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Latest From Legal Issues

Drug Product Hopping Bill Should Specify Anti-Competitive 'Window', Congress Advised

House bill in the works to deter brand product switches should specify what behavior would be unacceptable, legal experts testify at congressional hearing.

Legislation Legal Issues

Will Purdue Bankruptcy Filing Resolve 'Unrelenting Chaos' Of Opioid Litigation?

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

Legal Issues Policy

EU Court Advances Understanding Of SPC Patent Puzzle

Pharmaceutical companies will have a better idea of the conditions under which a supplementary protection certificate can be granted after an advocate general of the European court explained how a new legal test established last year should be used. However, lawyers caution that the opinion still leaves some aspects to be clarified.

Europe Intellectual Property

Pink Sheet Podcast: Upcoming Opioids Policy Meeting, Improving US FDA's Rare Disease Legalese

Pink Sheet reporters discuss the proposed US opioid lawsuit settlement, Public Citizen's opioid citizen petition denial, and the upcoming US FDA public meeting on opioid standards, as well as a proposal to better outline agency flexibility with rare disease drugs.

Drug Approval Standards Neurology

Purdue Nears Settlement Of Opioid Multidistrict Litigation, But State AGs Vow To Press On

Lead plaintiffs counsel have accepted Purdue's proposed settlement offer to resolve more than 2,000 opioid suits, but more than half of state attorneys general reject the proposal.

Legal Issues Policy

Genentech Is Second Biologic Titan To Resolve Trade Secret Suit; Former Employees Still On Hook

Genentech reaches memorandum of understanding with JHL Biotech involving four biosimilars while continuing its suit against former employees; Amgen settlement with Coherus ended litigation entirely.

Intellectual Property Biosimilars
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