Fresh From the Bench: Latest Federal Circuit Court Cases
CASE OF THE WEEK
AVX Corporation v. Presidio Components, Inc., Appeal No. 2018-1106 (Fed. Cir. May 13, 2019)
Following an inter partes review upholding the patentability of certain challenged claims, the Court dismissed Petitioner AVX Corporation’s appeal, finding that AVX lacked Article III standing to appeal the Patent Trial and Appeal Board’s decision. (Prior Federal Circuit precedent has established that the statutory right to initiate a USPTO proceeding does not guarantee Article III standing to appeal the result.) In this case, AVX submitted evidence of vigorous competition between itself and Patent Owner Presidio Components in the electronic capacitor market, including four district court actions over patents owned by one party or another in the preceding decade. However, at the time of the appeal, Presidio had not alleged that AVX infringed the patent that was the subject of the IPR, and the Court found that AVX was not engaged in any conduct “even arguably” covered by the upheld claims.
ALSO THIS WEEK
Nuvo Pharmaceuticals (Ireland) Designated Activity Company v. Dr. Reddy’s Laboratories Inc., Appeal Nos. 2017-2473, -2481, -2484, -2486, et al. (Fed. Cir. May 15, 2019)
In this appeal from an ANDA litigation in the U.S. District Court for the District of New Jersey, the Federal Circuit reversed the district court’s finding of validity on the ground of written description under 35 U.S.C. § 112, ¶ 1. On appeal, the generic pharmaceutical company defendants argued that the district court erred in holding that the specification of the patents-in-suit, which cover a combination pain medication containing an NSAID and acid inhibitor, adequately described amounts of uncoated acid inhibitor effective to raise gastric pH to 3.5 to allow for release of the NSAID to treat pain. The Court found that because the patents expressly claim a specific result, i.e., effectiveness of uncoated acid inhibitor, and because the prior art taught away from the concept of effective uncoated acid inhibitor, the specification should have done more than simply calling generally for effective amounts of uncoated acid inhibitor. Rather, the specification must have shown that the inventor was actually in possession of and invented what he claimed by including either supporting experimental data or some reason, theory, or alternative explanation as to why the claimed invention is possessed by the inventor.
The opinion can be found here.
BTG International Limited v. Amneal Pharmaceuticals LLC, Appeal Nos. 2019-1147, -1148, -1323, -1324, -1325 (Fed. Cir. May 14, 2019)
In a combined appeal from a district court opinion and three PTAB decisions, all of which found the asserted claims obvious, the Federal Circuit affirmed one of the PTAB decisions and held the remainder to be moot. The claims relate to a pharmaceutical for treating prostate cancer. At issue was the construction of the term “treatment.” The patent owners alleged that the term should require an anti-cancer effect as opposed to simply a reduction in side effects. Relying on the specification and the claims, the Federal Circuit agreed with the PTAB that, at least as used in this patent, “treating” cancer can involve, in essence, treating side effects as opposed to the cancer itself. The Court then analyzed the obviousness determination made by the PTAB, finding it to be supported by substantial evidence.
The opinion can be found here.
Novartis Pharm. Corp. v. West-Ward Pharm. Int’l Ltd., Appeal No. 2018-1434 (Fed. Cir. May 13, 2019)
In this ANDA case, the Federal Circuit affirmed the Delaware district court’s ruling that generic drug maker West-Ward had failed to establish the obviousness of Novartis’s patent claims over a combination of prior art references. Novartis’s patent was directed to a method of using an active ingredient, everolimus, to inhibit the growth of advanced renal cell carcinoma (RCC) tumors. The district court ruled that West-Ward had failed to (i) demonstrate a motivation to combine the prior art references; and to (ii) show that the skilled artisan would have had a reasonable expectation of success in combining the prior art to arrive at the claimed method. On appeal, the Federal Circuit first rejected the Delaware court’s finding that a motivation to combine was lacking, finding that the court had applied too strict a standard by requiring the defendant to show that the skilled artisan would have selected everolimus to treat advanced RCC. Instead, the district court’s finding that the prior art would have led the ordinarily skilled artisan to pursue everolimus was sufficient to establish motivation to combine. However, the Federal Circuit agreed with the district court that West-Ward had failed to show a reasonable expectation of success in combining the references to arrive at the claimed treatment method. Among other things, West-Ward’s reliance on successful Phase I clinical results was unpersuasive given that Phase I trials are directed to safety rather than efficacy. The Federal Circuit also noted the high rate at which cancer-fighting drugs fail in subsequent Phase II and Phase III clinical trials, which are directed to efficacy. The Federal Circuit also pointed to statements in the prior art references that the mechanisms of RCC tumor inhibition were poorly understood at the relevant time.
The opinion can be found here.
Bradium Technologies LLC v. Iancu, Appeal Nos. 2017-2579, 2017-2580 (Fed. Cir. May 13, 2019)
In an appeal from two IPR decisions finding patents obvious, the Federal Circuit upheld the Board’s claim construction and affirmed the obviousness determinations. The patents concerned communications of large scale images over networks and displaying those images on devices with limited processing power. In a detailed, 32 page opinion, the Federal Circuit upheld the board’s claim construction of “limited bandwidth communications channel” as “a communications channel whose bandwidth is limited,” finding the plain and ordinary meaning correct. Bradium had wanted a narrower construction aligned with wireless or narrow-band communications. The Federal Circuit also held that it was appropriate to rely on inventor testimony in support of the claim construction in the limited circumstances for which the inventor’s testimony was relied upon here. Following analysis of the claim construction, the Court affirmed the obviousness determination by the PTAB for each of the asserted claims, holding that the PTAB’s findings were supported by substantial evidence. The Court also found that Bradium had waived certain arguments by failing to raise them to the PTAB.
The opinion can be found here.
Written by: Scott Eads and Nika Aldrich, Schwabe, Williamson & Wyatt
Contributors: Jason Wrubleski, Erin Forbes