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Merck

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

ANDA Update - Volume 2, Number 2

by McDermott Will & Emery on

180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more

Merck Files DJ Complaint Against Genentech’s Cabilly III Patent

by Goodwin on

Merck Sharp & Dohme Corp. has challenged Genentech’s U.S. Patent No. 7,923,221 (Cabilly III) with a complaint for declaratory judgment in the Central District of California. The patent relates to methods to produce antibody...more

IPR Tracker: IPR2016-01373 (U.S. Patent No. 6,331,415) (Merck Sharp & Dohme Corp.) (Cabilly II Patent) – Petition for IPR

by Goodwin on

Merck Sharp & Dohme Corp. has filed an IPR petition on U.S. Patent No. 6,331,415. This patent has been challenged several times over the past year with mixed results: IPR2015-01624 (instituted); IPR2016-00383 (not...more

Merck’s Lantus Biosimilar Queued for an FDA Submission?

by Goodwin on

Merck, known as MSD outside the United States and Canada, announced promising results from two Phase III studies evaluating MK-1293 – Merck’s biosimilar to Lantus (insulin glargine). Lantus is used for the treatment of...more

On Sale Bar Invalidates Safyral, Beyaz Folate Patent

by Foley & Lardner LLP on

In Merck & CIE v. Watson Laboratories, Inc., the Federal Circuit found communications between Merck and a potential joint venture partner amounted to a commercial offer to sell that invalidated the Orange Book-listed folate...more

English High Court considers co-existence provisions under German and English law

by Dechert LLP on

In two recent IP decisions in the English High Court, the interpretation of a settlement agreement and a co-existence agreement have been carefully considered. In DKH Retail and Others v SRG Apparel Plc and Others, English...more

Merck & Cie v. Watson Laboratories, Inc. (Fed. Cir. 2016)

The Federal Circuit had the occasion to revisit the proper application of the on-sale bar under 35 U.S.C. § 102(b) in ANDA litigation over claim 4 of U.S. Patent No. 6,441,168, which reads...more

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