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Arthrex, Still Without Director Review, Gets Constitutional Review from Patent Commissioner

A panel of the US Court of Appeals for the Federal Circuit considered whether the Patent Commissioner, on assuming the role of the US Patent & Trademark Office (PTO) Director, can constitutionally evaluate the rehearing of Patent Trial & Appeal Board (Board) inter partes review (IPR) decisions. The panel concluded that neither Appointments Clause jurisprudence nor the Federal Vacancies Reform Act (FVRA) impeded the Commissioner from exercising the PTO Director’s authority. Arthrex, Inc. v. Smith & Nephew, Inc. et al., Case No. 18-2140 (Fed. Cir., May 27, 2022) (Moore, C.J.; Reyna, Chen, JJ.)

Approximately one year ago, Arthrex succeeded in the Supreme Court of the United States on its argument that the Appointments Clause of the Constitution was violated unless a presidentially appointed and Senate-confirmed officer (such as the PTO Director) could review the Board’s final IPR decisions. (United States v. Arthrex, Inc.) The case returned to the PTO on remand. At the time, the position of PTO Director was vacant, and there was no acting director. Pursuant to the FVRA, the Commissioner of Patents (a position filled by the Secretary of Commerce) exercised the PTO Director’s authority to review Board decisions and ultimately rejected Arthrex’s challenge to the Board’s unpatentability determination. Arthrex appealed.

Arthrex contended that the Commissioner could not constitutionally exercise the PTO Director’s IPR review authority without running afoul of the Appointments Clause, that the FVRA barred the Commissioner’s exercise of authority and that the Commissioner violated separation of powers. Arthrex also challenged the ruling on the merits. None of these challenges were successful.

First, the Federal Circuit concluded that Arthrex reinforced long-settled Supreme Court precedent that an inferior officer could exercise a principal officer’s authority constitutionally on a temporary basis without violating the Appointments Clause. Here, the Court concluded that the Commissioner’s exercise of the PTO Director’s IPR review authority until a new director was installed presented no problem.

Second, the FVRA provides a statutory framework for the exercise of a principal officer’s duties under certain circumstances, which, if the law applied, would not have allowed the Commissioner to review IPR decisions. However, the Federal Circuit explained that the FVRA narrowly governs only those duties of an officer that are statutorily non-delegable (i.e., which US Congress has required to be exercised personally by the officer). According to the Court, such provisions did not apply here because nothing demonstrated that the PTO Director’s newly created authority to review IPR decisions was non-delegable.

Third, the Federal Circuit rejected Arthrex’s argument that the Commissioner’s service as the PTO Director violated the line of precedent that limits Congress’ ability to circumscribe the president’s removal authority for superior officers. Arthrex contended that the Commissioner, a non-superior officer, could be removed only for “misconduct or nonsatisfactory performance” and therefore could not fill the role of the PTO Director. The panel disagreed, explaining that the president could name an acting director “with the stroke of a pen,” and so the limits on removing the Commissioner from his role as Commissioner [...]

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Time Bar Dismissal Saves Patent Found Unpatentable

The US Court of Appeals for the Federal Circuit dismissed an appeal, finding it lacked appellate jurisdiction to review a Patent Trial & Appeal Board (Board) decision to vacate an institution decision of inter partes review (IPR) based in part on the Board’s time bar evaluation. Atlanta Gas Light Co. v. Bennet Regulator Guards, Inc., Case No. 21-1759, (Fed. Cir., May 13, 2022) (Lourie, Stoll, JJ.) (Newman, J. dissenting)

