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The Future of Skinny Labeling in Patent Litigation Will be Reconsidered

The US Court of Appeals for the Federal Circuit has now vacated its prior ruling finding induced infringement based on so-called skinny labeling on a pharmaceutical product. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA Inc., Case no.18-1876 (Fed. Cir. Feb. 9, 2021) PER CURIAM. The case concerns communications regarding generic approvals and “skinny labels,” which permit companies to sell pharmaceutical products that omit certain patented uses.

On Oct. 2, 2020, a panel of the Federal Circuit (PROST, C.J ., NEWMAN and MOORE, JJ.) issued an opinion finding that Teva induced infringement of a patent covering GlaxoSmithKline’s (GSK’s) drug Coreg® (carvedilol). In a per curiam Order, the Court has now vacated that opinion and set a new round of oral arguments that was held on February 23.

Teva had requested an en banc rehearing the case, which was denied in the Order vacating the Oct. 2, 2020 opinion while ordering panel rehearing limited to the following issue:

Whether there is substantial evidence to support the jury’s verdict of induced infringement during the time period from January 8, 2008 through April 30, 2011.

Background

GSK’s patent covers a method of using carvedilol, the active ingredient in Coreg®, for the treatment of congestive heart failure. In 2007, the FDA approved Teva’s application to market generic carvedilol tablets. To obtain that approval prior to the expiration of the patent (or prevailing on noninfringement, invalidity, or unenforceability of the patent in litigation), Teva had “carved out” certain patent-protected left ventricular dysfunction uses and only included claims to treat hypertension, i.e., claims not covered by the GSK patent. That original patent expired in 2007, but it was reissued in 2008.

Teva had deliberately omitted congestive heart failure in its label until the FDA made it add that indication in 2011. In accordance with the Order, the February 23 oral argument focued on alleged infringement in the period before the label change, i.e., the period 2008 and 2011. The outcome is expected to turn on associated activities and statements made by Teva that went beyond the approval of the generic drug with skinny labeling, where Teva did not explicitly claim that their product was for the patent-protected uses.




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Increasing Transparency and Reducing Transaction Costs in 5G SEP Licensing

The advent of 5G promises a new era of speed, throughput and bandwidth for cellular networks, however the world of telecommunications and licensing faces several challenges in preparation for its arrival. Although wireless technology has continued to evolve over the years, traditional SEP licensing models have seemingly been left behind and may no longer be adequate to address the needs of companies seeking to implement 5G into their products. As the Internet of Things becomes an increasingly integral part of products across market areas, more and more companies of all industries and sizes will need to invest in 5G technology to become part of the network.

The growing number of players and technology complexity involved with 5G has created an unprecedented need for simpler and more transparent frameworks for licensing, patent pools and standards that can be scaled across diverse market segments. Existing methods require significant investments of time, budget and technological and legal depth that no longer suit the broad array of companies that will be utilizing the new technology.

At Premier Cercle’s IP Tech Summit 2020, McDermott Partner Dr. Henrik Holzapfel was joined by a panel of experts from organizations at the forefront of 5G innovation. Click here to watch as they discuss these challenges and their vision for the future of licensing in the world of wireless connectivity.




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A Closed Book: No Past Infringement, No Reading Between the Lines into the Future

The US Court of Appeals for the Sixth Circuit affirmed a district court’s grant of summary judgment in favor of the defendant, finding no current or future copyright infringement. OverDrive Inc. v. Open E-Book Forum dba International Digital Publishing Forum, Case No. 20-3432 (6th Cir. Jan. 27, 2021) (Sutton, J.)

OverDrive is a digital reading platform and a member of International Digital Publishing Forum, a nonprofit trade association dedicated to the development of electronic publishing standards. The Forum has an intellectual property policy, approved by Overdrive and its other members, which provides that while its members retain copyrights in their contributions, they also grant the Forum a license to “reproduce, adapt, distribute, perform, display, and create derivative works” of any copyrighted contributions to EPUB, the leading eBook file format. The license also allowed the Forum to sublicense others to do the same.

