Federal Circuit Holds Patentee To Its Choice During Prosecution, Invalidating Key Patents
On March 26, 2020, the Court of Appeals for the Federal Circuit (CAFC) affirmed the judgement of the Patent Trial and Appeal Board (Board) concerning claim construction. Genentech, Inc. v. Iancu, F.3d __, (Fed. Cir. Mar. 26, 2020). The CAFC found a single statement in the prosecution history instructive on claim construction where the claims and specification do not clearly define the claimed term. The claims were clearly under that claim construction.
The Company’s patents at issue are directed to methods of treating cancer patients who over-express a certain protein. The claims require administering a combination of a suppressant of that protein and an anti-cancer agent known as a taxoid, and in particular require either (i) that the combination treatment be “in an amount effective to extend the time to disease progression in said human patient…” or (ii) “administering an effective amount of [the] combination.”
During prosecution, the examiner rejected the claim term as being “a relative term undefined by the claim, without ‘a standard for ascertaining the requisite degree,’ and that ‘one of ordinary skill would not be reasonably apprised of the scope of the invention.’” Slip. Op., at 6. The Company responded that the “the combination … is administered in an amount effective to extend the time to disease progression relative to an untreated patient.” Id. The Company’s response led to the issuance of the patent.
Various of the Company’s competitors collectively filed inter partes reviews challenging the Company’s patents. The Board construed these terms to mean in comparison to an untreated patient—consistent with the Company’s position during prosecution. The Company appealed to the CAFC and argued for a narrower construction—that the comparison be to a patient who received the taxoid alone, not an untreated patient—so as to avoid certain prior art. In particular, the Company argued that the Board erred in relying on its response to the patent office to “override the meaning evident from the specification.” Id., at 7. The court rejected the Company’s argument because (i) the specification did not define the disputed terms, (ii) the Company expressly rejected the narrower construction during prosecution, and (iii) the Company had provided an unequivocal, direct response to the examiner on this issue. Thus, the patents were invalid in view of prior art.