News & Analysis as of

Merck

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 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

Breaking News: PTAB Grants One Petition and Denies Another for Review of Genentech’s Cabilly Patent

by Goodwin on

Merck Sharp & Dohme filed two petitions for inter partes review of Genentech’s U.S. Patent 6,331,415, one of the “Cabilly Patent,” which claims processes and materials broadly applicable to recombinant antibody manufacturing....more

Pharmaceutical Product Liability Class Action Filed Relating to Olmetec Drug

by Bennett Jones LLP on

Earlier this month a proposed class action was filed in Montreal by the Consumer Law Group alleging that Merck, Shering-Plough and Daiichi Sankyo (the Defendants) provided inadequate warnings about the drugs Olmetec and...more

Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC, Civ. No. 13-2088-GMS, 2016 U.S. Dist. LEXIS 114419 (D. Del. Aug 26, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: NuvaRing® (etonogestrel /...more

E.D. Pennsylvania Limits Protected Activity Under SOX

In Westawski v. Merck & Co., No. 14-cv-3239 (E.D. Pa. Oct. 18, 2016), the Eastern District of Pennsylvania granted Defendant Merck & Co. (Company) summary judgment on Plaintiff Joni Westawski’s (Plaintiff) SOX whistleblower...more

New Results Presented at ESMO: Merck’s Keytruda® Has Potential to be Used as First-Line Therapy for Non-Small Cell Lung Cancer

by Goodwin on

At yesterday’s European Society for Medical Oncology (ESMO) meeting, Merck Sharp & Dohme Corp. announced positive data from two studies regarding its Keytruda ® (pembrolizumab) biologic. According to Merck’s press release,...more

Sanofi Sues Merck Over Proposed Insulin Glargine Biosimilar

by Goodwin on

Last week, Sanofi-Aventis U.S. LLC filed a complaint against Merck Sharp & Dohme Corp. over its proposed biosimilar to Lantus (insulin glargine injection). The complaint asserts that Merck will infringe 10 different U.S....more

US Biosimilar Pathway Update

Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US. Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, was the first biosimilar to be approved. Zarxio, a...more

FDA Accepts Merck’s Lantus Biosimilar for Review

by Goodwin on

We recently posted that Merck had announced “promising” results from Phase III studies evaluating MK-1293, an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2...more

Your daily dose of financial news - The Brief – 8.3.16

by Robins Kaplan LLP on

Look to Miami for the latest legal troubles for the country’s biggest banks. After most have finally put to bed the remnants of Great Recession RMBS litigation, a new tack by the city is looking to hold them responsible for...more

Australian Regulators Approve Samsung Bioepis’s Etanercept Biosimilar Brenzys

by Goodwin on

On July 22, 2016, Australia’s Therapeutic Goods Administration approved Samsung Bioepis’s biosimilar of Amgen’s Enbrel (etanercept), which is approved for treatment of rheumatoid arthritis. Samsung Bioepis’s product, called...more

Merck & Cie v. Watson Labs., Inc.

by Robins Kaplan LLP on

Case Name: Merck & Cie v. Watson Labs., Inc., 2015-2063, -2064, 2016 U.S. App. LEXIS 8782 (Fed. Cir. May 13, 2016) (Circuit Judges Dyk, Mayer, and Hughes presiding; Opinion by Mayer, J.) (Appeal from D. Del., Andrews, J.)...more

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