IP UPDATE
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IP UPDATE
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Results for "Trademark Precedent"
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Seal of Disapproval: TTAB Refuses Registration of County Logos

by | Aug 18, 2022 |

The Trademark Trial & Appeal Board (Board) issued a precedential decision affirming the US Patent & Trademark Office (PTO) Examining Attorney’s refusal to register two different logo marks filed by southern California’s County of Orange because the marks consisted of and comprised, respectively, an insignia of a municipality. The Board found that a logo adopted by a government entity does not have to be “official” to constitute an insignia for which trademark registration is prohibited under Section 2(b) of the Trademark Act, 15 U.S.C. §1052(b). In re County of Orange, Ser. Nos. 87419378; 87639750 (TTAB, Aug. 4, 2022) (Shaw, Coggins, Allard, Administrative Trademark Judges).

The County applied to register two logo marks. The US trademark applications described one mark as “a circle with the image of three oranges in front of an orange grove and . . . mountains with the words ‘COUNTY OF ORANGE’ . . . and . . . ‘CALIFORNIA’ . . . [around] the circle” (Circle Mark). The second logo mark featured a park ranger badge design that encompassed the Circle Mark in its entirety.

The PTO examining attorney refused registration of both logo marks under Section 2(b), which imposes an absolute bar on registration on either the Principal or Supplemental Register of a mark that “[c]onsists of or comprises the flag or coat of arms or other insignia of the United States, or of any State or municipality, or of any foreign nation, or any simulation thereof.”. This section reflects the sentiment that such symbols are indicia of government authority that ought to be reserved solely for signifying the government, and which should not be registered as symbols of origin for commercial goods and services.

On appeal to the Board, the County argued that the logo marks did not constitute “insignia” because they were not an “official” seal of the County, and, even if they were, registration should not be precluded because the County is not a “municipality.” Considering both of these arguments in turn, the Board provided analysis specific to both the circle and badge iterations of the applied-for logos.

The County argued first that the proposed marks could not constitute an insignia of Orange County, California, because the County created and adopted an official seal (a design of an orange having a stem with three leaves) more than a century ago, in accordance with the applicable state government code requiring a two-step process for adopting an official seal.

The Board found this argument unpersuasive, noting that although the Circle Mark had not undergone the state’s two-step process to become an “official” seal, Section 2(b) does not distinguish between “official” and “unofficial” insignia. Therefore, formal adoption of an “official” seal is not required for an insignia to otherwise fall under the Section 2(b) bar to registration.

The Board explained that the County uses the Circle Mark for a plethora of official government business [...]

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PTO Presentation Seeks to Clarify Subject Matter Eligibility Requirements

by | Aug 18, 2022 |

On August 9, 2022, the US Patent & Trademark Office (PTO) gave a public presentation, “Subject Matter Eligibility Under 35 U.S.C. § 101: USPTO Guidance and Policy.” During the presentation, the PTO indicated that its goal is to identify eligible subject matter and not reject patent applications under 35 U.S.C. § 101 where possible. However, subject matter eligibility must be determined in accordance with Supreme Court precedent as set forth in Bilski v. Kappos (2010); Mayo Collaborative Servs. v. Prometheus Labs, Inc. (2012); Association for Molecular Pathology v. Myriad Genetics, Inc. (2013); and Alice Corp. v. CLS Bank International (2014). The PTO presented several biotech examples demonstrating how subject matter ineligible claims could be redrafted to encompass eligible subject matter.

The PTO presented a detailed explanation of the two-step subject matter eligibility flowchart in MPEP § 2106 and emphasized the differences between the two prongs of Step 2A. The first prong is to evaluate whether the claim recites a judicially recognized exception to eligibility. If the claims do not recite an exception, they qualify as eligible subject matter. If the claims do recite a judicial exception, the analysis proceeds to the second prong of Step 2A, which is to evaluate whether the claims recite additional elements that integrate the exception into a practical application of the exception. If the claims do recite additional elements integrating the exception into a practical application of the exception, they qualify as eligible subject matter. If the claims do not do so, the analysis proceeds to Step 2B to determine whether the claims recite additional elements that amount to significantly more than the judicial exception.

