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Second Circuit Tells Rapper to Face the Music for Failing to Register the Work

by Karen Gover | May 23, 2024 | Copyrights

The US Court of Appeals for the Second Circuit affirmed the dismissal of a copyright infringement claim by one rap artist against another on the grounds that the plaintiff failed to register the work in question. The Court emphasized the distinction between a musical work and a sound recording of that work, noting that they are separately copyrightable and require separate registrations. Nwosuocha v. Glover, Case No. 23-703 (2d Cir. May 10, 2024) (Jacobs, Park, Nathan, CJ.) (per curium) (nonprecedential)

In fall 2016, the rapper Emelike Nwosuocha, who goes by Kidd Wes, wrote and published a song called “Made in America.” In May 2017, Kidd Wes registered an album that included “Made in America” with the US Copyright Office and was issued a sound recording registration. In 2018, the rapper Donald Glover, known as Childish Gambino, released the song “This is America.” The song won in all four of its nominated categories at the 61st Grammy Awards in 2019: Song of the Year, Record of the Year, Best Rap/Sung Performance and Best Music Video. Kidd Wes then filed a complaint in the US District Court for the Southern District of New York against Glover and his music labels, alleging infringement of his copyright.

A valid copyright registration is a prerequisite to suit under 17 U.S.C. § 411(a). Here, Kidd Wes only registered his copyright for the sound recording of “Made in America,” not for the musical work itself. Since his infringement allegations concerned the work and not the recording of the work, the district court granted Childish Gambino’s motion to dismiss the claim for failure to register the copyright at issue. The court also dismissed the claim for the independent reason that Childish Gambino’s song did not infringe.

Kidd Wes appealed, arguing that § 411(b) permits suit “regardless of whether the certificate [of registration] contains any inaccurate information,” unless the inaccuracy was knowing or material, and that the distinction between a sound recording and a musical work is an administrative classification imposed by the Register of Copyrights and therefore has “no significance with respect to the subject matter of copyright or the exclusive rights provided by [Title 17 of the United States Code].”

The Second Circuit rejected both lines of argument. First, the Court noted that failing to register the musical work “Made in America” is not the same as accidentally including inaccurate information on the registration form. The Court explained that “the difference between forgiving technical mistakes in a copyright application and allowing applications to create registrations in material never mentioned” is an important distinction, and they should not be conflated.

Second, the Second Circuit noted that the distinction between a musical work and a sound recording of that work is not just an administrative classification, but a distinction created by statute. (17 U.S.C. §§ 102(a)(2) and (a)(7).) The distinction is important, the Court explained, because “sound recordings and musical works are different artistic works that can be copyrighted by different creators and are infringed in different ways.”

Having [...]

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Prime Delivery: Amazon Program Now Offers Personal Jurisdiction to Patent Holders

by Courtney Seams | May 16, 2024 | Patents

Addressing the issue of personal jurisdiction in the context of a declaratory judgment case involving a program for resolving patent infringement claims, the US Court of Appeals for the Federal Circuit concluded that a patent owner has personal jurisdiction in the forum of an alleged infringer when it files a program claim against the alleged infringer. SnapRays, dba SnapPower v. Lighting Defense Group, Case No. 23-1184 (Fed. Cir. May 2, 2024) (Moore, CJ. Lourie, Dyk, JJ.)

The Amazon Patent Evaluation Express (APEX) program helps resolve patent infringement claims against sellers on Amazon. Under APEX, a patent owner submits an APEX Agreement to Amazon that identifies the allegedly infringed patent claim and the Amazon listings with the alleged infringing products. Amazon then sends this APEX Agreement to the seller, who can do one of the following to avoid removal of their accused listings:

Opt into APEX and let a third party determine whether their product likely infringes
Resolve the claim directly with the patent owner
File a lawsuit for declaratory judgment of noninfringement. If the seller does nothing, its listings are automatically removed from Amazon within three weeks of receipt of the APEX Agreement.

