The complaint

The case is ViiV Healthcare Company, Shionogi & Co., Ltd., and ViiV Healthcare UK (No.3) Limited v. Aurobindo Pharma Ltd. and Aurobindo Pharma USA, Inc., No. 1:26-cv-01175 (D. Del.). The complaint is dated September 18, 2026, and the docket shows it filed that day as ECF No. 1 (10 pages). Plaintiffs assert U.S. Patent 9,242,986 in a Hatch-Waxman action over Aurobindo's ANDA No. 210642 for abacavir sulfate, dolutegravir sodium, and lamivudine tablets, a generic version of TRIUMEQ (abacavir, dolutegravir, and lamivudine) tablets. The complaint says Shionogi is the assignee of the '986 patent and ViiV Healthcare UK (No.3) Limited is its exclusive licensee.

What the patent covers

U.S. Patent 9,242,986, titled Synthesis of Carbamoylpyridone HIV Integrase Inhibitors and Intermediates, issued January 26, 2016. Claim 1 recites a crystal form of a sodium salt of a compound of formula AA, whose structure the claim shows, having characteristic diffraction peaks at 6.4, 9.2, 13.8, 19.2 and 21.8 degrees two-theta (each plus or minus 0.2 degrees) in an X-ray powder diffraction pattern. The complaint says the patent is listed in the Orange Book for TRIUMEQ (NDA No. 205551), will expire on December 8, 2029, and has pediatric exclusivity through June 8, 2030; the docket's ANDA information entry lists the same expiration date and a thirty-month stay deadline of no earlier than February 6, 2029. (Compl. paras. 20 to 23; ECF No. 3.)

What the lawsuit alleges

Plaintiffs allege that Aurobindo's notice letter dated August 5, 2026, received August 6, 2026, included a Paragraph IV certification, and that submitting ANDA No. 210642 to obtain approval before the '986 patent expires is an act of infringement under 35 U.S.C. 271(e)(2). They allege that commercial manufacture and sale after approval would infringe under 271(a), and would induce or contribute to infringement under 271(b) and (c). The complaint alleges that the notice letter does not dispute that the proposed product will infringe claims 1 to 6 unless those claims are found invalid, and alleges, on information and belief, that Aurobindo lacked a good faith basis for alleging noninfringement of claims 7 to 12 and invalidity of claims 1 to 6. (Compl. paras. 25 to 40.)

The prayer seeks an order under 35 U.S.C. 271(e)(4)(A) that any FDA approval take effect no earlier than the patent's expiration plus any extensions or exclusivities, a permanent injunction, and a finding that the case is exceptional. (Compl. Prayer.)

What to watch next

Waivers of service for both defendants were filed on October 7, 2026 (ECF Nos. 8 and 9), and a proposed consent judgment was filed on October 28, 2026 (ECF No. 10). Watch for the court's action on the proposed consent judgment.