This is the third time this case has been before the Federal Circuit. On July 18, 2012, Bennett served Atlanta Gas with a complaint alleging infringement of its patent. The district court dismissed the complaint without prejudice. More than two and a half years after service of the complaint, Atlanta Gas filed an IPR petition. Bennett argued that Atlanta Gas’s IPR petition was time barred, but the Board disagreed, instituted review of all claims and found every claim unpatentable in a final written decision. After receiving the final decision, Bennett sought sanctions for Atlanta Gas’s failure to notify the Board of Atlanta Gas’s changed parentage. On appeal, the Federal Circuit vacated the Board’s final written decision, finding the IPR time barred under 35 U.S.C. §315(b). (Bennett Regulator Guards, Inc. v. Atlanta Gas Light Co.). The Supreme Court thereafter issued its decision in Thryv, Inc. v. Click-To-Call Tech, where it held that time bar determinations are not reviewable. On remand from the Supreme Court, the Federal Circuit affirmed the Board’s unpatentability decision, did not address the time bar decision and remanded the case back to the Board to finalize its order on sanctions (Bennett II). On remand, the Board vacated its institution decision in light of the US Patent & Trademark Office’s (PTO) changed policy on time bar evaluations and declined to award the requested sanctions. Atlanta Gas appealed.

The Federal Circuit dismissed the appeal for lack of jurisdiction. Atlanta Gas argued that the Board’s decision was a final sanctions decision that is reviewable under 28 U.S.C. § 1295(a)(4)(A) and that any portion of the Board’s determination beyond the sanctions award violated the Court’s mandate in Bennett II. Bennett countered that the Court lacked jurisdiction under 35 U.S.C. § 314(d) and the Supreme Court’s Thryv decision and that the Board’s decision was not inconsistent with the Bennett II mandate. The Court agreed, concluding that it lacked jurisdiction because the Board’s decision was based in part on its time bar evaluation and, therefore, was not purely a sanctions decision. Additionally, the Court found that the time bar determination was within the scope of the mandate, albeit mooting its determination of unpatentability.

Judge Newman dissented. In her view, the sanctions order was the only issue on appeal. She also pointed out the inconsistency with the Bennett II mandate, noting the contradiction in the Federal Circuit currently mooting the unpatentability decision with the Bennett II decision finding the patent unpatentable. She explained that denial of appellate review could be seen as authorizing the Board to vacate its final decisions [...]

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Robotic Skepticism May Not Trump Motivation to Combine

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board (Board) decision finding the challenged claims patentable because the Board impermissibly rested its motivation-to-combine analysis on evidence of general skepticism in the field of invention. Auris Health, Inc. v. Intuitive Surgical Operations, Case No. 21-1732 (Fed. Cir. Apr. 29, 2022) (Dyk, Prost, JJ.) (Reyna, J., dissenting).

Intuitive owns a patent that describes an improvement over earlier robotic surgery systems that allows surgeons to remotely manipulate surgical tools using a controller. The patent focuses on solving the problem of swapping surgical tools by implementing a pulley system that allows tools to be swapped in and out more quickly. Auris petitioned for inter partes review (IPR) of the patent, arguing that a combination of two references disclosed every limitation of the challenged claims. Auris further argued that a skilled artisan would be motivated to combine the references to decrease the number of assistants needed during surgery. While the Board agreed that the combination of the two references disclosed every limitation of the challenged claims, it found that a person of ordinary skill in the art would not be motivated to combine the references because of general skepticism from surgeons “about performing robotic surgery in the first place.” Auris appealed.

The Federal Circuit began by explaining that the motivation-to-combine inquiry asks whether a skilled artisan “not only could have made but would have been motivated to make the combinations . . . of prior art to arrive at the claimed invention.” The Court also explained that as to the “‘would have’ question, ‘any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.’”

The Federal Circuit concluded that generic industry skepticism about robotic surgery cannot, on its own, preclude a finding of a motivation to combine. The Court explained that although industry skepticism can play a role as a secondary consideration in an obviousness finding, such evidence must be specific to the invention and not simply the field as a whole. The Court concluded that the Board’s motivation-to-combine determination was based almost exclusively on evidence of general skepticism. Thus, the Court vacated the decision and remanded the case, directing the Board to examine the evidence using the correct obviousness criteria.

