Back in May 2023, Alnylam brought suit against Pfizer and BioNTech in the District of Delaware, alleging infringement of patents directed to vaccine lipid nanoparticle technology. On August 12, 2024, Chief Judge Connolly issued a memorandum opinion construing the claim term “vaccine” in one of the asserted patents (U.S. Patent No. 11,590,229). The parties’ dispute did not concern the meaning of “vaccine”; rather, the parties disputed whether the term was limiting, i.e., an element of the claims.
Alnylam argued that “[n]othing about [the asserted claims] suggests that the term ‘vaccine’ is meant to be a limitation.” Judge Connolly disagreed, and he pulled no punches. Judge Connolly noted that Alnylam’s counsel took this position “steadfastly and without any hint of irony” at oral argument. Although he “do[es] not fault Alnylam’s counsel for making this argument,” he said “it made me think at the time that I was in a nonsensical wonderland,” with an interesting citation: “See Alice in Wonderland (Walt Disney Productions 1951).”
One reason why Judge Connolly did not fault Alnylam is because Pfizer and BioNTech “accepted the fundamental premise of Alnylam’s argument—namely, that a patent does not necessarily claim what it claims if what it claims is set forth in the claim’s introductory words (i.e., the claims’ preamble).” Another reason was that “the real culprit here is a long line of binding Federal Circuit case law that has endorsed the Mad Hatter logic of that premise.” Judge Connolly stated that “[t]he Federal Circuit has expressly held on numerous occasions that ‘[g]enerally, the preamble [of a claim] does not limit that claim’” and that “‘[p]reamble language that merely states the purpose or intended use of an invention is generally not treated as limiting the scope of the claim.’” Alnylam made such an argument in this case—that “vaccine” does not limit the claims because it appears in the claims’ preambles and “simply provides the ‘intended use’ for the invention.”
Judge Connolly also recognized that the Federal Circuit has also repeatedly held that “[t]he preamble limits the claimed invention if it is ‘necessary to give life, meaning, and vitality to the claim.’” According to Judge Connolly: “And as I, for one, do not understand how the purpose or intended use of a claimed invention would not give meaning or vitality to that invention, the parties’ dispute before me presents a conundrum. The purpose or intended use of something is the very reason for which that something is made or done. What could say more about the life, meaning, and vitality of a claimed invention than the claimed purpose or intended use of the invention?” Although the claim term “vaccine” appeared in the preambles of the claims at issue here, Judge Connolly said that “[i]t is undisputed that ‘vaccine’ describes the intended use of the claimed invention,” and therefore “it can be reasonably disputed that the term ‘vaccine’ gives life, meaning, and vitality to the claims.”
After voicing his vexations, Judge Connolly construed “vaccine” to be limiting “because “that construction comports with common sense, the very notion of ‘a claim,’ and the fundamental canon that a claim should be construed to give effect to all its terms.” He said: “I think it fair to say that rational jurors would find it confusing, question my competency, and perhaps even laugh out loud were I to instruct them that [the asserted claims] do not claim what they explicitly claim and that to establish infringement of the claims Alnylam need not prove that the accused products are vaccines.”
Judge Connolly concluded his opinion by inviting the Federal Circuit to join the party, as “this case well illustrates the need for the Federal Circuit to jettison its rulings that treat language in the preamble of a patent claim as not limiting the scope of the claim.” Noting that he is “not alone in this view,” Judge Connolly quoted a prominent legal scholar, Mark Lemley, and several paragraphs of Judge Dyk’s dissenting opinion in Am. Med. Sys., Inc. v. Biolitec, Inc., 618 F.3d 1354 (Fed. Cir. 2010).
He ended the opinion like this: “If this case is appealed, I hope the Federal Circuit will view it as an opportunity to clarify its jurisprudence in this area. All the words of a patent claim should matter. The purpose and intended use ( and meaning and vitality) of a patent claim as well as common sense call for a simple rule of law: A claim claims what it claims, nothing more and nothing less.”
Stay tuned to Big Molecule Watch for updates on this litigation!