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A Maze-Like Path and Laundry List Don’t Provide Written Description

by | Mar 16, 2023 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) decision that there was insufficient written description in the asserted priority applications to support a genus claim because of a lack of ipsis verbis disclosure and insufficient blaze marks. The Court concluded that the priority applications did not support an early priority date. Regents of the University of Minnesota v. Gilead Sciences, Inc., Case No. 21-2168 (Fed. Cir. March 6, 2023) (Lourie, Dyk, Stoll, JJ.)

Gilead filed a petition for inter partes review (IPR) challenging Minnesota’s patent directed to phosphoramidate prodrugs preventing virus reproduction or cancerous tumor growth. Gilead’s US Food & Drug Administration-approved drug, sofosbuvir, is marketed by Gilead to treat chronic hepatitis C infections and falls within claim 1 of the patent.

The 2014 application that issued as the challenged patent claimed priority to four applications. In the IPR, Gilead argued that the claims were anticipated by a Gilead-owned patent publication (Sofia). The publications used in the decision are as follows:

NP3 and NP2 have the same disclosure. NP2 and P1 contain similar disclosures, which the Board called NP2-P1. The broader claim in NP2-P1 has a relationship of genus to the narrower subgenus claims in the patent at issue. There was no dispute that Sofia disclosed every limitation of each challenged claim. The Board held that NP2-P1 failed to provide a sufficient written description to support the asserted priority date of the challenged claims, which were therefore found to be anticipated by Sofia. Minnesota appealed.

Minnesota argued the following to the Federal Circuit:

  • The Board erred in holding that the NP2-P1 applications have insufficient written description.
  • The Board ran afoul of Administrative Procedure Act (APA) requirements.
  • Minnesota is a sovereign state entity immune from IPR.

35 U.S.C. § 120 sets forth requirements for a patent application to benefit from a filing date of an earlier application. Minnesota asserted that the NP2-P1 priority applications literally described or provided blaze marks to the challenged subgenus claims. The Federal Circuit disagreed, explaining that written description for a genus claim of chemical compounds raises “particular issues,” requiring a description of the outer limits of the genus and either a representative number of members or structural features common to the members of the genus. The Court found that the asserted priority applications (NP2-P1) did not provide such description and the challenged claims were not entitled to the filing dates of those applications.

The Federal Circuit found that the asserted priority applications did not provide ipsis verbis disclosure of the challenged subgenus claim. The Court quoted an oft-noted saying associated with Yogi Berra, a catcher for the New York Yankees some 50 years ago, about a notable failure to provide direction: “when one comes to a fork in the road, take it.” The Court also cited its 1996 decision in [...]

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Charter Schools Aren’t Immune from Trademark Suits

by | Mar 16, 2023 |

The US Court of Appeals for the Fifth Circuit affirmed a district court’s dismissal of a trademark suit against a charter school operator and public school district in Texas but explained that the charter school was not automatically immune from lawsuits based on sovereign immunity. Springboards to Education, Inc. v. McAllen Indep. School District, Case Nos. 21-40333; -40334 (5th Cir. Mar. 8, 2023) (Smith, Duncan, JJ.) (Oldham, J., concurring).

Springboards sells products to school districts in connection with its Read a Million Words Campaign. The campaign incentivizes school children to read books through promises of induction into the Millionaires’ Reading Club and access to rewards such as t-shirts, backpacks and fake money. Springboards’s goods typically bear any combination of trademarks that the company registered with the US Patent & Trademark Office, including “Read a Million Words,” “Million Dollar Reader,” “Millionaire Reader” and “Millionaires’ Reading Club.”

Springboards filed a complaint for trademark infringement, trademark counterfeiting and false designation of origin against McAllen Independent School District (MISD), a public school district in Texas, and IDEA Public Schools, a nonprofit organization operating charter schools in Texas. Both MISD an IDEA moved to dismiss for lack of subject matter jurisdiction, arguing that they were arms of the state and thus entitled to sovereign immunity. They also moved for summary judgment for lack of infringement. The district court ruled that only IDEA enjoyed sovereign immunity and accordingly granted IDEA’s motion to dismiss but denied MISD’s. The district court granted MISD’s motion for summary judgment after concluding that Springboards could not establish that MISD’s program was likely to cause confusion with Springboards’s trademarks. Springboards appealed.