Lighting Defense Group (LDG), a Delaware company whose principal place of business is in Arizona, submitted an APEX Agreement alleging that SnapPower’s Amazon products (electrical outlet covers with integrated technology) infringed one of its patents. SnapPower, a Utah company whose principal place of business is in Utah, then filed a declaratory judgment action against LDG in Utah. LDG then filed a motion to dismiss for lack of personal jurisdiction. The district court granted the motion, finding that SnapPower did not demonstrate that LDG purposefully directed activities at SnapPower in Utah and that there was no evidence that LDG reached out to Utah other than through responses to SnapPower’s communications. SnapPower appealed.

The Federal Circuit reversed, finding that LDG was subject to personal jurisdiction under the Court’s three-prong test because (1) LDG purposefully directed its activities at SnapPower in Utah, (2) LDG’s submission of the APEX Agreement was directed to SnapPower in Utah and aimed to affect activities in Utah and (3) it would not be unreasonable to find personal jurisdiction over LDG in Utah.

In assessing the first prong, the Federal Circuit found that LDG knew, via APEX’s terms, that Amazon would notify SnapPower of the APEX Agreement and that the options available to SnapPower included a claim for declaratory judgment. Further, the Court found that the APEX Agreement had more power than cease and desist letters because of the automatic removal of the listings after three weeks, which would affect sales and activities in Utah.

In assessing the second prong, the Federal Circuit found that personal jurisdiction comported with due process because LDG’s actions aimed to affect marketing, sales and other activities in Utah and because the suit arose out of LDG’s activities in the forum.

In assessing the final prong, the Federal Circuit rejected LDG’s argument that allowing personal jurisdiction would “open the [...]

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Take Three for Take-Two: Jury Finds Implied License for Tattoos on Video-Game Avatar

by Karen Gover | May 9, 2024 | Copyrights

A jury rejected allegations that a video-game maker’s use of tattoos in a game violated the copyright of the artist who inked them, finding the video-game maker had an implied license to depict a player’s tattoos in its likeness of him. Hayden v. 2K Games Inc., Case No. 1:17-cv-02635 (N.D. Ohio)

Jimmy Hayden is a tattoo artist who has created works for many National Basketball Association (NBA) stars, including Lebron James, Shaquille O’Neal, Kyrie Irving, Danny Green and Tristan Thompson. Hayden filed suit against Take-Two Interactive Games, a developer, publisher and marketer of interactive entertainment and video games, in 2017 for the depiction of his copyrighted tattoos on the likenesses of James, Green and Thompson in the popular NBA 2K game series. The NBA 2K series allows players to control realistic avatars of more than 400 NBA players.

In January 2024, the district court dismissed the infringement claims concerning four of the six tattoos but ruled that claims concerning two of the tattoos on James could proceed to trial. The jury found that Take-Two’s agreement with the NBA and its players’ union to use James’s likeness included an implied license to depict his tattoos.

Practice Note: A likely issue on appeal will be whether the jury was correctly instructed in the implied license doctrine, which involves inferring intent from the parties’ conduct, as well as whether it applied the doctrine correctly.

Similar Cases

This case is the latest in a series of disputes between tattoo artists and the use of their work in video games. In 2020, Take-Two was sued in the US District Court for the Southern District of New York over its depiction of tattoos on NBA players, including James, Kenyon Martin and Eric Bledsoe. In that case, Solid Oak Sketches, Inc. v. Take-Two Games, Inc. (499 F.Supp.3d 333 (S.D.N.Y. 2020)), the district court granted Take-Two’s motion for summary judgment, finding that the tattoos depicted on the basketball players were not substantially similar to the actual tattoos, that the video game company’s use was within the license granted by the players to use their likeness and that the video game’s use of the copyrighted tattoos was transformative.

