Allele Biotechnology and Pharmaceuticals v. Pharmaceuticals
Allele Biotechnology and Pharmaceuticals, Inc. v. Regeneron Pharmaceuticals, Inc.
- Philip Halpern
- 7:20-cv-08255
- U.S. District Court · Southern District of New York
- 16
In Allele Biotechnology v. Regeneron, Judge Halpern construed four patent terms, rejecting Regeneron’s proposed added limitations.
Allele Biotechnology and Pharmaceuticals, Inc. and Regeneron Pharmaceuticals, Inc.; the claim constructions will govern how the patent terms are applied in later proceedings, including any determination of infringement.
What happened
Allele Biotechnology and Pharmaceuticals, Inc. v. Regeneron Pharmaceuticals, Inc. concerns a patent for engineered yellow-green fluorescent proteins. The parties asked the court to define four disputed terms before deciding whether Regeneron infringed the patent.
The court ruled that “isolated” means the protein is present somewhere other than its natural environment. It declined to add performance requirements to “monomeric or dimeric LanYFP fluorescent protein” and “monomeric polypeptide,” finding that their ordinary meanings were not disputed. It also rejected Regeneron’s argument that “non-naturally occurring” was unclear.
Judge Halpern construed “non-naturally occurring” to mean different in amino acid sequence from a yellow-green fluorescent protein of the species Branchiostoma lanceolatum found as-is in nature. This claim-construction order defined the patent terms but did not decide whether infringement occurred.
The detailed version
- Allele Biotechnology and Pharmaceuticals v. Pharmaceuticals · No. 7:20-cv-08255
- Philip Halpern
- Dec. 5, 2022
Background
Allele alleged that Regeneron infringed U.S. Patent No. 10,221,221, which concerns engineered yellow-green fluorescent proteins derived from LanYFP, a fluorescent protein from Branchiostoma lanceolatum. The patent claims non-naturally occurring, isolated monomeric or dimeric LanYFP fluorescent proteins and isolated monomeric polypeptides with specified sequence identities and mutations.
The parties disputed four claim terms: “isolated”; “monomeric or dimeric LanYFP fluorescent protein”; “monomeric polypeptide”; and “non-naturally occurring.” A claim-construction proceeding, sometimes called a Markman proceeding, determines the legal meaning of patent terms so that a fact finder can later apply those meanings when considering infringement and other issues.
Rulings on the disputed terms
“Isolated”
Allele proposed that “isolated” means the protein is present in a place other than its natural environment. Regeneron proposed that the protein must be separated from its natural environment, which Regeneron said required affirmative separation from the cell in which the protein was expressed.
The court adopted Allele’s construction: “the protein is present in other than its natural environment.” The court reasoned that Regeneron’s proposed requirement would exclude patent embodiments describing fluorescent proteins that had not been separated from the cells in which they were expressed. The court also found that statements by the patent examiner about possible purification did not establish that affirmative separation was required.
“Monomeric or dimeric LanYFP fluorescent protein” and “monomeric polypeptide”
Allele argued that both terms should retain their plain and ordinary meanings. Regeneron proposed adding requirements that the proteins have improved extinction coefficient, quantum yield, and brightness compared with mCitrine.
The court declined to construe these terms beyond their plain and ordinary meanings. It found that Regeneron had not shown that the terms were ambiguous or that Allele had clearly given up part of their ordinary scope during the patent-approval process. The court therefore did not add Regeneron’s proposed performance limitations.
“Non-naturally occurring”
Allele proposed that this phrase means “different in amino acid sequence from a yellow/green fluorescent protein of the species Branchiostoma lanceolatum that is found ‘as is’ in nature.” Regeneron argued that the phrase was indefinite, meaning insufficiently clear to determine what falls within the patent claims.
The court rejected Regeneron’s indefiniteness argument and adopted Allele’s proposed construction. The court found that a skilled person could compare a protein sequence with the GenBank database and other available databases to determine, with reasonable certainty, whether the protein was naturally occurring. The court also relied on the patent specification and prosecution history, including Allele’s statements that the claimed proteins differed in sequence from the naturally occurring tetrameric LanYFP protein.
Disposition
The court construed the disputed terms as stated in the order. Specifically, it adopted constructions for “isolated” and “non-naturally occurring,” and declined to construe the two monomeric or dimeric terms beyond their plain and ordinary meanings. The order did not decide whether Regeneron infringed the patent or resolve any ultimate patent-validity issue.
Read the full 16-page opinion on CourtListener, the free public archive maintained by the Free Law Project.