The Fifth Circuit began with the jurisdictional issue of whether IDEA and MISD enjoyed sovereign immunity. The Court explained that determining whether an entity is an arm of the state is governed by the Clark factors, which were set forth in the Fifth Circuit’s 1986 decision in Clark v. Tarrant County. Those factors are as follows:

  1. Whether state statutes and case law view the entity as an arm of the state
  2. The source of the entity’s funding
  3. The entity’s degree of local autonomy
  4. Whether the entity is concerned primarily with local, as opposed to statewide, problems
  5. Whether the entity has the authority to sue and be sued in its own name
  6. Whether the entity has the right to hold and use property.

The Fifth Circuit analyzed each of the factors and concluded that IDEA was not an arm of the state. The Court found that factors 1 and 3 favored sovereign immunity while factors 2, 4, 5 and 6 did not. The Court’s decision focused heavily on factor 2, explaining that the inquiry under factor 2 has two parts: the state’s liability in the event there is a judgment against the defendant, and the state’s liability for the defendant’s general debts and obligations. The district court had concluded that factor 2 weighed in favor of immunity because 94% of IDEA’s funding came from the state and federal sources. The [...]

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Stryking Noncompete Preliminary Injunction

by | Mar 9, 2023 |

The US Court of Appeals for the Sixth Circuit upheld a district court’s grant of a preliminary injunction restricting a former employee from working for conflicting organizations or communicating with a competitor’s counsel. Stryker Emp. Co., LLC v. Abbas, Case No. 22-1563 (6th Cir. Feb. 16, 2023) (Clay, Bush, JJ.; Sutton, C.J.) The Court found that the preliminary injunction was an appropriate measure to protect the plaintiff’s confidential information that was consistent with the employee’s noncompete agreement.

Stryker develops and manufactures spinal implants and related medical products. From 2013 through mid-2022, Stryker employed Abbas in various roles relating to finance and sales. As part of his job duties, Abbas led sales and finance projects, assisted with Stryker’s litigation efforts, and cultivated relationships with customers, distributors and sales representatives. These responsibilities required Abbas to have access to Stryker’s confidential information and trade secrets.

In April 2022, Abbas entered into a confidentiality, noncompetition and nonsolicitation agreement with Stryker. This agreement prohibited Abbas from disclosing Stryker’s confidential information without its consent and barred Abbas from working for “any Conflicting Organization” in which Abbas could use Stryker’s confidential information to boost the marketability of a “Conflicting Product or Service.” The noncompete provision was time limited to one year following Abbas’s departure from Stryker.

In summer 2021, a competing spinal implant manufacturer, Alphatec, began recruiting Abbas for a finance position. After determining that the finance position was too similar to Abbas’s previous work at Stryker, Alphatec created a new “sales role” that was allegedly “crafted to protect Stryker’s confidential information.” Abbas resigned from Stryker in May 2022 to take the newly created role.

Shortly after Abbas resigned, Stryker sued for breach of contract, misappropriation of trade secrets and violation of the Michigan Uniform Trade Secrets Act. Stryker also requested a no-notice temporary restraining order (TRO) and preliminary and permanent injunctions. The district court granted Stryker’s motion for preliminary injunction prohibiting Abbas from the following:

  • Working in any capacity for Alphatec or any “Conflicting Organization”
  • Having any ex parte communications with Alphatec’s counsel or otherwise disclosing information concerning Stryker’s litigation strategies.

Abbas appealed, arguing that the noncompetition portion of the preliminary injunction amounted to an industry-wide ban and that the communication portion impermissibly disqualified counsel.

The Noncompetition Provision

The Sixth Circuit first noted that federal law, rather than state law, defines a court’s power to issue a noncompetition restriction in a preliminary injunction. Under federal law, courts have discretion to craft preliminary injunctions based on the equities of a case and can even “proscribe activities that, standing alone, would have been unassailable.” Applying this standard, the Sixth Circuit reasoned that the preliminary injunction was not overly broad but instead preserved the status quo. First, the district court found that Abbas often worked beyond the scope of his position. Second, the district court agreed to entertain a motion to vacate the injunction if Alphatec created a new position for Abbas that Stryker found acceptable. Third, the injunction merely sought to enforce the noncompetition agreement, which [...]