In another case, Alexander v. Take-Two Interactive Software, Inc. et al. (Case No. 18-cv-966-SMY, (S.D. Ill. 2022)), a tattoo artist won a jury trial concerning the depiction of tattoos on professional wrestler Randy Orton in Take-Two’s WWE 2K video game series. In that case, the jury awarded Alexander $3,750 in damages, finding that the reproduction of the tattoos was not fair use, but the small size of the award reflected their finding that the game’s profits were not attributable to the copied tattoos.

Unclean Hands Aren’t Just for Toddlers

by Jacob Michael Bass | Apr 25, 2024 | Patents

In an action involving manufacturers of a self-sealing dining mat for toddlers, the US Court of Appeals for the Federal Circuit affirmed a district court’s finding that the defendants were barred from obtaining relief on their counterclaims under the unclean hands doctrine, thereby vacating the district court’s other findings on inequitable conduct, obviousness, attorneys’ fees and costs. Luv N’ Care, Ltd. et al. v. Laurain et al., Case No. 22-1905 (Fed. Cir. Apr. 12, 2024) (Reyna, Hughes, Stark, JJ.)

Luv N’ Care and Nouri E. Hakim (collectively, LNC) filed suit against Lindsey Laurain and Eazy-PZ (EZPZ), asserting various claims for unfair competition under the Lanham Act and Louisiana law. LNC also sought declaratory judgment that EZPZ’s design patent was invalid, unenforceable and not infringed. After the suit was filed, the US Patent & Trademark Office (PTO) issued Laurain a utility patent directed toward self-sealing dining mats. Laurain subsequently assigned her rights to EZPZ, which then asserted counterclaims for utility patent, design patent and trademark infringement.

Following discovery, the district court granted LNC’s motion for summary judgment, finding all claims of EZPZ’s utility patent as obvious in view of three prior art references. EZPZ moved for reconsideration, which the district court denied, indicating that a “ruling providing further reasoning will follow in due course.” Before any such ruling issued, the PTO issued an ex parte reexamination certificate confirming the patentability of the utility patent claims two days before the district court’s bench trial began.

EZPZ did not provide this reexam certificate to the district court prior to the bench trial. During the bench trial, the district court found that EZPZ had not committed inequitable conduct but that EZPZ’s litigation conduct constituted unclean hands. After the district court entered judgment, EZPZ moved for reconsideration of summary judgment based on the ex parte reexamination certificate. The district court denied this motion and found that the evidence did not compel alteration of the prior ruling that the utility patent was invalid. It also denied LNC’s motion for attorneys’ fees and costs. EZPZ appealed.

The Federal Circuit affirmed the unclean hands determination but vacated the district court’s rulings on inequitable conduct, invalidity, attorneys’ fees and costs. As to unclean hands, the Court reasoned that EZPZ failed to disclose patent applications related to the utility patent until well after the close of discovery and dispositive motion practice. EZPZ also blocked LNC’s efforts to discover Laurain’s prior art searches by falsely claiming that she had conducted no such searches and that all responsive documents had been produced. It further found that EZPZ witnesses, including Laurain and EZPZ’s former outside counsel, repeatedly gave evasive testimony during depositions and at trial. The Court affirmed the district court’s determination that EZPZ’s misconduct bore an immediate and necessary connection to EZPZ’s claims for infringement because the undisclosed material was directly relevant to the development of LNC’s litigation strategy and undermined LNC’s ability to press its invalidity and unenforceability challenges. The Court found no clear error in the district court’s reasoning that [...]

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Late Expert Report Dooms Copyright Case

by Karen Gover | Apr 18, 2024 | Copyrights

The US Court of Appeals for the Sixth Circuit weighed in for a third time on an eight-year copyright battle, this time finding that a district court did not abuse its discretion in excluding the plaintiff’s proposed expert or granting summary judgment to the defendant with respect to a copyright claim related to software. RJ Control Consultants, Inc., et al. v. Multiject, LLC, et al., Case No. 23-1591 (6th Cir. Apr. 3, 2024) (Siler, Cole, Mathis, JJ.)

