Private Equity's Inversion Excursion: Pepper Hamilton Talks Tax With the Deal
Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more
Precedential Federal Circuit Opinions - TEVA PHARMACEUTICALS USA v. CORCEPT THERAPEUTICS, INC. [OPINION] (2021-1360, 12/07/2021) (MOORE, NEWMAN, and REYNA) - Moore, C.J. The Court affirmed the PTAB’s IPR decision...more
In 2018 we reported on a number of developments in life sciences IP and regulatory law. Our most-read articles were: #1 a June update on biosimilars (authored by Urszula Wojtyra); #2 a “live” summary chart of Vanessa’s Law...more
The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more
Gilead prevails in SOVALDI appeal - The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). In the trial decision, as previously reported, the...more
A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more
The following are highlights of developments in Canadian life sciences intellectual property and regulatory law in 2016, updating our 2016 mid-year highlights. 1. Substantive patent law developments - Utility and...more
Shearman & Sterling’s bi-annual Trends & Patterns in FCPA Enforcement report provides insightful analysis of recent enforcement trends and patterns in the US, the UK and elsewhere, as well as helpful guidance on emerging best...more
It has been over three years since the Supreme Court’s Actavis decision. Since then, numerous putative class actions alleging harm to competition as a result of “reverse-payment” settlements have flooded the courts. The...more
About the PTAB Life Sciences Report: Each month we will report on recent developments at the PTAB involving life sciences patents. Argentum Pharmaceuticals LLC. v. Janssen Oncology, Inc. - PTAB Petition: ...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Unimed Pharmaceuticals LLC et al. v. Lupin Atlantis Holdings SA et al. 1:15-cv-00904; filed October 9, 2015 in the...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Astellas Pharma Inc. et al. v. Apotex Inc. et al. 1:15-cv-00857; filed September 22, 2015 in the District Court of...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Tris Pharma Inc. v. Par Pharmaceutical Inc. et al. 1:15-cv-00068; filed January 21, 2015 in the District Court of...more
As reported previously, the first post-Actavis jury verdict in a “reverse payment” antitrust case handed a win to the defendants. Now, plaintiffs in In re: Nexium (Esomeprazole) Antitrust Litigation have moved for a new...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Par Pharmaceutical Inc. 1:14-cv-01494; filed December 18 2014 in the District...more
After six weeks of trial and two days of deliberation, the jury has returned its verdict in favor of the defendants in In re: Nexium. This trial began as a challenge to the allegedly anticompetitive effects of the settlements...more
Today, the Nexium district court will hear arguments on the Ranbaxy defendants’ motion for a mistrial. As we have previously reported, In re: Nexium is the first pay-for-delay case to go to trial since the Supreme Court’s...more
As we previously reported, the In re: Nexium trial is the first pay-for-delay trial in the wake of the Supreme Court’s Federal Trade Commission v. Actavis decision. But if the Nexium defendants have it their way, plaintiffs’...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. AstraZeneca Pharmaceuticals LP et al. v. Pharmadax USA, Inc. et al. 1:14-cv-07105; filed November 3, 2014 in the...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. AstraZeneca Pharmaceuticals LP et al. v. Pharmadax USA, Inc. et al. 8:14-cv-01710; filed October 23, 2014 in the Central...more
Much has happened since our last post on the Nexium “pay for delay” class action lawsuit. Jury selection began in the District of Massachusetts on Monday, October 20, 2014. The day prior, one of the generic drug makers, Dr....more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cadence Pharmaceuticals Inc. et al. v. InnoPharma Licensing LLC et al. 1:14-cv-01225; filed September 24, 2014 in the...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. GlaxoSmithKline LLC et al. v. Glenmark Generics Inc. USA 1:14-cv-00877; filed July 3, 2014 in the District Court of...more