Litigation

FDA law experts do not buy the outsourcers’ argument that the agency must go through notice-and-comment rulemaking to remove a drug from the shortage list.

Determining what falls within the statutory definition of ‘biological product’ is an interpretative question that courts, rather than the agency, must resolve, Lilly said in a lawsuit repeatedly citing the US Supreme Court’s June decision in Loper Bright.

Hikma has asked the US Court of Appeals for the Federal Circuit for a full court rehearing of a panel decision that reopened a dispute with Amarin over a skinny-label generic version of Vascepa.

Days after Sandoz received US FDA approval for its Enzeevu aflibercept biosimilar, Regeneron sued alleging that Sandoz failed to follow the “patent dance” set out in the BPCIA framework and claiming infringement of multiple patents on its Eylea.

India prohibits the manufacture and sale of over 150 fixed-dose combinations (FDCs) that lack therapeutic justification and pose potential health risks, though all eyes are on how effectively the regulatory apparatus enforces the ban, not the first in the area, amid legal action. One firm has secured an ad interim ruling for its combination drug.

MSN Laboratories will be unable to move forward with any potential ‘at-risk’ launch for its generic version of Novartis’ Entresto blockbuster in the US for now after the originator won a stay of the firm’s ANDA approval pending appeal from the US Court of Appeals for the District of Columbia Circuit.

Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.

But the overall impact of the Supreme Court decision may not seem as “immediate” in 340B compared to other federal programs.

Experts expect litigation challenging Medicare’s definitions of single-source drug and bona fide marketing to get a boost from recent Supreme Court rulings, but overall, the IRA is likely better positioned in a post-Chevron world than older Medicare statutes.

The US Federal Trade Commission’s focus on potential anti-competitive behavior by pharmacy benefit managers picks up steam as Chair Lina Khan approaches the end of her term.

Reading Hikma’s press releases and other public documents made it “at least plausible” that a physician would look to prescribe Hikma’s generic Vascepa product for any of its indications, including the highly-valued, patent-protected cardiovascular indication, the US Federal Circuit decided, reopening a lawsuit against the generics firm.

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits.

Rahul Rao, the deputy director of the FTC Bureau of Competition, discussed the agency’s thinking on recent pharma deals that it viewed as anti-competitive.

The US Court of Appeals for the Second Circuit afirmed a US district court decision to dismiss purchaser and payer claims linked to so-called “pay-for-delay” agreements with generics firms over nebivolol rivals to Bystolic.

The fourth court loss for pharma in industry's attempts to kill Medicare’s drug price negotiation program adds to the list of reasons courts have rejected legal challenges to the Inflation Reduction Act.

Leaders from Novartis, Bayer, Sun Pharma, the Indian Pharmaceutical Alliance, Médecins Sans Frontières and Anand and Anand discuss India’s evolving intellectual property rights landscape, including pre-grant oppositions, enforcement action and other realities. Concerns around evergreening, restrictions on patent-eligible subject matter and compulsory licensing were also key talking points at a recent conference in Hyderabad.

Changes to inhaler pricing may be more ‘business as usual’ for the drug industry than the Vermont senator wants to let on. FTC, meanwhile, is keeping the patent pressure on Teva, the only inhaler manufacturer to not act following Sanders’ investigation.

Company sought court order to vacate agency’s approval of the fibrinogen products of three blood centers, saying they were wrongly exempt from clinical trials required for Octapharma’s Fibryga.

FDA’s efforts to tackle misinformation may face fewer legal obstacles moving forward, following oral arguments at the Supreme Court on a case that could have broad ramifications for how the government communicates public health information.

Class action complaint alleges Boehringer Ingelheim engaged in a ‘Respimat Orange Book scheme’ to thwart generic competition for Combivent Respimat and Spiriva Respimat that cost payors millions, if not billions, in overcharges.