In 2016, the Forum entered into an asset-transfer agreement with the World Wide Web Consortium, an international organization dedicated to developing web standards. The agreement granted the Consortium a “license to use” the Forum’s intellectual property to carry out digital publishing activities. The agreement further provided that the Forum would dissolve and its intellectual property rights, including any in EPUB, would be owned by the Consortium. The Consortium began developing improvements to EPUB. Shortly thereafter, the Forum and the Consortium entered into a second agreement, which provided that the Consortium’s license to “use” the intellectual property encompassed a license to “reproduce, adapt, distribute, perform, display and create derivative works.” In the second agreement the Forum agreed to begin the dissolution process only if and only when it transferred its intellectual property to the Consortium.

OverDrive sought a declaratory judgment that the Forum had violated and would violate its copyrights in EPUB. OverDrive claimed that the Forum infringed its copyrights by giving the Consortium access to EPUB. At the close of discovery, the Forum moved for summary judgment, which the district court granted for two reasons. First, it found that the Forum’s license defeated the infringement claim. Second, it found the claim for future infringement was not ripe. OverDrive appealed.

The Sixth Circuit agreed that the “use” license granted by Overdrive gave the Forum the right to “reproduce, adapt, distribute, perform, display and create derivative works” of Overdrive’s EPUB copyrights, and permitted the Forum to use the copyrighted work in these ways. The license also gave the Forum an unrestricted right to grant sublicenses with respect to those same copyrights. In turn, the appellate court concluded that the Forum permissibly sublicensed EPUB to the Consortium, including any of OverDrive’s copyrights in EPUB.

In support of its claims of future copyright infringement, OverDrive argued that once the Forum dissolved, the Consortium would lose its sublicense and its work on EPUB would then constitute copyright infringement. The Sixth Circuit disagreed. The ripeness doctrine two-question inquiry asks:

  • Does the claim arise in a concrete factual context and concern a dispute that is likely to come to pass?
  • What is the hardship [...]

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2G or Not 2G: Patent License Applies to Future Generation Wireless Networks

In interpreting a patent license agreement originally drafted in the era of third generation (3G) cellular networks, the US Court of Appeals for the Federal Circuit found that the license agreement covered subsequent wireless network generations, affirming a district court decision that infringement claims were barred by the license agreement and the doctrine of patent exhaustion. Evolved Wireless, LLC v. HTC Corp., Case Nos. 20-1335, -1337, -1339, -1340, -1363 (Fed. Cir. Jan. 26, 2021) (Dyk, J.) However, the Court vacated-in-part the district court’s decision and remanded for findings based on supplemental evidence of the license’s termination.

In order for cellular wireless networks to work properly, each component within the network must operate according to a shared set of standards. Early generation wireless networks were specific to a particular geographic location. Subsequent “generations” became harmonized according to global standards set by international organizations. Despite some harmonization, two separate 3G standards existed, known as WCDMA and CDMA2000. The fourth generation (4G) addressed this dichotomy by harmonizing newer technologies into a single standard known as Long Term Evolution (LTE). Nonetheless, devices exist that may be compatible with one or more 3G or 4G standards. These are referred to as “single-mode” or “multi-mode” devices depending on their compatibility characteristic. Patents that cover one or more technologies necessary for standards harmonization are referred to as standard-essential patents (SEPs) and must be licensed on fair, reasonable and non-discriminatory terms.

LG Electronics developed a patent that describes a method for handing over a mobile device from one cell tower to another under the LTE standard. LG subsequently declared the patent to be essential to the LTE standard and granted a license to Qualcomm, a developer and supplier of wireless components. LG then sold the patent to TQ Lambda, which sold it to Evolved Wireless. Evolved filed infringement lawsuits against various mobile device manufacturers, all of which incorporated Qualcomm components in their accused products. Because the patent remained subject to the LG-Qualcomm license, the central question was whether the accused products fell within the scope of the license agreement.

The license agreement did not identify specific patents, but granted Qualcomm and its customers the right to use LG’s patents that are “technically or commercially necessary to make, sell, or use a ‘subscriber unit,'” defined in the license as “a Complete CDMA Telephone or a CDMA Modem Card, and any subsequent generation products.” The district court found that the accused products were covered by the license agreement and granted summary judgment in favor of the defendants under the theory that the license agreement authorized Qualcomm’s use of the patent and that the doctrine of patent exhaustion precluded an infringement action against Qualcomm’s customers (i.e., the defendants). Evolved appealed.