While there is significant overlap between Step 2A prong two and Step 2B, the PTO noted that under Step 2A prong two, the additional elements may be well understood, routine, conventional activity, unlike in Step 2B. For example, if conventional steps were used to affect a particular treatment or prophylaxis for a disease or medical condition, or if conventional material was used in an unconventional application, the claims would be subject matter eligible.

The PTO warned against claiming methods as a series of mental processes, mere data gathering or steps that merely apply the judicial exception.

As noted, the PTO highlighted techniques for transforming subject matter ineligible claims into subject matter eligible claims. These techniques include reciting properties that naturally occurring compositions do not possess, showing that the claimed composition possesses properties not found in naturally occurring compositions, using a conventional material or conventional method in an unconventional application and specifying a particular treatment.

Practice Note: Readers may be interested in an IP Update Legislative Alert reporting on a bill introduced by Senator Tillis to amend §101, which can be found here.



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Rage against the Machine: Inventors Must Be Human

by | Aug 11, 2022 |

The US Court of Appeals for the Federal Circuit found that an artificial intelligence (AI) software system cannot be listed as an inventor on a patent application because the Patent Act requires an “inventor” to be a natural person. Thaler v. Vidal, Case No. 21-2347 (Fed. Cir. Aug. 5, 2022) (Moore, Taranto, Stark, JJ.)

Stephen Thaler develops and runs AI systems that generate patentable inventions, including a system that he calls his “Device for the Autonomous Bootstrapping of Unified Science” (DABUS). In 2019, Thaler sought patent protection for two of DABUS’s putative inventions by filing patent applications with the US Patent & Trademark Office (PTO). Thaler listed DABUS as the sole inventor on both applications. The PTO found that the patent applications lacked valid inventorship and sent a Notice of Missing Parts requesting that Thaler identify a valid inventor. Thaler petitioned the director to vacate the notices. The PTO denied the petitions, explaining that a machine does not qualify as an inventor and that inventors on patent applications must be natural persons. Thaler then pursued judicial review in the district court. The district court agreed with the PTO, concluding that an “inventor” under the Patent Act must be an “individual,” and that the plain meaning of “individual” is a natural person. Thaler appealed.

The sole issue on appeal was whether an AI software system can be an “inventor” under the Patent Act. The Federal Circuit started with the statutory language of the Patent Act, finding that it expressly provides that inventors are “individuals.” The Court noted that while the Patent Act does not define “individual,” the Supreme Court has explained that the term “individual” refers to a human being unless there is some indication that Congress intended a different reading. The Federal Circuit also found that this result was consistent with its own precedent, which found that neither corporations nor sovereigns can be inventors; instead only natural persons can be inventors.

The Federal Circuit rejected Thaler’s policy argument that inventions generated by AI should be patentable to encourage innovation and public disclosure. The Court found that these policy arguments were speculative, lacked any basis in the text of the Patent Act, and were contrary to the unambiguous text of the Patent Act. The Court also rejected Thaler’s reliance on the fact that South Africa has granted a patent with DABUS as an inventor, explaining that the South African Patent Office was not interpreting the US Patent Act. The Court concluded that since Congress has determined that only a natural person can be an inventor, AI cannot be an inventor.

Practice Note: The Federal Circuit’s decision comes on the heels of a decision from the US Copyright Office Review Board finding that a work must be created by a human being to obtain a copyright. The Federal Circuit also noted that it was not confronted with the question of whether inventions made by human beings with the assistance of AI are eligible for patent protection.



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No Winners Here: A Case Can Have No Prevailing Party

by | Jul 21, 2022 |

In a matter of first impression, the US Court of Appeals for the Eleventh Circuit found that there may be no prevailing party for purposes of assessing costs and attorneys’ fees under Federal Rule of Civil Procedure 54(d). Royal Palm Properties, LLC v. Pink Palm Properties, LLC, Case No. 21-10872 (11th Cir. July 7, 2022) (Wilson, Rosenbaum, Covington, JJ.)

