Webinar: Orange Book listing sheets under the microscope
Key Considerations for Reshoring U.S. Drug Manufacturing
Drug Pricing Initiatives During the Trump Presidency
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Patent law in Europe: What pharmaceutical companies need to know
EU excessive pricing laws
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
In a stunning Federal Register Notice published May 10, 2024, the U.S. Patent and Trademark Office (USPTO) proposes to impose a new requirement on terminal disclaimers filed to overcome obviousness-type double patenting...more
The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more
The U.S. Department of Justice Antitrust Division ("DOJ") recently resolved a criminal case with Teva Pharmaceuticals and Glenmark Pharmaceuticals via deferred prosecution agreements ("DPAs"), which include a novel remedy for...more
The China National Intellectual Property Administration, a newly established administrative authority on patent infringement disputes, recently issued its first decisions, addressing questions many companies had on the...more
On June 21, 2022, Novartis Pharmaceuticals Corp.'s patent for a method of treating multiple sclerosis with fingolimod (Gilenya®) was held invalid for lack of written description under 35 U.S.C. § 112(a). Gilenya® was...more
In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more
China has recently unveiled its own version of a patent linkage system that has been highly watched by stakeholders and industry observers. This new system will also create a new form of pharmaceutical patent litigation in...more
In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the European Courts. In two recent rulings – “Lundbeck and...more
On 25 March 2021, the European Court of Justice (ECJ) ruled for the second time on a “pay-for-delay” settlement. These are settlements of a patent dispute that involve payments or other value transfers from the originator...more
Article 76 of the Amendment establishes the longanticipated patent linkage scheme in China. It aims to allow early resolution of patent disputes between innovators and generic companies during the drug review and approval...more
The DOJ Antitrust Division’s multi-year criminal cartel investigation of the generic pharmaceutical industry is gaining steam. The latest company to settle is Taro Pharmaceuticals which agreed to enter a deferred prosecution...more
The Justice Department’s Antitrust Division announced a major guilty plea with Sandoz, Inc., in its expanding criminal investigation of the generic pharmaceutical industry....more
On February 25, 2019, the Third Circuit held that the Federal Trade Commission cannot bring litigation in federal court based on past conduct, absent factual allegations demonstrating that a defendant “is violating or is...more
In a novel interpretation of the Federal Trade Commission (FTC) Act, the U.S. District Court for the District of Delaware recently held in FTC v. Shire ViroPharma that the FTC had failed to plead the facts necessary to invoke...more
A few months ago, the Irish drug company Allergan moved to shield its key patents on its dry-eye drug Restasis from challenge at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent Office by assigning these patents to...more
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
In a recent decision denying the defendant’s motion to dismiss, Judge Mitchell Goldberg of the Eastern District of Pennsylvania allowed the manufacturer of a generic version of Suboxone to proceed upon an interesting theory...more
One of the least disputed elements of class certification is Rule 23(a)(1) numerosity, and so there is relatively little analysis from the courts about it. Last month, however, a divided panel of the Third Circuit provided a...more
On June 20, 2016, the full Federal Circuit denied Mylan’s petitions for rehearing en banc in Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016), leaving intact the panel’s decision affirming two...more
Although the Hatch-Waxman Act was passed by Congress decades ago, it still produces new questions. Despite vigorous argument by the patent owner, a district court dismissed a count alleging that the ANDA-filer infringed under...more
The philosopher George Santayana is usually best remembered for the pithy saying, ‘Those who cannot remember the past are condemned to repeat it.” Santayana was an essayist, poet, professor and novelist. According to...more
Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more
On June 17, 2015, the U.S. District Court for the Eastern District of Pennsylvania approved a consent order (the “Consent Order”) between the Federal Trade Commission and defendants Cephalon, Inc. and its parent, Teva...more
2013 brought generic drug companies increased financial and legal hurdles when it came to marketing their products in the U.S. First, substantial new GDUFA “user fees” got levied on generics for access to the FDA. Then, the...more
The United States Department of Justice Antitrust Division (DOJ) recently served two U.S.-based generic pharmaceutical manufacturers with criminal grand jury subpoenas. It is reported that the subpoenas request all...more