News & Analysis as of

Merck

Seyfarth Shaw LLP

Federal Court Leaves Opportunity For A “Compelling” Exhaustion Argument

by Seyfarth Shaw LLP on

Seyfarth Synopsis: The U.S. District Court for the District of New Jersey recently issued a ruling with respect to Defendants’ “compelling” exhaustion argument that Plaintiffs failed to exhaust administrative remedies with...more

Goodwin

New IPR Petitions Filed Against GSK Vaccine Process Patents

by Goodwin on

Yesterday, Merck Sharp & Dohme Corp. filed four IPR petitions (IPR2018-01229, IPR2018-01236, IPR2018-01234, and IPR2018-01237) against GlaxoSmithKline process patents – US Patent Nos. 8,753,645 and 9,265,839. The ‘645 and...more

Goodwin

Trial Begins in Insulin Glargine Follow-On Biologics Litigation

by Goodwin on

On May 29, 2018, a week-long bench trial began before Judge Andrews in Sanofi-Aventis U.S. LLC v. Merck Sharpe & Dohme Corp. in the District of Delaware. As we reported here, Sanofi had sued Merck for patent infringement...more

Goodwin

Delaware Court Denies Merck Summary Judgment Motion in Insulin Glargine Case

by Goodwin on

As we previously reported, Sanofi-Aventis sued Merck Sharp & Dohme in the District of Delaware for patent infringement based on Merck’s proposed follow-on biologics of Sanofi-Aventis’s Lantus® and Lantus® SoloSTAR® ([rDNA...more

Goodwin

Q1 2018 Earnings Roundup: Biosimilars Update

by Goodwin on

Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls. Below are some highlights...more

Shearman & Sterling LLP

Excessive Pricing, ‘Pay-For-Delay’ and Rebates: A New Era of Enforcement in the Pharmaceutical Industry

by Shearman & Sterling LLP on

The European Commission (EC) and other national competition authorities (NCAs) have traditionally shied away from investigating allegations of excessive pricing and appearing as price regulators. Commissioner Vestager warned...more

Robins Kaplan LLP

Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC, 881 F.3d 1376 (Fed. Cir. 2018) (Circuit Judges Taranto, Clevenger, and Stoll presiding; Opinion by Stoll, J.) (Appeal from D. Del., Robinson, J.)....more

Benesch

Court Kills Compound Patent For Failing to Enable Full Claim Scope

by Benesch on

On February 16, 2018, Judge Stark of the District of Delaware overturned the largest patent verdict in history. This extremely contentious patent infringement suit between Idenix Pharmaceuticals LLC (“Idenix”), a subsidiary...more

Nutter McClennen & Fish LLP

Massachusetts Supreme Judicial Court Recognizes ‘Innovator Liability’

by Nutter McClennen & Fish LLP on

On March 16, 2018, in a matter of first impression in Massachusetts, the Supreme Judicial Court (“SJC”) joined a minority of states in recognizing a tort theory of “Innovator Liability” – namely, that brand-name drug...more

Goodwin

Merck Launches Ontruzant®, First Trastuzumab Biosimilar in Europe

by Goodwin on

Last week it was reported (here and here) that Merck launched Samsung Bioepis’ Ontruzant® in the United Kingdom, the first biosimilar trastuzumab launched in Europe. Ontruzant® is a biosimilar of Roche’s Herceptin® and is...more

Patterson Belknap Webb & Tyler LLP

Hepatitis C Patent Falls for Non-Enablement, Wiping Out $2.5 Billion Infringement Verdict

In a hard-fought patent battle involving “groundbreaking” work by both parties, Chief Judge Stark of the U.S. District Court for the District of Delaware ruled that plaintiff Idenix’s patent for treating Hepatitis C virus...more

Dorsey & Whitney LLP

SEC Settles With Corporate Insider Who Traded Then Lied

by Dorsey & Whitney LLP on

Some corporate insiders make the mistake of trading while in possession of material non-public information. Others compound the error by lying to the SEC staff during an ensuing investigation. ...more