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Claim Duality: Multiple Dependent Claims Can Be Both Patentable and Unpatentable

by | Mar 9, 2023 |

Addressing, for the first time, the issue of patentability of multiple dependent claims under 35 U.S.C. § 112, fifth paragraph, the Director of the US Patent & Trademark Office (PTO) granted rehearing and modified the Patent Trial & Appeal Board’s (Board) Final Written Decision after finding that the patentability of a multiple dependent claim should be considered separately as to each of the claims from which it depends. Nested Bean, Inc. v. Big Beings US Pty. Ltd. et al., IPR2020-01234 (PTO Feb. 24, 2023) (Vidal, Dir.) (precedential).

Nested filed a petition for inter partes review challenging claims 1 through 18 of a patent owned by Big Beings. Claims 1 and 2 were independent, and claims 3 to 16 were multiple dependent claims, which depended directly from either claim 1 or 2. The Board granted institution and ultimately issued a Final Written Decision finding that Nested did not establish that claims 1, 17 and 18 were unpatentable, but that Nested had established that claims 2 through 16 were unpatentable.

Big Beings filed a Request for Director review, noting that each of claims 3 to 16 were multiple dependent claims that depended from both claims 1 and 2. Big Beings argued that because the Board found that Nested failed to show that claim 1 was unpatentable, the Board should have also found that Nested failed to show that claims 3 through 16, as depending from claim 1, were unpatentable. The Director granted review.

35 U.S.C. § 112, fifth paragraph, states, in relevant part, “[a] multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered.” Big Beings argued that the statute requires the Board to separately consider the patentability of alternative dependencies of a multiple dependent claim. Nested responded by arguing that the statute should be read so that if any version of a multiple dependent claim is found unpatentable over the prior art, then all versions of the claim should be found unpatentable.

The Director found that this was an issue of first impression. Relying on 37 C.F.R. § 1.75(c) and 35 U.S.C. § 282, the Director concluded that “a multiple dependent claim is the equivalent of several single dependent claims. Thus, in the same way that the unpatentability of multiple single dependent claims would each rise or fall separately, so too should the dependent claims covered by a multiple dependent claim.” The Director also noted that the Federal Circuit in Dow Chemical and Dayco Products explained that “not addressing claim validity on an individual basis is an error and contravenes 35 U.S.C. 282[.]” The PTO Director concluded, quoting the Manual of Patent Examining Procedure (MPEP), that “a multiple dependent claim must be considered in the same manner as a plurality of single dependent claims.”



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Out of Tune: Eleventh Circuit Permits Retrospective Relief for Timely Copyright Claims under Discovery Rule

by | Mar 9, 2023 |

The US Court of Appeals for the Eleventh Circuit furthered a circuit split in holding that, as a matter of first impression, a copyright plaintiff’s timely claim under the discovery rule is subject to retrospective relief for infringement occurring more than three years before the suit was filed. Nealy v. Warner Chappell Music, Inc., Case No. 21-13232 (11th Cir. Feb. 27, 2023) (Wilson, Jordan, Brasher, JJ.)

Section 507(b) of the Copyright Act includes a three-year statute of limitations that runs from the time the claim accrues, and a claim may only accrue one time under the discovery rule. In 2014, the US Supreme Court held in Petrella v. Metro-Goldwyn-Mayer, Inc., that the equitable doctrine of laches does not bar copyright claims that are otherwise timely under the three-year limitations period set forth in § 507(b). The circuits are split on Petrella’s application—the Second Circuit strictly limits damages from copyright infringement to the three-year period before a complaint is filed, whereas the Ninth Circuit permits retrospective relief for infringement occurring more than three years before the lawsuit’s filing as long as the plaintiff’s claim is timely under the discovery rule.

Music Specialist and Sherman Nealy (collectively, Music Specialist) filed a copyright infringement suit against Warner alleging that Warner was using Music Specialist’s musical works based on invalid third-party licenses and in violation of 17 U.S.C. § 501. The alleged copyright infringement occurred as early as 10 years before Music Specialist filed the present lawsuit. The district court denied Warner’s motion for summary judgment on statute of limitation grounds, finding that there was a genuine dispute of material fact regarding when Music Specialist’s claim accrual occurred. In a separate order, the district court certified for interlocutory appeal whether “damages in this copyright action are limited to the three-year lookback period as calculated from the date of the filing of the Complaint pursuant to the Copyright Act and Petrella.” Music Specialist appealed.

