Mylan Pharmaceuticals

News & Analysis as of

Allergan, Inc. v. Teva Pharmaceuticals USA, Inc.

Case Name: Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Civ. No. 15-cv-1455 (WCB), 2016 U.S. Dist. LEXIS 51851 (E.D. Tex. Apr. 19, 2016) (Bryson, J.) - Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine...more

EMA Accepts Mylan and Biocon’s Application for Authorization to Market a Pegfilgrastim Biosimilar

Mylan N.V. and Biocon Ltd. recently announced that the European Medicines Agency has accepted Mylan’s Marketing Authorization Application for a proposed biosimilar version of Amgen’s Neulasta (pegfilgrastim). In Europe,...more

Biosimilars Development Updates

We previously reported on collaborations between Amgen and Allergan on oncology-related biosimilars. On July 21, Amgen and Allergan announced results of a Phase III trial for their ABP 980 product, which is being developed...more

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

Mylan and Biocon Present Trastuzumab Biosimilar Data at ASCO

On June 3, Mylan N.V. and Biocon Ltd. presented phase 3 clinical data regarding their trastuzumab product (dubbed MYL-1401O), which is a proposed biosimilar to Genentech’s Herceptin, at the 2016 American Society of Clinical...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

Court Report - May 2016 #2 (Part II)

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Amgen Inc. et al. v. Sandoz Inc. et al. 3:16-cv-02581; filed May 12, 2016 in the Northern District of California - .....more

Court Report - May 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Hetero USA, Inc. et al. 3:16-cv-02356; filed April 26, 2016 in the...more

Biosimilars in India News: Recent Guidelines from India’s CDSCO and a Pending Case on “Biosimilar” Trastuzumab

A recent court ruling and a new publication on guidelines for biosimilars in India may offer further guidance on what biosimilar and biologic stakeholders can expect from Indian regulatory authorities. In late March,...more

Court Report - April 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Forest Laboratories, LLC et al. v. Amerigen Pharmaceuticals, Inc. et al. 1:15-cv-00966; filed October 23, 2015 in the...more

Acorda Therapeutics Inc. v. Mylan Pharms. Inc.

Case Name: Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 2015-1456, 2015-1460, 2016 U.S. App. LEXIS 4942 (Fed. Cir. Mar. 18, 2016) (Circuit Judges Newman, O’Malley, and Taranto presiding; Opinion by Taranto, J.; Concurring...more

Court Report - April 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Unimed Pharmaceuticals, LLC et al. v. Amneal Pharmaceuticals, LLC 1:15-cv-00964; filed October 22, 2016 in the District...more

Filing an ANDA May Expose Generic Manufacturers to Nationwide Personal Jurisdiction in Patent Infringement Suits

On March 18, 2016, the Federal Circuit affirmed the District of Delaware’s ruling in two companion cases that West Virginia-based defendant Mylan Pharmaceuticals is subject to specific personal jurisdiction in Delaware....more

Report And Recommendation Regarding Motion To Dismiss Is Denied In Part And Granted In Part

Fallon, M. J. Report and recommendation recommending that defendants’ motion to dismiss for lack of personal jurisdiction and failure to state a claim be denied in part and granted in part. The disputed technology in...more

March 2016 Life Sciences Litigation Update

Federal Circuit Affirms Broad Personal Jurisdiction Over ANDA Filers. On March 18, 2016, in the first decision of its kind since the U.S. Supreme Court decided Daimler AG v. Bauman, 134 S. Ct. 746 (2014), the Federal...more

Court Report - March 2016 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Fresenius Kabi USA, LLC et al. v. Mylan Laboratories Ltd. et al. 1:15-cv-00942; filed October 19, 2015 in the District...more

Federal Circuit Patent Updates - March 2016

Clare v. Chrysler Group LLC (No. 2015-1999, 3/31/16) (Prost, Moore, Wallach) - Moore, J. Affirming summary judgment of non-infringement of patents related to storage compartment for pickup trucks. The Court rejected...more

Federal Circuit Finds Personal Jurisdiction over Mylan in Two Hatch-Waxman Appeals

On Friday, March 18, the Court of Appeals for the Federal Circuit affirmed two District of Delaware rulings that non-resident defendant generic ANDA filer, Mylan, is subject to personal jurisdiction in two Hatch-Waxman suits...more

Federal Circuit Finds Personal Jurisdiction Based On Plans To Market ANDA Product

In Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., the Federal Circuit held that the filing of an Abbreviated New Drug Application (ANDA) and intentions to market the product across the United States–including in the...more

Federal Circuit Clarifies Scope of Personal Jurisdiction in Hatch-Waxman Cases

On March 18, 2016, a panel of the Federal Circuit issued its decision in Acorda Therapeutics Inc. v. Mylan Pharms. Inc. and AstraZeneca AB v. Mylan Pharms. Inc., holding that Mylan is subject to specific personal jurisdiction...more

ANDA Filings Create Personal Jurisdiction Everywhere

In Acorda Therapeutics, Inc. v, Mylan Pharmaceutical Inc., [2015-1460) (March 18, 2016), the Federal Circuit affirmed that Mylan was subject to specific personal jurisdiction in the District of Delaware, The Federal Circuit...more

Federal Circuit Issues Sprawling Opinion Certain to Continue Big Pharma Forum Shopping in ANDA Litigation

In an opinion handed down Friday that will continue the trend of forum shopping, the Federal Circuit in Acorda Therapeutics Inc. v. Mylan Pharmaceuticals, Inc., 2015-1456, (Fed. Cir. 2016) held that the filing of an...more

Breaking News – No Circuit Split (Yet) Over Post-Bauman General Jurisdiction by Consent

We’ve been watching competing interlocutory appeals in a couple of post-Bauman personal jurisdiction cases out of Delaware: Acorda Therapeutics, Inc. v. Mylan Pharmaceuticals, Inc., 78 F. Supp.3d 572 (D. Del. 2015), and...more

Court Report - March 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Unimed Pharmaceuticals LLC et al. v. Lupin Atlantis Holdings SA et al. 1:15-cv-00904; filed October 9, 2015 in the...more

Court Report - February 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Astellas Pharma Inc. et al. v. Apotex Inc. et al. 1:15-cv-00857; filed September 22, 2015 in the District Court of...more

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