Pfizer Seeks Dismissal of Allele’s Patent Infringement Suit Over COVID-19 Vaccine Research Tool

Allele Technologies recently initiated patent infringement litigation against Pfizer and BioNTech in a federal court in California, alleging unauthorized use of its patented fluorescent protein technology during the development of the Pfizer-BioNTech COVID-19 vaccine. The lawsuit centers on U.S. Patent No. 10,221,221 (the ’221 patent), which covers mNeonGreen, a fluorescent protein marketed by Allele as a research tool.

Allele contends that Pfizer and BioNTech employed mNeonGreen in clinical trials for their vaccine candidate BNT162b1. According to Allele’s original complaint filed in October 2020, mNeonGreen “facilitates quick, targeted, and precise receptor research” and was instrumental in selecting the most potent vaccine candidate, thereby accelerating development and saving lives.

To support its claim, Allele submitted a preprint article, now published in Nature, detailing the methods Pfizer used to discover BNT162b1. The paper confirms Pfizer’s use of mNeonGreen in their vaccine research.

In response, Pfizer filed a motion to dismiss the complaint, invoking the Hatch-Waxman safe harbor provision codified at 35 U.S.C. § 271(e)(1). This exemption protects certain acts related to drug development and regulatory approval from constituting patent infringement. Pfizer argues that the use of mNeonGreen was limited to testing blood samples from clinical trial participants to generate data for the Food and Drug Administration (FDA), which falls within the safe harbor.

Pfizer further contends that even if data from these tests were used in selecting the final vaccine for emergency use authorization (EUA), such use does not amount to infringement. The company requests dismissal under Federal Rule of Civil Procedure 12(b)(6), warning that the lawsuit could become “another burden” on their ongoing vaccine efforts.

Allele counters Pfizer’s arguments by accusing the defendants of seeking relief from patent infringement claims solely to protect their substantial profits, estimated at $4.35 billion from the pandemic vaccine sales. Allele notes that Pfizer and BioNTech hold an extensive portfolio of patents themselves and have actively opposed initiatives aimed at expanding vaccine access in low-income countries through compulsory licensing or relaxed patent laws.

Allele’s amended complaint alleges that Pfizer and BioNTech have commercialized the vaccine internationally, with foreign sales expected to constitute the majority of their revenue, forecasted up to $26.44 billion. The complaint asserts that these overseas commercial uses fall outside the scope of the safe harbor immunity.

The dispute underscores the complex interplay between patent rights and public health imperatives amid the global COVID-19 crisis. Pfizer’s invocation of the safe harbor defense contrasts with its opposition to patent relaxation efforts at the World Health Organization, highlighting tensions in balancing intellectual property protections with equitable vaccine access.

The court’s decision on Pfizer’s motion to dismiss remains pending. Meanwhile, the case exemplifies the challenges pharmaceutical companies face from patent litigation even during a public health emergency.

Documents relevant to the case include Allele’s original complaint, Pfizer’s motion to dismiss, Allele’s amended complaint, Allele’s opposition to the motion, and Pfizer’s reply brief.

This litigation adds to the broader discourse on how patent law impacts vaccine development and distribution during pandemics, raising questions about the scope of legal protections for research tools and the limits of regulatory exemptions.