Allele is accusing Pfizer and BioNTech of infringing one of their patents during the research that led to their COVID-19 vaccine, according to a complaint recently filed in a federal court in California, United States. The case relates to U.S. patent 10,221,221 (the ’221 patent), directed to a fluorescent protein that can serve as a research tool. Allele, which markets the protein under the name “mNeonGreen”, argues that their research tool was used in clinical trials that studied BNT162b1. Pfizer is asking the court to dismiss the case and says that it may become a “burden” in their efforts against COVID-19.
The ongoing litigation is one of the many examples evidencing that patents are in fact a barrier in the development and scale up manufacture of COVID-19 vaccines.
mNeonGreen “facilitates quick, targeted, and precise receptor research.” Using this technology “was the critical link in [Pfizer’s] COVID-19 vaccine development and its continued trial success,” according to the original complaint filed by Allele in October 2020. mNeonGreen “has been an instrumental driver in selecting the most potent vaccine candidate, which has saved precious time and lives as a result,” Allele adds. To evidence that Pfizer and BioNTech used this research tool Allele submitted a preprint now published in Nature describing the methods employed by defendants to discover BNT162b1. The paper explains that Pfizer indeed used mNeonGreen to discover their COVID-19 vaccine.
Pfizer requested the court to dismiss the complaint under the Hatch-Waxman safe harbor coded at 35 U.S.C. § 271(e)(1), which exempt acts relating to drug development and approval from patent infringement. Pfizer also make a number of additional legal defenses, including that the use or disclosure of data obtained from clinical testing does not constitute an act of patent infringement as argued by Allele in their complaint. Noticeably, in their request for a dismissal of this case Pfizer also acknowledges that patent litigation may become a “burden” in their effort against COVID-19.
“This tactic cannot succeed because the purported new allegations in the Amended Complaint still do not change the critical fact that the only alleged use of mNeonGreen is in testing blood drawn from clinical study participants to generate data for the FDA. That use does not constitute infringement under Section 271(e)(1) as a matter of law. Evenif Pfizer and BioNTech allegedly also made later uses of the data generated from the clinical testing, or if that clinical trial testing allegedly was involved in selecting the final vaccine to obtain EUA, that does not change the result. This Court should dismiss Allele’s Amended Complaint under Rule 12(b)(6) before this lawsuit becomes another burden on Pfizer and BioNTech as they continue their work on this vital vaccine.”
Allele countered these arguments stating that the defendants want to be relieved from the “burden” of patent infringement because it is interfering with their efforts “to make an estimated $4.35 billion in profit from the coronavirus pandemic.” A recent forecast estimate that Pfizer will make far more than that for the sale of their vaccines. Allele explained that Pfizer and BioNTech “hold a thicket of patents” and know that they can assert them against others. Interestingly, Allele also reminded the Court about Pfizer’s “forceful[]” opposition to “the World Health Organization’s initiative to expand vaccine access to poor countries by granting compulsory patent rights or otherwise relaxing patent laws.”
“The FAC alleges that Defendants have enjoyed commercial use overseas with foreign sales anticipated to comprise the majority of Defendants’ revenue, including through lucrative vaccine contracts, with revenue forecasts up to $26.44 billion. FAC ¶¶ 47, 48, 34. To protect their foreign interest, Defendants have also applied for patent coverage and forcefully opposed the World Health Organization’s initiative to expand vaccine access to poor countries by granting compulsory patent rights or otherwise relaxing patent laws. FAC ¶¶ 47, 50. Defendants’ infringing uses to advance interests abroad fall outside the Safe Harbor immunity.”
Whether this case will be dismissed remains to be seen. What is clear is that Pfizer, a giant pharmaceutical company, sees patent litigation during a pandemic as a “burden” to the development and global distribution of vaccines. They seek immunity to infringement under the Hatch-Waxman safe harbor, an exception in U.S. law. This stance seems in contrast to their own efforts against any relaxation of patent protection or initiatives to promote open licensing. It is also a clear evidence that even the largest pharmaceutical companies are facing an immediate risk of patent litigation during the pandemic.
1. Allele original complaint
2. Pfizer motion to dismiss
3. Allele amended complaint
4. Allele opposition to motion to dismiss
5. Pfizer reply to opposition to dismiss