Platinum Optics Technology Inc. v. Viavi Solutions Inc., No. 2023-1227 (Fed. Cir. (PTAB) Aug. 16, 2024). Opinion by Cecchi (sitting by designation), joined by Moore and Taranto.
Viavi owns a patent related to optical filters with layers of hydrogenated silicon and to sensor systems comprising such optical filters. Viavi sued Platinum Optics for infringement in two lawsuits in the Northern District of California. In response, Platinum Optics petitioned for IPR challenging certain claims in Viavi’s patent.
The California court dismissed the patent infringement claims in both Viavi I and Viavi II with prejudice. In the IPR proceeding, the Patent Trial and Appeal Board issued a final written decision holding that Platinum Optics failed to show the challenged claims were unpatentable. Platinum Optics appealed the Board’s decision.
The Federal Circuit dismissed the appeal on the ground that Platinum Optics failed to establish an injury in fact sufficient to confer standing to appeal. Although “a party does not need Article III standing to appear before an administrative agency,” “standing is required once the party seeks review of an agency’s final action in a federal court.”
Platinum Optics made two arguments. First, Platinum Optics argued that it has standing to appeal the Board’s decision based on potential infringement liability stemming from supplying accused filters accused in Viavi II to parts integrators overseas. The Federal Circuit disagreed, explaining that “mere speculation about a possibility of suit, without more, is insufficient to confer standing.” Thus, Platinum Optics failed to establish an injury in fact based on its continued distribution of the filters accused in Viavi II.
Second, Platinum Optics argued that it has standing to appeal based on its development of new models of the filters. Platinum Optics relied on a declaration by a company representative asserting that Platinum Optics continues to develop new models of filters and that the company expects Viavi will assert its patent again. The Federal Circuit held that this was insufficient to confer standing. The declaration “does not provide any detailed plans for development of these new filters. Nor does [it] explain the particulars of these new models, or how the models may relate to the [Viavi] patent.”
The court thus ruled that the “vague and conclusory statements” in the declaration are insufficient to establish that Platinum Optics has concrete plans for the development of the filters. Platinum Optics therefore failed to establish that its development activities “will cause a substantial risk of infringement or will likely cause Viavi to assert a claim of infringement.”
Allergan USA, Inc., et al. v. MSN Laboratories Private Ltd., et al., No. 2024-1061 (Fed. Cir. (D. Del.) Aug. 13, 2024). Opinion by Lourie, joined by Reyna. Opinion concurring in part and dissenting in part by Dyk.
The FDA approved a New Drug Application for eluxadoline tablets, which Allergan markets and sells under the brand name Viberzi®. The drug compound and compositions thereof are covered by a number of patents, including five at issue here.
Sun Pharmaceutical submitted an Abbreviated New Drug Application seeking FDA approval to market and sell a generic version of Viberzi. Sun made Paragraph IV certifications that the claims of Allergan’s patents are invalid or would not be infringed by Sun’s generic product. Allergan then sued for infringement, and the parties eventually stipulated that Sun would infringe all asserted claims if those claims are valid.
The district court held a bench trial on the validity issues. Following trial, the court ruled that claim 40 of Allergan’s ’356 patent is invalid for obviousness-type double patenting (ODP) and that the asserted claims of the other four patents are invalid for lack of written description.
As to claim 40, Allergan did not contest Sun’s argument that the claim is not patentably distinct from the reference claims. Instead, Allergan argued that the ’356 patent was the first patent claiming eluxadoline to be filed and the first patent to issue, and so claim 40 is not subject to ODP over later-filed, later-issued claims of the reference patents. The district court disagreed.
As to the claims of the remaining patents, Sun argued that they are invalid for lack of written description because there is no support in the specification for a pharmaceutical tablet that does not include a glidant. The district court agreed with Sun, finding that for all the formulations disclosed in the patent specification, “a glidant is used without any indication that it was not required to practice the invention.”
Allergan appealed, and the Federal Circuit reversed as to both issues. First, as to claim 40, the question on appeal was: “can a first-filed, first-issued, later-expiring claim be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date?” The Federal Circuit held that it cannot. The reference claims “are not proper ODP references.” The Federal Circuit explained that this “is the only conclusion consistent with the purpose of the ODP doctrine, which is to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter.” “To hold otherwise … would not only run afoul of the fundamental purposes of ODP, but effectively abrogate the benefit Congress intended to bestow on patentees when codifying [patent term adjustments].”
Turning to the written description issue, the Federal Circuit determined that “the written description generally matches the scope of the claims.” The issue was whether the inventors possessed “a formulation that lacked a component [a glidant] that is not claimed, or only optional.” The district court held that they did not, but the Federal Circuit disagreed because “the specification describes at least two embodiments in which a glidant is not required.” Also, claim 1 as originally filed recited a formulation without a glidant, and “originally filed claims have long been held to be part of the specification to be considered in any § 112 analysis.”
On that issue, the Federal Circuit also determined that it was not error for the district court to have relied on expert testimony when evaluating the written description. The “proper inquiry must be into the specification first and then guided by expert testimony,” which had occurred here.
Judge Dyk dissented as to the written description issue. Judge Dyk would affirm as to that issue “because ample expert testimony supports the district court’s factual finding.” “The unrebutted expert testimony was that a person of ordinary skill in the art would normally use a glidant and that, absent a teaching to the contrary, he would interpret the specification to show that the inventor possessed only formulations that include a glidant.”
Celanese International Corp., et al. v. ITC, et al., No. 2022-1827 (Fed. Cir. (ITC) Aug. 12, 2024). Opinion by Reyna, joined by Mayer and Cunningham.
Celanese launched an ITC investigation alleging that Anhui Jinhe Industrial and Jinhe USA violated 19 U.S.C. § 337 by importing Ace-K (an artificial sweetener) made using a process that infringes Celanese’s patents.
During the investigation, Jinhe moved for summary determination of no violation on the ground that the claims were invalid under the on-sale bar provision, 35 U.S.C. § 102(a)(1). It was undisputed that Celanese’s patented process was in secret use in Europe before the critical date of the asserted patents, and it was also undisputed that Celanese had sold Ace-K made using the patented process in the United States before the critical date. Jinhe thus argued that the pre-critical date sales triggered the on-sale bar. In response, Celanese argued that the AIA changed pre-AIA law such that Celanese’s pre-critical date sales of Ace-K made using its secret process would not trigger the on-sale bar.
Relying on the Supreme Court’s decision in Helsinn Healthcare v. Teva Pharmaceuticals, the ALJ rejected Celanese’s argument. The ALJ held that the prior sales triggered the on-sale bar and that the AIA did not overturn settled pre-AIA precedent. Celanese petitioned for review by the Commission, which the Commission denied. Celanese then appealed.
The Federal Circuit agreed with the Commission that, consistent with the Supreme Court’s holding in Helsinn, the AIA did not change the on-sale bar to cover Celanese’s scenario. As a starting point, the Federal Circuit explained that it “has long held that sales of products made using a secret process before the critical date would bar the patentability of that process.” Next, the court “presume[d] that when Congress reenacted the ‘on sale’ language, Congress was aware of pre-AIA precedent and adopted the settled judicial interpretation of the term.”
On that backdrop, the Federal Circuit affirmed. “The ‘on sale’ category … has never required that a qualifying commercial sale reveal to the public the details of the claimed invention,” and the AIA did not change that fact. Accordingly, the Federal Circuit held “that the enactment of the AIA did not constitute a foundational change in the theory of the statutory on-sale bar provision, 35 U.S.C. § 102(a)(1), in particular, to require that sales of products made using a secret process cannot trigger the on-sale bar.”