Merck

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Sanofi Sues Merck Over Proposed Insulin Glargine Biosimilar

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

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

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

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.

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

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

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

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?

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

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

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

EP Biosimilar Competition Causes a Drop in Sales for Remicade

Remsima, a biosimilar of Remicade (infliximab), was granted a marketing authorization throughout the European Union in 2013. Earlier this week, Merck reported a 30% drop in Remicade first-quarter sales due to “the...more

District Court Applies Mayo To Treatment Claims But Denies Motion To Dismiss BMS Keytruda Litigation

The U.S. District Court for the District of Delaware accepted Merck’s arguments that method of treatment patents asserted by BMS against its Keytruda product “touch[] upon a natural phenomenon” such that they should be...more

Federal Circuit Maintains “Substantial Evidence” Standard of Review in AIA Post Grant Proceedings

On April 26, 2016, the Federal Circuit denied a petition seeking rehearing en banc of its application of the “substantial evidence” standard of review in post-grant administrative proceedings, in the case of Merck & Cie v....more

Court Report - April 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Teva Pharmaceuticals USA Inc. et al. v. Biocon Ltd. et al. 1:16-cv-00278; filed April 19, 2015 in the District Court of...more

Bristol-Myers Squibb v. Merck – Mayo/Alice Rule Reaches Medical Treatment Methods.

In Bristol-Myers Squibb v. Merck, Civil Action No. 150572-GMS (D. Del., 2016), Bristol-Myers sued Merck for inducing infringement of U.S. Pat. No. 9,073,994. ...more

SEC Files Another Insider Trading Administrative Proceeding

The SEC filed another settled insider trading action as an administrative proceeding. The Commission has increasingly been filing insider trading cases in an administrative forum this year. In the Matter of Eric J. Wolff,...more

IP Newsflash - March 2016

DISTRICT COURT CASES - New York Court Invalidates Targeted-Advertising Patents under Alice - A federal judge in the Southern District of New York granted counterclaim-defendant TNS’s motion for summary judgment...more

Intellectual Property Newsletter - January/February 2016

2015 U.S. Trademark Developments Every Food and Beverage Lawyer Should Know - In 2015, U.S. courts provided trademark practitioners with several issues to discuss and debate. Identified and summarized below are the top...more

Written Description: A License to Hunt or a Wild Goose Chase?

Order Denying Gilead’s Motion for Summary Judgment and Granting Merck’s Motion for Summary Judgment, Gilead Sciences, Inc. v. Merck & Co., Inc. et al., Case No. 5:13-cv-04057 (Judge Beth Freeman) - Gilead sued Merck on...more

“Substantial Evidence” Review Dooms PTAB Appeal - Merck & Cie v. Gnosis S.P.A.

Addressing the issue of obviousness in the context of an inter partes review (IPR), the U.S. Court of Appeals for the Federal Circuit affirmed a decision by the Patent Trial and Appeal Board (PTAB or Board) under a...more

Patents – Year In Review

In 2015, Canadian courts and the Patent Appeal Board issued decisions which deemed non-infringing alternatives to affect damages for patent infringement, assessed a license agreement by reference to U.S. patent law, and...more

Court Denies Motion to Compel Under Newly Amended FRCP 26(b)(1) (California)

Gilead Sciences v. Merck, 2016 WL 146574 (N.D. Cal. Jan. 13, 2016) - In this patent infringement case, the defendant sought additional discovery on the contents of certain “tubes of compounds” that the plaintiff’s...more

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