Royal Palm Properties sued Pink Palm Properties for trademark infringement. Pink Palm countersued, seeking cancellation of the trademark and a declaratory judgment of noninfringement. Following a three-day trial, the jury found that Pink Palm did not infringe the trademark and that the trademark was not invalid on the grounds asserted by Pink Palm. Pink Palm moved for judgment as a matter of law (JMOL), asking the court to overrule the jury’s determination that the trademark was valid. The district granted Pink Palm’s motion and invalidated the trademark. Pink Palm subsequently moved for costs, which the district court granted because Pink Palm was the prevailing party in light of the order granting JMOL. Royal Palm appealed.

The Eleventh Circuit reversed the district court’s grant of JMOL, reinstating the jury’s verdict and the trademark’s validity. In light of this reversal, the district court, on remand, ruled that Pink Palm was no longer the prevailing party for purposes of costs and was not entitled to an award of attorneys’ fees under the Lanham Act’s exception case doctrine. Pink Palm appealed.

Before addressing whether the district court erred by failing to name Pink Palm as the prevailing party, the Eleventh Circuit addressed the threshold question of whether courts are required to name a prevailing party in every case. The Court noted that while the Supreme Court of the United States has issued multiple opinions providing guidance on how to determine the prevailing party, it has not yet addressed whether there must be a prevailing party under Federal Rule of Civil Procedure 54.

Not finding any precedent in its own circuit, the Eleventh Circuit first looked to Federal Circuit precedent, which has stated that a district court must declare a prevailing party and that “punting is not an option.” The Court next explored holdings by the Eighth, Fifth and Second Circuits. Those courts have found that where the parties each brought unsuccessful claims and outcome did not materially alter the legal relationship between the parties, there is no prevailing party.

The Eleventh Circuit agreed with Eighth, Fifth and Second Circuit precedent and concluded that the text of Rule 54(d) does not allow for multiple prevailing parties, and there is not always a prevailing party in every case. A district court in the Eleventh Circuit may find (at most) one prevailing party, but it is not required to do so in every case. The Court found that both Royal Palm and Pink Palm had rebuffed the other’s claim regarding the trademark, leading to no material alteration in the legal relationship between the parties, and thus there was no prevailing party.



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Heightened Written Description Standard for Negative Limitations?

by | Jun 30, 2022 |

Addressing the issue of negative claim limitations, the US Court of Appeals for the Federal Circuit granted a petition for panel rehearing, vacated its prior decision (authored by now-retired Judge O’Malley) and reversed the district court’s finding that the patent was not invalid for inadequate written description. Novartis Pharms. v. Accord Healthcare Inc., Case No. 21-1070 (Fed. Cir. June 21, 2022) (Moore, C.J.; Hughes, J.) (Linn, J., dissenting).

This is the second time this Hatch-Waxman case has been before the Federal Circuit. Novartis sued HEC, alleging that HEC’s abbreviated new drug application infringed a patent directed to methods of treating remitting multiple sclerosis (RRMS) with fingolimod or a fingolimod salt at a daily dose of 0.5 mg without an immediately preceding loading dose. The district court found sufficient written description for the claimed 0.5 mg daily dose and no-loading dose negative limitation. In January 2022, the Federal Circuit affirmed the district court’s decision finding adequate written description.

HEC petitioned for panel rehearing. The Federal Circuit granted the petition, vacated its January 2022 decision and reversed the district court’s judgment finding adequate written description for the no-loading dose negative limitation. The majority explained that “silence is generally not disclosure” because “[i]f it were, then every later-added negative limitation would be supported so long as the patent makes no mention of it.” The majority also explained that implicit disclosure cannot satisfy the written description requirement if it would render the limitation obvious to a skilled artisan. The majority emphasized that while a negative limitation need not be recited in the specification in haec verba, there generally must be something in the specification that conveys to a skilled artisan that the inventor intended the exclusion—for example, a description of a reason to exclude the relevant element. Here, the majority found that the specification made no mention of the presence or absence of a loading dose. This silence cannot support a later-added claim limitation that precludes loading doses, particularly where there was no evidence that the patentee precluded the use of a loading dose and skilled artisans agreed that loading doses are sometimes given to RRMS patients.

