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

by | Dec 14, 2023 |

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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Sound the Alarm: Reasonable Royalty Apportionment Analysis Overlooks “Sleep State”

by | Dec 14, 2023 |

After a jury found infringement of two patents and awarded almost $2.2 billion in damages, the US Court of Appeals for the Federal Circuit reversed the infringement finding for one asserted patent, vacated the damages award for the other asserted patent, and reversed the district court’s refusal to allow the alleged infringer to add a licensing defense. VLSI Technology LLC v. Intel Corporation, Case No. 22-1906 (Fed. Cir. Dec. 4, 2023) (Lourie, Dyk, Taranto, JJ.)

VLSI sued Intel for infringement of two patents. During the litigation, third party Finjan underwent a change in control after which it was controlled by the same parent entity as VLSI. Intel sought to amend its answer to add a licensing defense based on the broad definition of “affiliates” in its license agreement with Finjan, arguing that as a consequence of the change in control Intel was licensed to patents owned by VLSI. The district court denied the motion to amend.

At trial, the jury found literal infringement of one patent and infringement under the doctrine of equivalents (DoE) for the other patent. The jury awarded $2.2 billion in damages. Intel appealed.

The patent that the jury found infringed under the DoE was directed to devices, such as computer processors, having the ability to operate at a variety of frequencies. Depending on the operating conditions, a master device can provide a trigger input to a controller in response to a desired increase in device performance, and the controller can then adjust the clock frequency accordingly. Intel argued that the evidence of equivalents presented to the jury was legally insufficient to support a finding of infringement.

The Federal Circuit agreed and reversed the jury’s finding under the DoE. The Court stressed that for a patent owner to prevail under a DoE assertion, it must provide “particularized testimony and linking argument as to the insubstantiality of the differences between the claimed invention and the accused device.” While VLSI’s proof of equivalence was limitation specific, the testimony provided during the trial was insufficient to explain the “insubstantiality” of the differences between the claims and the Intel products. The Court specifically cited trial testimony by VLSI’s expert, who characterized the differences as “a difference of where an engineer draws the line . . . it’s a design choice.” In its explanation of why the analysis and testimony was insufficient, the Court explained that “[i]t is not enough [] to say that the different functionality-location placements were a ‘design choice.’ . . . VLSI had to prove—with particularized testimony and linking argument—that the elements of the Intel arrangement were substantially the same as the elements of the claimed arrangement. But VLSI offered no meaningful testimony doing so.”

Intel also appealed the damages award based on the patent that was found to be literally infringed. That patent was directed to certain features that provide separate scalable (as opposed to fixed) power supply voltages for both processors and memory devices, depending on the need of the device. VLSI’s expert presented a calculation of damages based [...]

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Word From on High: Provide Reasoned Explanation When Departing From Established Practice

by | Dec 7, 2023 |

In a decision on motion in an appeal from the Trademark Trial & Appeal Board, the US Court of Appeals for the Federal Circuit admonished the Board on remand to “furnish a reasoned explanation” when departing from its “established practice” on the issue of waiver. Universal Life Church Monastery v. American Marriage Ministries, Case No. 22-1744 (Fed. Cir. Nov. 22, 2023) (Chen, Cunningham, Stark, JJ.) (unpublished).

Universal Life Church filed an application to register the mark GET ORDAINED in two classes of services: ecclesiastical services and retail store services. As to both classes, American Marriage opposed on the grounds that the mark was merely descriptive and failed to function as a trademark. The Board sustained the opposition against both classes of service notwithstanding that American Marriage did not present any argument regarding retail store services. Universal Life argued that American Marriage waived its opposition to registration of the mark for retail services—an argument ignored by the Board in its decision. Universal Life appealed.

After oral argument at the Federal Circuit, the parties jointly moved to vacate the Board’s decision as it related to retail store services or to remand the matter to the Board to consider a party stipulation to that effect.

The Federal Circuit denied the motion, finding no entitlement to the “extraordinary remedy of vacatur” or circumstances necessitating a remand.

Instead, the Federal Circuit vacated the Board’s decision based on its failure to explain why American Marriage’s silence on registrability for retail store services did not constitute waiver, or to “furnish a reasoned explanation for departing from [the Board’s] established practice of deeming unargued claims waived.”

