Merck

News & Analysis as of

“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

Court Report - December 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Merck Sharp & Dohme Corp. et al. v. Med-Pharmex, Inc. 3:15-cv-01905; filed August 28, 2015 in the Southern District of...more

Teaching Away Must Be Apparent from the Art as a Whole, and not Just Isolated Examples

In Merck & Cie v. Gnosis S.P.A., [20140-1779] (Fed. Cir. 2015) the Federal Circuit affirmed a PTAB decision in an IPR that the claims were invalid for obviousness, rejected patent owner Merck’s arguments that the prior art...more

Merck & Cie v. Gnosis S.P.A. (Fed. Cir. 2015)

As she has done many times before (and so many times that she has been unfairly characterized as a scold on the Federal Circuit), Judge Lorraine Newman dissented from the panel majority decision affirming an obviousness...more

Federal Circuit Addresses Substantial Evidence as Standard of Review in IPR

In June, 2014, the PTAB declared all challenged claims in two IPR trials brought by Gnosis S.p.A. to be unpatentable based on obviousness grounds. Gnosis S.p.A. v. S. Ala. Medical Science Found., IPR2013-00116 and Gnosis...more

Court Report - November 2015 #5

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Merck Sharp & Dohme Corp. v. Savior Lifetec Corp. 5:15-cv-00415; filed August 21, 2015 in the Eastern District of North...more

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

Case Name: Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc., Civ. No. 14-874-SLR-SRF, 2015 U.S. Dist. LEXIS 85279 (D. Del. July 1, 2015) (Fallon, M.J.) - Drug Product and Patent(s)-in-Suit: Nasonex® (mometasone...more

Court Report - November 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Amgen Inc. et al. v. Apotex Inc. et al. 0:15-cv-61631; filed August 6, 2015 in the Southern District of Florida. •...more

Merck Sharp & Dohme Corp. v. Sandoz Inc.

Case Name: Merck Sharp & Dohme Corp. v. Sandoz Inc., Civ. No. 3:12-cv-03289-PGS-LHG, 2015 U.S. Dist. LEXIS 113710 (D.N.J. Aug. 27, 2015) (Sheridan, J.) - Drug Product and Patent(s)-in-Suit: Emend® (fosaprepitant...more

Merck & CIE v. Watson Labs., Inc.

Case Name: Merck & CIE v. Watson Labs., Inc., Civ. Nos. 13-978-RGA, 13-1272-RGA, 2015 U.S. Dist. LEXIS 115245 (D. Del. Aug. 31, 2015) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Safyral® and Beyaz®...more

Patent Update: Infringement and “Non-Infringing Alternatives”

If you are a patent owner, you are entitled to damages if someone infringes your patent. The measure of damages is compensatory damages, lost profits or a “reasonable royalty”. Is it fair for the infringer to say that the...more

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