On October 4, 2024, District Judge Philip M. Halpern (S.D.N.Y.) denied Defendant Regeneron Pharmaceuticals Inc. (“Regeneron”)’s Motion for Summary Judgment that (1) Allele was not entitled to any pre-suit infringement damages because it did not properly mark; and (2) that Regeneron did not willfully infringe the ’211 patent. Slip Op. at 1-2. The Court also granted Plaintiff Allele Biotechnology & Pharmaceuticals, Inc. (“Allele”)’s Motion for Summary Judgment that the 35 U.S.C. § 271(e)(1) safe harbor provision did not protect the Defendant’s use. Id. at 2.
Allele owns U.S. Patent No. 10, 211, 221 (“the ’211 patent”) that claims mNeonGreen, a fluorescent protein reagent used for measuring virus neutralizing activity. Id. at 2. Allele licenses mNeonGreen to academic and commercial entities who distribute mNeonGreen plasmids to other entities that use them. Id. at 2.
Regeneron makes REGEN-COV, a drug used to treat COVID-19. Id. Regeneron used mNeonGreen in multiple ways when developing REGEN-COV. Specifically, it was used to select a pair of antibodies for inclusion in the REGEN-COV cocktail, to test the potency of manufactured lots of REGEN-COV, and to test REGEN-COV antibodies against COVID-19 variants. Id.
Allele sued Regeneron for infringement stemming from the unauthorized use of mNeonGreen. Id. at 1. Regeneron sought summary judgment that: (1) Allele was not entitled to any pre-suit infringement damages because it did not properly mark under 35 U.S.C. § 287; and (2) that Regeneron did not willfully infringe the ’211 patent. Id. at 1-2. For its part, Allele sought summary judgment that the safe harbor provision did not apply to Regeneron’s infringement of the ’211 patent. Id. at 8.
With regard to Regeneron’s lack of marking motion, the Court held that Allele did not need to mark the mNeonGreen plasmids. Id. at 4. The Court reasoned that mNeonGreen plasmids are not components of mNeonGreen. Rather, they are small DNA molecules that can be used to make the mNeonGreen protein in a lab. Id. at 5. Thus, since the resulting mNeonGreen protein itself would not be marked, the Court held that marking the plasmids would not further the policy aim of the marking statute and denied Regeneron’s Motion. Id.
With regard to Regeneron’s lack of willful infringement motion, the Court found deposition testimony and email conversations where Allele representatives initiated licensing discussions with Regeneron employees to be sufficient proof to show prior knowledge of the ’211 patent and denied the motion. Id. at 8.
With regard to Allele’s motion, Allele tried to show that the safe harbor provision did not apply to Regeneron’s use of mNeonGreen. The safe harbor provision provides that using 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” is not patent infringement. Id. at 8. However, Regeneron was not seeking FDA approval in order to introduce a product to the market to compete with mNeonGreen. Further, mNeonGreen was not subject to FDA review or pre-marketing approval. As such, the Court held that the safe harbor provision did not apply. Id. at 10.
The case is Allele Biotechnology & Pharms., Inc. v. Regeneron Pharms., Inc., No. 20-CV-08255 (PMH) (S.D.N.Y. Oct. 4, 2024).