This case concerns a copyright infringement claim filed by Paul Rogers through his company RJ Control Consultants (RJC) against his former friend Jack Elder, sole owner of Multiject. Multiject engineers and sells industrial accessories related to plastic injection molding. Rogers developed technical diagrams and software source code for a rotary turntable control system for Multiject. After Elder obtained copies of the code and drawings, he fired Rogers and hired a different company, RSW, to implement the technology. Rogers obtained copyright registrations for the code and drawings and filed suit against Elder, Multiject and RSW for copyright and trademark infringement, as well as certain state law claims.

The district court granted summary judgment to the defendants on RJC’s copyright infringement and trademark infringement claims and declined to exercise supplemental jurisdiction over the state law claims. RJC appealed the dismissal of its copyright infringement claim. In December 2020, in RJ Control I, the Sixth Circuit affirmed the decision regarding the technical drawings but reversed and remanded the copyright claim to the district court, finding that the software technology was complex and required an expert to answer material questions related to the functionality of the code.

On remand, the district court established deadlines for expert disclosures and for filing dispositive motions and motions challenging experts. Both parties timely served expert disclosures in which they identified the names of their respective experts, but neither side produced an expert report with their disclosures.

In April 2021, the district court extended the discovery and motions deadlines but not the expert disclosure deadline. The defendants moved to exclude RJC’s expert on the grounds that RJC failed to properly disclose the expert because RJC did not produce an expert report. The defendants also filed motions for summary judgment. The district court granted the defendants’ motions, finding that RJC “failed to put forth any expert evidence that identifies any specific portions of the code that they claim are protectible.” RJC appealed.

The Sixth Circuit dismissed the second appeal for lack of appellate jurisdiction, finding that the district court’s decision was not final because the court had not disposed of Multiject and Elder’s counterclaim (RJ Control II). The case was remanded again. On remand, the district court dismissed the then-pending counterclaim. RJC appealed again.

RJC argued that the Sixth Circuit lacked jurisdiction to decide RJ Control I, just as it did in RJ Control II, because at that time the counterclaim remained pending in district court. The Court agreed and vacated its decision in RJ Control I, but then affirmed [...]

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Mandamus Denied but Jurisdictional Door Left Open a Crack

by Thomas DaMario | Apr 4, 2024 | Patents

The US Court of Appeals for the Federal Circuit denied a patent owner’s writ of mandamus seeking to prevent a defendant from amending its answer to add an affirmative licensing defense, but also noted that the defense was added only after the district court found that there were no remaining claims. In re VLSI Technology LLC, Case No. 24-116 (Fed. Cir. Mar. 18, 2024) (Moore, Taranto, Chen, JJ.)

VLSI asserted four patents against Intel in the Northern District of California. In December 2023, the district court granted summary judgment that two of the patents were not infringed and denied summary judgment of noninfringement on the remaining two patents. The parties additionally submitted cross motions for summary judgment on a licensing defense that turned on a forum selection clause, but the court denied both motions. To deprive the court of jurisdiction, VLSI granted Intel a covenant not to sue for infringement of the remaining two patents in the case. Two days later, Intel moved to amend its answer to add a counterclaim for a declaratory judgment that Intel was licensed to VLSI’s entire patent portfolio. The district court granted Intel’s motion, and VLSI filed a mandamus petition to block Intel’s amendment.

The Federal Circuit denied VLSI’s petition for two primary reasons. First, the Court determined that VLSI had not shown that it had no other available means of obtaining relief. The district court expressly invited the parties to brief issues pertaining to Intel’s licensing defense in subsequent briefing, and VLSI had since filed a motion to dismiss pertaining to this very issue. The Court also noted that VLSI could raise this issue on appeal after a final judgment. Second, the Court determined that VLSI failed to show that the district court abused its discretion in allowing Intel to amend its answer, finding that Intel acted diligently in seeking to amend its answer and that VLSI had long since known about the potential defense.

