7:20-cv-08255
S.D.N.Y.Dec 5, 2022Background:
- Parties: Allele Biotechnology (plaintiff) sued Regeneron (defendant) alleging infringement of U.S. Patent No. 10,221,221 for a "Monomeric Yellow-Green Fluorescent Protein from Cephalochordate."
- Patent scope: claims recite a genus of "non-naturally occurring isolated monomeric or dimeric LanYFP fluorescent proteins" and "isolated non-naturally occurring monomeric polypeptides" defined by sequence-identity thresholds to SEQ ID NO:1/2 and specific mutation sets.
- Prosecution history: the PTO rejected the application three times under §§101/102/112; applicant added "non-naturally occurring," "isolated," and monomeric/dimeric language and emphasized engineered sequence changes and functional differences to overcome rejections.
- Disputed claim terms: the parties asked the court to construe four terms—"isolated," "monomeric or dimeric LanYFP fluorescent protein," "monomeric polypeptide," and "non-naturally occurring."
- Procedural posture: the District Court held a Markman hearing and issued constructions for the disputed terms.
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| "isolated" | Means "the protein is present in other than its natural environment" (Allele). | Requires affirmative separation/purification from the cell (Regeneron). | Court adopted Allele's construction: "the protein is present in other than its natural environment." |
| "monomeric or dimeric LanYFP fluorescent protein" | Plain and ordinary meaning; no construction needed (Allele). | Argues prosecution statements limit scope to proteins with improved extinction coefficient, quantum yield, and brightness over mCitrine (Regeneron). | Court declined to construe; left term to plain and ordinary meaning and rejected disavowal argument. |
| "monomeric polypeptide" | Plain and ordinary meaning; no construction needed (Allele). | Same as above—Regeneron seeks to read-in functional/brightness limits from prosecution. | Court declined to construe; left plain and ordinary meaning and rejected disavowal argument. |
| "non-naturally occurring" | Means "different in amino acid sequence from a yellow/green fluorescent protein of the species Branchiostoma lanceolatum that is found 'as is' in nature." | Indefinite because new natural proteins may be undiscovered, so one cannot be certain (Regeneron). | Court adopted Allele's construction and held term not indefinite—comparison to databases like GenBank provides reasonable certainty. |
Key Cases Cited
- Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996) (claim construction is a question of law for the court).
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claims read in light of the specification and person of ordinary skill in the art).
- Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996) (specification is the primary guide to claim meaning; may act as a dictionary).
- Oatey Co. v. IPS Corp., 514 F.3d 1271 (Fed. Cir. 2008) (do not exclude a specific embodiment from claim scope absent probative evidence).
- Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014) (definiteness requires reasonable certainty to a person of ordinary skill in the art).
- Teva Pharm. USA, Inc. v. Sandoz, Inc., 574 U.S. 318 (2015) (factual findings in claim construction receive deference on appeal).