The Eleventh Circuit concluded that where a copyright plaintiff has a timely claim for infringement occurring more than three years before the filing of the lawsuit, the plaintiff may obtain retrospective relief for that infringement. The Court found that Petrella focused on the application of 17 U.S.C. § 507(b) to claim accrual under the injury rule, not the discovery rule, and was therefore inapplicable. The injury rule precludes recovery for harms occurring earlier than three years before the plaintiff files suit. On the other hand, the discovery rule permits damages recovery for infringing acts that copyright owners reasonably become aware of years later. Therefore, the discovery rule permits timely claims for infringement that occurred more than three years before the suit. The Eleventh Circuit found that the Supreme Court expressly reserved application of the discovery rule’s propriety for a future case and that, in the Eleventh Circuit’s opinion, the plain text of the Copyright Act does not place a time limit on remedies for an otherwise timely claim.

Practice Note: The Eleventh Circuit disagreed with the Second Circuit’s [...]

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Patent Law Principles Apply to Claim Scope: Orange Book Delisting and Listing and Regulations

by | Mar 9, 2023 |

The US Court of Appeals for the Federal Circuit ordered that the only Orange Book patent asserted in a lawsuit must be delisted since its claims were directed to the computer-implemented distribution system and not a method of use. Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, Case No. 23-1186 (Fed. Cir. Feb. 24, 2023) (Lourie, Reyna, Taranto, JJ.)

Jazz Pharmaceuticals holds a new drug application (NDA) for Xyrem, an oral sodium oxybate solution prescribed to help those with certain narcolepsies manage cataplexy. Sodium oxybate itself is no longer covered by patents because it has been used in relation to narcolepsy since the 1960s. For this reason, Jazz built its patent portfolio around Xyrem’s formulation, use and distribution.

Jazz uses a single-pharmacy distribution system for Xyrem, known as a risk evaluation mitigation strategy (REMS). Implementing REMS was a condition of Xyrem’s US Food & Drug Administration (FDA) approval because it mitigates safety risks of dangerous active pharmaceutical ingredients such as sodium oxybate. One of Jazz’s patents is directed to this REMS distribution system. Abbreviated New Drug Application (ANDA) 505(b)(2) NDA (Hybrid NDA) approval is similarly conditioned on implementing a REMS that is sufficiently comparable to any that the NDA holder must implement. The FDA eventually determined that single-pharmacy systems were unnecessary for Xyrem and potentially detrimental.

Avadel submitted a hybrid NDA for a drug that requires only a single nightly dose, unlike Xyrem, which requires a patient to wake up during the night to ingest a second dose. Avadel’s application also proposed a more lenient REMS that utilizes multiple pharmacies. In view of these differences, Avadel believed that it could avoid a lengthy FDA approval process because all of Jazz’s Xyrem Orange-Book-listed patents seemed addressable without making any Paragraph IV certifications. As for the REMS patent, Avadel filed a statement under 21 U.S.C. § 355(b)(2)(B) because the patent was listed as claiming a method of use and Avadel was not seeking approval for the REMS system to which that patent’s claims were directed.

Jazz sued Avadel asserting seven patents, of which the REMS patent was the only Orange-Book-listed patent. Avadel asserted a counterclaim requesting that the district court order Jazz to delist the REMS patent from the Orange Book. The district court subsequently held a Markman hearing finding that the REMS patent’s claims were directed to a system and not a method. The district court granted Avadel’s motion for judgment on the pleadings, finding that the REMS patent did not claim “the drug for which the application was approved” and thus had to be delisted from the Orange Book. Jazz appealed.

Jazz argued that because the FDA permitted the REMS patent to be Orange Book listed, Avadel was prohibited from availing itself of the statutory delisting provision. The Federal Circuit disagreed, concluding that the language of the delisting provision was only concerned with whether a listed patent met the provisions’ conditions at the time of the triggering litigation.

Jazz also argued that there was no evidence that Congress imported patent-law [...]