On appeal, Evolved argued that the accused products did not meet the definition of “subscriber units” and that it had submitted supplemental evidence that the license had been terminated that the district court had ignored. Evolved argued that that term “subsequent generation products” in the license did not include products that [...]

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Old Dawg, New Tricks: Bankruptcy Successor Is Also Inter Partes Re-Exam Successor

Reversing the Patent Trial and Appeal Board, the US Court of Appeals for the Federal Circuit concluded that because a plaintiff was a successor in bankruptcy, it was a successor in an inter partes re-examination. The Court held that the plaintiff should be substituted for the original requestor following the sale of the original re-examination requestor’s right, title and interest in, to and under its assets to a holding company, which further assigned such assets and interests to the plaintiff. Mojave Desert Holdings, LLC v. Crocs, Inc., Case No. 20-1167 (Fed. Cir. Feb. 11, 2021) (Dyk, J.)

The dispute originated in 2012 when Crocs sued Dawgs for patent infringement. Dawgs responded by filing a third-party request for inter partes re-examination, which the US Patent & Trademark Office granted. The examiner rejected Crocs’ challenged patent claim as anticipated, and Crocs appealed to the Board.

While the appeal was pending, Dawgs filed a petition under chapter 11 of the Bankruptcy Code. Dawgs moved the bankruptcy court to approve the sale of all of its assets to a recently formed entity, Dawgs Holdings, free and clear of all liens, claims and encumbrances pursuant to Bankruptcy Code. The relevant provision of the Asset Purchase Agreement assigned Dawgs Holdings:

[a]ll of [Dawgs’] right, title and interest in, to and under all of the assets, properties and rights of every kind and nature, whether real, personal or mixed, tangible or intangible (including intellectual property and goodwill) . . . .

The sale order carved out from the free and clear language “any Claims [Crocs] . . . may hold for patent infringement occurring post-Closing.” Shortly after the closing, Dawgs Holdings assigned all rights, including explicitly the claims asserted by Dawgs in the district court action and the inter partes re-examination, to Mojave.

Months later, Mojave moved the Board to change the real party-in-interest from Dawgs to Mojave. The Board dismissed and expunged the request because:

  • The sale from Dawgs to Dawgs Holdings was silent with respect to the inter partes re-examination.
  • Mojave was not a party to the inter partes re-examination proceeding.
  • Mojave did not have standing to update the real party-in-interest.
  • Mojave did not file its submission within 20 days of any change of the real party-in-interest as required by 37 CFR § 41.8(a).

Subsequently, the Board reversed the examiner’s rejection of Crocs’ patent claim, which decision Dawgs appealed to the Federal Circuit, while simultaneously filing a motion to substitute Mojave.

In granting the substitution motion, the Federal Circuit noted the broad language describing the sale of all of Dawgs’ assets to Dawgs Holdings. The Court distinguished the sale language from the sale language in other cases where a buyer in bankruptcy may only acquire “substantially all” of the assets of another entity. Because the language describing the transfer from Dawgs to Dawgs Holdings was so broad, the Federal Circuit concluded that the transfer from Dawgs Holdings to Mojave included the interests in Dawgs’ claims and its successor-in-interest requestor status in the inter [...]

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Attempts to Appeal Institution Decision Is SIPCOed

Reinforcing the impact of the Supreme Court of the United States’ 2019 decision in Thryv v. Click-to-Call, the US Court of Appeals for the Federal Circuit reiterated that the Patent Trial and Appeal Board’s threshold determination as to whether it will institute a proceeding under the America Invents Act (AIA), in this instance a Covered Business Method (CBM) review, is not appealable because it is closely tied to the institution decision. cxLoyalty, Inc. v. Maritz Holdings Inc., Case Nos. 20-1307, -1309 (Fed. Cir. Feb. 8, 2021) (Prost, C.J.)

cxLoyalty petitioned for CBM review of a patent owned by Maritz. The patent relates to a system and method for permitting a loyalty program customer to redeem loyalty points for rewards offered by vendors without human intervention. A participant (i.e., a customer) uses a graphical user interface (GUI) to communicate with a web-based vendor system (e.g., an airline reservation system). An application programming interface (API) facilitates information transfer between the GUI and the vendor system.

