IP Law Daily, PATENT—S.D.N.Y.: Safe Harbor Defense does not apply to use of patented fluorescent protein, (Oct 7, 2024)

By Brian Craig, J.D.

The monomeric yellow-green fluorescent protein called mNeonGreen is a research tool that is not under the scope of the safe harbor provision.

In an infringement suit between two biotechnological companies over a patent for a monomeric yellow-green fluorescent protein called mNeonGreen owned by Allele Biotechnology and Pharmaceuticals, Inc., the federal district court in New York has held that the Safe Harbor Defense does not immunize Regeneron Pharmaceuticals, Inc.’s alleged improper use. In granting summary judgment in favor of Allele that prevents Regeneron from asserting the Safe Harbor Defense, the court held that mNeonGreen is a research tool not under the scope of the safe harbor provision that encourages the development of generic drugs. The court also held sufficient evidence exists for Allele to move forward with claims for willful infringement and damages for pre-suit infringement at trial (Allele Biotechnology and Pharmaceuticals, Inc. v. Regeneron Pharmaceuticals, Inc., No. 7:20-cv-08255-PMH (S.D.N.Y. Oct. 4, 2024)).

The biotechnology company Allele Biotechnology and Pharmaceuticals, Inc. (“Allele”) owns U.S. Patent No. 10,221,221 (the ’221 Patent) which describes a monomeric yellow-green fluorescent protein that Allele markets under the name mNeonGreen. Allele Biotechnology filed a patent infringement suit against a competing biotechnology company, Regeneron Pharmaceuticals, Inc. (“Regeneron”). The fluorescent protein reagent mNeonGreen is used as a tool for applications in biotechnology and medicine including to measure virus neutralizing activity. Allele licenses the use of mNeonGreen to academic and commercial entities. After discovery, the parties filed cross motions for summary judgment. Regeneron moved for summary judgment seeking to preclude damages for pre-suit infringement under the Marking Statute and to preclude claims for willful infringement. Allele moved for summary judgment on Regeneron’s assertion of the Safe Harbor Defense.

Marking Statute Defense. The court first denied Regeneron’s motion for summary judgment seeking to preclude damages for pre-suit infringement under the Marking Statute. Requiring Allele to mark the mNeonGreen plasmid does not fulfill the Marking Statute’s policy goal of notifying the public concerning the patent status of its items in commerce. Allele and its licensees did not have an obligation under the Marking Statute to mark the mNeonGreen plasmids with the ’221 Patent number.

Willful infringement. The court also denied Regeneron’s motion for summary judgment on the issue of willful infringement. The parties had previous licensing discussions with multiple emails and multiple phone calls. A rational jury could infer from deposition testimony and other evidence that Regeneron had pre-suit knowledge of the ’221 Patent.

Safe Harbor Defense. Finally, the court held that Safe Harbor Defense does not immunize Regeneron’s alleged infringement. The Safe Harbor Defense applies to use 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.” 35 U.S.C. § 271(e)(1). The U.S. Court of Appeals for the Federal Circuit has held that despite the broad contours of the exemption, some activities are outside its protection. For example, research tools or devices that are not themselves subject to FDA approval may not be covered. The protein mNeonGreen is not subject to FDA review or pre-marketing approval. The protein mNeonGreen is characterized as a research tool and used to measure the effectiveness of pharmaceutical products in development. The court held that the safe harbor provision does not apply to Regeneron’s use of the patented mNeonGreen markers as a component in one of many tests to generate data for the FDA. Accordingly, the court granted summary judgment in favor of Allele on the Safe Harbor Defense to prevent Regeneron from asserting the defense.

The Case is No. 7:20-cv-08255-PMH.

Judge: Halpern, P.

Attorneys: Aaron E. Schindler (Perkins Coie LLP) for Allele Biotechnology and Pharmaceuticals, Inc. Arlene Lee Chow (Latham & Watkins LLP) for Regeneron Pharmaceuticals, Inc.

Companies: Allele Biotechnology and Pharmaceuticals, Inc.; Regeneron Pharmaceuticals, Inc.

Cases: Patent NewYorkNews