In a decision that issued last week, a Patent Trial and Appeal Board (“PTAB”) panel instituted inter partes review (“IPR”) of a petition filed by Merck Sharp & Dohme LLC (“Merck”) for a patent owned by The Johns Hopkins...more
On March 13, 2024, Merck Sharp & Dohme, LLC (“Merck”) filed four additional IPRs challenging The Johns Hopkins University (“JHU”) patents covering methods of treatment using pembrolizumab, which Merck sells under the trade...more
Anticipation of a claim generally requires that a single prior art reference explicitly discloses each and every claim element. However, absent an express teaching in the prior art, a claim may also be anticipated if it is...more
The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) decision that prior art disclosing a class of 957 salts could not inherently anticipate claims to a salt within the class because...more
Last week Pfizer filed a lawsuit in a federal court of Australia against respondents Samsung Bioepis, Merck, Sharp & Dohme, Organon, and Arrow, to halt sales of their biosimilar BRENZYS (etanercept). Pfizer alleges that the...more
In a patent infringement action brought under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, in relation to sitagliptin phosphate monohydrate (Merck’s JANUVIA), Justice Furlanetto of the Federal...more
About Life Sciences Court Report: We will periodically report on recently filed biotech and pharma litigation. ...more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Case Name: Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC, Civ. No. 15-250-SLR, 2017 U.S. Dist. LEXIS 12165 (D. Del. Jan. 30, 2017) (Robinson, J.). Drug Product and U.S. Patent: Nasonex® (mometasone furoate nasal...more
Case Name: Merck Sharp & Dohme Corp. v. Hospira Inc., 14-cv-915-RGA, 2016 U.S. Dist. LEXIS 139721 (D. Del. Oct. 7, 2016) (Andrews, J.). Drug Product and Patent(s)-in-Suit: Invanz® (ertapenem); U.S. Patents Nos. 5,952,323...more
Case Name: Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc., No. 14-874-SLR, 2016 U.S. Dist. LEXIS 158514 (D. Del. Nov. 16, 2016) (Robinson, J.). Drug Product and Patent(s)-in-Suit: Nasonex® (mometasone furoate...more
Case Name: Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC, Civ. No. 13-2088-GMS, 2016 U.S. Dist. LEXIS 114419 (D. Del. Aug 26, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: NuvaRing® (etonogestrel /...more