Working in patent law for as long as I have, I've developed a fair collection of dictionaries I can turn to when I'm working on a Markman brief and require a bit of support.
(Eds. Note - It's also useful for playing especially cutthroat games of scrabble!)
Perusing these tomes has given me an appreciation for the subtle art of the dictionary and the intense (bordering on worrisome) logophilia of those who create them. I am a particular fan of the OED's practice of including quotations featuring the usage of the word, beginning with the first extant, and showing its varying usages throughout history.
(Eds. Note—I swear, I'm not as lame as this post makes me sound. I just think writing a dictionary would be fun . . . .)
The lesson of todays case, Astellas Pharma Inc. v. Lupin Ltd., C.A. No. 23-819-JFB-CJB, D.I. 200 (D. Del. Apr. 19, 2024) (R&R), is that such artistry is best left for the dictionaries.
The patent in Astellas required treatment with a controlled release formulation "such that the treating is with a reduced food effect." The defendant (opposing a request for preliminary injunction) argued that "reduced" food effect was an indefinite term of degree. In support they pointed to a passage in the specification that seemed to provide several possible definitions for "reduced":
The wording “the effects by food are reduced” as used herein means, for example, a reduction by 10% or more, a reduction by 20% or more in another embodiment, and a reduction by 30% or more in still another embodiment, in comparison with Cmax of a conventional formulation. Alternatively, the term means, for example, a reduction of 10% or more with respect to the rates of decrease of Cmax and AUC in administration after food intake, in comparison with Cmax and AUC in administration in the fasted 15 state, a reduction of 20% or more in another embodiment, and a reduction of 30% or more in still another embodiment.
Astellas at 14 (quoting '451 patent, col. 7:57-67)
Judge Burke found this inconsistency persuasive, noting that it shed light on the ambiguity of the term and the potential for inconsistent results:
[E]ven if column 7 did not provide one, clear explicit definition for “reduced food effect,” it does seem to be providing multiple possible, plausible definitions for that term. It is not clear to the Court that “reduced food effect” has a universally understood plain and ordinary meaning. And so column 7’s content puts a fine point on the difficulty here for Plaintiffs. It demonstrates just how important it is that, among the wide array of possibilities out there, the record needs to indicate with reasonable certainty just what is the actual definition of “reduced food effect” that a POSITA should use in order to understand how the claimed invention works. Put differently, column 7 highlights the criticality of this further question: Of all of the possible definitions for “reduced food effect” that there could be in this art, which one does the patent mean to use?
Id. at 21.
Ultimately, Judge Burke found that this ambiguity could not be resolved (a lengthy section of the opinion dealt with the deficiencies in the plaintiffs proffered constructions), and thus that the defendant had raised a substantial question of patentability sufficient to defeat the preliminary injunction.
So for those of you out there with the thankless task of drafting patent specifications. Bear in mind that a single, concise definition is often the best.
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