Seismic Policy Shift to Open VA Schedule Contract to Non-TAA Compliant Covered Drugs
Client Alert | less than 1 min read | 04.21.16
On April 19, 2016, VA posted new guidance mandating that all manufacturers of covered drugs offer to the VA all such drugs, regardless of country of origin, so that VA may evaluate for non-availability waivers. While this major shift in policy potentially reopens sales of non-TAA compliant covered drugs to VA hospitals and other purchasers under a 65 I B VA Federal Supply Schedule contract, the fast approaching and tight deadlines require (a) existing FSS contract holders quickly to calculate and modify their contract to include pricing information about such covered drugs and (b) those manufacturers without an FSS contract quickly to initiate obtaining one.
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Client Alert | 2 min read | 11.14.25
Claim construction is a key stage of most patent litigations, where the court must decide the meaning of any disputed terms in the patent claims. Generally, claim terms are given their plain and ordinary meaning except under two circumstances: (1) when the patentee acts as its own lexicographer and sets out a definition for the term; and (2) when the patentee disavows the full scope of the term either in the specification or during prosecution. Thorner v. Sony Comput. Ent. Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). The Federal Circuit’s recent decision in Aortic Innovations LLC v. Edwards Lifesciences Corp. highlights that patentees can act as their own lexicographers through consistent, interchangeable usage of terms across the specification, effectively defining terms by implication.
Client Alert | 6 min read | 11.14.25
Microplastics Update: Regulatory and Litigation Developments in 2025
Client Alert | 6 min read | 11.13.25