Judge Reyna issued a dissenting opinion in which he disagreed as to whether  the Federal Circuit should implement a rule that general skepticism cannot  support a finding of no motivation to combine. Judge Reyna expressed concern that the majority opinion could be understood to create an inflexible, rigid rule that the Board cannot consider evidence of skepticism toward the invention , including whether that skepticism would have dissuaded a skilled artisan from making the proposed combination. Judge Reyna also argued that notwithstanding the majority opinion, the Board did not rely solely on general skepticism, but rather provided additional explanation as to why the “no [...]

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Hypothetical Device Doesn’t Meet Domestic Industry Requirement

In a consolidated appeal from the International Trade Commission (Commission) and two inter partes review (IPR) proceedings before the Patent Trial & Appeal Board (Board), the US Court of Appeals for the Federal Circuit affirmed the Commission’s findings that a hypothetical device does not meet the domestic industry requirement, as well as findings by the Board and the Commission that asserted claims of the involved patents were invalid as obvious. Broadcom Corp. v. ITC, Case Nos. 20-2008; 21-1260, -1362, -1511 (Mar. 8, 2022) (Lourie, Hughes, Stoll, JJ.)

Broadcom filed a complaint at the Commission alleging a violation of 19 U.S.C. § 1337 based on products imported by many respondents, including Renesas Electronics, that allegedly infringed two patents. The first patent is directed to reducing power consumption in computer systems, and the second patent is directed to a memory access unit that improves upon conventional methods of requesting data located at different addresses within a shared memory. The Commission’s administrative law judge issued an initial determination that Broadcom failed to satisfy the technical prong of the domestic industry requirement for the power consumption patent and that one of the asserted claims of the memory access patent was obvious over the prior art. The Commission affirmed both findings.

During the course of the Commission investigation, Renesas petitioned for IPR of both patents. The Board found that two asserted claims of the power consumption patent were obvious but Renesas failed to show that six other asserted claims would have been obvious. The Board also found that all petitioned claims of the memory access patent would have been obvious over the cited art.

Both parties appealed. Renesas appealed the Board’s ruling that six claims of the power consumption patent would not have been obvious in light of the cited art, and Broadcom appealed the Board’s ruling that two claims of the power consumption patent and five claims of the memory access unit patent would have been obvious. Broadcom also appealed the Commission’s decision that there was no violation with respect to the power consumption patent and that the asserted claims of the memory access unit patent would have been obvious.

The Federal Circuit first addressed the Commission’s decision that there was no domestic industry for the power consumption patent. Citing its 2013 decision in Microsoft Corp. v. ITC, the Court explained that a complainant must show that a domestic industry product exists that actually practices at least one claim of the asserted patent. Broadcom identified its System on a Chip (SoC) as a domestic industry article, but there was no dispute that the SoC did not contain a “clock tree driver” required by the asserted claims. To overcome this admitted deficiency, Broadcom argued that a domestic industry existed because Broadcom collaborates with customers to integrate the SoC with external memory to enable retrieval and execution of the clock tree driver feature. The Court rejected this argument, finding that Broadcom posited only a hypothetical device and failed to identify a specific integration [...]

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Too Much to Say? Word Limits Don’t Prevent Estoppel

The US Court of Appeals for the Federal Circuit found that the Patent Trial & Appeal Board (Board) did not err in finding that a petitioner was estopped from maintaining a third inter partes review (IPR) of a patent claim after a final determination of two other IPRs challenging the same claim on different grounds. The Federal Circuit also found that it did not have jurisdiction to review the merits decision of the third IPR because the petitioner lacked statutory authorization to appeal as of the issuance of the prior two final written decisions. Intuitive Surgical, Inc. v. Ethicon LLC, Case No. 20-1481 (Fed. Cir. Feb 11, 2022) (O’Malley, Clevenger, Stoll, JJ.)

