Pfizer wants patent case tossed under safe harbor rules

Pfizer and BioNTech asked a federal judge to toss out a patent lawsuit filed by a pharmaceutical company that accused them of illegally using its invention to develop a COVID-19 vaccine.

Pfizer and BioNTech defended their actions in a dismissal motion filed Monday, arguing that their use of Allele Biotechnology's mNeonGreen fluorescent protein was protected under the federal safe harbor rules as their research related to gaining federal approval to begin administering the vaccine. The patented mNeonGreen was never sold to third parties, nor are any of its contents in the vaccine, Pfizer and BioNTech argued.

Pfizer is represented by David J. Noonan and Genevieve M. Ruch of Noonan Lance Boyer & Banach LLP. Stanley E. Fisher, Thomas H.L. Selby and Charles L. McCloud of Williams & Connolly are also representing Pfizer.

Elizabeth L. Brann of Paul Hastings LLP is representing BioNTech.

Allele is represented by Ben Wagner of Troutman Pepper Hamilton Sanders.

"Allele's complaint fails to state a claim for infringement of the '221 patent as a matter of law because the accused conduct is protected by the Hatch-Waxman Act's statutory 'safe harbor'," the dismissal motion reads. The Hatch-Waxman Act is codified under 35 USC 271(e) (1) and states that using a patented invention solely for uses reasonably related to the development or submission of information to federal agencies that regulate the use or sale of drugs and biological products, the defendants argued.

Senior U.S. District Judge Marilyn Huff of the Southern District of California has been assigned the case.

Allele sued Pfizer and BioNTech in October, saying they used without permission its mNeonGreen protein as a research tool during the vaccine's clinical trial stage. The mNeonGreen was patented on March 5, 2019. Allele Biotechnology v. Pfizer, Inc., et al., 3:20-CV-01958 (S.D. Cal., filed Oct. 5, 2020). Pfizer applied for emergency use application from the FDA in November, which was granted in December. Pfizer used the mNeonGreen in tests conducted on blood samples from clinical trial subjects to gather and compile data to give to the FDA.

Noonan argued that Allele's allegations state that mNeonGreen was used throughout the vaccine trials, which is the kind of conduct immunized by 35 USC 271 (e) (1). The safe harbor provision's immunity is broad, and as confirmed by the U.S. Supreme Court in Merck KGaA v. Integra Lifesciences I, LTD, 545 US 193, 202 (2005), it "extends to all uses of patent inventions that are reasonably related to the development and submission of any information" to the FDA for things like a vaccine, Noonan wrote.

Noonan cited Eli Lilly & Co. v. Medtronic Inc., 496 US 661, 671 (1990) in which the U.S. Supreme Court held the term "patented invention" is defined to include all inventions as long as they are reasonably related to the FDA process.

"As Justice [Antonin] Scalia wrote for the court, the term 'patented invention' means just that -- an invention that has been patented," and the phrase in 271(e) (1) is defined to include all inventions, Noonan wrote. Calling it a research tool doesn't exempt it from the broad definition of "patented invention," he wrote.

Allele's lawyer, Ben Wagner, said he has a different view of Scalia's opinion in Lilly.

In an interview Tuesday, Wagner said the immediate case was exactly like Proveris, as the Federal Circuit applied Supreme Court precedent that found research tools, even those being used by companies seeking federal approval, don't get a free pass under the safe harbor act.

Pfizer's lawyers completely overstated what Lilly stood for, Wagner said. All Lilly answered was the question of whether 271(e) (1) includes medical devices as well as drugs, he said. Scalia wrote that the statute doesn't distinguish between medical devices and human drugs or medicine, Wagner said. Instead, the late justice simply found medical devices subject to FDA approval are included in the safe harbor provision, Wagner said.

There have been instances when a patented invention described as a research tool isn't protected, Noonan conceded. For example, Proveris Sci. Corp. v. Innovasystems Inc., (Fed. Cir. 2008), which was about an aerosol spray apparatus. In Proveris, he said, the U.S . Court of Appeals for the Federal Circuit ruled if one is using a patented item to get a product through federal approval, it's not exempt from safe harbor, especially if the invention is used in research even if it is going to be turned over to the FDA.

Noonan said that's not the case in the immediate action.