News & Analysis as of

Merck

Dutch Supreme Court hands down landmark decision on infringement of second medical use patents

by Hogan Lovells on

On 3 November 2017, the Dutch Supreme Court (Hoge Raad) handed down a landmark decision on the infringement of second medical use patents in the Merck Sharp & Dohme Corp. (“MSD”) v. Teva Pharma B.V. and Pharmachemie B.V....more

Merck Sharp & Dohme Corp. v. Actavis Labs. Fl, Inc.

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme Corp. v. Actavis Labs. Fl, Inc., No. 15-cv-6075 (PGS) (DEA), 2017 U.S. Dist. LEXIS 164131 (D.N.J. Sept. 29, 2017) (Sheridan, J.)... Drug Product and Patent(s)-in-Suit: Noxafil®...more

Merck Sharp & Dohme Corp. v. Hospira, Inc. (Fed. Cir. 2017)

The Federal Circuit continues its explication of the law of obviousness post-KSR Int'l. v. Teleflex Inc. (and Judge Pauline Newman continues to disagree with her brethren in some regards) in a decision handed down last...more

FDA Approves Companion Dx for PD-1 Inhibitor

by Foley & Lardner LLP on

According to the American Cancer Society (“ACS”), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer). About 14% of all new cancers are lung...more

Competition News - September 2017

by Dentons on

A look back on a decision imposing a fine on Facebook for having provided the European Commission with inaccurate information on its acquisition of WhatsApp - On May 18, 2017, the European Commission imposed a €110 million...more

Fresenius Kabi completes acquisition of Merck KGaA’s biosimilars business

by Goodwin on

Last week Fresenius Kabi announced that it has successfully closed its acquisition of Merck KGaA’s biosimilars business, which comprises Merck’s entire biosimilars development pipeline. According to Fresenius, the product...more

Third Circuit Follows ANZ Securities Decision and Reverses for Dismissal of Exchange Act Claims as Untimely

by Carlton Fields on

On June 28, 2017, Bruce Berman and Steve Blickensderfer posted in this space about the Supreme Court’s recent decision in California Public Employees Retirement System v. ANZ Securities, Inc., 137 S. Ct. 2042 (2017). In that...more

Uptick in University Enforcement of Intellectual Property an Indication of Stricter Enforcement Policy or a Passing Trend?

by Miles & Stockbridge P.C. on

Universities have traditionally been reluctant to enforce their intellectual property (IP) against third parties. There are many reasons for this position, including adverse publicity associated with such suits, the time...more

Sanofi Sues MSD Regarding Follow-On Insulin Glargine Biologics

by Goodwin on

On August 8, Sanofi-Aventis filed a complaint for patent infringement against Merck Sharp & Dohme in the U.S. District Court for the District of New Jersey regarding Merck’s proposed follow-on biologics of Sanofi-Aventis’s...more

SDNY Judge Adheres To Prior Ruling That Discovery Rule Applies To Securities Act Statute Of Limitations

by Shearman & Sterling LLP on

On July 28, 2017, Judge Victor Marrero of the United States District Court of the Southern District of New York denied a motion for reconsideration of an earlier decision declining to dismiss as untimely a putative class...more

Patent Judgments and Awards - Merck Ordered to Pay $14 Million in Attorneys’ Fees to Rival Gilead After a Patent Infringement...

by Knobbe Martens on

Merck Ordered to Pay $14 Million in Attorneys’ Fees to Rival Gilead After a Patent Infringement Trial Involving Hepatitis C Drugs - On July 14, 2017, in a stunning reversal of fortune, a federal court in San Jose, CA,...more

Samsung Bioepis and Merck & Co. Launch Renflexis, A Lower-Priced Competitor to Inflectra

by Goodwin on

Merck & Co. and Samsung Bioepis announced today the U.S. launch of Renflexis (infliximab), a biosimilar of Janssen’s Remicade. Renflexis was approved on April 21 by the FDA for all eligible indications. ...more

Merck Receives Tentative FDA Approval for Lantus Follow-on

by Goodwin on

On July 20, 2017, Merck & Co. announced that the FDA granted tentative approval of its 505(b)(2) application for Lusduna™ Nexvue™ (insulin glargine injection), its follow-on version of Sanofi SA’s Lantus. Merck’s product...more

German Federal Court: Permission granted - HIV/AIDS drug distribution continued

by Hogan Lovells on

The X. Civil Senate of the German Federal Court of Justice has granted a motion by three companies of the Merck Sharp & Dohme group (Merck) for a preliminary permission for the continued distribution of Isentress®, a drug...more

Provisional Decision in UK Drug Pricing Investigation of Merck Sharp & Dohme

by Goodwin on

The Competition and Markets Authority (CMA) in the United Kingdom announced a provisional decision finding that Merck Sharp & Dohme (MSD) violated competition law with its discount pricing on Remicade. This provisional...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

Merck Sharpe & Dohme and Genentech Jointly Move to Terminate Cabilly IPR

by Goodwin on

Merck Sharpe & Dohme and Genentech have filed a Joint Motion to Terminate IPR2016-00710, relating to U.S. Patent No. 6,331,415. As we reported earlier, the ‘415 patent is known as one of the “Cabilly” patents, and is...more

Fresenius Kabi Acquires Merck KGaA’s Biosimilars Business

by Goodwin on

On Monday, April 24, 2017, Fresenius Kabi and Merck KGaA announced that Fresenius will be acquiring Merck KGaA’s biosimilars business. According to Merck KGaA’s press release, Merck KGaA’s biosimilar portfolio focuses on...more

EPA Wastewater Settlement Highlights Industry Focused Enforcement Initiative

by Williams Mullen on

EPA and the Department of Justice recently settled a Clean Water Act enforcement action with EMD Millipore Corp. of Jaffrey, NH, by lodging a Consent Decree in the U.S. District Court for the District of New Hampshire. The...more

Merck v. Gnosis: Standard of Review of Factual Findings in IPRs

by Goodwin on

We post frequently about IPRs here on the blog, because they are an efficient and relatively quick way to get a decision on validity of the patents that cover drugs, biologic or otherwise. In Merck & Cie v. Gnosis S.p.A.,...more

Merck Sharp & Dohme Corp. v. Hospira Inc.

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme Corp. v. Hospira Inc., 14-cv-915-RGA, 2016 U.S. Dist. LEXIS 139721 (D. Del. Oct. 7, 2016) (Andrews, J.). Drug Product and Patent(s)-in-Suit: Invanz® (ertapenem); U.S. Patents Nos. 5,952,323...more

Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc., No. 14-874-SLR, 2016 U.S. Dist. LEXIS 158514 (D. Del. Nov. 16, 2016) (Robinson, J.). Drug Product and Patent(s)-in-Suit: Nasonex® (mometasone furoate...more

BMS settles Keytruda patent suit against Merck

by Goodwin on

As we previously reported, Bristol-Myers Squibb Co. and Ono Pharmaceutical Company sued Merck & Co. in 2015 alleging that Merck’s sale of Keytruda® infringes a patent directed to the use of anti-PD-1 antibody to treat...more

Lessons From The Largest Patent Damages Award In History

by Womble Bond Dickinson on

By now, most everyone in the patent community has heard about the $2.54 Billion dollar jury verdict in a battle over Hepatitis C medication that resulted from a jury trial in December 2016. In Delaware federal district...more

Product Liability: 2016 Year in Review | News & Insight

Massachusetts state and federal courts issued a number of important product liability decisions in 2016. The Product Liability and Toxic Tort Litigation Group at Nutter recently reviewed these cases. Highlighted below are...more

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