With respect to the substantive issue of whether the district court had subject matter jurisdiction, the Federal Circuit declined to offer an opinion at this stage. Nevertheless, in an apparent message to the court below, the final sentence of the Court’s opinion reads, “[w]e only note that Intel’s motion to amend its answer was filed after the court determined there were no remaining claims, such that no case or controversy remained before the court.”

Gentlemen, Start Your Engines: Even Bland Works Support Copyright

by Kathleen Lynch | Mar 7, 2024 | Copyrights

The US Court of Appeals for the Sixth Circuit affirmed an award of profit disgorgement and attorneys’ fees in a copyright infringement case, holding that even “workaday” or “humdrum” subject matter can support a valid copyright. Premier Dealer Servs. Inc. v. Allegiance Adm’rs LLC, Case No. 23-3394 (6th Cir. Feb. 26, 2024) (Sutton, C.J.; Clay, Bloomekatz, JJ.)

Premier and Allegiance both administered car dealers’ loyalty programs. Customers enrolled in these programs were required to meet certain conditions (such as changing the car’s oil at predetermined intervals), and if a part under warranty broke, the dealer would help the car owner initiate a claim through the loyalty program administrator. In conjunction with administering these programs, Premier created a loyalty certificate. The certificate collected the customer’s personal information and provided the program’s terms and conditions. Premier registered its certificate for copyright protection in 2008.

In 2018, Tricolor – one of Premier’s large, long-standing customers – switched its program to Allegiance. When Allegiance took over, it repurposed Premier’s loyalty certificate by simply updating the administrator’s contact information. Allegiance and Tricolor continued to use the otherwise unaltered certificate. Premier sued for copyright infringement.

The district court found that the certificate’s “dull” subject matter did not preclude copyright protection, enjoined Allegiance from further copyright infringement, and awarded Premier disgorgement of Allegiance’s profits as well as attorneys’ fees, totaling more than $1 million. Allegiance appealed, challenging the certificate’s copyrightability and the damages calculations.

As to the copyrightability of the certificate, the Sixth Circuit explained that while copyright requires originality, it is a low threshold that can be shown by making “non-obvious choices” or evidencing some creative spark. “[A]rtistic merit” is not necessarily required. The Court noted three categories that copyrights will not cover:

Facts that already exist in the world (although the expression of facts may be copyrightable)
Merger, “when there is only a single way to express a given set of facts” and
Scenes a faire, in which industry norms require expressing facts in a particular way.

Premier’s copyright was registered and therefore presumed valid, meaning the burden was on Allegiance to rebut that presumption. The Sixth Circuit rejected Allegiance’s challenge to the originality of Premier’s copyright, primarily because copyrights “protect all manner of works – mundane or lofty . . . so long as they satisfy the modest imperatives of originality.” Allegiance argued that Premier’s forms collected client information in a way that was unoriginal, because there was only one way to collect the information (merger) and because the layout was typical for the industry (scenes a faire). The Court looked to areas in which Premier indicated creativity, noting that its forms differed from other loyalty program certificates in evidence. Further, Premier made the creative choice to allow program members to select from various schedules for oil changes, instead of a single predetermined timetable. This and other evidence suggested choice, ideas and creativity, despite the functionality of the loyalty certificates.

The Sixth Circuit hinted at how Allegiance might have better established the [...]

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Rock On: Clichéd Song Themes Don’t Infringe Copyright

by Karen Gover | Mar 7, 2024 | Copyrights

The US Court of Appeals for the Fifth Circuit affirmed a district court’s summary judgment grant to an alleged song copier, finding neither evidence of factual copying nor striking similarity between the two songs. Kirk Johnston v. Chad Kroeger et al., Case No. 23-50254 (5th Cir. Feb. 19, 2024) (Jones, Haynes, Douglas, JJ.) (per curiam) (non-precedential).