The Board instituted CBM review and concluded that the original claims in the patent were ineligible for patenting under 35 USC § 101, but that the proposed substitute claims were patent eligible. The Board found the original and substitute claims amounted “to a fundamental economic practice long prevalent in commerce” and therefore were directed to abstract ideas. However, the Board found that, unlike the original claims, the substitute claims contained an inventive concept. cxLoyalty appealed the Board’s ruling as to the substitute claims. Maritz cross-appealed the Board’s determination that the patent was eligible for CBM review and the Board’s ruling as to the original claims.

The Federal Circuit quickly disposed of Maritz’s challenge to the CBM-eligibility of the patent, citing to its 2020 SIPCO v. Emerson decision. In SIPCO, the Court held that Thryv made clear that the Board’s threshold determination as to whether a patent qualifies for CBM review is a non-appealable decision. Whether CBM review is an available mechanism is conditioned on whether the patent qualifies, since patents that are directed to “technological inventions” are excluded from CBM review. Because the determination of whether a patent qualifies for CBM review is inextricably tied to the decision to institute, it is not appealable. SIPCO was decided after briefing but before oral argument of this case. Indeed, Maritz’s counsel acknowledged during oral argument that SIPCO foreclosed Maritz’s CBM eligibility challenge.

As to the merits, the Federal Circuit agreed with the Board that both the original and substitute claims were directed to patent-ineligible subject matter under § 101. Maritz argued that the claim features of permitting a participant to redeem points for rewards “without knowing that the actual transaction is a currency transaction at less than the perceived price” saved the claims from being merely abstract ideas. The Court disagreed. After applying the Alice/Mayo two-step analysis, the Court found that 1) the claims were directed to abstract ideas, and 2) the claims merely recited generic and conventional computer components or functionality for carrying out the abstract [...]

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Patent Extension Requires Board or Court Reversal, Multiple Examiner Actions Not Enough

The US Court of Appeals for the Federal Circuit affirmed a grant of summary judgment for the Director of the US Patent and Trademark Office (PTO), holding that the statutory language authorizing so-called “C-delay” patent term adjustment requires an adverse patentability finding that is reversed by a court or the Patent Trial & Appeal Board. Chudik v. Hirshfeld, Case No. 20-1833 (Fed. Cir. Feb. 8, 2021) (Taranto, J.) C-delay adds to a patent’s term to account for delay experienced during appellate review of an adverse patentability finding. C-delay does not apply when the examiner reopens examination after final rejection (in this case, four times over an 11-year period) because appellate review is not triggered when an examiner, and not the Board or a court, undoes a final unpatentability decision by reopening examination.

Chudik filed a patent application, and the examiner rejected all pending claims as unpatentable. Chudik declined to appeal, instead filing a request for continued examination. Over the next eight years, the examiner issued four more final rejections. After each rejection, Chudik filed a notice of appeal and opening brief, and after each notice of appeal, the examiner reopened prosecution rather than answering the appeal. The patent finally issued more than 11 years after Chudik filed the application. The PTO added time to the term of the patent for A-delay (where the PTO fails to meet certain prescribed deadlines) and B-delay (each day that the patent application’s pendency extends beyond three years), but not C-delay.

The C-delay provision of the Patent Act provides for a patent term adjustment where the delay is due to “appellate review by the [Board] or by a Federal Court in a case in which the patent was issued under a decision in the review reversing an adverse determination of patentability.” Chudik challenged the PTO’s calculation of the patent extension, arguing that he was entitled to C-delay patent term adjustment for the time his four notices of appeal were pending in the PTO. Chudik argued that the C-delay provision’s “appellate review” included the examiner’s decision to undo her final action through a reopening of prosecution. The PTO rejected that argument, concluding that the C-delay provision did not apply because the Board’s jurisdiction over the appeals never attached and no Board or reviewing court reversed an adverse determination of patentability.

Chudik then sued the PTO director in federal district court, again arguing that “appellate review” referred to the Board’s entire review process, starting when the notice of appeal is filed. Chudik also argued that “a decision in the review reversing an adverse determination of patentability” covered an examiner’s own decision, through a reopening of prosecution. Although characterizing it as “based on a reasonable construction of statutory text,” the court rejected Chudik’s challenge. Applying Chevron, the district court held that the PTO’s position must be affirmed because that position was reasonable. Chudik appealed to the Federal Circuit.

