Bristol-Myers Squibb and Pfizer Sue TAHO Over an Apixaban Oral Film Seeking FDA Approval.

The case

The case is Bristol-Myers Squibb Company v. TAHO Pharmaceuticals Limited, No. 1:26-cv-01374 (D. Del.), filed October 23, 2026. The complaint is signed by Rodger D. Smith II of Morris, Nichols, Arsht & Tunnell LLP in Wilmington, Delaware. It also lists Anthony D. Raucci of the same firm and, as of counsel, Amy K. Wigmore, Heather M. Petruzzi, Andrew J. Danford and Gillian T. Farrell of Wilmer Cutler Pickering Hale and Dorr LLP.

The complaint describes Bristol-Myers Squibb as a Delaware corporation based in Princeton, New Jersey, Pfizer as a Delaware corporation based in New York, New York, and, on information and belief, TAHO as a Taiwanese corporation based in Taipei. It says the two plaintiffs jointly own the patent and that Eliquis (apixaban) tablets are sold under NDA No. 202155.

The application and the notice letter

According to the complaint, TAHO submitted application No. 219493 under 21 U.S.C. 355(b)(2) for apixaban oral film, 2.5 mg and 5 mg, with a paragraph IV certification as to U.S. Patent No. 9,326,945. It says TAHO notified the plaintiffs by letter dated September 8, 2026, received no earlier than September 9, and that the letter asserts the '945 patent "will not be infringed" by the film's commercial manufacture, importation, use, sale or offer for sale. The complaint alleges, on information and belief, that TAHO made no paragraph IV certification on U.S. Patent No. 6,967,208, which it says expires May 21, 2027 with pediatric exclusivity, and it says TAHO therefore will not receive FDA approval before that date. It says the plaintiffs' counsel reviewed portions of the application under an agreed offer of confidential access, and that the suit was filed before 45 days had passed from the plaintiffs' receipt of the notice letter.

The patent and the asserted claims

U.S. Patent No. 9,326,945, titled Apixaban Formulations, issued May 3, 2016. The complaint says it expires August 24, 2031, including pediatric exclusivity. It cites Bristol-Myers Squibb Co. v. Aurobindo Pharma USA Inc., 477 F. Supp. 3d 306 (D. Del. 2020). The final judgment in that case, entered August 13, 2020 by Chief Judge Leonard P. Stark, held claims 21 and 22 of the '945 patent infringed and not invalid as against three generic drug applicants. The Federal Circuit affirmed on September 3, 2021, in Bristol-Myers Squibb Co. v. Sigmapharm Laboratories, LLC, 858 F. App'x 359.

Claim 1 covers a solid pharmaceutical composition with crystalline apixaban particles having a D90 of about 89 microns or less, in which at least 77 weight percent of the apixaban dissolves within 30 minutes in a pH 6.8 phosphate buffer containing 0.05 percent sodium lauryl sulfate. Claim 12, also an independent claim, recites the same particle size and dissolution limits, measured with USP Apparatus 2 at a paddle speed of 75 rpm in 900 mL of 0.05 M sodium phosphate at pH 6.8 with 0.05 percent sodium lauryl sulfate at 37 degrees C.

The complaint alleges that the notice letter, materials TAHO provided to the plaintiffs' counsel and public information show that TAHO's oral film is a solid pharmaceutical composition containing crystalline apixaban particles with a D90 within the claimed limit, and that they support the conclusion that the film has, or will need to have, the claimed dissolution profile. It points to TAHO's own U.S. Patent No. 12,036,216, which it says describes crystalline apixaban in oral films and immediate release apixaban film formulations. It also alleges, on information and belief, that to meet 2018 FDA guidance on dissolution testing for immediate release products, the film will need to have the dissolution profile recited in claims 1 and 12.

The count and the relief sought

The complaint's single count alleges infringement of the '945 patent, including claims 1 and 12, under 35 U.S.C. 271(e)(2)(A) by submitting the application, and that commercial manufacture, use, sale, offer or importation of the film would infringe under 35 U.S.C. 271(a), (b) and (c). It asks for judgments that the '945 patent is not invalid or unenforceable and is infringed; an order under 35 U.S.C. 271(e)(4)(A) that approval be effective no earlier than the patent's expiration, including exclusivities; an injunction; damages or other monetary relief, including costs, fees and interest, if TAHO commercializes the film before expiration; and monetary relief on the basis that the case is exceptional.