This is an important written description case involving ranges, and highlights a tension within the court over when special disclosure is required within the specification.
Indivior UK v. Dr. Reddy’s Labs (Fed. Cir. 2021)
IPR challenges are limited only to obviousness and anticipation arguments, and so a patent cannot be directly challenged via IPR for lack of enablement or written description. However, Section 112(a) issues do arise in situations where the challenged patent purports to claim priority back to a prior filing. The priority claim fails if the earlier filing fails to support the challenged claims, and this permits assertion of intervening prior art.
Dr. Reddy challenged Invidior’s U.S. Patent 9,687,454 via IPR. The patent claims priority to a chain of prior applications:
- The ‘454 patent is a continuation of application No. 14/715,462, filed on
May 18, 2015, now abandoned;
- The ‘462 Application is a continuation of application No. 14/478,786, filed on
Sep. 5, 2014, now abandoned;
- The ‘786 Application is a continuation of application No. 13/964,975, filed on Aug. 12, 2013, now abandoned;
- The ‘975 Application is a continuation of application No. 13/923,749, filed on Jun. 21, 2013, now abandoned;
- The ‘749 Application is a continuation of application No. 12/537,571, filed on Aug. 7, 2009, now Pat. No. 8,475,832.
The challenged patent covers a sublingual film containing some drug treatment. The claims include several different limitations regarding the amount of polymeric matrix used for the film.
- Claim 1: “about 40 wt % to about 60 wt % of a watersoluble polymeric matrix”;
- Claims 7 & 12: “about 48.2 wt % to about 58.6 wt %”; and
- Claim 8: “about 48.2 wt %”;
The problem though is that the original specification does not recite any of these amounts or ranges directly. The specification does include two tables that collectively include four examples that, when calculated-out, all fall within the range of 48.2-58.6%. However, that calculation process is not express in the specification and the specification does not note particular reason why the particular endpoints form a “range.” On appeal, the court agreed with the PTAB that “written description support of a claimed range” requires “more clarity.”
Here, one must select several components, add up the individual values, determine the aggregate percentages, and then couple those aggregate percentages with other examples in the ’571 application to create an otherwise unstated range. That is not a written description of the claimed range.
Slip Op. The court also notes that the specification provided no additional support for particular ranges and instead indicated that “[t]he film may contain any desired level of . . .polymer” and that in one embodiment it is “at least 25%.”
[The patentee] failed to provide persuasive evidence demonstrating that a person of ordinary skill would have understood from reading the ’571 application that it disclosed an invention with a range of 48.2 wt % to 58.6 wt %. A written description sufficient to satisfy the requirement of the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention. “[A] patent is not a hunting license. It is
not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson, 383 U.S. 519, 536 (1966).
Slip Op. Although the ranges were not supported, the court did find sufficient evidence to affirm the PTAB’s determination that the individual point of “about 48.2 wt %” was supported by the original specification: “given that claim 8 does not recite a range, but only a specific amount, which can be derived by selection and addition of the amounts of selected, but identified, components, we accept that there is substantial evidence to support the Board’s decision concerning claim 8.” Without that priority, the claims were clearly invalidated by prior art published between 2009 and 2015.
The majority opinion was filed by Judge Lourie and joined by Judge Dyk.
Judge Linn wrote in dissent, arguing that the majority’s approach creates “an overly demanding standard for written description of ranges” and is contrary to cases such as In re Wertheim, 541 F.2d 257 (C.C.P.A. 1976) and Nalpropion Pharms., Inc. v. Actavis Labs. FL, Inc., 934 F.3d 1344 (Fed. Cir. 2019). The majority had recognized the value of those precedents, but argued that written description is an intensely fact intensive question.