Intuitive Surgical concurrently filed three separate IPR petitions for a patent owned by Ethicon relating to a robotically controlled endoscopic surgical instrument. All three petitions challenged a single claim of the patent, relying on different combinations of prior art references. The Board instituted on two of the petitions at the same time and on the third petition one month later. The Board issued simultaneous final written decisions in the first two IPRs, upholding the patentability of the challenged claim. As the third IPR remained ongoing, Ethicon filed a motion to terminate Intuitive as a party to the IPR, arguing that it was estopped from proceeding under 35 U.S.C. § 315(e)(1). The Board agreed, terminating Intuitive as a party and issuing a decision upholding the patentability of the challenged claim. Intuitive appealed.

Intuitive argued that § 315(e)(1) should not apply to simultaneously filed petitions. Section § 315(e)(1) precludes a petitioner from maintaining a proceeding before the Board on any ground that it “raised or reasonably could have raised during that inter partes review.” Intuitive argued that it could not have reasonably raised all of its grounds in one petition because of the 14,000-word limit, and that simultaneously filed petitions do not conflict with the purpose of § 315(e)(1)—to prevent abusive IPR conduct. The Federal Circuit disagreed, finding that § 315(e)(1) estops a petitioner as to grounds it reasonably could have raised in another IPR, even if the petitions are filed on the same day. The Court went on to note multiple ways around the word limit issue, none of which Intuitive attempted. Intuitive could have sought to consolidate the proceedings or divided its petitions on a claim-by-claim basis instead of by grounds (something which the Court noted is not prohibited by § 315(e)(1)). Intuitive also argued that, under the Court’s decision in Shaw, it was only estopped from raising instituted grounds, but the Court cited its recent decision in California Institute of Technology v. Broadcom Limited, which overruled Shaw, explaining that estoppel applies to all grounds that could have been reasonably included in the petition.

The Federal Circuit also considered whether Intuitive was authorized to pursue an appeal given the termination. Intuitive argued that it had the right to appeal the Board’s decision in the third IPR because it was once a party to the IPR. [...]

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Bargained-Away Rights to File for IPR May Not Be Recovered

In a precedential opinion, the US Court of Appeals for the Federal Circuit reversed a district court’s denial of a plaintiff’s requested injunction seeking to force a patent challenger to abandon its petitions for inter partes review (IPR). Nippon Shinyaku Co. Ltd. v. Sarepta Therapeutics, Inc., Case No. 2021-2369 (Fed. Cir. Feb. 8, 2022) (Newman, Lourie, Stoll, JJ.)

Nippon Shinyaku and Sarepta Therapeutics executed a mutual confidentiality agreement (MCA) to facilitate discussion of “a potential business relationship relating to therapies for the treatment of Duchenne Muscular Dystrophy.” The MCA established a mutual covenant not to sue for “any legal or equitable cause of action, suit or claim or otherwise initiate any litigation or other form of legal or administrative proceeding against the other Party . . . in any jurisdiction in the United States or Japan of or concerning intellectual property in the field of Duchenne Muscular Dystrophy” during a covenant term. The mutual covenant explicitly “include[d], but [wa]s not limited to, patent infringement litigations, declaratory judgment actions, patent validity challenges before the U.S. Patent and Trademark Office or Japanese Patent Office, and reexamination proceedings before the U.S. Patent and Trademark Office” (emphasis added). The MCA also included a forum selection clause to govern post-term intellectual property disputes between the parties, which stipulated:

that all Potential Actions arising under U.S. law relating to patent infringement or invalidity, and filed within two (2) years of the end of the Covenant Term, shall be filed in the United States District Court for the District of Delaware and that neither Party will contest personal jurisdiction or venue in the District of Delaware and that neither Party will seek to transfer the Potential Actions on the ground of forum non conveniens (emphasis added).

“Potential actions” were defined as:

any patent or other intellectual property disputes between [Nippon Shinyaku] and Sarepta, or their Affiliates, other than the EP Oppositions or JP Actions, filed with a court or administrative agency prior to or after the Effective Date in the United States, Europe, Japan or other countries in connection with the Parties’ development and commercialization of therapies for Duchenne Muscular Dystrophy (emphasis added).