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Compelling Clarity: PTO Director Explains Compelling Merits Test

by | Mar 9, 2023 |

US Patent & Trademark Office (PTO) Director Katherine K. Vidal issued a precedential opinion clarifying the standard under which the Patent Trial & Appeal Board (Board) can institute on an inter partes review (IPR) petition despite the Fintiv factors militating toward denial. CommScope Techs. LLC v. Dali Wireless, Inc., IPR2022-01242 (PTO Feb. 27, 2023) (Vidal, Dir.) (precedential).

This opinion follows the Director’s Interim Procedure for Discretionary Denials memorandum (Guidance Memo) and her opinion in OpenSky Indus. v. VLSI Tech. In the guidance memo, the Director explained that when there is “compelling evidence of unpatentability,” the Board may decline to exercise its discretion to deny IPR institution.

In this case, Dali Wireless sued CommScope in the district court, alleging infringement of its patent. CommScope filed a petition to institute an IPR proceeding against the asserted patent. The Board granted the petition and instituted an IPR proceeding while the district court litigation was ongoing.

In granting the petition, the Board acknowledged that it would normally perform a Fintiv analysis to determine whether it should deny the petition in light of the parallel district court proceeding. However, considering the Guidance Memo and the “compelling invalidity challenge” presented by the petitioner, the Board skipped the Fintiv analysis and instituted on the petition. The Director instituted sua sponte review.

Recognizing some ambiguity in both OpenSky and the guidance memo, the Director made her decision precedential to clarify:

My Guidance Memo states that “the PTAB will not deny institution based on Fintiv if there is compelling evidence of unpatentability.” Although I now recognize that this instruction could be read to allow for a compelling merits determination as a substitute for a Fintiv analysis, that was not my intent. By that instruction, I intended for PTAB panels to only consider compelling merits if they first determined that Fintiv factors 1–5 favored a discretionary denial . . . . In circumstances where . . . the Board’s analysis of Fintiv factors 1–5 favors denial of institution; the Board shall then assess compelling merits. In doing so, the Board must provide reasoning sufficient to allow the parties to challenge that finding and sufficient to allow for review of the Board’s decision.

A determination of whether the petition presents a compelling merits case for invalidity requires a merits case that meets a higher standard than the “reasonable likelihood” test required by 35 U.S.C. § 314(a).

The Director found that the Board’s decision was deficient in both parts of the analysis. The Board did not perform any analysis of the Fintiv factors but instead went straight to a determination of whether the petition presented a compelling invalidity challenge. In connection with that determination, the Board failed to provide any reasoning that explained why it found the merits case presented in the petition compelling.

Finding that the Board’s reasoning was conclusory, the Director vacated the Board’s decision to institute IPR review and remanded for further proceedings consistent with her decision.

Practice Note: Less [...]

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Thank You to Our Readers

by | Mar 6, 2023 |

We greatly appreciate our readers over the past year and are pleased to share that we were recently recognized for our intellectual property thought leadership in the 2023 JD Supra Readers’ Choice Awards, which acknowledge top authors and firms for their thought leadership in key topics during all of last year.

Sarah Bro, a regular contributor to IP Update, was recognized as a “Top Author” for trademarks. She focuses her practice on trademark prosecution, enforcement and brand portfolio management, as well as licensing, due diligence, copyright, right of publicity and domain name matters.

Through our various blogs and thought leadership pieces, we are dedicated to maintaining our position as a leading firm for intellectual property work and keeping clients abreast of significant and relevant topics in the industry.



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Little Weight Given to Conclusory Expert Declaration That Repeats IPR Petition Verbatim

by | Mar 2, 2023 |

The US Patent & Trademark Office Director affirmed and designated as precedential a Patent Trial & Appeal Board (Board) decision denying institution of an inter partes review (IPR) petition where the expert declaration presented conclusory assertions without underlying factual support and repeated verbatim the petitioner’s argument. Xerox Corp. v. Bytemark, Inc., IPR2022-00624 (PTAB Aug. 24, 2022) (Wood, Grossman, Tartal, APJs); Xerox Corp. v. Bytemark, Inc., IPR2022-00624 (Feb 10, 2023) (Vidal, Dir.)

