A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.
Bradium Technologies LLC v. Iancu, Nos. 2017-2579, -2580 (Fed. Cir. (PTAB) May 13, 2019). Opinion by Reyna, joined by Moore and Chen.
On appeal from final written decisions in two IPR proceedings, the Federal Circuit affirmed the Patent Trial and Appeal Board’s claim construction and consequent determination that the challenged claims were unpatentable as obvious.
Microsoft filed IPR petitions challenging the claims of two patents assigned to Bradium. The patents are directed to retrieving large-scale images over network communication channels in low-bandwidth conditions and to displaying such images on client devices with limited processing power. Bradium argued that the claim term “limited bandwidth communications channel” is restricted to “a wireless or narrowband communications channel.” The Board disagreed and adopted the term’s plain and ordinary meaning of “a communications channel whose bandwidth is limited.” The Board explained, for example, that the term is not restricted to a wireless channel, nor does it “imply a specific cause for the bandwidth limitation.” Under the assigned claim construction, the Board determined that all of the claims in the two challenged patents were obvious over the cited prior art.
The Federal Circuit affirmed the PTAB’s claim construction and obviousness determination. In doing so, the Federal Circuit rejected Bradium’s primary argument that the PTAB’s construction was overbroad. The Federal Circuit explained that the “single statement” in the specification on which Bradium relied was “not a clear and unambiguous definition limiting the term to only one cause, contrary to its plain and ordinary meaning.” Further, the Board’s construction was consistent with the testimony of the inventor. Therefore, the Board had correctly construed the disputed term. Next, applying the claim construction to the cited prior art, the Federal Circuit determined that substantial evidence supported the PTAB’s obviousness determinations.
AVX Corp. v. Presidio Components, Inc., No. 2018-1106 (Fed. Cir. (PTAB) May 13, 2019). Opinion by Taranto, joined by Newman and O’Malley.
The Federal Circuit dismissed this appeal because AVX lacked Article III standing to appeal the Patent Trial and Appeal Board’s final written decision.
AVX filed a petition for IPR challenging all claims of a patent owned by Presidio. The Board instituted review and issued a final written decision finding that certain claims were unpatentable as obvious and upholding the patentability of the remaining claims. AVX appealed and, as part of its arguments, sought to establish constitutional standing to contest the adverse findings by the Board.
In dismissing the appeal, the Federal Circuit reiterated that “[a] person does not need to have Article III standing to file an IPR petition and obtain a Board decision, because Article III requirements do not apply to administrative agencies.” However, “any party that appeals to this court must have standing under Article III before we can consider the merits of the case.”
AVX raised two arguments regarding standing to appeal. First, AVX argued that it is injured, and thus has standing, because the statutory estoppel provision of 35 U.S.C. § 315(e) prevents AVX from asserting the same challenges in the future. The Federal Circuit disagreed, explaining that the court in prior decisions had “already rejected invocation of the estoppel provision as a sufficient basis for standing.” The Federal Circuit also observed that the court has never decided “whether the estoppel provision would have the effect that AVX posits—specifically, whether § 315(e) would have estoppel effect even where the IPR petitioner lacked Article III standing to appeal the Board’s decision to this court.” For its second argument, AVX reasoned that it is injured because the Board’s decision reduces AVX’s ability to compete with Presidio. The court rejected this theory as well, explaining that AVX had not shown that “it is engaging in, or has nonspeculative plans to engage in, conduct even arguably covered by the upheld claims of [Presidio’s] patent.” The Federal Circuit therefore dismissed the appeal.
Novartis Pharmaceuticals Corp., et al. v. West-Ward Pharmaceuticals Int’l Ltd., No. 2018-1434 (Fed. Cir. (D. Del.) May 13, 2019). Opinion by Stoll, joined by Plager and Clevenger.
The Federal Circuit affirmed the district court’s determination that certain claims of a patent held by Novartis were not invalid as obvious.
West-Ward’s predecessor filed an ANDA seeking to manufacture and sell generic versions of Novartis’s Afinitor product in which the compound everolimus is the active ingredient. Novartis responded by filing a lawsuit for infringement of its patent covering methods of using everolimus to treat advanced renal cell carcinoma (RCC). The parties stipulated to infringement and conducted a bench trial on validity. The district court found that, based on the prior art, a person of ordinary skill “would have been motivated to pursue everolimus” as a potential treatment option, but “would not have been motivated to select everolimus.” Therefore, the district court found a lack of motivation to combine. Additionally, the court found that a skilled artisan would not have had a reasonable expectation of success in using everolimus to treat advanced RCC.