The Federal Circuit affirmed the district court’s decision, finding that the PTO’s interpretation of the C-delay provision’s statutory language was [...]

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Stick to the Fax: Conflicting Statements Made During Prosecution Lead to Indefiniteness

In deciding whether use of the term “passive link” to define a connection between a computer terminal and a fax machine rendered a patent claim indefinite, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding of invalidity based on conflicting statements made by the patent owner during prosecution. Infinity Computer Products, Inc. v. Oki Data Americas, Inc., Case No. 20-1189 (Fed. Cir. Feb. 10, 2021) (Prost, C.J.)

Infinity owns a patent directed to providing a circuit for interfacing a personal computer with a facsimile machine to enable the facsimile to be used as a scanner or a printer for a personal computer. The patent seeks to accomplish all of the objectives of a scanner or a printer in a simple, straightforward manner through the use of a circuit of highly simplified design and low cost. The patent claims recite that this functionality is accomplished “through a bi-directional direct connection via a passive link between the facsimile machine and the computer.” Infinity asserted the patent against Oki in district court.

The term “passive link” does not appear in the patent specification. Infinity introduced this term during prosecution to overcome rejections based on a prior art patent to Perkins. During prosecution, Infinity unsuccessfully argued that unlike Perkins, the claimed invention permits uninterrupted transfer of signals between the facsimile and the computer without the use of intervening circuitry. Infinity engaged in multiple rounds of amendment and response with the examiner before finally overcoming the rejections based on Perkins by arguing that the invention “creates a passive link between the facsimile machine and the computer [and] therefore does not require any intervening apparatus as does Perkins.” Perkins used a modem, characterized by Infinity as the “intervening apparatus,” internal to the computer. Infinity argued that the modem “should be regarded as a peripheral device to the computer which processes data before it is transmitted to the I/O bus of the computer,” effectively drawing the boundary of the “passive link” at the I/O bus of the computer.

After allowance, the patent was the subject of three ex parte re-examination proceedings. The patent was a continuation-in-part of a parent application, and in order to overcome a prior art reference asserted in the re-examination proceeding, Infinity argued that the claimed “passive link” element was entitled to the priority date of an earlier parent application. Infinity specifically noted that the patent’s description of “the RJ11 telephone cable and use thereof in communicating data between the fax machine 30 and the PC computer 40 meets the definition of ‘passive link.'” In doing so, Infinity pointed to certain figures in the parent application specification that disclosed fax modem circuitry internal to the computer, effectively drawing the boundary of the “passive link” at the computer’s external port—before the I/O bus.

The district court found that there was a discrepancy on the boundary of the “passive link” because during prosecution it was defined as at the I/O bus of the computer, but during the ex parte re-examination it [...]

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Fairness Is the Limit for Asserting False Advertising Claims

Addressing whether Lanham Act claims for false advertising or false association under § 43(a) (15 USC § 1125(a)) are subject to a statute of limitations, the US Court of Appeals for the Fourth Circuit concluded that the sole time limit on bringing such claims is the equitable doctrine of laches. Belmora LLC v. Bayer Consumer Care AG, Case No. 18-2183 (4th Cir. Feb. 2, 2021) (Floyd, J.)

The facts of the underlying dispute are straightforward. Bayer has sold the pain reliever naproxen as FLANAX in Mexico since 1972 and in the United States as ALEVE. Belmora began selling naproxen under the name FLANAX in the United States in 2004, where it used similar packaging and described the drug as one sold successfully in Mexico. Both companies tried to register the mark with the US Patent & Trademark Office, where proceedings unfolded. Ultimately, in April 2014, the Trademark Trial and Appeal Board cancelled Belmora’s trademark registration, finding that Belmora had blatantly misused FLANAX by drawing on the popularity of Bayer’s Mexican product. Two months later, Bayer brought claims against Belmora under § 43(a) of the Lanham Act and California unfair competition law in the US District Court for the Central District of California. The suit was transferred to the Eastern District of Virginia, where Belmora moved to dismiss, arguing that § 43(a) and state law claims were barred by the statute of limitations. Bayer replied that § 43(a) had no statute of limitations, and that the time to bring the state law claims had been tolled during the Board’s proceedings. The district court granted both of Belmora’s motions, and the appeal followed.

