News & Analysis as of

Patents Pharmaceutical Industry

Allergan, Inc. v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Allergan, Inc. v. Teva Pharms. USA, Inc., 15-1455-WCB, 2017 U.S. Dist. LEXIS 4545 (E.D. Tex. Jan. 12, 2017) (Bryson, J.). Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine ophthalmic solution); U.S....more

Clarity on Doctrine of Equivalents Analysis for Chemical Claims

Mylan Institutional LLC v. Aurobindo Pharma Ltd, No. 2017-1645 (Fed. Cir. May 19, 2017) - On May 19, 2017, the Federal Circuit addressed and modified a rare grant of a preliminary injunction based on the doctrine of...more

Sanofi v. Lupin Atlantis Holdings SA

by Robins Kaplan LLP on

Case Name: Sanofi v. Lupin Atlantis Holdings SA, Civ. No. 15-415-RGA, 2017 U.S. Dist. LEXIS 10653 (D. Del. Jan. 26, 2017) (Andrews, J.). Drug Product and U.S. Patent: Multaq® (dronedarone tablets); U.S. Patent No....more

Practical Issues for the Pharmaceutical and Biopharmaceutical Industry in the Wake of TC Heartland

The US Supreme Court this week held that the broad venue provision of 28 U.S.C. § 1391(c) does not apply to patent law—at least, when the defendant is a domestic entity. This decision arises after years of judicial...more

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

by Robins Kaplan LLP on

Case Name: Shire Development, LLC v. Mylan Pharms., Inc., No: 12-1190-T-36AEP, 2017 U.S. Dist. LEXIS 11441 (M.D. Fla. Jan. 27, 2017) (Honeywell, J.). Drug Product and Patent(s)-in-Suit: Lialda® (mesalamine); U.S. Patent...more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In Mylan v. Aurobindo the Circuit affirms the grant of a preliminary injunction based upon the infringement of one of the three patents in suit. However, the panel reverses the injunction as to the other two patents based on...more

Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC, Civ. No. 15-250-SLR, 2017 U.S. Dist. LEXIS 12165 (D. Del. Jan. 30, 2017) (Robinson, J.). Drug Product and U.S. Patent: Nasonex® (mometasone furoate nasal...more

5 Key Takeaways: Patent Strategies Applicable for Repurposing & Rescuing of Drugs

Kilpatrick Townsend Partner Ken Weber, Ph.D. recently presented “The Role of Patents in Repurposing and Rescuing Old Drugs” at the STC 2017 Spring Seminar Series in Albuquerque, New Mexico. This presentation defined the role...more

In re copaxone consolidated cases

by Robins Kaplan LLP on

Case Name: In re copaxone consolidated cases, No. 14-1171-GMS (consolidated) 2017 U.S. Dist. LEXIS 12168 (D. Del. Jan. 30, 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Copaxone® (prefilled syringes of...more

Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

by Pepper Hamilton LLP on

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

PTAB Life Sciences Report -- Part II - May 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Argentum Pharmaceuticals LLC. v. Alcon Research, Ltd. PTAB Petition: IPR2017-01053; filed...more

Fish Client Coherus BioSciences Prevails in ‘135 IPR Decision

by Fish & Richardson on

REDWOOD CITY, Calif., May 16, 2017 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (Nasdaq:CHRS), announced that the Patent Trial and Appeal Board (“PTAB”) of the U.S. Patent and Trademark Office ruled in favor of Coherus’...more

Par Pharm., Inc. v. Luitpold Pharms., Inc.

by Robins Kaplan LLP on

Case Name: Par Pharm., Inc. v. Luitpold Pharms., Inc., No. 16-2290 (WHW)(CLW), 2017 U.S. Dist. LEXIS 15050 (D.N.J. Feb. 1, 2017) (Walls, J.). Drug Product and Patent(s)-in-Suit: Adrenalin® (epinephrine); U.S. Patents...more

The Pricing of Patented Drugs in Canada: Stakeholder Consultation Period Open Until June 28, 2017

by Smart & Biggar on

The Patented Medicine Prices Review Board (PMPRB) regulates the price of patented medicines in Canada by determining whether a price is excessive. The Board is revisiting its approach to pricing, and has now released a...more

Key Trends In Pharmaceutical IPRs Filed By Generic Petitioners

by Foley & Lardner LLP on

We reviewed a sub-group of two hundred and four (204) IPRs filed by generic drug companies against pharmaceutical patents to assess PTAB outcomes and key trends in dealing with this technology field. The survey captured IPR...more

AstraZeneca AB v. Aurobindo Pharma Ltd.

by Robins Kaplan LLP on

Case Name: AstraZeneca AB v. Aurobindo Pharma Ltd., 14-664-GMS, 2017 U.S. Dist. LEXIS 14647 (D. Del. Feb. 2, 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Onglyza® (saxagliptin) and Kombiglyze™ XR (saxaglibtin...more

Endo Pharma. Solutions Inc. v. Custopharm, Inc.

by Robins Kaplan LLP on

Case Name: Endo Pharma. Solutions Inc. v. Custopharm, Inc., 14-1422-SLR, 2017 U.S. Dist. LEXIS 19035 (D. Del. Feb. 10, 2017) (Robinson, J.). Drug Product and Patent(s)-in-Suit: Aveed® (testosterone undecanoate); U.S....more

PTAB Life Sciences Report - May 2017 #2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Mylan Pharmaceuticals, Inc. v. Cosmo Technologies Ltd. PTAB Petition: IPR2017-01034; filed...more

CFDA’s New Draft Policy Introduces the Chinese Version of Patent Linkage

by Allen & Overy LLP on

On May 12, Chinese Food and Drug Administration (CFDA) issued Policy Notice No. 55, entitled “Policies Relevant to the Protection of the Rights and Interests of Innovators for the Encouragement of Innovation in Drugs and...more

Supreme Court Hears Oral Arguments in Sandoz Inc. v. Amgen

by Jones Day on

On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more

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

by Robins Kaplan LLP on

Case Name: Helsinn Healthcare S.A. v. Dr. Reddy's Labs., Ltd., No. 12-2867 (MLC) (DEA), 2017 U.S. Dist. LEXIS 21477 (D.N.J. Feb. 14, 2017) (Cooper, J.). Drug Product and Patent(s)-in-Suit: Aloxi® (palonosetron); U.S....more

100 Days Plus Under Trump: What They Mean for Biologics

President Donald J. Trump has now been in office for just over one hundred days. Observers have been quick to mark this milestone and assess the new administration’s performance, especially on headline-grabbing issues like...more

Recro Gainesville LLC v. Actavis Labs. FL, Inc.

by Robins Kaplan LLP on

Case Name: Recro Gainesville LLC v. Actavis Labs. FL, Inc., Civ. No. 14-1118-GMS, 2017 U.S. Dist. LEXIS 24428 (D. Del. Feb. 22, 2017) (Sleet, J.). Drug Product and U.S. Patent: Zohydro® ER (hydrocodone bitartrate...more

Apotex Inc. v. Alcon Research, Ltd.

by Robins Kaplan LLP on

Case Name: Apotex Inc. v. Alcon Research, Ltd., No. 16-3145-WTL-MJD, 2017 U.S. Dist. LEXIS 27016 (S.D. Ind. Feb. 27, 2017) (Lawrence, J.). Drug Product and Patent(s)-in-Suit: Pataday® (olopatadine); U.S. Patents Nos....more

Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc. (D.N.J. 2017)

Last month, in Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc., Senior District Judge William H. Walls of the U.S. District Court for the District of New Jersey issued an amended opinion granting the motion for...more

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