The Federal Circuit noted that the Board’s established waiver practice for inter partes proceedings was that “[i]f a party fails to reference a pleaded claim or affirmative defense in its brief, the Board will deem the claim or affirmative defense to have been waived.”

The Federal Circuit cited several precedential Board decisions, including General Mills v. Fage Dairy Processing Industry (2011), where the Board “deemed opposition claims directed to one class in a multi-class application as waived when there was an ‘absence of arguments in opposers’ brief as to anything other than [goods in the non-waived class].’” The Board’s precedent requires that “in an opposition proceeding for a multi-class application, ‘[e]ach international class stands on its own, for all practical purposes like a separate application, and [the Board] must make determinations for each separate class.’”



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PTO Creates Separate Design Patent Bar

by | Dec 7, 2023 |

The US Patent & Trademark Office (PTO) published its final rule, creating a separate design patent bar where admitted design patent practitioners will practice in design patent proceedings only. (88 Fed. Reg. 78644 (Nov. 16, 2023).)

Prior to this rulemaking, there was a single patent bar for those who practice in patent matters before the PTO, including in utility, plant and design patent proceedings. PTO regulations previously required that all patent bar practitioners pass a registration exam and possess specific and stringent scientific and technical qualifications, such as an engineering degree or substantial course work in physics, biology, chemistry or the like.

The new rule creates a separate design patent bar that still requires members to pass the current registration exam but permits applicants to have a bachelor’s degree, master’s degree or PhD in any of the following areas from an accredited college or university:

  • Industrial design
  • Product design
  • Architecture
  • Applied arts
  • Graphic design
  • Fine/studio arts
  • Art teacher education.

The new rules expanding the patent bar admission criteria are intended to encourage broader participation and to keep up with the ever-evolving technology and related teachings that qualify someone to practice before the PTO. Practitioners currently admitted before the PTO will not be impacted by the change and can continue to prosecute utility, plant and design patents.

The rule will take effect on January 2, 2024.



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Delay Is Okay: Final Written Decisions Can Be Issued After Statutory Deadline

by | Nov 30, 2023 | ,

In a matter of first impression, the US Court of Appeals for the Federal Circuit concluded that the Patent Trial & Appeal Board has the authority to issue a final written decision (FWD) in a post-grant review (PGR) proceeding after the statutory deadline has passed. Purdue Pharma L.P. v. Collegium Pharm., Inc., Case No. 22-1482 (Fed. Cir. Nov. 21, 2023) (Dyk, Hughes, Stoll, JJ.)

Purdue owns a patent directed to a pharmaceutical formulation meant to prevent or deter the abuse of opioid analgesics through the use of an aversive agent. On March 13, 2018, Collegium filed a PGR petition asserting that the patent claims were invalid. On September 24, 2019, Purdue filed a notice of bankruptcy and imposition of automatic stay, after which the Board stayed the PGR proceeding. The Board’s one-year deadline to issue an FWD under 35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c) expired on October 4, 2019. After the bankruptcy court lifted the stay on the PGR proceeding on September 1, 2020, Purdue argued that the Board no longer had the authority to issue an FWD because the 18-month statutory deadline to do so had passed. The Board disagreed and issued an FWD finding the challenged claims unpatentable. Purdue appealed.

Purdue argued that the Board did not have authority to issue an FWD after the deadline established by 35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c) had passed. Purdue advanced four arguments in favor of its proposed interpretation of § 326(a)(11):

  1. The use of “shall” and “requiring” deprives the Board of the authority to issue an FWD.
  2. The “negative words” of “not later than 1 year” and “by not more than 6 months” indicate a loss of authority.
  3. The statutory language in § 326(a)(11) requires PGR proceedings to be conducted “in accordance with” the Board’s jurisdictional grant in 35 U.S.C. § 6, and therefore the Board’s jurisdiction expires when the deadline in § 326(a)(11) expires.
  4. The exceptions in § 326(a)(11) for “good cause” and “joinder” demonstrate that those are the only limited instances where the Board may issue an FWD after the statutory deadline.

None of Purdue’s arguments persuaded the Federal Circuit. The Court reasoned that § 328(a) plainly requires the issuance of an FWD and that “[h]ad Congress meant to deprive the agency of power in § 326(a)(11), it knew how to do it” vis-à-vis the use of specific language, like the language it used in other sections of the America Invents Act (AIA), such as 35 U.S.C. § 315(b) and 35 U.S.C. § 321(c), both of which specifically deny agency power after a temporal deadline.