The day the covenant term ended, Sarepta filed seven petitions for IPR at the Patent Trial & Appeal Board (Board). Nippon Shinyaku filed suit in the US District Court for the District of Delaware for breach of contract, declaratory judgment of noninfringement and invalidity and patent infringement. Nippon Shinyaku motioned for a preliminary injunction to enjoin Sarepta from proceeding with the IPR petitions and to force Sarepta to withdraw them. The district court denied Nippon Shinyaku under each of the preliminary injunction factors (likelihood of success on the merits, irreparable harm in the absence of extraordinary preliminary relief, balance of harms in its favor and relief being in the public interest).

The district court explained that any irreparable harm arguments fell within Nippon Shinyaku’s contract interpretation arguments, and that Nippon Shinyaku’s balance of hardships and public interest arguments relied on Sarepta’s ability to file [...]

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Federal Circuit Tosses Shaw: IPR Estoppel Applies to All Grounds That Reasonably Could Have Been Raised

March 2022 Update: The Federal Circuit has issued an errata to this decision. Read about it here.

Addressing inter partes review (IPR) estoppel after the Supreme Court of the United States’ 2018 decision in SAS Institute, Inc. v. Iancu, the US Court of Appeals for the Federal Circuit overruled its decision in Shaw Industries Group v. Automated Creel Systems, stating that the only plausible reading of 35 U.S.C. § 315(e)(2) estops a party from raising all claims and grounds that reasonably could have been included in the party’s petition for IPR. The Court also rejected the district court’s two-tier damages model as contrary to customary patent damages calculations. California Institute of Technology v. Broadcom Limited, Case Nos. 20-2222; 21-1527 (Fed. Cir. Feb. 4, 2022) (Lourie, Linn, Dyk, JJ.) (Dyk, J., dissenting in part).


California Institute of Technology (Caltech) filed suit against Broadcom and Apple, alleging patent infringement directed to the generation and repetition of information in a wireless data transmission system. Wireless transmission systems generally use data repetition so that the transmitted information may be decoded even when data loss occurs. The patented circuitry discloses a form of irregular data repetition in which portions of the information bits may be repeated a varying number of times.

Apple filed multiple IPR petitions challenging the validity of the claims at issue. The Patent Trial & Appeal Board (Board) concluded in all cases that Apple failed to show that the challenged claims were unpatentable as obvious. At the district court, Apple and Broadcom raised new arguments of obviousness not asserted in the IPR proceedings. The district court granted Caltech’s motion for summary judgment of no invalidity, precluding Apple and Broadcom from raising arguments at trial that they reasonably could have raised in their IPR petitions.

At trial, the district court instructed the jury that “repeat” means “generation of additional bits, where generation can include, for example, duplication or reuse of bits.” Apple and Broadcom argued that the Broadcom chips (which were integrated into Apple devices) did not infringe the asserted claims because they did not repeat information at all. With respect to one of the asserted patents, the district court did not provide a jury instruction relating to its construction that the claim language “information bits appear in a variable number of subsets” requires irregular information bit repetition. The jury found infringement of all asserted claims. Apple and Broadcom filed post-trial motions for judgment as a matter of law (JMOL) and a new trial, both of which the district court denied.

The district court adopted Caltech’s proposed two-tier damages theory, explaining that Broadcom and Apple’s products were different and therefore possessed different values simply because they were “different companies at different levels in the supply chain.” The district court ultimately entered judgment against Broadcom for $288 million and against Apple for $885 million. Broadcom and Apple appealed.

The Appeal

Broadcom and Apple argued that the district court’s construction of “repeat” was inconsistent with the claim language and specification. The Federal Circuit [...]

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IPR Petition Cannot Be Based on Applicant Admitted Prior Art

Addressing the type of prior art that may form the basis of an inter partes review (IPR) proceeding, the US Court of Appeals for the Federal Circuit vacated an unpatentability finding based on “applicant admitted prior art” in the challenged patent. Qualcomm Inc. v. Apple Inc., Case Nos. 20-1558, -1559 (Fed. Cir. Feb. 1, 2022) (Taranto, Bryson, Chen, JJ.)

