Claim Construction Arguments Shine Bright

• Jurisdiction: United States,Federal
• Law Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
• Subject Matter: Intellectual Property, Patent
• Author: Ms Melanie Magdun, Justin J. Hasford and Stacy Lewis
• Published date: 01 March 2023

Holding

In Allele Biotechnology and Pharmaceuticals Inc. v. Regeneron Pharmaceuticals Inc., 20-CV-08255 (SDNY Dec. 5, 2022), the United States District Court for the Southern District of New York construed four disputed terms "isolated," "monomeric or dimeric LanYFP fluorescent protein," "monomeric polypeptide," and "non-naturally occurring" in favor of Plaintiff Allele.

Background

Allele Biotechnology ("Allele") is the patent holder of U.S. Patent No. 10,221,221 ("the '221 Patent"), which is titled "Monomeric Yellow-Green Fluorescent Protein from Cephalochordate." The '221 Patent is directed to novel green/yellow fluorescent proteins derived by protein engineering based on an exemplary wild-type tetrameric yellow fluorescent protein from Branchiostoma lanceolatum ("LanYFP"), a marine invertebrate of the cephalochordate subphylum. Allele Biotechnology, at *1.

Allele alleged that Regeneron infringed five claims of the '221 Patent, set forth below, all of which contain at least one of the disputed terms and are therefore relevant to the instant claim construction:

Claim 1: A non-naturally occurring isolated monomeric or dimeric LanYFP fluorescent protein comprising a polypeptide having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 1, wherein the protein comprises at least one mutation selected from the group consisting of: F15I, R25Q, A45D, Q56H, F67Y, K79V, Sl00V, F115A, I118K, V140R, T141S, M143K, L144T, D156K, T158S, S163N, Q168R, V171A, N174T, I185Y, and F192Y;

Claim 2: The non-naturally occurring LanYFP fluorescent protein of claim 1, wherein the protein is a monomer;

Claim 3: An isolated non-naturally occurring monomeric polypeptide encoded by a nucleic acid having at least 90% sequence identity to SEQ ID NO: 2 SEQ ID. No. 2, where the nucleotide sequence encodes for a polypeptide which comprises at least one mutation selected from the group consisting of: Il 1 SK or Nl 7 4 T, at least one mutation selected from the group consisting of: V140R, L144T, D156K, T158S, Q168R, and F192Y, and at least one mutation selected from the group consisting of: R25Q, A45D, S163N, F151, Q56H, F67Y, K79V, Sl00V, F115A, T141S, M143K, V171A, and 1185Y;

Claim 4: The non-naturally occurring isolated monomeric or dimeric LanYFP fluorescent protein of claim 1, wherein the protein comprises at least one mutation selected from the group consisting of: Il 1 SK and Nl 7 4 T, at least one mutation selected from the group consisting of: V140R, L144T...