Fresh From the Bench: Latest Federal Circuit Court Case
CASE OF THE WEEK
Adapt Pharma Operations Limited v. Teva Pharmaceuticals USA, Inc., Appeal No. 2020-2106 (Fed. Cir. Feb. 10, 2022)
In our Case of the Week, the Court of Appeals for the Federal Circuit, in both the majority opinion and dissent, provided an extended discussion of obviousness analyses. This discussion comes in the context of the Federal Circuit affirming the U.S. District Court for the District of New Jersey’s finding, namely, that U.S. Patent Nos. 9,468,747; 9,561,177; 9,629,965; and 9,775,838 were obvious over prior art.
The patents-in-suit claim methods of treating opioid overdose by intranasal administration of a naloxone formulation, as well as devices for intranasal administration. Naloxone blocks opioids from reaching opioid receptors, thus helping reverse the effects of opioid overdose. Plaintiffs sell the FDA-approved nasal spray NARCAN, which includes naloxone as an active ingredient.
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By Tyler Hall
ALSO THIS WEEK
Intuitive Surgical, Inc. v. Ethicon LLC, Appeal No. 2020-1481 (Fed. Cir. Feb. 11, 2022)
For the second time in two weeks, the Federal Circuit issued a decision that substantially broadens the scope of IPR (inter partes review) estoppel. Last week, we covered the Court’s decision in California Institute of Technology v. Broadcom Limited, Appeal Nos. 2020-2222, 2021-1527 (Fed. Cir. Feb. 4, 2022), holding that IPR estoppel is limited to grounds that reasonably could have been raised in the petition. See that write-up here. This week, the Court put guardrails around the concept of what a petitioner “reasonably could have raised” in an IPR, foreclosing arguments based on the page limits.
In June 2018, Intuitive filed three simultaneous IPR petitions challenging the same claim of an Ethicon patent relating to robotic surgery, with each petition challenging the patent on different prior art grounds. However, one of the IPRs was accorded a later filing date than the other two, and those IPRs terminated in final written decisions in January 2020 while the third remained pending.
Upon issuance of the earlier decisions, the Board found that Intuitive was estopped under 35 U.S.C. § 315(e)(1) from maintaining the remaining pending action, as Intuitive could not “request or maintain a proceeding before the Office with respect to [the challenged] claim on any ground that the petitioner raised or reasonably could have raised during that inter partes review.” The Board issued its decision terminating Intuitive as a party simultaneously with a final written decision on the third IPR in February 2020, and Intuitive appealed both the estoppel finding and the decision on the merits.
The Federal Circuit agreed with the Board, rejecting Intuitive’s argument that the 14,000-word limit for IPR petitions meant that it could not have “reasonably raised” all of its prior art grounds in the earlier-decided petitions. The Court maintained that Intuitive could simply have phrased its arguments more precisely, or alternatively could have moved for consolidation of the three IPRs to proceed on the same schedule for hearing and final written decision. Because it was undisputed that Intuitive actually knew of the asserted prior art grounds that were not included in petitions filed on the same day, the Court held that § 315(e)(1) was clear that Intuitive could not maintain an action challenging the same claims as IPRs that had been resolved in final written decisions. Because 35 U.S.C. §§ 141(c) and 319 limit the statutory right of appeal in IPR decisions to “parties” to the action, and because Intuitive was not a “party” to the third IPR when the final written decision issued, the Court held that Intuitive had no standing to pursue an appeal and thus had no jurisdiction to review the merits of the Board’s decision on patentability, and dismissed the appeal.
The opinion can be found here.
GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., Appeal No. 2018-1976, -2023 (Fed. Cir. Feb. 11, 2022)
As the latest chapter in a long ongoing saga, the Federal Circuit denied en banc review of the panel’s August 2021 decision in this case, which we covered as our Case of the Week here. That decision was a rehearing of an October 2020 decision, which we covered as our Case of the Week here. The case involves the use of “skinny labels” on generic drugs that are created to avoid assertions of induced infringement. Judges Newman, O’Malley, Taranto, Chen, and Stoll joined an eight-page opinion by Chief Judge Moore concurring in the denial of rehearing en banc. Judges Prost, Dyk, and Reyna issued a combined 16 pages of opinions dissenting from rehearing en banc.
