Resources Forced Withdrawal of Double-Patenting Proposed Rule, US PTO Says

 
• By 

The US PTO faces criticism after withdrawing a proposed rule intended to address double-patenting by changing terminal disclaimers.

Skinny Label Limits: Supreme Court Denies Norwich Bid For US Xifaxan Reprieve

 
• By 

Removing the patent-protected indication from the label of Norwich Pharmaceuticals's proposed generic for Xifaxan did not convince the US Supreme Court to hear its petition to review a case from Bausch Health that blocked approval until 2029.

New UK Rules On Supplementary Protection Certificates – Will You Be Affected?

 
• By 

Companies are being encouraged to look at whether they will be impacted by new UK rules on supplementary protection certificates that come into effect from the beginning of next year.

Apotex And Heritage Reach $50m Settlements For US Price-Fixing Claims

 
• By 

Two more generics manufacturers have settled claims with 50 US attorneys general that they artificially inflated and manipulated the prices of generic drugs for nearly a decade.


Medicare Definitions Of ‘Bona Fide Marketing,’ And ‘Single-Source Drug’ May Be Inconsistent With Law, Appeals Court Says

 

An appeals court panel seemed skeptical of whether AstraZeneca has standing in its Administrative Procedure Act challenges against the IRA’s drug price negotiation program, but suggested a company with standing might be successful in their court.

IRA Litigation: Pharma’s Exit Options Irk Third Circuit Judges

 

Two of three appeals court judges hearing Bristol Myers Squibb and Janssen’s appeal questioned whether Medicare’s drug price negotiation program was truly structured in a way that gives manufacturers a choice not to participate.

Teva Fined Half A Billion Dollars Over European Copaxone Antitrust Breach

 
• By 

Teva has been fined €463m – just over half a billion US dollars – over a breach of EU antitrust rules, after the European Commission found that it abused its dominant position to delay competition to Copaxone, including by misusing the patent system and disparaging rivals. The firm has strongly disagreed with the decision – which is claims is “legally untested” and “not supported by the facts” – and says it will appeal.

Medicare Negotiations: Industry Makes Headway At Appeals Court With First Amendment Argument

 

Judges on the Third Circuit panel in the BMS and JNJ IRA cases seemed sympathetic to industry’s concerns about the government using the term “maximum fair price” in the IRA’s Medicare drug price negotiation program.


PBMs, FTC and IRA: Experts Tackle Pharma’s Tough Acronyms At BioFuture Conference

 

Some of the industry’s biggest challenges, and potential solutions, were hot topics at the BioFuture conference in New York.

Ad/Promo: How To Get The US FDA’s Attention To Prescription Drug Advertising Complaints

 
• By 

Multiple and repeated complaints will sharpen the Office of Prescription Drug Promotion’s focus on an advertisement, Director Catherine Gray said, while Foley Hoag partner August Horvath said the self-regulatory NAD process is best suited to complaints that lack a ‘great scientific basis’ for objecting.

Vaccine Misinformation: Meiji Considers Legal Action Amid Japan Launch Of Kostaive

 
• By 

Dispute around the first-in-world license for a self-amplifying mRNA COVID-19 vaccine castes light on Japan’s ongoing dilemma between a government trying to build its own capabilities to attract, develop and manufacture new modalities and the anti-vax movement in the country.

Déjà Vu: Revived Mifepristone Case Puts FDA And Pharma At Risk Again

 

The outcome of the November presidential election may impact whether the government is willing to defend FDA's relaxation of the mifepristone REMS. The case poses risks for the broader drug approval process.


Make Sure EU SPC Applications Cite The ‘First’ Marketing Authorization, Firms Told

 
• By 

A ruling by the Court of Justice of the EU has produced a clear definition of what constitutes the “first” marketing authorization when companies apply for SPCs on pharmaceutical products.

Mileage of FTC Suit Against PBMs May Vary, Experts Suggest

 
• By 

With a single drug category and an uncertain political future, the FTC’s legal efforts may gain limited traction. Was focusing on insulin rebating a wisely targeted approach or did the case underemphasize the ‘emotionally more powerful consumer deception issue’?

India Rare Diseases: Court Shows Path For Policy Action, Funding, Price Issues

 

A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to cause a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the companies that have been part of pricing discussions.

Pink Sheet Podcast: SubQ Drugs And Price Negotiations, GLP-1s In Court, US FDA Approach To Black Box AI

Pink Sheet reporter and editors discuss an emerging pharma strategy to avoid Medicare price negotiations, legal wrangling related to compounding GLP-1 drugs for obesity and diabetes, and the varying opinions of FDA officials on the acceptability of artificial intelligence models that are not fully explainable.


GLP-1s: Compounders Get Temporary Reprieve But US FDA May Be Building Stronger Case

 

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.

Teva Inks $450m Deals Over US Kickback Claims, Including Alleged Copay Violations

 
• By 

Teva resolved two US Department of Justice civil suits accusing the firm of violating the US Anti-Kickback Statute and the False Claims Act by allegedly conspiring to fix the price of three generic drugs and paying Medicare patients’ copays for its multiple sclerosis brand product Copaxone.

Shot Across The Bow? Express Scripts Lawsuit Aims To Prevent Fall-Out From FTC PBM Report

 
• By 

Pharmacy benefit manager sues Federal Trade Commission, claiming chair Khan has orchestrated a campaign against PBMs that is not based in fact.

Pink Sheet Podcast: US FDA Worries About Celebs Endorsing Drugs, Post-Chevron Lawsuits Emerging

 

Pink Sheet reporter and editor discuss the FDA’s latest advertising enforcement letter, which targeted a migraine treatment TV commercial featuring Serena Williams, and its impact on drug promotion, as well as the now growing list of legal cases targeting agency decisions with Chevron deference overturned.