Kirk Johnston is a musician and songwriter who plays guitar for the Texas rock band Snowblind (now called Snowblind Revival). In 2001, he wrote a song called “Rock Star.” Four years later, the Canadian rock band Nickelback released a song called “Rockstar” that became one of its most popular singles. In 2020, Johnston sued Nickelback, its record label and its music publishing company for copyright infringement. Nickelback moved for summary judgment, and the district court referred the motion to a magistrate judge. The judge recommended summary judgment in favor of Nickelback, finding no genuine dispute of material fact as to factual copying and finding that the two songs did not sound alike. The district court accepted the magistrate judge’s recommendation and dismissed Johnston’s infringement claim. Johnston appealed.

The Fifth Circuit reviewed the motion of summary judgment de novo. With respect to the element of factual copying, Nickelback’s members and executives claimed that they had never even heard of Johnston’s song. The Court found Johnston’s circumstantial evidence that Nickelback had access to his song unpersuasive. Johnston said that access could be inferred from the fact that the two bands were “moving in relatively the same circles” and that executives associated with Nickelback likely attended Snowblind’s shows. The Court said that Johnston’s arguments regarding the likelihood that Nickelback had access to his song “Rock Star” required “leaps of logic” not supported by the record and were “mere speculation.”

Johnston also unsuccessfully argued that the district court erred by not applying the “more discerning ordinary observer test” and by considering all versions of the songs on the record rather than just the “stripped down” versions. The Fifth Circuit pointed out that those standards only apply under a substantial similarity analysis, which requires a plaintiff to establish factual copying. Because there was no proof of access, much less copying, Johnston had to show a “striking similarity” between his song and Nickelback’s hit.

Johnston argued that his expert demonstrated that there were clear lyrical and musical similarities between the hooks of the songs, both of which concern the desire to be a rock star. However, the Fifth Circuit noted that the expert’s analysis was unpersuasive as to both the musical and lyrical similarities; concluding that neither was sufficiently similar to preclude all explanations but copying. The other themes in the song that Johnston pointed to as strikingly similar were “making lots of money,” “connections to famous people” and “references to sports.” The Court pointed out that as a general matter, those categories “are mere clichés of being a rockstar that are not unique to the rock genre.” As the Court put it, “[s]inging about being a rockstar is not [...]

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Espresso Yourself: When Prosecution History as a Whole Doesn’t Demonstrate Clear, Unmistakable Disclaimer

by Katherine Pappas | Jan 4, 2024 | Patents

The US Court of Appeals for the Federal Circuit reversed and remanded a district court’s claim construction and related summary judgment rulings after determining that the district court erred in construing a claim term by improperly limiting the plain and ordinary meaning of the term. K-fee System GmbH v. Nespresso USA, Inc., Case No. 22-2042 (Fed. Cir. Dec. 26, 2023) (Taranto, Clevenger, Stoll, JJ.)

K-fee filed a lawsuit against Nespresso alleging infringement of three K-fee patents directed toward coffee machine portion capsules that use a barcode. The district court issued a claim construction order construing the term “barcode,” which was present in every asserted claim. In the claim construction order, the district court characterized the dispute as “whether statements made by K-fee System GmbH . . . before the EPO [European Patent Office] concerning the meaning of ‘barcode’ should influence the plain and ordinary meaning of that limitation in these proceedings.”

In the EPO, Nespresso’s foreign affiliate had challenged the validity of K-fee’s related European patent, and K-fee had responded seeking to distinguish a particular piece of prior art (Jarisch/D1). Because the statements made to the EPO were submitted to the US Patent & Trademark Office during prosecution of the asserted patents, the district court analyzed the statements as part of the intrinsic record. The district court concluded that K-fee had “argued strenuously before the EPO for a particular ‘plain and ordinary meaning,’ which excluded ‘bit codes’—codes made up of two binary symbols.” Based on the EPO submissions, the district court construed the claim term “barcode” to:

its plain and ordinary meaning (i.e., a code having bars of variable width, which includes the lines and gaps), the scope of which is understood by the clear and unequivocal statements K-fee made to the EPO (i.e., the scope of barcode does not include the type of bit code disclosed in Jarisch/D1).