Qualcomm owns a patent directed to integrated circuit devices having power detection circuits for systems with multiple supply voltages. The patent seeks to solve problems associated with stray currents causing level shifters in integrated circuits to trigger input/output devices for transmission, which results in erroneous output signals from the circuit. The patent describes various prior art methods for solving the stray current problem.

Apple filed IPR petitions based on two grounds. The first was based on the combination of four prior art references. In its final written decision, the Patent Trial & Appeal Board (Board) found that the combination of these four references did not render the challenged claims invalid. The second ground relied on the applicant admitted prior art disclosed in the specification of the challenged patent in combination with another prior art reference (Majcherczak). During the IPR proceedings, Qualcomm admitted that the combination of the applicant admitted prior art and Majcherczak taught every element of the challenged claims but argued that Apple’s use of the applicant admitted prior art as the basis for an invalidity ground is barred in an IPR proceeding. The Board disagreed with Qualcomm and found the challenged claims unpatentable based on Apple’s second ground. Qualcomm appealed.

Qualcomm argued on appeal that IPR proceedings may only be based on “prior art patents or prior art printed publications” and that 35 U.S.C. § 311(b), which governs IPR proceedings, does not allow for the use of “a patent owner’s admissions” that is contained in non-prior art documents. Apple countered, arguing that any prior art that is contained in “any patent or printed publication, regardless of whether the document itself is prior art, can be used as a basis for [an invalidity] challenge.”

The Federal Circuit agreed with Qualcomm, finding that applicant admitted prior art in a challenged patent may not form the “basis” for an invalidity claim in an IPR proceeding. The Court explained that invalidity grounds advanced in an IPR must be based on patents or printed publications that are themselves prior art to the challenged patent. In reaching this conclusion, the Court relied on the 2019 Supreme Court opinion in Return Mail, Inc. v. U.S. Postal Serv., which referred to “patents and printed publications” in the context of § 311(b) as “existing at the time of the patent application.” The Court also looked to its own interpretations of “prior art consisting of patents or printed publications” in the context of ex parte reexamination proceedings under 35 U.S.C. §§ 301 and 303, which “permits the Director to institute a reexamination after ‘consideration of other patents or printed publications.’” Accordingly, the Court vacated the unpatentability [...]

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Improper Claim Construction Requires Partial Remand of Obviousness Determination

The US Court of Appeals for the Federal Circuit issued decisions in two separate inter partes reviews (IPRs), one involving a patent related to radio frequency communication systems and the other involving a patent related to multi-processor systems. Intel Corporation v. Qualcomm Incorporated, Case No. 20-1664 (Fed. Cir. Dec. 28, 2021) (Prost, Taranto, Hughes, JJ.); Intel Corporation v. Qualcomm Incorporated, Case Nos. 20-1828, -1867 (Fed. Cir. Dec. 28, 2021) (Prost, Taranto, Hughes, JJ). Based on issues of claim construction and obviousness, the Court affirmed in part and vacated in part the Patent Trial and Appeal Board’s (Board) decision in the radio frequency communication systems patent IPR and vacated the Board’s decision in the multi-processor systems patent IPR.

Radio Frequency Communication System Patent IPR (1664)

In the IPR related to the radio frequency communication systems patent, Intel proposed that the claim term “radio frequency input signal” should take its ordinary meaning of an input signal having a radio frequency. Qualcomm argued that a person of skill in the art reading the patent would understand the phrase to reference the radio frequency signal that is received before down-conversion, and thus proposed that the term should mean “a signal centered at a carrier frequency at which the signal was transmitted/received.” The Board agreed with Qualcomm based on the intrinsic evidence.

