The appeal
Vertex Pharmaceuticals Inc. appeals from Vertex Pharmaceuticals Inc. v. Lupin Limited, No. 1:22-cv-00966-SB (D. Del.), a Hatch-Waxman case under 35 U.S.C. 271(e)(2)(A) against Lupin Limited and Lupin Pharmaceuticals, Inc. The district court docket shows a judgment entered September 11, 2026 (D.I. 291), Vertex's notice of appeal filed October 9, 2026 (D.I. 293), and the Federal Circuit's notice of docketing entered October 15, 2026 (D.I. 294).
The patents and the generic
According to the opinion, four Vertex patents were at issue. U.S. Patents 10,646,481 and 11,564,916 claim a drug containing exactly 80 percent ivacaftor, and U.S. Patents 12,458,635 and 10,272,046 claim about 80 percent ivacaftor. Kalydeco is the commercial embodiment. The opinion recounts that an examiner first rejected Vertex's claims over Vertex's own earlier publication, which described dispersions of about 10 to about 80 percent ivacaftor by weight; that a new examiner allowed claims to 80 percent ivacaftor after Vertex presented evidence of surprising solubility at that level; that, in another application, a claim to about 72 to about 88 percent was rejected as obvious; and that the examiner allowed an about-80-percent claim while offering 79.9 percent as an example of about 80 percent. Lupin's ANDA product contains an amorphous solid dispersion of 74.257 or 74.258 percent ivacaftor, uses some different inactive ingredients, and is made by wet granulation, while Vertex combines its ingredients dry.
The ruling
Vertex conceded no literal infringement of the exact-80-percent claims. On the about-80-percent claims, the court had construed "about" to have its plain and ordinary meaning, so the dispute turned on how a skilled formulator would read it. Judge Bibas found Vertex's expert, who read about 80 percent as a "high drug load" covering at least 70 to 90 percent, unauthoritative, and adopted the reading of Lupin's expert, who defined "about" as "nearly the same as" and limited it to less than a couple of percentage points, a reading the court found consistent with the examiner's statements. Because Lupin's product differs by more than a couple of points, there was no literal infringement. On the doctrine of equivalents, the court held that the claim language and prosecution history bar stretching about 80 percent to 74.257 percent, citing Ortho-McNeil Pharmaceutical, Inc. v. Caraco Pharmaceutical Laboratories, Ltd., 476 F.3d 1321, 1328 (Fed. Cir. 2007), and that even if the doctrine applied, bioequivalence and similar dissolution profiles do not prove infringement, citing Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282, 1298 (Fed. Cir. 2009). The opinion concludes that Vertex "is entitled to the patent claims that it prosecuted successfully, not the ones that it failed to prove," and rejects all of its infringement claims.
Practice pointers
A numeric limit that carried allowance over the applicant's own earlier publication leaves little room for "about" or for equivalents. The court treated examiner statements about how much variance a term allows as evidence of ordinary meaning, citing Salazar v. Procter & Gamble Co., 414 F.3d 1342, 1347 (Fed. Cir. 2005). In ANDA cases, arguments resting on bioequivalence or matching dissolution profiles did not establish equivalence by themselves.
What to watch next
Watch for Vertex's opening brief and whether it frames the meaning of "about" as a claim construction question or attacks the fact findings, which Federal Rule of Civil Procedure 52(a)(6) protects unless clearly erroneous. The appeal can end at any time, including by settlement or voluntary dismissal.