The Federal Circuit also considered the legislative history of § 316(a)(11), recognizing that Congress created PGR and inter partes review (IPR) proceedings when enacting the AIA to, among other things, replace the “lengthy and inefficient” reexamination proceeding. The Court reasoned that prohibiting an FWD after the statutory deadline would “force” parties to commence district court litigation—an act contrary to the purpose of the AIA, which [...]

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PTO Provides Guidance for Computer-Related Design Patent Applications

by | Nov 30, 2023 |

The US Patent & Trademark Office (PTO) published a notice regarding supplemental guidance for PTO personnel examining design patent claims containing computer-generated images. 88 Fed. Reg. 80277 (Nov. 17, 2023).

The guidance clarifies how to satisfy the article of manufacture requirement under 35 U.S.C. 171 for ornamental designs relating to computer-generated icons shown on a display panel, as discussed in Section 1505.01(a)(I) of the Manual of Patent Examining Procedure (MPEP). According to the guidance, “the mere display of a computer-generated electronic image . . . on a display panel does not constitute statutory subject matter under 35 U.S.C. 171.” However, a computer icon or a graphical user interface (GUI) shown on a display panel (e.g., a computer screen, monitor, computer display system, mobile phone screen or virtual/augmented reality goggles) is more than a mere display of a picture on a screen because it constitutes an integral and active component in the operation that is embodied in and/or applied to a programmed computer displaying the computer icon or the GUI. Thus, if a computer icon or GUI is properly presented and claimed (e.g., the drawing fully discloses the design as embodied in the article of manufacture), it is eligible under 35 U.S.C. 171.

In addressing the foregoing distinctions, the guidance sets forth specific standards for PTO personnel, including consideration of the complete disclosure when evaluating whether a design claim containing a computer-generated electronic image complies with the article of manufacture requirement. For example, given that computer icons or GUIs are considered to be two-dimensional images, which standing alone are surface ornamentation (i.e., an ornament, impression, print or picture), the guidance stipulates that the title and the claim should not be for a computer icon or a GUI alone, but rather an article of manufacture, such as a “display panel with a computer icon.” The guidance further provides examples of acceptable claim language and specific examination scenarios for evaluation.



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Wave Goodbye: Arguments Incorporated by Reference Are Waived

by | Nov 30, 2023 |

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s patentability determination, finding that the patent challenger waived an argument it attempted to incorporate by reference to another brief. Medtronic, Inc. v. Teleflex Life Scis. Ltd., Case No. 2022-1721 (Fed. Cir. Nov. 16, 2023) (Lourie, Prost, Chen, JJ.)

Teleflex owns a patent directed to a method for using a guide extension catheter with a guide catheter. Medtronic challenged the patent in two inter partes review (IPR) proceedings, arguing that certain claims were obvious in light of Ressemann and Itou and that another claim was obvious in light of Ressemann, Itou and Kataishi. Teleflex argued that Itou was not prior art because the claimed invention was conceived prior to Itou’s filing date and was either actually reduced to practice before the critical date or diligently pursued until its constructive reduction to practice date. Medtronic did not contest Teleflex’s demonstration of conception but instead challenged Teleflex’s alleged showings of both actual reduction to practice and diligence until constructive reduction to practice.

The Board ultimately found that Itou did not qualify as prior art and that Medtronic therefore had not shown that the challenged claims were unpatentable. One of the issues before the Board was whether in vivo testing was required for actual reduction to practice because the claims at issue were method claims reciting “advancing . . . a guide catheter . . . through a main blood vessel to an ostium of a coronary artery.” The Board ultimately found that no such testing was required, explaining that Medtronic “was unable to identify any legal precedent requiring in vivo performance of a claimed in vivo method to show actual reduction to practice.” According to the Board, actual reduction to practice could “be verified using a physical model that replicates the anatomy in which the method would likewise be performed in vivo.” Medtronic appealed.

Medtronic challenged the Board’s determination regarding constructive reduction to practice, arguing as follows:

In addressing diligence, the Board simply adopted its earlier erroneous diligence analysis in IPR2020-00132. Appx61–62. Therefore, if this Court vacates the Board’s diligence holding in No. 21-2356, it should likewise vacate the Board’s decision here. Appellant’s Br. at 41.

