Merck

News & Analysis as of

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

Federal Circuit Review | January 2016

The Federal Circuit Will Review Appeals from Inter Partes Review Proceedings Under the “Substantial Evidence” Standard - In Merck & Cie v. Gnosis S.p.A., Appeal No. 2014-1779, the Federal Circuit affirmed a PTAB IPR...more

BioPharma Patents: Quick Tips & News - January 2016

Subject matter eligibility and “laws of nature.” As reported in our July 2015 newsletter, the Federal Circuit invalidated claims to a method of diagnosing fetal abnormalities without amniocentesis. This precedent—if it...more

Merck Resolves Investors’ Class Action Lawsuit Related To Vioxx

In 2004, Merck pulled its painkiller, Vioxx, from the market after a study linked the drug to increased risks for heart attack and strokes. On Friday, January 15, 2016, Merck announced that it had agreed to pay $830 million...more

Court Report - January 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Merck Sharp & Dohme B.V. v. Teva Pharmaceuticals USA Inc. 1:15-cv-00806; filed September 11, 2015 in the District Court...more

PTAB Trial Standard Of Review Requires Affirmance Despite Contrary Evidence

In Merck & Cie v. Gnosis S.p.A., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that held the challenged claims obvious in an Inter Partes Review (IPR) proceeding. Although the...more

Federal Circuit Affirms PTAB's IPR Decision Invalidating A Pharmaceutical Patent

On December 17, 2015, in Merck v. Gnosis, the Federal Circuit affirmed the PTAB’s IPR Decision finding a pharmaceutical patent invalid for obviousness. Justice Newman vigorously dissented from the majority’s view (Justices...more

Federal Circuit Affirms Invalidity Of A Merck Patent Based On Substantial Evidence Standard

In a recent case, the Court of Appeals for the Federal Circuit affirmed the PTAB’s decision that certain claims of Merck’s U.S. Patent No. 6,011,040, which were challenged by Gnosis, were invalid as anticipated or obvious....more

Court Report - January 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Spectrum Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals LLC - 2:15-cv-01697; filed September 3, 2015 in the...more

Court Report - December 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Warner Chilcott (US), LLC et al. v. Teva Pharmaceuticals USA, Inc. et al. - 1:15-cv-00761; filed August 31, 2015 in...more

Top Patent Law Stories In 2015

I will try to keep this post as brief as possible, since I posted at length on all of the stories. There was a lot of IP action in 2015 – much involving the Fed. Cir. and Supreme Court’s resolution of cases in progress in...more

“Destroying Things Is Much Easier Than Making Them” – The Worst Prescription Drug/Medical Device Decisions of 2015

In the original Hunger Games movie, while Katniss and Rue are plotting to blow up the Careers’ food stash, Katniss remarks that “destroying things is much easier than making them.” That’s how we feel about our bottom ten...more

Fed. Cir. Defers to PTAB Finding of Obviousness in First Pharma IPR Reviews (Merck v. Gnosis)

On December 17, 2015, the Federal Circuit issued a precedential decision affirming a determination by the Patent Trial and Appeal Board (“PTAB”) that patent claims related to methods of treating elevated homocysteine levels...more

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