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No Due Process Violation When New Panel Hears Substantive Arguments

Affirming a Patent Trial and Appeal Board (Board) non-obviousness determination, the US Court of Appeals for the Federal Circuit found that the Board did not abuse its discretion in sanctioning a patent owner who engaged in ex parte communications by having a new panel hear the merits of the petition. Apple Inc. v. Voip-Pal.com Inc., Case Nos. 18-1456, -1457 (Fed. Cir. Sept. 25, 2020) (Reyna, J.).

Voip-Pal sued Apple for allegedly infringing two of its patents directed to routing communications between two different types of networks: public and private. Apple then petitioned for inter partes review (IPR) of several claims from both patents, arguing they were invalid as obvious. The Board ultimately found the claims were not invalid because Apple did not provide evidentiary support as to the motivation to combine multiple references.

During the IPR proceedings, Voip-Pal’s former CEO sent six letters to various parties, copying members of Congress, the President, federal judges and administrative patent judges at the Board criticizing the IPR system, complaining about the cancellation rate and requesting judgment in favor of Voip-Pal. The letters did not discuss the underlying merits of Apple’s petitions. In view of Voip-Pal’s conduct, Apple requested that the Board sanction Voip-Pal by entering adverse judgment against Voip-Pal or by vacating the final written decisions and assigning a new panel to preside over “constitutionally correct” new proceedings going forward.

For the sanctions proceeding, a new panel replaced the initial panel and determined that Voip-Pal had engaged in sanctionable conduct, and further determined that it  would preside over Apple’s petition for rehearing. The new panel found that Apple failed to show the initial panel had misapprehended or overlooked any matter, and even if the final panel were to accept Apple’s view of the prior art, it would not reach a different conclusion. Apple appealed.

On appeal, the Federal Circuit first addressed whether the appeal was moot. Before oral argument, the Court found in separate proceedings that some, but not all, of the claims at issue were invalid. Apple argued that this case mooted the entire appeal, even though the claims did not entirely overlap. Starting with the overlapping claims, the Court found that the appeal was moot in regards to these claims because Apple no longer had the potential for injury. However, the Court rejected Apple’s argument that the appeal was moot under a theory of claim preclusion in regards to the non-overlapping claims. The Court explained that any preclusive effect from the other appeal must be decided by a future court in any subsequent action brought by Voip-Pal. Thus, any discussion regarding claim preclusion would be advisory in nature and outside the scope of the Court’s Article III jurisdiction.

Turning to the merits, the Federal Circuit affirmed the Board did not violate the Administrative Procedure Act (APA) or Apple’s due process rights. The Board’s rules provide that “[t]he Board may impose a sanction” and explains that “[s]anctions include entry of one or more” of eight defined actions. Although the Board’s sanctions imposed [...]

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Inherent Claim Limitation Necessarily Present in the Prior Art Invalidates Patent

Addressing the issue of obviousness, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding that a patent was invalid based on inherency because the claim limitation was necessarily present in the prior art. Hospira, Inc. v. Fresenius Kabi USA, LLC, Case Nos. 19-1329, -1367 (Fed. Cir. Jan. 9, 2020) (Lourie, J).

The patent at-issue is directed to premixed pharmaceutical compositions of dexmedetomidine that do not require reconstitution or dilution prior to administration and remains stable and active after prolonged storage. Hospira makes and sells dexmedetomidine products, including a ready-to-use product called Precedex Premix covered by the patent at-issue. Fresenius filed an Abbreviated New Drug Application (ANDA) seeking approval by the Food and Drug Administration (FDA) to market a generic ready-to-use dexmedetomidine product. Hospira brought suit alleging infringement under the Hatch-Waxman Act.

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Inherency Can Be Used in Obviousness Analysis to Supply Missing Limitation

Finding that inherency can be used to show the presence of a missing claim limitation, the US Court of Appeals for the Federal Circuit affirmed a district court decision that asserted claims in pain management method patents were invalid as obvious. Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd., Case No. 18-2361 (Fed. Cir., Dec. 27, 2019) (Reyna, J.).

Persion has US Food and Drug Administration (FDA) approval for its extended release hydrocodone product, Zohydro ER, and also owns two patents directed to methods of treating pain with extended release hydrocodone in patients with mild to moderate hepatic impairment. Persion sued Alvogen for infringement of certain claims in these two patents after Alvogen filed an Abbreviated New Drug Application (ANDA) requesting approval from the FDA to market a generic version of Zohydro ER. The asserted claims include: (i) non-adjustment claims directed to administering a dose of hydrocodone to patients with mild to moderate hepatic impairment without adjusting the dose relative to a healthy liver patient, and (ii) pharmacokinetic claims directed to pharmacokinetic parameters achieved after treatment with hydrocodone.

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