Harness, Dickey & Pierce, PLC

ANDA Your Patent is Not Infringed

In Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC, [2017-1560] (February 9, 2018), the Federal Circuit affirmed the district court finding that it did not abuse its discretion in denying Merck’s request for...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

Knobbe Martens

Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC

by Knobbe Martens on

Federal Circuit Summaries - Before Taranto, Clevenger, and Stoll. Appeal from the United States District Court for the District of Delaware. Summary: Proceeding to trial despite a party’s violation of a discovery order...more

Goodwin

Trastuzumab Biosimilar Demonstrates Equivalence

by Goodwin on

The Journal of Clinical Oncology reported that Merck and Samsung Bioepis’ biosimilar to trastuzumab (Herceptin®), SB3, demonstrated equivalence to trastuzumab in recent Phase III trials. According to the report, in a phase...more

Robins Kaplan LLP

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, No. 2016-2583, 2017 U.S. App. LEXIS 20441 (Fed. Cir. Oct. 19, 2017) (Circuit Judges Dyk, Linn, and Hughes presiding; Opinion by Hughes, J.) (Appeal from D....more

Robins Kaplan LLP

Merck Sharp & Dohme Corp. v. Hospira, Inc.

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme Corp. v. Hospira, Inc. 874 F.3d 724, No. 17-1115, 2017 U.S. App. LEXIS 21201 (Fed. Cir. Oct. 26, 2017) (Circuit Judges Newman, Lourie, and Hughes presiding; Opinion by Lourie, J.; Dissent by...more

Goodwin

Year in Review: Top 5 Biosimilars Deals of 2017

by Goodwin on

Here are our picks for the top-5 biggest deals in the world of biosimilars in 2017...more

Hogan Lovells

Dutch Supreme Court hands down landmark decision on infringement of second medical use patents

by Hogan Lovells on

On 3 November 2017, the Dutch Supreme Court (Hoge Raad) handed down a landmark decision on the infringement of second medical use patents in the Merck Sharp & Dohme Corp. (“MSD”) v. Teva Pharma B.V. and Pharmachemie B.V....more

Robins Kaplan LLP

Merck Sharp & Dohme Corp. v. Actavis Labs. Fl, Inc.

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme Corp. v. Actavis Labs. Fl, Inc., No. 15-cv-6075 (PGS) (DEA), 2017 U.S. Dist. LEXIS 164131 (D.N.J. Sept. 29, 2017) (Sheridan, J.)... Drug Product and Patent(s)-in-Suit: Noxafil®...more

McDonnell Boehnen Hulbert & Berghoff LLP

Merck Sharp & Dohme Corp. v. Hospira, Inc. (Fed. Cir. 2017)

The Federal Circuit continues its explication of the law of obviousness post-KSR Int'l. v. Teleflex Inc. (and Judge Pauline Newman continues to disagree with her brethren in some regards) in a decision handed down last...more

Foley & Lardner LLP

FDA Approves Companion Dx for PD-1 Inhibitor

by Foley & Lardner LLP on

According to the American Cancer Society (“ACS”), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer). About 14% of all new cancers are lung...more

Dentons

Competition News - September 2017

by Dentons on

A look back on a decision imposing a fine on Facebook for having provided the European Commission with inaccurate information on its acquisition of WhatsApp - On May 18, 2017, the European Commission imposed a €110 million...more

Goodwin

Fresenius Kabi completes acquisition of Merck KGaA’s biosimilars business

by Goodwin on

Last week Fresenius Kabi announced that it has successfully closed its acquisition of Merck KGaA’s biosimilars business, which comprises Merck’s entire biosimilars development pipeline. According to Fresenius, the product...more

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Updated: May 25, 2018:

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Privacy Officer
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10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Privacy Officer
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Sausalito, California 94965

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