The Federal Circuit determined that the district court erred in its motivation-to-combine analysis, but nonetheless affirmed based on the district court’s finding that a person of ordinary skill would not have reasonably expected success in using everolimus to treat advanced RCC. Regarding motivation to combine, the Federal Circuit held that the district court erred by applying a heightened standard. Specifically, it was “improper to require West-Ward to prove that a person of ordinary skill would have selected everolimus over other prior art treatment methods.” The proper inquiry “is whether a person of ordinary skill would have been motivated to modify the prior art disclosing use of temsirolimus to treat advanced RCC with the prior art disclosing everolimus.” That question was answered affirmatively when the district court found a motivation to pursue everolimus as a potential treatment option. Nevertheless, because the district court did not clearly err in finding a lack of reasonable expectation of success, the Federal Circuit affirmed the judgment as to validity.
BTG Int’l Ltd., et al. v. Amneal Pharmaceuticals LLC, et al., Nos. 2019-1147, -1148, 1323, -1324, -1325 (Fed. Cir. (D.N.J. & PTAB) May 14, 2019). Opinion by Wallach, joined by Moore and Chen.
Addressing consolidated appeals stemming from three IPR proceedings and a parallel district court litigation, the Federal Circuit affirmed the construction of “treatment” to include both anti-cancer effects and steroid effects. The Federal Circuit also affirmed the determination, based on that construction, that the claims would have been obvious over the prior art.
The representative patent claim recites a method for the “treatment” of prostate cancer by administering “a therapeutically effective amount of abiraterone acetate … and a therapeutically effective amount of prednisone.” The Patent Owner argued that the term “treatment” requires prednisone to have an anti-cancer effect, but both the Patent Trial and Appeal Board and the Federal Circuit disagreed. The “patent’s claims, specification, and prosecution history teach that ‘treatment’ includes both anti-cancer effects and palliation or reduction in side effects of a different anti-cancer drug.” For instance, the specification states that a “therapeutic agent” may be either “an anti-cancer agent or a steroid.” The specification further explained that prednisone is both an anti-cancer agent and a steroid, meaning that “‘treating’ with prednisone must logically include more than just anti-cancer effects and should include the long-familiar steroid effects of palliation and reduction of side effects.”
Turning to the obviousness determination, the Federal Circuit ruled that substantial evidence supported the Board’s finding that the “prior art provides a reasonable expectation that prednisone could be used as a therapeutic agent in the treatment of prostate cancer.” That finding provided an independent basis for affirming the Board’s determination of obviousness.
Nuvo Pharmaceuticals (Ireland) Designated Activity Co., et al. v. Dr. Reddy’s Laboratories Inc., et al., Nos. 2017-2473, -2481,-2484, -2486, -2489, -2491, -2492, -2493 (Fed. Cir. (D.N.J.) May 15, 2019). Opinion by Clevenger, joined by Prost and Wallach.
Following a bench trial, the district court upheld the asserted patent claims as nonobvious under 35 U.S.C. § 103 and sufficiently enabled and described under § 112. On appeal, the Federal Circuit reversed, concluding that the claims lack adequate written description support.
The claims at issue concern using a proton pump inhibitor (PPI) to prevent gastrointestinal problems stemming from non-steroidal anti-inflammatory drugs. The claims were challenged on a myriad of grounds, including insufficient written description support. In that regard, the challengers argued that the claims cover uncoated PPIs effective to raise the gastric pH to at least 3.5, that persons skilled in the art would not have expected uncoated PPIs to be effective, and that “the specification provides no experimental data or analytical reasoning showing the inventor possessed an effective uncoated PPI.” The Federal Circuit agreed, concluding that the district court clearly erred in finding that the specification supported the claimed efficacy of uncoated PPIs.
In its analysis, the Federal Circuit noted that the written description requirement is not necessarily met simply because “the claim language appears in ipsis verbis in the specification.” Additionally, the court recognized that “our case law does not require experimental data demonstrating effectiveness,” nor does it require “theory or explanation of how or why a claimed composition will be effective.” “Nevertheless,” the Federal Circuit concluded, in this case “a person of ordinary skill in the art would not have known or understood that uncoated PPI is effective,” and “there is nothing in the specification of the patents-in-suit showing ‘that the inventor actually invented the invention claimed.’” The specification was therefore “fatally flawed” by “not demonstrat[ing] that the inventor possessed more than a mere wish or hope that uncoated PPI would work.”