“‘The alleged patent infringement—asserted uses by Pfizer and BioNTech of the patented invention to generate data from clinical trials in support of seeking FDA approval—are precisely the type of activity that is protected by the ‘safe harbor’ from patent infringement claims under 35 U.S.C. § 271(e)(1).'” – Pfizer Memorandum on Motion to Dismiss
Pfizer and BioNTech have hit back at Allele Biotechnology and Pharmaceuticals, Inc.’s October 2020 complaint accusing the COVID-19 vaccine manufacturers of infringing Allele’s U.S. patent covering a particular “tag” used to track vaccine in a patient’s blood.
Early last year, scientists at U.S.-based Pfizer and Germany-based BioNTech began working to develop a vaccine against SARS-CoV-2, the virus that causes COVID-19. The vaccine, designated BNT162b2, utilizes a composition in which messenger RNA (“mRNA”) is encapsulated in lipid nanoparticles and injected into the body. When administered, the mRNA prompts the body’s cells to make a protein that is part of the SARS-CoV-2 virus. This protein, in turn, elicits the body’s own immune system to produce neutralizing antibodies against the virus. Once antibodies are present, the body can fight off, or “neutralize,” the real virus.
U.S. regulatory approval requires Pfizer and BioNTech to show that their vaccine is safe and effective against SARS-CoV-2 infection. To meet the Food and Drug Administration’s (FDA’s) requirements, Pfizer and BioNTech have been and “continue to be engaged in large scale clinical trials to evaluate, among other things, whether individuals who receive the vaccine are less susceptible to COVID-19 infection.” As part of these trials, the results of laboratory tests on blood samples drawn from patients in the clinical trials who received the vaccine are evaluated. One of these tests is a “neutralization assay,” which is a laboratory procedure to detect the presence of antibodies in the blood of a patient after receiving a vaccination capable of neutralizing the SARS-CoV-2 virus.
The California Complaint
As part of the assay mentioned above, a fluorescent “tag” is used to track the vaccine in a patient’s blood. Allele alleged in its complaint filed in October 2020 that Pfizer and BioNTech infringed their patent for their particularly engineered tag. Specifically, Allele said that the defendants worked together to develop their BNT162 mRNA-based vaccine candidate and used Allele’s tag, called mNeonGreen, to do so. The patent in question is United States Patent No. 10,221,221 (the ‘221 patent) which is generally directed to “isolated nucleic acid sequences encoding a monomeric green/yellow fluorescent proteins, and fragments and derivatives thereof.” This manufactured mNeonGreen monomer is among the brightest and most stable monomeric fluorescent reporter proteins currently known. In practice, “mNeonGreen facilitates quick, targeted, and precise receptor research, including for potential therapeutics to treat COVID-19.”
Pfizer Responds to Allele’s Complaint
Pfizer responded to Allele’s complaint on February 8, invoking the safe harbor of 35 U.S.C. § 271(e)(1). Allele alleges that “mNeonGreen has been used throughout Pfizer and BioNTech’s COVID-19 vaccine trials” and seeks damages as a result of this alleged infringement. Interestingly, Allele is not accusing Pfizer or BioNTech of selling mNeonGreen, incorporating mNeonGreen into the vaccine itself, or using mNeonGreen in the process of making the vaccine. Instead, Allele accuses the defendants of infringing the ‘221 patent during clinical trial testing of the vaccine. Pfizer claims that “the alleged patent infringement—asserted uses by Pfizer and BioNTech of the patented invention to generate data from clinical trials in support of seeking FDA approval—are precisely the type of activity that is protected by the ‘safe harbor’ from patent infringement claims under 35 U.S.C. § 271(e)(1).”
That provision, enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984 (“the Hatch-Waxman Act”), immunizes parties from allegations of patent infringement when the accused actions are undertaken in order to develop information for submission to the FDA pursuant to a federal law regulating the manufacture, use or sale of drugs. Pfizer notes that “this immunity is broad” and, in the words of the United States Supreme Court, “extends to all uses of patent inventions that are reasonably related to the development and submission of any information” to the FDA for products like the Pfizer/BioNTech vaccine.
As such, “even if” Allele’s allegations are taken as true, the activity conducted by Pfizer and BioNTech should be judged under the Hatch-Waxman Act’s statutory “safe harbor,” said Pfizer’s memo. The provision states, in relevant part:
It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.
The safe harbor provision allows companies like Pfizer and BioNTech “to engage in otherwise infringing activities necessary to obtain regulatory approval.” The statute accomplishes this by immunizing the use of a “patented invention”—which the Supreme Court has held “is defined to include all inventions,”—so long as the use of that invention is “reasonably related” to development and submission of information to the FDA. Further, Pfizer argues that Congress “exempted from infringement all uses of patented compounds ‘reasonably related’ to the process of developing information for submission under any federal law regulating the manufacture, use, or distribution of drugs.” So long as the use of the patented invention is reasonably related to developing information for FDA approval, the safe harbor applies regardless of “the phase of research in which [the information] is developed or the particular [regulatory] submission in which it could be included.”
Pfizer’s response reasons that the alleged infringing use of that patented invention—testing conducted on blood samples from clinical trial subjects in order to obtain data for submission to the FDA as part of the approval process for the COVID-19 vaccine—is “reasonably related” to the development and submission of information to the FDA in order to obtain regulatory approval.
Particularly, Allele’s complaint repeatedly alleges that the acts of infringement constitute ongoing trials to general data and information in order to gain regulatory approval for Pfizer’s vaccine candidate. For example, Allele said that “BioNTech adopted the technology protected by the ’221 Patent in its COVID-19 vaccine trial,”; that BioNTech “used (and continues using in its trials) the DNA construct described in the Cell Host Article to develop and test its SARS-CoV2 vaccine,”; and that “the mNeonGreen protein used by Defendants throughout their COVID-19 vaccine trial literally infringes . . . the ’221 Patent.”
Pfizer contends that upon reading the plain language of the safe harbor provision, Allele’s allegations characterizing mNeonGreen as a “research tool” that “does not require government approval for clinical use” does not upset the clear meaning of the provision. Thus, regardless of whether Allele alleges that mNeonGreen is a “research tool,” the invocation of that phrase “does not negate the language and application of 35 U.S.C. §271(e)(1).”
Allele has also filed a complaint against Regeneron in New York claiming infringement of the same patent.
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