Intel argued before the Board that certain claims of the radio frequency communication systems patent would have been obvious in light of the Der reference and the Valla reference. Qualcomm argued that a skilled artisan would not have been motivated to combine Der and Valla, because Der’s transistor would defeat the intended purpose of Valla’s amplifier. The Board agreed with Qualcomm. Qualcomm also submitted substitute claims. The Board accepted the substitute claims after finding that a skilled artisan would have lacked reason to combine Der and the Burgener reference to achieve the substitute claims. Intel appealed.

The Federal Circuit first addressed the threshold question of whether it had jurisdiction since no lawsuit had been filed against Intel. Despite the absence of any lawsuit against Intel itself, the Court found that Intel had standing because it had engaged in acts that previously resulted in assertion of the patent against one of Intel’s customers. Because Intel continues to sell the relevant products to that customer and others, it must address the risk of an infringement suit by Qualcomm. Qualcomm also refused to offer a covenant not to sue or stipulate that it would not reassert its prior infringement allegations involving the Intel products. The Court found that this refusal made Intel’s risk more than “mere conjecture or hypothesis.” Therefore, the Court found that Intel had standing to pursue the appeal.

Turning to the merits, the Federal Circuit affirmed the Board’s construction of “radio frequency input signal.” The Court explained that while both parties’ proposed constructions had appeal when considered in a vacuum, the proper inquiry required analysis of the surrounding claim language and specification. The Court found that linguistic clues in the claims suggested that [...]

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Shots Fired: Challenger Must Have Requisite Standing Before Appealing Unfavorable IPR Decisions

The US Court of Appeals for the Federal Circuit found, in the context of an appeal from an inter partes review (IPR) decision, that the appellant had Article III standing and affirmed a Patent Trial & Appeal Board (Board) decision, holding the challenged claims unpatentable as obvious. ModernaTX, Inc. v. Arbutus Biopharma Corporation, Case No. 20-2329 (Fed. Cir. Dec 2, 2021) (Lourie, J.)

Arbutus owns a patent pertaining to “stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.” Moderna petitioned for IPR of the patent, asserting three grounds:

  1. Moderna alleged that all claims of the challenged patent would have been anticipated and/or obvious in light of International Pat. Publ. WO 2005/007196 (‘196 PCT) or US Pat. Publ. 2006/0134189 (‘189 publication).
  2. Moderna alleged that all claims of the challenged patent would have been obvious over a combination of the ‘196 PCT, the ‘189 publication, Lin and Ahmad.
  3. Moderna alleged that all claims of the challenged patent were anticipated by US Pat. Publ. 2006/0240554 (‘554 publication), and alternatively that the claims would have been obvious over the ‘554 publication.

The Board rejected each of Moderna’s allegations, finding that the claims were not unpatentable as obvious. Moderna appealed.

Before addressing Moderna’s appeal on its merits, the Federal Circuit addressed whether Moderna had proper standing to challenge the Board’s decision. The Court stated that well-established precedent dictates that an appellant seeking review of a Board decision in an IPR must have suffered an injury in fact that is fairly traceable to the challenged conduct of the appellee and is likely to be redressed by a favorable judicial decision. The Court underscored that under IPR statute, there is no standing requirement for petitioners to request institution of IPR by the Board, meaning that a requester need not have a concrete stake in the outcome. Additionally, where the statue itself grants judicial review (such as in the case of an IPR), standing criteria of immediacy and redressability may be “relaxed.” Nonetheless, the Court explained that a party’s participation in the underlying IPR alone does not confer standing on that party to appeal the Board decision before an Article III court such as the Federal Circuit. The party seeking review (in this case Moderna) must show that it possesses requisite injury for standing to appeal.

Moderna asserted that substantial risk existed that Arbutus would bring an infringement suit against Moderna based on Moderna’s COVID-19 vaccine if the challenged patent was to remain valid. In support, Moderna submitted a declaration from its senior vice president and deputy general counsel that Moderna was working to harness proprietary mRNA technology and planned on releasing and applying for emergency use authorization for a COVID-19 vaccine in December 2020. The declaration also described how Arbutus’s conduct created a substantial risk that it would bring subsequent infringement action against Moderna. An example of such conduct was a series of public statements [...]

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