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Hot Topics in International Trade A Year in Review (Quickly)
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
Virginia AG Jason Miyares, along with a bipartisan coalition of eight other state AGs and in coordination with six other AGs, has announced a settlement in principle with Mylan Inc. to resolve allegations that it contributed...more
A bipartisan coalition of 50 states, D.C., and two territories reached settlements with Heritage Pharmaceuticals, Inc. and Apotex Corp. to resolve allegations of price fixing generic drugs in violation of the Sherman Act....more
The Supreme Court of California is gearing up to decide an important question for the future of product liability law: Do drug manufacturers have a duty to innovate? In other words, does a manufacturer of a non-defective drug...more
On August 1, 2024, following five years of litigation, Tevra’s antitrust suit against Bayer Healthcare LLC came to an end. Tevra, a manufacturer of generic version topical flea and tick medications, alleged that Bayer engaged...more
It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more
ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more
Can a drug manufacturer refuse to provide samples of its innovator product under the CREATES Act if it thinks that the requester will not actually use them to develop a biosimilar or generic drug? A recently filed suit in the...more
Clients often ask if a law firm can represent both brand and generic drug manufacturers. It’s a reasonable question, particularly when the popular perception is that potential conflicts pigeonhole law firms, forcing them to...more
In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more
Given its growing role as the “pharmacy to the world,” FDA Commissioner Robert Califf, M.D., recently took a trip to India and offered some of his (and FDA's) views upon his return. During his visit, Commissioner Califf met...more
On September 5, 2023, the United States Government Accountability Office (GAO) published its report titled Medicare Part D: CMS Should Monitor Effects of Rebates on Plan Formularies and Beneficiary Spending.The report...more
On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of...more
A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse...more
On April 27, 2021, the United States Tax Court held that legal fees incurred by generic drug manufacturers in connection with “Section 271(e)(2)” patent infringement suits are deductible as ordinary business expenses and need...more
The US Court of Appeals for the Fourth Circuit revived an antitrust suit alleging that a pharmaceutical manufacturer illegally maintained its monopoly for its innovator drug by precluding competition beyond the expiration...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
The Federal Circuit’s October 2020 split decision in GSK v. Teva made waves throughout the pharmaceutical industry and among Hatch-Waxman litigators. In the broadest reading, some see the majority opinion as rendering any...more
On Wednesday, July 15, the House Energy and Commerce (E&C) Committee advanced several bills to the House floor that demonstrate continued interest in health policy matters other than the COVID-19 pandemic. The Fairness in...more
On June 10, 2020, the Attorneys General from forty-six states, the District of Columbia, and four United States territories filed a lawsuit against twenty-six drug manufacturers, accusing them of a long-standing antitrust...more
In her opinion issued on June 4, 2020, Advocate General (AG) Juliane Kokott recommended that the European Court of Justice (ECJ) dismiss in its entirety the appeal by Lundbeck A/S and Lundbeck Ltd against the General Court’s...more
On April 22, 2020, the Third Circuit Court of Appeals vacated and remanded an order certifying a class of direct purchaser plaintiffs in In re: Lamictal Direct Purchaser Antitrust Litigation, holding that the district court...more
On Monday, in the much-anticipated decision in Acetris Health, LLC v. U.S. 18-2399, the Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled that U.S. manufacture of a drug is sufficient to confer U.S....more
When Big Pharma insists its sky-high prices are justified, patients may want to keep in mind key findings just revealed about prescription drugs and their makers...more