The Federal Circuit explained that it did not vacate the diligence holding in the prior decision, so Medtronic’s condition precedent had not been met. Medtronic nevertheless urged the Court to decide the diligence question. The Court refused, finding that Medtronic improperly incorporated by reference an argument from another brief. The Court explained that it would be fundamentally unfair to allow Medtronic to use incorporation by reference to exceed the word limit on briefs. The Court observed that parties pursuing appeals must make certain strategic decisions concerning what material to include in their opening briefs, and here, Medtronic affirmatively chose not to include developed arguments on diligence. The Court therefore found that Medtronic waived its challenge to the Board’s diligence finding. With the diligence issue waived and conception stipulated, the Court affirmed [...]

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Distinguishing Drinkware—Provisional Priority Determined Differently in Pre- and Post-AIA Patents

by | Nov 30, 2023 | ,

In a precedential final written decision, the Patent Trial & Appeal Board concluded that a patent does not need to contain a claim supported by a provisional application’s disclosure to draw priority to that provisional for prior art purposes post America Invents Act (AIA). Penumbra, Inc. v. RapidPulse, Inc., IPR2021-01466, paper 34 (PTAB Mar. 10, 2023) (designated precedential Nov. 15, 2023) (Melvin, Cotta, Wisz, APJs).

Penumbra filed an inter partes review (IPR) petition targeting a patent directed to a “thrombectomy system,” which is a system for removing blood clots in the brain. Penumbra challenged the claims on four different grounds, and each included the Tiegen reference. Therefore, the petition would fail if the Tiegen reference was not prior art.

The challenged patent was filed on July 18, 2019, and drew priority to a provisional application filed on October 24, 2018. Tiegen drew priority to two provisional applications—one dated December 12, 2018, and another dated July 24, 2018. Whether Tiegen was prior art thus depended on whether the challenged patent could draw priority to its provisional application, and whether Tiegen could draw priority to its July 24, 2018, provisional. RapidPulse challenged Tiegen on both bases.

First, the Board assessed the proper priority date for the challenged patent. The Board explained that in order for the patent to draw priority to its provisional application, that provisional application had to provide written support for the challenged patent’s claims. Penumbra argued that the challenged patent’s provisional application did not have written support for the claimed “prevent[ing] forward flow.” RapidPulse responded, arguing that the disclosure of a “minimal amount of momentum from the fluid column” disclosed the claimed “preventing forward flow.” Forward flow generates momentum from the fluid column, so minimizing momentum required preventing fluid flow, according to RapidPulse. RapidPulse also pointed to embodiments that had substantially no forward flow from the distal end of the system.

Penumbra responded by explaining that the provisional application required forward flow in some embodiments, and nothing in the specification stated that the flow should be prevented. The Board agreed, explaining that the provisional application included embodiments with forward flow, and while the provisional recited some embodiments with small amounts of forward flow, the provisional did not indicate that the low forward flow was significant. The Board observed that “one cannot disclose a forest in the original application, and then later pick a tree out of the forest.”

Having determined that the priority date of the challenged patent was July 18, 2019, the Board turned to the priority date of Tiegen. The Board distinguished the present case over Dynamic Drinkware, a 2015 US Court of Appeals for the Federal Circuit case. Dynamic Drinkware states that for prior art purposes, a prior art patent can only draw priority to a provisional application if the prior art patent contains a claim supported by that provisional application. The Board explained that Dynamic Drinkware does not apply post-AIA. Instead, the Board found that, based on the language of AIA 35 [...]

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TikTok Makes It Out of West Texas to Sunny Northern California

by | Nov 16, 2023 |

The US Court of Appeals for the Fifth Circuit granted a writ of mandamus ordering the transfer of a case, finding that the district court’s denial of the motion to transfer “was so patently erroneous” that the extreme measure was appropriate. In re TikTok, Inc., Case No. 23-50575 (5th Cir. Oct. 31, 2023) (Smith, Southwick, Wilson, JJ.)

In the underlying case, Beijing Meishe Network Technology Co. sued TikTok in the US District Court for the Western District of Texas, alleging infringement, trade secret misappropriation and false advertising. All claims stemmed from the theory that a former Meishe employee disclosed copyrighted source code for video and audio editing software to TikTok, which TikTok then implemented into its app. Meishe and TikTok are Chinese companies, and both the alleged disclosure and TikTok’s alleged code implementation occurred in China, assisted by TikTok engineers in California. TikTok has no engineers in Texas but does maintain a business office there, although not within the Western District.

