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Keeping Watch on the Inflation Reduction Act: Medicare Poses Part D Formulary Access Challenges

Key points include access to medicines in medicare is reduced as the IRA is implemented; fewer drugs are covered on Medicare Part D formularies in 2025 relative to 2024; medicines for serious conditions with high unmet needs...more

Relevance of Trade Secret Ownership for Misappropriation: I-Mab Biopharma v. Inhibrx Inc.

In I-Mab Biopharma v. Inhibrx, Inc., a trade secret misappropriation case, a federal jury in Delaware sided with the defendants, Inhibrx and its co-founder Brendan Eckelman, on all counts. The jury found no existence of a...more

Silvergate Pharmaceuticals v. Bionpharma: The Relevance of Offers of Confidential Access Under the Hatch-Waxman Statute and Awards...

In Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc., the US District Court for the District of Delaware decided an open question regarding pre-filing investigation and attorney fees under Title 35 of the US Code, Section...more

Clarifying the Enforceability of Post-patent Expiration Royalties Under Brulotte

A closer look at Ares Trading S.A. v. Dyax Corporation - The August 2024 Third Circuit decision in Ares Trading S.A. v. Dyax Corporation contributes to the discussion of Brulotte and its progeny. Similar to C.R. Bard v....more

C.R. Bard v. Atrium: The Impact of FDA Approval Timelines on Royalty Payments

A case pending in the Ninth Circuit Court of Appeals highlights the importance of negotiating the term of royalty payments in the license of Food and Drug Administration (FDA)-regulated products. This is particularly notable...more

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