Judge Linn (a member of the majority in the January 2022 opinion) dissented, arguing that the majority applied a heightened written description standard requiring not only a “reason to exclude” but a showing that the negative limitation was also “necessarily excluded.” He stated that the question was not whether the patentee precluded the use of a loading dose, but whether the claim limitation that precluded a loading dose was supported by the specification’s written description that disclosed only a daily dose. Judge Linn argued that disclosure along with the testimony of Novartis’s experts implied an absence of a loading dose to a skilled artisan, and that is all that is required for adequate written description. Citing precedent and the US Patent & Trademark Office’s guidance in the Manual of Patent Examining Procedure, he argued that newly added claims or claim limitations may be supported [...]

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Clarification or Raising the Bar? PTO Director Issues New Guidance for Discretionary PTAB Denials

by | Jun 30, 2022 | ,

On June 21, 2022, US Patent & Trademark Office (PTO) Director Katherine K. Vidal issued a memorandum addressing interim procedures for discretionary denials in America Invents Act (AIA)-post grant proceedings at the Patent Trial & Appeal Board (Board). In 2020, in order to minimize the potential conflict between the Board and parallel district court proceedings, the PTO designated the Board’s opinion in Apple v. Fintiv as precedential. Since Fintiv, the Board has issued several discretionary denials of institution based on parallel proceedings in district (and in some cases other administrative) courts. Director Vidal’s memo seeks to provide additional guidance on the PTO’s interpretation of Fintiv and its progeny and addresses multiple factors that were previously left to individual administrative law judge (ALJ) interpretation.

The memo includes rendering an initial evaluation of the merits of the petition. In particular, the Board will not deny institution of an inter partes review (IPR) or post-grant review (PGR) under Fintiv when a petition presents compelling evidence of unpatentability. This standard is higher than the institution standard, which requires only that “there is a reasonable likelihood that petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” While the memo does not elaborate on the evidence required to meet this compelling standard, numerous decisions were cited as illustrative. (See: e.g., Illumina Inc. v. Trs. of Columbia Univ., IPR2020-00988, Paper 20 (PTAB Dec. 8, 2020); Synthego Corp. v. Agilent Techs., Inc., IPR2022-00402, Paper 11 (May 31, 2022); Samsung Elecs. Co. v. Scramoge Tech., Ltd., IPR2022-00241, Paper 10 (June 13, 2022).)

Additionally, Director Vidal confirmed that Fintiv does not apply to parallel proceedings before the International Trade Commission nor where there has been a stipulation not to pursue the same grounds in a district court proceeding. The stipulation applies to grounds that are actually raised in the petition and any grounds that could have reasonably been raised in the petition, suggesting that there may be some dispute later in the district court proceeding about what grounds “could have reasonably been raised in the petition.”

Finally, the memo clarified the second factor of the Fintiv analysis: the speed with which the district court case may go to trial and be resolved. The Board will consider not only the scheduled trial date, but also the median time-to-trial for the particular district court, number of cases before the specific district court judge and the speed and availability of other dispositions.

Practice Note: While the standard for institution has not changed, the new compelling standard effectively ups the bar for any IPR, PGR or covered business method (CBM) proceedings where there is a parallel district court case. Prior to filing a new petition, patent challengers should objectively weigh the merits of their challenge or consider stipulating not to pursue the same invalidity grounds in the parallel district court proceeding.



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

by | Jun 2, 2022 |

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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It’s Not in the Bag: TTAB Refuses to Register Generic Handbag Design

by | Apr 28, 2022 |

Ending a hard-fought three-year campaign to secure registration of a popular handbag, the US Patent & Trademark Office (PTO) Trademark Trial & Appeal Board designated as precedential its decision refusing registration of the product configuration mark, deeming it a generic configuration not eligible for trademark registration. The Board also concluded that even if the bag design had not been generic, the applicant failed to make a necessary showing that the design of the bag had acquired distinctiveness. In re Jasmin Larian, LLC, Serial No. 87522459 (TTAB, Jan. 19, 2022; redesignated Mar. 29, 2022) (Cataldo, Lynch, Allard, ATJ).

Fashion brand CULT GAIA’s “ARK” handbag is composed of bamboo strips creating a creating a see-through “sunburst design,” and has been carried by celebrities such as Beyoncé and Jessica Alba. The brand’s founder and CEO Jasmin Larian sought registration on the Principal Register of the following mark for a three-dimensional handbag:

After several years of examination, the examining attorney ultimately issued a final refusal on the ground that the proposed configuration was a generic configuration, or alternatively, was a nondistinctive product design that had not acquired distinctiveness. Larian appealed to the Board.

