News & Analysis as of

Generic Drugs Patents

District of Delaware “Clips”- Off Venue-Discovery for Medical Device Company but Allows It for Pharmaceutical Company

by Orrick - IP Landscape on

Boston Sci. Corp. v. Cook Grp., Inc., No. 15-980-LPS-CJB, 2017 U.S. Dist. LEXIS 146126, at *2 (D. Del. Sep. 11, 2017); Bristol-Myers Squibb Co. v. Mylan Pharm., Inc., No. 17-379-LPS, 2017 U.S. Dist. LEXIS 146372, at *3 (D....more

Pharma and Biologic Disputes in Canada – New Regulations Take Effect September 21, 2017

by Bennett Jones LLP on

Pharma and biologics manufacturers will soon have big decisions to make regarding their pharmaceutical and biological product strategy in Canada. On September 6, 2017, the Governor General in Council, on recommendation of the...more

News from Abroad -- Mexican Antitrust Authority Study on Generic Drug Entry – Recommendations on Changes to Public Policy -- Part...

In the first three installments of this series, we've explained the general purpose of the study, and gone through the sections of patents, marketing authorizations and strategic behavior of the study published on August 9,...more

News from Abroad -- Mexican Antitrust Authority Study on Generic Drug Entry -- On Patents and Marketing Authorizations -- Part III

In the first and second installments of this series, we've explained the general purpose and the patents and marketing authorizations sections of the study published on August 9, 2017 by the Federal Commission for Economic...more

News from Abroad -- Mexican Antitrust Authority Study on Generic Drug Entry -- On Patents and Marketing Authorizations -- Part II

In the first installment of this series, we outlined the general contents of the study published on August 9, 2017 by the Federal Commission for Economic Competition, highlighting that the Antitrust authority is calling for...more

News from Abroad -- Mexican Antitrust Authority Issues Broad Study on Generic Drug Entry into Mexican Market -- Part I

Study Suggests Several Changes to Legislation on Patents, Marketing Authorizations, and Government Procurement - In July of 2016, the Federal Commission for Economic Competition announced a broad ranging study on the entry...more

Considerations for Developing a Global Patent Term Extension Strategy

Many jurisdictions provide for the extension of the term of the patents that cover a regulated product. Patent term extension (PTE) is particularly important in the bio/pharma industry given that development of an innovative...more

Patent Term Extension Considerations for BioPharma Patents

Time spent on securing marketing approval for regulated products, such as pharmaceuticals, medical devices and agrochemicals effectively shortens the term of patent protection during which an innovator can recover its...more

Alza Corp. v. Amneal Pharmaceuticals of New York, LLC

by Robins Kaplan LLP on

Case Name: Alza Corp. v. Amneal Pharmaceuticals of New York, LLC, Civ. No. 16-cv-914-RGA, 2017 U.S. Dist. LEXIS 53551 (D. Del. Apr. 7, 2017) (Andrews, J.)....more

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

by Robins Kaplan LLP on

Case Name: Par Pharm., Inc. v. Luitpold Pharms., Inc., 2017 U.S. Dist. LEXIS 62020 (D.N.J. Apr. 24 2017) (Walls, J.)....more

Horizon Pharma Ireland Ltd. v. Actavis Laboratories, UT, Inc.

by Robins Kaplan LLP on

Case Name: Horizon Pharma Ireland Ltd. v. Actavis Laboratories, UT, Inc., No. 14-7992 (NLH/AMD) (D.N.J. May 12, 2017) (Hillman, J.)....more

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

by Robins Kaplan LLP on

Case Name: Teva Pharms. USA, Inc. v. Sandoz Inc., Civ. No. 17-275(FLW), 2017 U.S. Dist. LEXIS 78002 (D.N.J. May 23, 2017) (Wolfson, J.)....more

GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA

by Robins Kaplan LLP on

Case Name: GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA, 2017 U.S. Dist. LEXIS 82534 (D. Del. May 23, 2017) (Burke, M.J.)....more

Sebela Int’l Ltd. v. Actavis Labs. Florida Inc.

by Robins Kaplan LLP on

Case Name: Sebela Int’l Ltd. v. Actavis Labs. Florida Inc., No. 14:6414 (CCC) (MF), 2017 U.S. Dist. LEXIS (D.N.J. June 16, 2017) (Cecchi, J.)....more

The Medicines Co. v. Mylan, Inc.

by Robins Kaplan LLP on

Case Name: The Medicines Co. v. Mylan Inc., Civ. No. 11-cv-1285, 2017 U.S. Dist. LEXIS 99898 (N.D. Ill. June 28, 2017) (St. Eve, J.)....more

Forest Labs., LLC v. Sigmapharm Labs., LLC

by Robins Kaplan LLP on

Case Name: Forest Labs., LLC v. Sigmapharm Labs., LLC, Civ. No. 16-cv-914-RGA, 2017 U.S. Dist. LEXIS 101653 (D. Del. June 30, 2017) (Robinson, J.)....more

The Medicines Co. v. Mylan Inc.

by Robins Kaplan LLP on

Case Name: The Medicines Co. v. Mylan, Inc., No. 2015-1113, -1151, -1181 (Fed. Cir. Apr. 6, 2017) (Circuit Judges Dyk, Wallach, and Hughes presiding; Opinion by Dyk, J.) (appeal from N.D. Ill., St. Eve, J.)....more

Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 855 F.3d 1356, 2017 U.S. App. LEXIS 7650 (Fed. Cir. May 1, 2017) (Circuit Judges Dyk, Mayer, and O’Malley presiding; Opinion by Dyk, J.) (appeal from D.N.J.,...more

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

by Robins Kaplan LLP on

Case Name: Braintree Labs., Inc. v. Breckenridge Pharm., Inc., No. 2016-1731 (Fed. Cir. May 5, 2017) (Circuit Judges Newman, Moore, and Wallach presiding; Opinion by Moore, J.) (appeal from S.D.N.Y., Nathan, J.)....more

Mylan Institutional LLC v. Aurobindo Pharma Ltd.

by Robins Kaplan LLP on

Case Name: Mylan Institutional LLC v. Aurobindo Pharma Ltd., 2017-1645, 2017 U.S. App. LEXIS 8792 (Fed. Cir. May 19, 2017) (Circuit Judges Lourie, Moore, and Reyna presiding; Opinion by Lourie, J.) (appeal from E.D. Tex.,...more

Federal Circuit Thoroughly Reverses District Court Findings of Velcade® Patent Obviousness

On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court...more

Rx IP Update - July 2017

by Smart & Biggar on

Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

Pharma and Biologics Disputes in Canada—Big Changes for Big and Small Molecule Litigation

by Bennett Jones LLP on

The patent litigation that propels generic and biosimilar products to market will soon change dramatically. July 15, 2017, marked the release of long-awaited proposed amendments to the Patented Medicines (Notice of...more

Italian time-machine : Limitation of the duration of an SPC may be decided by the Italian Patent Office

by Hogan Lovells on

The Board of Appeal of the Italian Patent Office (Commissione dei Ricorsi), by decision published on June 26, 2017, acknowledged the right of the patent holder to ask the Italian Patent Office for the limitation of the...more

Court of Milan rules on interim measure ordering the halt of the pricing and reimbursement procedure of a generic product

by Hogan Lovells on

By order issued on June 18, 2017, in summary proceedings brought by Teva against Mylan and Synthon for the alleged infringement of EP 2 361 924 (covering a manufacturing process for the active ingredient glatiramer acetate),...more

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