This post falls in a category we could broadly refer to as "ouch, that hurts." Maybe we can all learn from times when things go wrong.
In Alnylam Pharma., Inc. v. Pfizer, Inc., C.A. No. 22-336-CFC (D. Del.), the plaintiff asked—as plaintiffs often do—for a "plain and ordinary meaning" construction of a key term in all asserted claims, "cationic lipid," and spelled out that plain meaning in general terms. Id., D.I. 63. The defendants proposed a much longer and more specific construction. Id.
At claim construction, the Court mostly adopted plaintiff's proposed construction, holding that a "cationic lipid" is a lipid that, under its plain and ordinary meaning, is positively charged or "may be protonated at physiological pH" (whatever that means):
During a claim construction hearing in August 2023, I adopted in all material respects Alnylam's proposed construction of "cationic lipid," and construed the term to have its "plain and ordinary meaning, which in the context of th[ese] patent[s], is a lipid that is positively charged or that may be protonated at physiological pH."
Id., D.I. 445 at 1-2.
At the expert report stage, the patentee's expert relied on that construction to argue infringement based on the fact that some portion of the accused product "can accept additional protons, i.e., may be pronotated" at the relevant pH. Id. at 2.
Defendants' expert apparently responded that there is no infringement because the majority of the product's molecules—the "predominant species (i.e., more than 50%)"—do not fit that definition. Id.
Plaintiff brought an O2 Micro motion, asking the Chief Judge Connolly to decide whose interpretation is right. The Court rejected the motion, finding that it had already decided the issue at claim construction:
[Plaintiff and patentee] Alnylam cites O2 Micro in its briefing for the proposition that "'[w]hen the parties present a fundamental dispute regarding the scope of a claim term, it is the court's duty to resolve it.'" . . . . In this case, the parties presented me almost two years with ago a fundamental dispute about the meaning of "cationic lipid," and I resolved that dispute in August 2023. As noted above, I resolved the dispute in Alnylam's favor and adopted Alnylam's proposed construction of cationic lipid.
It was clear to everyone—the parties and me—at the time of my ruling that under the plain and ordinary meaning of cationic lipid, the lipid's charge is determined by looking at its predominant species. For Alnylam to now insist otherwise is troubling. Alnylam stated in its claim construction briefing [that "]the reference to a charged or a neutral lipid refers to the nature of the predominant species and does not require that all of the lipid be present in the charged or neutral form." . . . And during the claim construction hearing, its counsel stated that "an amine at [a pKa of 9] is protonatable as [that term is] used in the field because, at physiological pH, 50 percent of the lipids at any given time will be positively charged."
Id. at 3-4.
Basically, it looks like patentee argued during construction that the plain meaning depends on the nature of the majority of the components of the claimed invention, and the Court adopted that plain meaning—although the literal text of the Court's claim construction order did not spell it out.
Then, at the expert report stage, the patentee realized that the accused product doesn't (or may not) meet that definition—which, again, is not in the literal text of the construction—and asked the Court to re-do claim construction under O2 Micro.
The Court did not go for it:
Thus, to be clear, I have already satisfied my obligations under O2 Micro. Alnylam got the claim construction of cationic lipid it asked for in August 2023, and O2 Micro does not entitle it to a new claim construction of that term. The fact that Alnylam is now "dissatisfied with its own proposed construction and s[eeks] a new one does not give rise to an O2 Micro violation." . . . I will therefore deny Alnylam's request for additional claim construction.
Id. at 5. Unsurprisingly, the Court also rejected a request by the patentee to strike the Defendants' experts "predominant species" argument:
I will also deny Alnylam's alternative request to preclude Dr. Little from offering at trial his opinion that, because the predominant species of ALC-0315 molecules are not or could not be positively charged at physiological pH, ALC0315 is not a cationic lipid under my construction of that term. Alnylam says that Dr. Little's opinion should be excluded under Federal Rule of Evidence 702 and Daubert . . . because it contradicts my claim construction. . . . But as discussed above, his opinion is entirely consistent with both my construction of cationic lipid and Alnylam's understanding of that construction when it asked me to adopt it.
Id.
One way takeaway from this is that a "plain and ordinary meaning" construction can include limitations that go beyond the literal words that are included (at least where, as here, the patentee admitted a particular plain and ordinary meaning during claim construction).
Another takeaway is that it's awfully risky to argue one thing to the Court at claim construction, win, and then argue the opposite at summary judgment.
Yet another is that, if you are the patentee and you're arguing for a claim construction, you'd better be sure that the accused product meets that construction.
If you enjoyed this post, consider subscribing to receive free e-mail updates about new posts.
