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PCSK9 Patent Case: Praluent Injunction Vacated, But May Well Return

 
• By Sue Sutter

Appeals court vacates injunction that Repatha marketer Amgen had won against Sanofi/Regeneron's Praluent, but notes 'a reduction in choice of drugs cannot be the sole reason for a district court to deny an injunction.'

A patent holder's request for a permanent injunction cannot be denied simply because removing an infringing drug from the market would reduce the number of available treatments, the federal appeals court ruled in a PCSK9 inhibitor patent dispute.

In an Oct. 5 opinion, a three-judge panel of the US Court of Appeals for the Federal Circuit unanimously...

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Aurobindo Expects US FTC Will Allow Lannett Acquisition

 
• By Vibha Ravi

Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.

Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending

 
• By Dean Rudge

Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.

Repurposed Generics For Rare Diseases: Janet Woodcock Proposes Shortcut

 
• By Grace Moser

A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 
• By Urtė Fultinavičiūtė

Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

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Japan To Cut Leqembi Price By 15% Following Cost Effectiveness Review

 
• By Lisa Takagi

While the government announces eight to 15% cuts to the four products, industry groups urges for its operational improvement without expansion.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.