Because there is no express statute of limitations for a § 43(a) claim, the question before the Court was whether to assume that Congress intended that the most analogous state law statute of limitations apply, or to apply either the most analogous federal statute or common law laches doctrine. “Conclud[ing] that § 43(a) is one such federal law for which a state statute of limitations would be an unsatisfactory vehicle for enforcement,” the Court held that laches was more appropriate, for primarily two reasons. First, the statutory text provides that § 43(a) damages are subject to the principles of equity, which would include the doctrine of laches. Second, the Court found persuasive the law of the Third, Seventh and Ninth Circuits, which each apply laches as to restrict the timeliness of as § 43(a) action. That said, the Court emphasized that on remand, the district court should consider the period for bringing a similar state action as part of the laches analysis, especially because the Fourth Circuit employs a presumption that claims brought after the expiration of the most-analogous statute-of-limitations are barred by laches.

The Court noted that Bayer could overcome a presumption of laches, and cited three factors for the district court to consider:

  • Bayer’s knowledge (or lack thereof) of Belmora’s adverse use
  • Whether Bayer’s delay was inexcusable or unreasonable
  • Whether Belmora had been unduly prejudiced by [...]

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A Shoe-In? Fleet Feet Gives Injunction Appeal the Moot Boot

The US Court of Appeals for the Fourth Circuit dismissed a preliminary injunction as moot where the enjoined party had discontinued the use complained of and had no future plan to restart it. Fleet Feet, Inc. v. Nike, Inc., Case No. 19-2390 (4th Cir. Jan. 26, 2021) (Diaz, J.) The Court denied the enjoined party’s request that it vacate the district court’s order granting the preliminary injunction despite mootness due to an ongoing litigation.

Fleet Feet is a retailer selling products related to running, including Nike merchandise. It is also a Nike competitor since Nike sells its own products. Fleet Feet obtained two trademark registrations, having already used both for years: “Running Changes Everything” in 2020, and “Change Everything” in 2015. In July 2019, Nike launched an advertising campaign with the tagline “Sport Changes Everything” scheduled to end at the February 2020 Super Bowl. Fleet Feet sued Nike for trademark infringement. The district court granted a preliminary injunction against Nike and set a $1 million injunction bond. The preliminary injunction order prohibited Nike from any use of the phrase “Sport Changes Everything” or any other designation confusingly similar to the Fleet Feet’s marks when advertising or selling goods and services. Nike discontinued its campaign two months before the scheduled end and appealed the preliminary injunction order.

Nike argued that the district court erred in its preliminary injunction factor analyses. But on appeal, the Fourth Circuit decided as a threshold matter that the end of Nike’s “Sport Changes Everything” campaign and its representation that there were no plans to use the term after the campaign rendered Nike’s appeal of the preliminary injunction “designed to interrupt that very campaign” moot. A case becomes “moot” when the “issues presented are no longer ‘live’ or the parties lack a legally cognizable interest in the outcome.” The Court found that Nike’s appeal of the preliminary injunction was nonjusticiable since there had been an event during the pendency of the appeal that made it impossible to grant effective relief to a prevailing party. Because of the conclusion of the 2020 Super Bowl and Nike’s representations that it did not plan to use the term afterwards, there was no possible relief to Nike based on the preliminary injunction’s interference with the campaign.

The Fourth Circuit disagreed with Nike that two issues remained live. First, Nike argued that the continued restraint on Nike’s speech due to the order’s prohibition of any confusingly similar designation to Fleet Feet continued to be a live issue. The Court explained that this was only a potential controversy, not a live controversy. Because Nike had not engaged in the speech barred by the order, had represented that it did not intend to do so in the future, and had not introduced any new slogans confusingly similar to Fleet Feet’s marks, no actual speech was threatened by the preliminary injunction.

Second, Nike argued that the potential recovery on the injunction bond was a live issue. Referring to the Supreme Court case Univ. of Tex. [...]

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