Based on that construction of “barcode,” Nespresso moved for summary judgment of noninfringement. It argued that its accused products operated identically to Jarisch capsules, which K-fee distinguished before the EPO, since both use a machine-readable code with only two binary symbols. The district court agreed. When applying its construction at summary judgment, the district court clarified that using “the type of bit code disclosed in Jarisch” … means “a binary code containing only ‘0s’ and ‘1s.’” Thus, the district court read K-fee’s EPO statements “to mean that a barcode must ‘contain more than only two binary symbols’ and, by extension, that any code that contains only two binary symbols could not be a barcode.” Because the court found that “there was no dispute that Nespresso’s accused products used a code having only two symbols,” it granted Nespresso’s motion for summary judgment of noninfringement. K-fee appealed.

Considering the issue de novo, the Federal Circuit reviewed K-fee’s statements to the EPO in context and disagreed “that the ordinary meaning of ‘barcode’ excludes ‘bit codes’ (in some sense, two-value codes) or even bit codes of ‘the type . . . disclosed in Jarisch’ to [...]

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If the Label Is Skinny Enough – No Inducement Under Hatch-Waxman

by Ian J. Howard | Dec 14, 2023 | Patents

The US Court of Appeals for the Federal Circuit made explicit what has long been considered implicit based on Warner-Lambert and its progeny, namely, that plaintiffs asserting an induced infringement theory to bar the entry of generic drugs in a Hatch-Waxman suit are subject to higher scrutiny than plaintiffs asserting the same theories outside of the Hatch-Waxman context. H. Lundbeck A/S v. Lupin Ltd., Case No. 22-1194 (Fed. Cir. Dec. 7, 2023) (Dyk, Prost, Hughes, JJ.)

Lundbeck owns the approved new drug application (NDA) for Trintellix®, a drug indicated for the treatment of major depressive disorder (MDD), as well as an expired compound patent for the associated active ingredient vortioxetine. Lundbeck also owns a patent that claims the use of vortioxetine as an antidepressant that can be prescribed in place of a traditional antidepressant to alleviate a patient’s negative sexual side effects, and another patent that claims the use of vortioxetine to treat cognitive impairment symptoms in patients with MDD.

Generic pharmaceutical companies filed abbreviated new drug applications (ANDAs) seeking approval to market generic versions of Trintellix® and asserting that Lundbeck’s unexpired patents listed in its NDA were invalid and would not be infringed by the generic companies. As required by the Hatch-Waxman Act (to prevent the entry of a generic on the market), Lundbeck sued the generic companies. At the district court, the defendants prevailed on the finding of noninfringement but lost on invalidity. Lundbeck appealed.

Lundbeck pressed its induced infringement and contributory infringement theories on appeal. Lundbeck argued that the generics infringed under the plain text of Hatch-Waxman (35 USC 271(e)(2)(A)) because they filed ANDAs seeking approval to market vortioxetine, and that “some uses of vortioxetine—for the treatment of patients that have previously taken other drugs but had to cease or reduce use due to sexually related adverse events and for the treatment of cognitive impairment—are covered by [Lundbeck’s listed] patents; and the labels do not prohibit prescribing vortioxetine for those uses, even though the defendants do not propose to market the drug for those patented uses.” In other words, Lundbeck argued that in terms of its inducement allegation, it made no difference whether a drug would be sold for a use not covered by Lundberg’s NDA-listed patents because the drug could be prescribed for those patented uses.

The Federal Circuit disagreed, explaining that “‘the use’ in § 271(e)(2)(A) refers to the use for which the FDA has granted an NDA” and for which the ANDA was submitted.” The Court emphasized that it is not “an act of infringement under . . . § 271(e)(2)(A) to submit an ANDA for a drug if just any use of that drug were claimed in a patent.” If it were, a brand could “maintain its exclusivity merely by regularly filing a new patent application claiming a narrow method of use not covered by its NDA,” which “would confer substantial additional rights on pioneer drug patent owners that Congress quite clearly did not intend to confer.” As the Court then held, “actions for [...]

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