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 | 6 min read | 11.26.25
From ‘Second’ to ‘First:’ Federal Circuit Tackles Obvious Claim Errors
Patent claims must be clear and definite, as they set the boundaries of the patentee’s rights. Occasionally, however, claim language contains errors, such as typographical mistakes or incorrect numbering. Courts possess very limited authority to correct such errors. The United States Court of Appeals for the Federal Circuit has emphasized that judicial correction is appropriate only in rare circumstances, where (1) the error is evident from the face of the patent, and (2) the proposed correction is the sole reasonable interpretation in view of the claim language, specification, and prosecution history. See Group One, Ltd. v. Hallmark Cards, Inc., 407 F.3d 1297, 1303 (Fed. Cir. 2005) and Novo Indus., L.P. v. Micro Molds Corp., 350 F.3d 1348, 1357 (Fed. Cir. 2003).
Client Alert | 5 min read | 11.26.25
Client Alert | 6 min read | 11.25.25
Brussels Court Clarifies the EU’s SPC Manufacturing Waiver Regulation Rules
Client Alert | 3 min read | 11.24.25
