Judge Bryson recently unsealed his opinion in Janssen Pharmaceuticals Inc. v. Tolmar, Inc., C.A. No. 21-1784-WCB (D. Del. Sept. 8, 2023), in which he grants summary judgment of no anticipation by a reference under (Pre-AIA) § 102(a).
As a reminder, pre-AIA § 102(a) covers prior art that was available "before the invention" of the patent.
Here, the plaintiff argued that it had reduced the invention to practice before the date of the prior art. The defendant responded that, sure, they reduced an embodiment to practice before the prior art, but they didn't conceive of the invention's full scope:
Tolmar does not appear to dispute that the June 2007 clinical trials practiced the claimed dosing regimens. Instead, it argues that Janssen has not provided evidence that it conceived of the “a month (±7 days)” limitation, recited in the third step of claim 1, prior to the filing of the December 2008 provisional patent application. As the parties point out, the 2007 clinical trials “permitted a ±3 day dosing window around the ‘monthly’ maintenance doses.” Dkt. No. 106 at 5; see also Dkt. No. 104 at 5.
Janssen Pharmaceuticals Inc. v. Tolmar, Inc., C.A. No. 21-1784-WCB, at 4 (D. Del. Sept. 8, 2023).
The full scope of the claims involved giving three doses of a drug, with the last dose given "a month ± 7 days" after the second dose. The plaintiff's "reduction to practice," however, was a clinical trial that gave the last dose just a month and +/- 3 days after the second dose.
Thus, the reduction to practice was narrower than the ultimate claims, in that a method that gave the last dose, say, a month and 6 days after the second dose, was not covered by the clinical trial but would fall within the claims.
Judge Bryson rejected the idea that a patentee must reduce the full scope of the claims to practice, holding instead that a reduction to practice is sufficient:
The problem for Tolmar is that in order to establish priority to an invention, the inventor “need[] only prove either that it reduced its invention to practice first or that it conceived of the invention first and was diligent in reducing it to practice.” . . . If reduction to practice is established, then evidence of conception is not necessary. . . . Accordingly, if Janssen can establish that it reduced the invention to practice prior to the publication of the Disputed References, it is irrelevant whether there is evidence that the inventors conceived of the “a month (±7 days)” limitation prior to that time.
Id. at 4-5.
In fact, the Court pointed out that an inventor who shows reduction to practice need not show conception at all, let alone conception of the full scope of the invention:
Tolmar cites several cases in support of its argument that evidence of conception is required in addition to evidence of reduction to practice. Those cases, however, address situations that are different from the one presented by this case, and they are not inconsistent with the general principle that reduction to practice is sufficient to establish priority independent of the inventor’s conception and diligence.
. . .
Proof of prior invention can consist of either proof of conception before the date of a prior art reference, followed by diligence leading to a subsequent reduction to practice or, alternatively, proof of reduction to practice prior to the date of the prior art reference, without the need to separately prove conception. . . .In this case, Janssen has offered evidence that it reduced the claimed invention to practice before the publication of the Disputed References by showing that it “(1) constructed an embodiment or performed a process that met all the claim limitations and (2) determined that the invention would work for its intended purpose.” [B]ecause Janssen reduced the invention to practice in that fashion, and did so prior to the publication of the Disputed References, Janssen was not required to show when it conceived of the plus-or-minus seven-day window recited in the claims.
Id. at 5-7.
In short, a patentee is not required to conceive the "full scope of the invention"—or anything else—as long as they constructed an embodiment or performed the process and determined the invention would work. Good to know!
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