Hikma's recent petition for certiorari revolves around its generic version of Amarin's Vascepa and the implications of the Federal Circuit's 'skinny label' decision. The petition emphasizes the need for clarity in determining when a 'skinny label' can lead to liability for patent infringement under 35 U.S.C. 271(b). With an increasing number of FDA approvals for new indications of existing drugs, it highlights the necessity of maintaining a balance between incentivizing drug development and enabling affordable access to older, off-patent treatments. Furthermore, it touches on the challenges of high drug prices and the role of insurers in seeking cost-effective solutions.
Hikma's petition asks the Court to clarify liability under 35 U.S.C. 271(b) for marketing a generic drug with a 'skinny label'.
In light of the majority of new FDA approvals being for new uses of approved drugs, the article emphasizes a balanced approach to drug patenting.
The importance of a system that promotes both new drug development and affordable access to off-patent uses of known drugs is highlighted.
Considerations around drug pricing and market competition among insurers and pharmacy benefit managers are crucial for effective pharmaceuticals regulation.
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