v. Teva Pharmaceuticals USA Inc. 1:15-cv-00806; filed September 11, 2015 in the District Court...more

Court Report - January 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Sage Labs Inc. v. Transposagen Biopharmaceuticals Inc. 1:15-cv-00791; filed September 9, 2015 in the District Court of...more

Federal Circuit Hears Argument on Personal Jurisdiction in Two Hatch-Waxman Appeals

On Monday, January 4, the Court of Appeals for the Federal Circuit heard oral argument in two appeals that may determine what effect the Supreme Court’s Daimler AG v. Bauman decision will have on the exercise of personal...more

A Stay of Litigation Pending IPR Does Not Provide a Basis For Extending 30-Stay of FDA ANDA Approval

On December 11, 2015, the United States District Court for the Southern District of Indiana granted a motion to stay a Hatch-Waxman litigation pending the outcome of inter partes reviews (IPRs) on two of the patents-in-suit...more

Claim Is Construed In ANDA Case

Tris Pharma, Inc. v. Actavis Laboratories FL, Inc., et al., C.A. No. 14-1309 – GMS, January 8, 2016. Sleet, J. Claim construction opinion issues regarding one term from four patents....more

Court Report - January 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Spectrum Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals LLC - 2:15-cv-01697; filed September 3, 2015 in the...more

Court Report - December 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Warner Chilcott (US), LLC et al. v. Teva Pharmaceuticals USA, Inc. et al. - 1:15-cv-00761; filed August 31, 2015 in...more

Directing a Known Treatment to a Sub-Population of Patients Is Obvious - Prometheus Labs, Inc. v. Roxane Labs., Inc.

Addressing obviousness issues, the U. S. Court of Appeals for the Federal Circuit affirmed the district court’s invalidity conclusion, agreeing that the elements present in the prior art—including earlier disclosed genus...more

Cubist Pharmaceuticals, Inc. v. Hospira Inc. (Fed. Cir. 2015)

Mistakes happen; there is even a book, entitled Human Error, that discusses how and why they happen. The Federal Circuit addressed the consequences of human error (or perhaps more accurately, instances where there was a...more

Washington Healthcare Update

This Week: Congress raced to exit for the holidays and passed a $1.5 trillion omnibus spending bill and $680 billion tax-extenders package on Friday. The omnibus funds the government through September 2016. President Obama...more

Court Report - December 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Merck Sharp & Dohme Corp. et al. v. Med-Pharmex, Inc. 3:15-cv-01905; filed August 28, 2015 in the Southern District of...more

Endo Pharmaceuticals Inc. v. Actavis Inc. (D. Del. 2015)

District Court Adopts Magistrate's Conclusion of Invalidity under § 101 and Grants Defendants' Motion to Dismiss Counts - Last month, in Endo Pharmaceuticals Inc. v. Actavis Inc., Judge Richard G. Andrews of the U.S....more

Court Report - November 2015 #6

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Forest Laboratories LLC et al. v. Amneal Pharmaceuticals LLC et al. 1:15-cv-00756; filed August 27, 2015 in the District...more

Post-Approval Quality Control Testing of Pharmaceutical Products: What Constitutes 35 U.S.C. § 271(g) Infringement or Falls Under...

The Federal Circuit recently affirmed that a generic pharmaceutical company’s use of post-approval quality control testing was not “making” under 35 U.S.C. § 271(g). See Momenta Pharmaceuticals, Inc. et al. v. Teva...more

Obviousness Versus Obviousness-Type Double Patenting

In Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc., the Federal Circuit affirmed the district court’s finding that Prometheus’ claims were invalid as obvious, but in so doing it cited its own precedent regarding...more

Court Report - November 2015 #5

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Merck Sharp & Dohme Corp. v. Savior Lifetec Corp. 5:15-cv-00415; filed August 21, 2015 in the Eastern District of North...more

Momenta Pharma., Inc. v. Teva Pharma. USA Inc.

In Momenta Pharma., Inc. v. Teva Pharma. USA Inc., Nos. 2014-1274, -1277, -1276, and -1278 (Fed. Cir. Nov. 10, 2015) (“Momenta II”), the Federal Circuit found that, pursuant to 35 U.S.C. § 271(g), “made” is limited to steps...more

Federal Circuit Affirms Invalidity of Method Species Claims Over Prior Art Genus

On November 10, 2015, the Federal Circuit issued its opinion in Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc. et al., No. 14-1634, -1635, slip op. (Fed. Cir. Nov. 10, 2015) affirming the district court’s decision...more

Court Report - November 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Vivus, Inc. v. Actavis Laboratories FL, Inc. 2:15-cv-06256; filed August 17, 2015 in the District Court of New...more

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