Taiho Pharmaceuticals Faces Patent Infringement Lawsuit from BMS and Pfizer Over Antithrombotic Drug BEQIA

Taiho Pharmaceuticals (6467.TW) has been served with a patent infringement lawsuit filed jointly by U.S. pharmaceutical giants Bristol Myers Squibb (BMS) and Pfizer. The suit, received by Taiho on October 23, 2026 (U.S. time), concerns BEQIA (TAH3311), an independently developed antithrombotic oral dissolving film drug.

The legal action was filed in the U.S. state of Delaware, a common jurisdiction for patent litigation involving pharmaceutical companies. Following the news, Taiho’s shares experienced significant volatility on the Taiwan stock market on October 27, initially dropping approximately 6% to NT$190 before rebounding to an intraday high of NT$209.5. As of 10:55 a.m. local time, the stock was trading near NT$202.5, flat from the previous close, with a trading volume of 930 lots.

BEQIA’s New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (FDA) on June 19, 2026, and has entered substantive review. The FDA’s Prescription Drug User Fee Act (PDUFA) goal date for a decision is set for April 22, 2027. This means Taiho is simultaneously navigating patent litigation and regulatory approval processes over the coming months.

Taiho Pharmaceuticals acknowledged that patent litigation is a routine aspect of competition in the U.S. pharmaceutical sector, especially for 505(b)(2) reformulated drugs like BEQIA. These drugs often face disputes over patent scope related to originator products during development and commercialization phases.

The company stated it has conducted thorough legal assessments of BEQIA’s patents and product technology and has engaged experienced U.S. legal counsel to manage the case according to applicable laws. Taiho affirmed its intention to actively protect its rights and those of its shareholders by taking necessary legal measures based on the product’s technical features and patent claims.

Taiho also highlighted that legal proceedings can clarify the parties’ rights and obligations and potentially serve as a foundation for commercial dialogue or cooperation. The company remains open to reasonable solutions that facilitate BEQIA’s entry into the U.S. market and accelerate its commercialization.

From a financial perspective, Taiho’s preliminary evaluation indicates that the lawsuit currently does not materially impact its overall operations or financial condition. However, future expenses related to the litigation will depend on its progression.

The company emphasized that the case is at an early stage, and the ultimate outcome and its effect on BEQIA’s commercialization timeline remain uncertain. Taiho committed to timely disclosure of significant developments in compliance with relevant laws and regulatory requirements.