Allele Biotechnology and Pharmaceuticals v. Pharmaceuticals

Background

Allele brought one patent-infringement claim against Regeneron involving United States Patent No. 10,221,221, which covers the fluorescent protein mNeonGreen. Regeneron used mNeonGreen to evaluate antibody candidates for possible inclusion in REGEN-COV, to test manufactured lots of REGEN-COV, and to test the antibodies against COVID-19 variants. Regeneron stopped using mNeonGreen in connection with REGEN-COV by November 19, 2020.

After discovery ended, both parties moved for summary judgment. Regeneron sought a ruling that Allele could not recover damages for infringement before the lawsuit because Allele and its licensees had not marked mNeonGreen plasmids with the patent number or provided actual notice. Regeneron also sought a ruling that it did not willfully infringe the patent. Allele sought a ruling that the statutory safe harbor for certain uses reasonably related to obtaining information for drug approval did not protect Regeneron’s conduct.

Marking Statute

The patent-marking statute, 35 U.S.C. § 287(a), can limit a patent owner’s ability to recover damages for infringement before the infringer received notice if the owner did not mark patented articles or otherwise provide notice. Regeneron argued that Allele and its licensees were required to mark the mNeonGreen plasmids.

The court rejected that argument. It explained that a plasmid is a small circular DNA molecule used to make the mNeonGreen protein, not a component of the protein itself. Because marking the plasmid would not mark the patented mNeonGreen protein, the court concluded that Allele and its licensees had no obligation under the marking statute to mark the plasmids with the patent number. The court therefore denied the branch of Regeneron’s summary-judgment motion seeking to bar damages for pre-suit infringement.

Willful Infringement

Willful infringement requires evidence that the accused infringer had a specific intent to infringe, and whether infringement was willful is generally a fact question. Regeneron argued that Allele lacked evidence that Regeneron knew about the patent before the lawsuit.

The court found enough circumstantial evidence for a reasonable jury to infer that Regeneron had pre-suit knowledge of the patent. The evidence included a paper reviewed by a Regeneron scientist that disclosed Allele had filed for patent protection, multiple calls and emails from Allele representatives seeking licensing discussions, and evidence that the email account used by Allele was maintained by Regeneron. The court also stated that the record could support a finding of post-suit willful infringement. It held that Regeneron had not shown an absence of evidence on knowledge or deliberate conduct and denied the branches of Regeneron’s motion addressing pre-suit and post-suit willful infringement.

Drug-Approval Safe Harbor

Section 271(e)(1) provides a safe harbor for certain uses of a patented invention that are reasonably related to developing and submitting information under federal drug-regulation laws. The court explained that the safe harbor does not necessarily cover research tools that are not themselves subject to FDA approval.

The court ruled that mNeonGreen was a research tool and was not subject to FDA review or premarketing approval. It also found that Regeneron was not seeking FDA approval to enter the market with a product competing with Allele or mNeonGreen. Relying on those facts and the Federal Circuit’s decision in Proveris, the court held that mNeonGreen was not a “patented invention” covered by the safe harbor and that the safe harbor did not immunize Regeneron’s infringement. The court therefore granted Allele’s motion for summary judgment on the safe-harbor issue.

Disposition

The court denied Regeneron’s motion for summary judgment and granted Allele’s motion for summary judgment. The Clerk was directed to terminate the pending motions, and the parties were directed to file pretrial materials by November 4, 2024.