Last Week in the Federal Circuit (November 22-27): Written Description - Cobbling Together Numbers After the Fact

The week of Thanksgiving was a slower one for the Federal Circuit. But we still got an interesting written description decision with a divided panel. Below we provide our usual weekly statistics and our case of the week—our highly subjective selection based on whatever case piqued our interest.

Precedential opinions: 1

Non-precedential opinions: 4

Rule 36: 0

Longest pending case from argument: Indivior UK Limited v. Dr. Reddy's Laboratories S.A., No. 20-2073 (84 days)

Shortest (non-Rule 36) pending case from argument: Brittex Financial, Inc. v. Dollar Financial Group, Inc., No. 21-1370 (22 days)

Case of the week: Indivior UK Limited v. Dr. Reddy's Laboratories S.A., No. 20-2073.

Panel: Judges Lourie, Linn, and Dyk, with Judge Lourie writing the opinion and Judge Linn concurring in part and dissenting in part.

You should read this case if: you have a matter involving written description support.

In this week’s case, the parties disputed whether patent claims had written description support in the originally filed patent application (so that the patentee could get the benefit of that application’s filing date). Appellant Indivior argued against the PTAB’s IPR holding that certain claims of its patent were unpatentable. Meanwhile, cross-appellant entities of Dr. Reddy’s Laboratories (collectively, “DRL”) argued against the PTAB’s holding that DRL failed to demonstrate the unpatentability of claim 8 of the same patent.

The patent generally describes orally dissolvable films with therapeutic agents. The independent claim at issue recited a polymer range of 40% to 60%, while dependent claims recited a narrower range (48.2% to 58.6%) and a specific value (48.2%).

The originally filed application (i) did not expressly claim the broader range, (ii) did not disclose the specific lower and upper bounds of 40% and 60% polymer, respectively, and, most importantly, (iii) did not disclose a range of 40% to 60% polymer. Furthermore, the application contained “conflicting statements,” including that the product may contain “any desired level of … polymer” and that one embodiment contains “at least 25%” polymer, which is well outside the broader claimed range.

Indivior pointed to tables of exemplary formulations comprising multiple polymers which, collectively, totaled up to values which fell within the claimed range of 40-60%. The court noted that to arrive at these specific, particular values within the range, one must select several components, add up their individual values, determine the aggregate percentages, and then couple those aggregate percentages with other examples to create an otherwise unstated range. “[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). Rejecting Indivior’s view of the written description requirement, the Court admonished that it is not enough to offer an “invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention.”

Indivior did not walk away empty handed, however. It successfully defended the Board’s determination that the specific polymer value (48.2%) in claim 8, which was not ever explicitly claimed or disclosed in the original application, was supported by the exemplary formulations from which that value could “be derived.” The Court affirmed that determination “out of deference to the Board’s factfinding.”

Judge Linn, concurring in part and dissenting in part, wrote that the case at hand was “factually indistinguishable” from that of Nalpropion Pharms., Inc. v. Actavis Labs. FL, Inc., 934 F.3d 1344 (Fed. Cir. 2019). There, the Court affirmed the district court’s determination that a claim reciting a range of 39%-70% had written description support based on tables in the specification showing discrete values of 39% and 67%. Judge Linn also argued, among other grounds for disagreement, that disclosure of discrete values should suffice to give written description support for a “closed range.”