Acknowledging the commercial success of the CULT GAIA ARK bag, the Board explained that the issue before it was whether the proposed mark was generic (i.e., a common handbag design), or, alternatively, whether the bag constituted a nondistinctive product design that had acquired distinctiveness. The Board tackled both questions, since similar evidence was relevant to both inquiries.

A trademark must be distinctive to be eligible for registration. Such distinctiveness is measured on a spectrum, where one side of the spectrum is made up of generic terms or generic designs (i.e., non-distinctive and non-protectable as trademarks) and the other side is made up of registrable trademarks that are arbitrary or fanciful. Suggestive trademarks fall somewhere in the middle. In the context of product designs, genericness may be found where the design is so common in the industry that the design cannot be said to identify a particular source of the product. Generic product designs fail to function as a trademark. Genericness is assessed by determining the genus of the goods or services at issue, then determining whether the consuming public primarily regards the design sought to be registered as a category or type of trade dress for the genus of goods or services. For the ARK bag, the applicant and the examining attorney agreed that “handbags” was the genus of the goods at issue. The relevant consuming public was found to consist of ordinary consumers who purchase handbags.

The Board reviewed the evidence of record to assess the significance of the bag design to ordinary consumers, i.e., whether they viewed the configuration of the bag as a source-identifying trademark or merely as a common handbag design. The Board detailed eight different categories of evidence, which, according to the Board, showed that “in the decades leading up to and the years immediately [...]

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Paradise Lost: Art Created by AI Is Ineligible for Copyright Protection

by | Mar 3, 2022 |

The US Copyright Office Review Board (“Board”) rejected a request to register a computer-generated image of a landscape for copyright protection, explaining that a work must be created by a human being to obtain a copyright. Second Request for Reconsideration for Refusal to Register A Recent Entrance to Paradise (Copyright Review Board Feb. 14, 2022) (S. Perlmutter, Register of Copyrights; S. Wilson., Gen. Counsel; K. Isbell, Deputy Dir. of Policy).

In 2018, Steven Thaler filed an application to register a copyright in a work named “A Recent Entrance to Paradise.” Thaler listed as the author of the work the “Creative Machine,” a computer algorithm running on a machine. Thaler listed himself as a claimant and sought to register the work as a “work-for-hire” as the “owner” of the Creative Machine. The Board refused to register the work, finding that it lacked the necessary human authorship. Thaler requested reconsideration, arguing that the “human authorship requirement is unconstitutional and unsupported by either statute or case law.”

After reviewing the work a second time, the Board found that Thaler provided no evidence of sufficient creative input or intervention by a human author. The Board refused to abandon its longstanding interpretation of the Copyright Act, as well as Supreme Court and lower court precedent, that a work meets the requirements of copyright protection only if it is created by a human author. The Board concluded that “A Recent Entrance to Paradise” lacked the required human authorship and therefore affirmed refusal to register. Thaler filed for a second reconsideration.

The Board found that Thaler’s second request for consideration repeated the same arguments as his first request. Relying on the Compendium of US Copyright Office Practices (the Office’s practice manual), the Board found that Thaler provided neither evidence that the work was a product of human authorship nor any reason for the Board to depart from more than a century of copyright jurisprudence.

The Board explained that the Supreme Court of the United States, in interpreting the Copyright Act, has described a copyright as the exclusive right of a human and her own genius going back to 1884. The Board noted that the Supreme Court has repeatedly articulated the nexus between the human mind and creative expression as a prerequisite for copyright protection. The human authorship requirement is further supported by the lower courts. For example, in 1997 the US Court of Appeals for the Ninth Circuit held in Urantia Found. v. Kristen Maaherra that a book containing words “‘authored’ by non-human spiritual beings” can only gain copyright protection if there is “human selection and arrangement of the revelations.”

The Board further explained that federal agencies have followed the courts. In the 1970s, the National Commission on New Technological Uses of Copyrighted Works (CONTU) studied the creation of new works by machines. CONTU determined that the requirement of human authorship was sufficient to protect works created with the use of computers and that no amendment to copyright law was necessary. CONTU explained that “the eligibility of [...]

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

by | Feb 17, 2022 |

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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