Bytemark owns a patent directed to a method and system for distributing electronic tickets. According to the patent, a user can procure and store an electronic ticket on a device such as a mobile phone, and when the user presents the ticket, the ticket taker can verify the ticket by inspecting a visual object that a human can perceive without a machine scan. In addition to using a validating visual object, the patent teaches data integrity checking to ensure that the ticket data and the software managing that ticket data on the user’s device has not been altered improperly. As to the data integrity concept, the claims of the patent recite a server that is configured to “store in a data record associated with the user account a data value indicating the fraudulent activity” (fraud limitation).

Xerox filed an IPR petition challenging certain claims of the patent as obvious over the Terrell prior art reference in combination with various secondary references. Xerox argued that Terrell disclosed that after fraudulent activity is detected, “the purchaser of the ticket could be blocked from further use of the system or pursued in respect of their potential fraud.” Xerox asserted that a skilled artisan would understand that such blocking would require recording the blocking in a data record associated with that user’s account, and would find it obvious that blocking the account of the purchaser from further use of the system would include storing a data value indicating the fraudulent activity in a data record associated with the user account.

Bytemark responded that Terrell, at most, taught blocking a ticket purchaser from further use of the Terrell system based on potential fraud, but nowhere indicated that this would be achieved by using a data value indicating fraudulent activity, as opposed to some other manner of blocking a user, such as deleting the user’s account or reporting the user for fraud. Bytemark further argued that Xerox’s argument that a skilled artisan would find the fraud limitation obvious was conclusory and an improper attempt to use a skilled artisan’s common knowledge to supply a wholly missing claim limitation without evidentiary support.

The Board agreed with Bytemark, finding that Xerox did not provide sufficient evidence or persuasive reasoning to support either of Xerox’s arguments. The Board explained that Terrell taught blocking the purchaser rather than the account of the purchaser and that it was far from clear that blocking the purchaser would “require” recording the blocking in a record in the purchaser’s account, as opposed to deleting the purchaser’s account altogether. The Board noted that the [...]

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Free Speech Shines Bright, Illuminates Patent Owner’s Right to Allege Infringement

by | Mar 2, 2023 |

The US Court of Appeals for the Federal Circuit reversed a district court’s preliminary injunction prohibiting a patent owner from communicating its view that a competitor infringed, finding that the speech restriction was improper because the infringement assertions were not objectively baseless. Lite-Netics, LLC v. Nu Tsai Capital LLC, Case No. 23-1146 (Fed. Cir. Feb. 17, 2023) (Lourie, Taranto, Stark, JJ.)

Lite-Netics and Nu Tsai Capital d/b/a Holiday Bright Lights (HBL) compete in the market for holiday string lights. Both companies use similar magnetic mechanisms that allow users to secure the end of the lights. Lite-Netics owns several patents that describe and claim magnetically secured decorative lights. In June 2017, Lite-Netics sent a cease-and-desist letter to HBL demanding that it stop selling lights alleged to infringe Lite-Netics’s patents. After remaining silent for five years, Lite-Netics sent another cease-and-desist letter in April 2022 demanding that HBL either explain why its products did not infringe the Lite-Netics patents or stop selling the products.

When HBL refused to stop selling the allegedly infringing products, Lite-Netics sent communications to HBL’s customers notifying them of their infringement claim and threatening “all legal rights and remedies” to stop the sale of HBL’s products. Lite-Netics then filed a lawsuit against HBL for infringement of the patents. HBL asserted counterclaims, including tortious interference with business relationships, defamation under Nebraska law and bad faith patent-infringement communications. HBL also sought a preliminary injunction to prevent Lite-Netics from publishing further accusatory statements. Finding that HBL would likely succeed on its tortious interference and defamation claims and that Lite-Netics’ infringement allegations were “objectively baseless,” the district court granted the preliminary injunction. Lite-Netics appealed.

The Federal Circuit reversed the district court, finding that in cases where an injunction restricts a party’s rights to First Amendment protected speech about its federal patent rights, federal law preempts state tort law. The Court explained that federal law requires a higher “bad faith” standard of proof for a preliminary injunction that would impinge on those federal rights. The Court found that HBL had failed to show that Lite-Netics’s allegations and the publication of its allegations were made in bad faith or that those allegations were objectively baseless. The Court therefore reversed and remanded to the district court for further proceedings.



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