News & Analysis as of


Massachusetts Supreme Judicial Court Recognizes ‘Innovator Liability’

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Third Circuit Follows ANZ Securities Decision and Reverses for Dismissal of Exchange Act Claims as Untimely

by Carlton Fields on

On June 28, 2017, Bruce Berman and Steve Blickensderfer posted in this space about the Supreme Court’s recent decision in California Public Employees Retirement System v. ANZ Securities, Inc., 137 S. Ct. 2042 (2017). In that...more

Uptick in University Enforcement of Intellectual Property an Indication of Stricter Enforcement Policy or a Passing Trend?

by Miles & Stockbridge P.C. on

Universities have traditionally been reluctant to enforce their intellectual property (IP) against third parties. There are many reasons for this position, including adverse publicity associated with such suits, the time...more

Sanofi Sues MSD Regarding Follow-On Insulin Glargine Biologics

by Goodwin on

On August 8, Sanofi-Aventis filed a complaint for patent infringement against Merck Sharp & Dohme in the U.S. District Court for the District of New Jersey regarding Merck’s proposed follow-on biologics of Sanofi-Aventis’s...more

SDNY Judge Adheres To Prior Ruling That Discovery Rule Applies To Securities Act Statute Of Limitations

by Shearman & Sterling LLP on

On July 28, 2017, Judge Victor Marrero of the United States District Court of the Southern District of New York denied a motion for reconsideration of an earlier decision declining to dismiss as untimely a putative class...more

Patent Judgments and Awards - Merck Ordered to Pay $14 Million in Attorneys’ Fees to Rival Gilead After a Patent Infringement...

by Knobbe Martens on

Merck Ordered to Pay $14 Million in Attorneys’ Fees to Rival Gilead After a Patent Infringement Trial Involving Hepatitis C Drugs - On July 14, 2017, in a stunning reversal of fortune, a federal court in San Jose, CA,...more

Samsung Bioepis and Merck & Co. Launch Renflexis, A Lower-Priced Competitor to Inflectra

by Goodwin on

Merck & Co. and Samsung Bioepis announced today the U.S. launch of Renflexis (infliximab), a biosimilar of Janssen’s Remicade. Renflexis was approved on April 21 by the FDA for all eligible indications. ...more

Merck Receives Tentative FDA Approval for Lantus Follow-on

by Goodwin on

On July 20, 2017, Merck & Co. announced that the FDA granted tentative approval of its 505(b)(2) application for Lusduna™ Nexvue™ (insulin glargine injection), its follow-on version of Sanofi SA’s Lantus. Merck’s product...more

German Federal Court: Permission granted - HIV/AIDS drug distribution continued

by Hogan Lovells on

The X. Civil Senate of the German Federal Court of Justice has granted a motion by three companies of the Merck Sharp & Dohme group (Merck) for a preliminary permission for the continued distribution of Isentress®, a drug...more

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