Generic Drugs

News & Analysis as of

BPCIA Helps Amgen Gain Dismissal of Genentech Complaint

Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to...more

Dechert survey: Developments in securities fraud class actions against U.S. life sciences companies

Life sciences companies continued to be popular targets of securities fraud class action lawsuits filed in 2016, and prudent life sciences companies should take heed of the results of this year’s decisions. In 2016,...more

Competition News March 2017

The French Supreme Court confirms the French Competition Authority’s approach on the squeeze-out strategies shared between a supplier and its distributor - In this case, Reckitt Benckiser (Reckitt), holder of rights on...more

February 2017: Life Sciences Litigation Update

Recently Amended FDA Rules Can Affect Settlements in Pharmaceutical Litigations. After more than thirteen years of bureaucratic analysis and rulemaking, the U.S. Food and Drug Administration recently implemented its new rules...more

Genentech’s BPCIA Complaint Against Amgen Dismissed

Today, Judge Gregory Sleet of the U.S. District Court of Delaware orally dismissed Genentech’s lawsuit against Amgen alleging violations of the BPCIA. Judge Sleet did not issue a written opinion, but his order states that...more

SCOTUS to Weigh In on Two Biosimilar Patents, Provisions of the BPCIA in 2017

2017 is shaping up to be a big year for biosimilars and for the Biologics Price Competition and Innovation Act of 2009 (BPCIA) specifically. The Supreme Court is scheduled to hear oral arguments on April 26, 2017, that will...more

The Government Seeks to Intervene in its Third Generic Drug Price-fixing Lawsuit

Since we last reported on the state and federal government’s generic drug pricing investigations and litigations (click here to read more), the U.S. Department of Justice (“DOJ”) has obtained its first guilty pleas. On...more

Wrong Inventor Defense Fails in Pharmaceutical Litigation

Addressing derivation and obviousness issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s denial of a generic drug manufacturer’s attempt to invalidate a patent based on the theory that the...more

The Federal Circuit Found Direct Infringement Attributable to Physicians Where “No Single Actor Performs All Steps of a Claim"

Can a patient’s action in taking a generic drug be attributable to a physician such that it can support a finding of the physician’s direct patent infringement? According to a recent precedential opinion of the Court of...more

Will You, Won't You Join The Biosimilar Patent Dance?

In the latest dispute surrounding the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the...more

On-Sale Bar for Contractor and Supplier Activities

The Federal Circuit addressed the potential for contract manufacturing to create an “on sale” bar to patentability, in a decision that could affect how supplier relationships are managed. Whether a sale or offer for sale of...more

Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent...

On February 2, 2017, the Federal Court of Appeal released a significant decision on accounting for profits, a remedy for patent infringement in Canada: Apotex Inc v ADIR, 2017 FCA 23. The appeal concerned two defences raised...more

Federal Trade Commission Deploys Antitrust Weaponry Against Pharmaceutical Company

In Federal Trade Commission v. Shire ViroPharma Inc. (D. Del. Feb. 7, 2017), the FTC has, for the first time, deployed its antitrust weaponry against a pharmaceutical company’s alleged practice of using the FDA’s...more

TrumpCare: The Pharmaceutical Industry and FDA

Hope in the Midst of Uncertainty - The New Year ushered a period of uncertainty for the pharmaceutical industry. We face the beginning of the Trump Administration and a Congress with both houses controlled by Republicans...more

Second Circuit Declares That, to Survive Motions to Dismiss, Antitrust Allegations Require Factual Support for All “Necessary...

Last Wednesday, the Second Circuit Court of Appeals partially vacated the judgment of the district court in In re Actos End-Payor Antitrust Litigation. In doing so, the Second Circuit allowed only plaintiffs’ claims that...more

Boletín Mensual de Comercio Internacional: Enero - Información con Énfasis en la Regulación Comercial y de Arbitraje Internacional

Durante el mes de Enero destacan los siguientes temas: Acceso, Compras, Propiedad Intelectual, Comercio, Inversión, Solución de Diferencias, Competencia, Subvenciones, Arbitraje Inversión....more

AKAMAI V – “How To” Induce Infringement of a Method of Treatment Claim

I have both been busy since the holiday season and frankly, uninspired by the case law that has appeared on the scene. Who can be enraptured by the fine points of standing when we are all speculating about whether Michelle...more

Endo Pharms. Inc. v. Amneal Pharms. LLC

Case Name: Endo Pharms. Inc. v. Amneal Pharms. LLC, Civ Nos. 14-1382-RGA, 14-1389-RGA, 2016 U.S. Dist. LEXIS 140112 (D. Del. Oct. 7, 2016) (Andrews, J.). Drug Product and Patent(s)-in-Suit: Opana® ER (oxymorphone...more

Merck Sharp & Dohme Corp. v. Hospira Inc.

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

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

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

Orexo AB v. Actavis Elizabeth LLC

Case Name: Orexo AB v. Actavis Elizabeth LLC, 14-cv-829-SLR, 2016 U.S. Dist. LEXIS 157683 (D. Del. Nov. 15, 2016) (Robinson, J.). Drug Product and Patents-in-Suit: Zubsolv® (buprenorphine / naloxone sublingual tablet);...more

Mylan Institutional LLC v. Aurobindo Phama Ltd

Case Name: Mylan Institutional LLC v. Aurobindo Phama Ltd, 2:16-cv-00491-RWS-RSP, 2016 U.S. Dist. LEXIS 180551 (E.D. Tex. Nov. 21, 2016) (Payne, MJ). Drug Product and Patents-in-Suit: isosulfan blue; U.S. Patents Nos....more

Aptalis Pharamtech, Inc. v. Apotex Inc.

Case Name: Aptalis Pharamtech, Inc. v. Apotex Inc., Civ. No. 14-1038-SLR, 2016 U.S. Dist. LEXIS 169520 (D. Del. Dec. 8, 2016) (Robinson, J.). Drug Product and U.S. Patent: Amrix® (cyclobenzaprine); U.S. Patents Nos....more

NEWSFLASH: What happens if you purchase a marketing authorisation then revoked for serious noncompliances with the Good Clinical...

Transfer of a MA, its subsequent revocation and compensation for damages - What happens if you purchase a marketing authorisation and that is then revoked for serious non-compliances with the Good Clinical Practice...more

Roxane Labs., Inc. v. Vanda Pharms., Inc.

Case Name: Roxane Labs., Inc. v. Vanda Pharms., Inc., No. 16-0179, 2016 U.S. Dist. LEXIS 175785 (S.D. Ohio Dec. 20, 2016) (Marbley, J.). Drug Product and Patent(s)-in-Suit: Fanapt® (iloperidone); U.S. Patents Nos....more

660 Results
|
View per page
Page: of 27
Cybersecurity

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×