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?
Second Circuit Affirms “Pay for Delay” Dismissal: On May 13, 2024, the Second Circuit affirmed dismissal of antitrust claims brought by wholesalers, retailers, and employee benefit funds that alleged they overpaid for the...more
The US Court of Appeals for the Second Circuit affirmed the dismissal of a lawsuit against pharmaceutical companies accused of violating antitrust laws by using reverse payments to delay entry of a generic version of a...more
Some product liability suits are dead on arrival. At least, that is the position the Fifth Circuit took late last week in affirming the dismissal of a pro se plaintiff’s suit against a collection of generic and brand-name...more
On July 24, 2020, Justice McHaffie of the Federal Court dismissed Natco’s application for judicial review, finding that Health Canada’s refusal to accept Natco’s Abbreviated New Drug Submission (ANDS) for its tenofovir...more
Generic manufacturers seeking to put an end to Hatch-Waxman Act patent litigation over a branded company’s Orange Book-listed patents can seek to do so by converting from Paragraph IV (“PIV”) patent certifications to...more
In 1984, Senator Orrin Hatch (R-UT) and Rep. Henry Waxman (D-CA) shepherded a grand legislative compromise through Congress that balanced the rights and solved inefficient regulatory consequences for both branded and generic...more
On June 17, 2019, the United States District Court for the District of Delaware, in Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc., et al., No. 18-cv-01043, held that venue was not proper in Delaware over Mylan...more
Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...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
On February 25, 2019, in FTC v. Shire ViroPharma, Inc., the U.S. Court of Appeals for the Third Circuit confirmed that the Federal Trade Commission (FTC) cannot plead its way into federal court via Section 13(b) of the FTC...more
This motion arose in the context of a section 8 action in which Apotex claims damages for delay in the issuance of its notice of compliance for its generic lansoprazole product (Takeda's PREVACID), due to prohibition...more
The District of Delaware dismissed a Hatch-Waxman Act ANDA lawsuit that Bristol-Myers Squibb had filed against Mylan Pharmaceuticals, finding that under the new venue rules established by the Supreme Court’s TC Heartland...more
Welcome to our inaugural issue of Product Lines—our e-newsletter focusing on toxic torts and products liability news and issues. As we all know, there are many issues that arise in this complex area of the law every day. We...more
Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more
Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more
On February 27, 2017, the Ontario Superior Court of Justice (2017 ONSC 1348) dismissed a motion for summary judgment brought by Abbott Laboratories and Takeda Pharmaceuticals, the defendants in an action for damages brought...more
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
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
How explicitly must a complaint sounding in antitrust allege causation? At oral argument last week, the Court of Appeals for the Second Circuit evaluated the sufficiency of the plaintiffs’ allegations that certain Takeda...more
Addressing Sherman Act and Lanham Act claims arising out of an Abbreviated New Drug Application (ANDA), the US Court of Appeals for the Second Circuit upheld the district court’s dismissal of the plaintiffs’ Sherman Act claim...more
On September 22, Judge Ronnie Abrams of the Southern District of New York dismissed an antitrust lawsuit against Takeda Pharmaceuticals and three generic drug manufacturers based on settlements they had reached regarding a...more
The disputed technology is a generic rivastigmine patch. Defendant is a New Jersey corporation with a principal place of business in Vermont. Only specific jurisdiction is at issue since it is not “at home” in Delaware. ...more
In November 2013 and this past October, Mintz Levin’s Health Care Qui Tam Update highlighted three separate qui tam False Claims Act (FCA) cases filed by Fox RX, Inc. (Fox), a former Medicare Part D plan sponsor. Fox filed...more