The opinion can be found here.
By Nika Aldrich
Junker v. Medical Components, Inc., Appeal No. 2021-1649 (Fed. Cir. Feb. 10, 2022)
In an appeal from a district court final judgment finding infringement and awarding damages, the Federal Circuit reversed, finding the patent at issue invalid. The case centered on a design patent for a “Handle for Introducer Sheath”—a medical device. Mr. Junker had been working on designs for an introducer sheath since the mid-1980s. By the 1990s, he was working with companies to manufacture his idea. On January 8, 1999, more than a year before the patent application date, a company that Mr. Junker had been working with sent a letter to Boston Scientific with bulk pricing information. The district court had found that the letter did not constitute an offer for sale and found the patent not-invalid. The Federal Circuit reversed, finding the letter did constitute an offer for sale and holding the patent invalid pursuant to the on-sale bar.
The opinion can be found here.
By Nika Aldrich
Uniloc USA, Inc. v. Apple Inc., Appeal Nos. 2021-1568, -1569, -1570, -1571, -1573 (Fed. Cir. Feb. 9, 2022)
In a second appeal from a district court’s decisions denying Uniloc’s motion to seal, the Federal Circuit vacated and remanded for a second time. Notably, Apple did not oppose Uniloc’s motion. Rather, the Electronic Frontier Foundation intervened, arguing in favor of unsealing. On the first appeal, the Court remanded with instructions for the district court to make a particularized determination as to whether “confidential licensing information of certain third-party licensees of Uniloc’s patents should be sealed.” Specifically, the Court gave remand instructions for the district court to “make particularized determinations as to whether and, if so, to what extent, the materials of each of these parties should be made public.” Ruling on the present appeal, the Court concluded that the district court failed to follow these remand instructions and held that such failure was an abuse of discretion. In addition, the Court held that the district court “made an error of law in making a blanket ruling that the public has a broad right to licensing information relating to patents.” The Court clarified that while the public does have an interest in patents, such interest is “in ensuring that patents are not procured by fraud, or other improper means.” The Court further emphasized that “no rule of law or binding precedent says that the public is generally entitled to know what consideration a patentee receives for licensing its patent.” The Court vacated and remanded a second time, instructing the district court to carry out the examination and make particularized determinations as previously instructed. Circuit Judge Mayer dissented “[b]ecause the third-party licensees failed to supply compelling reasons for overriding the strong presumption in favor of public access.”
The opinion can be found here.
By Annie White
Nippon Shinyaku Co. v. Sarepta Therapeutics, Inc., Appeal No. 2021-2369 (Fed. Cir. Feb. 8, 2022)
In an appeal from the district court’s decision denying Nippon Shinyaku Co., Ltd.’s motion for preliminary injunction, the Federal Circuit reversed and remanded for entry of preliminary injunction. The main issue on appeal was one of contractual interpretation. Interpreting the mutual confidentiality agreement (the “MCA”) at issue, the Federal Circuit held that, as a matter of law, the forum selection clause in the MCA precluded the filing of IPR petitions during the two-year period following the expiration of the covenant not to sue. Because Sarepta Therapeutics, Inc. filed IPR petitions during that time in violation of the forum selection clause, Nippon Shinyaku was likely to succeed on the merits of its claim for breach of contract. In so holding, the Federal Circuit reemphasized the general principle that parties are entitled to bargain away their rights to file IPR petitions, including through the use of forum selection clauses. The Federal Circuit found that the remainder of the preliminary injunction factors rose and fell with the arguments regarding likelihood of success on the merits and found these factors also favored granting the preliminary injunction.
The opinion can be found here.
Edited by: Scott D. Eads and Nika Aldrich, Schwabe Williamson & Wyatt
Contributors: Tyler Hall, Jason Wrubleski, Annie White and Mario Delegato