TikTok moved under 28 U.S.C. § 1404 to transfer the case to the Northern District of California. The district court took 11 months to rule on the motion, and in the meantime the case continued through discovery. After the district court denied the motion, TikTok petitioned the Fifth Circuit for a writ of mandamus.

The sole issue on mandamus was the propriety of the district court’s refusal to transfer venue. To succeed on a writ of mandamus, a petitioner must satisfy the reviewing court regarding the following questions:

  1. Are there other ways to obtain the desired relief?
  2. Is the reviewing court’s right to issue the writ “clear and indisputable”?
  3. Is the writ appropriate, given the circumstances?

The Fifth Circuit focused on the second question, its right to issue the writ. In the Fifth Circuit, the 2008 en banc In re Volkswagen case mandates an eight-factor test that a district court must consider in deciding a § 1404 transfer motion. No one factor is dispositive, and the Fifth Circuit has cautioned against tallying the yes/no results or denying transfer just because most factors are neutral. Unsurprisingly, in the 15 years since Volkswagen, district courts applying these factors have reached inconsistent results. Even the Fifth Circuit has reached “conflicting outcomes” when reviewing these cases. The Fifth Circuit therefore took the opportunity to address each factor.

The Fifth Circuit found that two factors weighed in favor of transfer:

  • The relative ease of access to sources of proof
  • The cost of attendance of willing witnesses

Regarding ease of access to proof, the Fifth Circuit clarified that factfinders analyze “relative ease of access, not absolute ease of access” to documents and other physical evidence. The district court had determined that this factor was neutral, given that most documentation was electronic. The Fifth Circuit disagreed, explaining that while the source code was electronically stored, it was protected by a high level of security clearance. Only certain TikTok employees based in California and China were able to access the code. Using the relative metric, [...]

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A Step Forward for Choreography and Copyright

by | Nov 16, 2023 |

In a rare ruling on infringement of a copyright on choreography, the US Court of Appeals for the Ninth Circuit reversed the dismissal of a copyright infringement action, holding that the district court erred in its application of the substantial similarity standard in terms of the line between animation and choreography, and remanded for further proceedings. Hanagami v. Epic Games, Inc., Case No. 22-55890 (9th Cir. Nov. 1, 2023) (Murguia, C.J.; Paez, Nguyen, JJ.)

Kyle Hanagami, a Los Angeles-based choreographer with a substantial social media following, brought this action against Epic Games, creator of the blockbuster video game Fortnite. Hanagami alleged that Epic infringed his copyrighted choreography by incorporating a portion of his dance work into a virtual animation, known as an “emote,” that players can purchase for video game avatars to perform. Hanagami has created choreography for famous pop stars and globally recognized brands. The five-minute choreographic work at issue in this action was originally published on YouTube in November 2017 and had received almost 36 million views as of Hanagami’s original March 2022 complaint.

In August 2020, Epic released a version of Fortnite that included a new emote called “It’s Complicated.” The allegedly copied choreography consisted of a two-second combination of eight bodily movements set to four beats of movement, which Hanagami alleged “contain[ed] the most recognizable portion” of his choreography. Hanagami brought federal claims alleging direct and contributory infringement of a copyright, as well as a state law unfair competition claim.

The district court granted Epic’s motion to dismiss wherein Epic asserted that Hanagami had not plausibly alleged that the Fortnite emote displayed “substantial similarity” to his choreographic work. Hanagami appealed.

At issue in this appeal was whether the district court had properly applied the Ninth Circuit’s two-part test for substantial similarity in assessing Hanagami’s infringement allegations. The first part, called the “extrinsic test,” focuses only on the protectable elements of the plaintiff’s expression and assesses the objective similarities between the original and the allegedly infringing work. The second part, referred to as the “intrinsic test,” gauges similarity of expression from the perspective of the ordinary reasonable observer and is reserved for the trier of fact. Hence, at the pleadings stage, only the extrinsic test is applied.

The Ninth Circuit concluded that the district court erred in its application of the extrinsic test in two ways. First, the district court incorrectly analyzed Hanagami’s choreography as a series of unprotectable “poses,” rather than as a movement sequence that includes expressive elements such as body position, timing, use of space, energy, pauses and repetition. The Court explained that when a dance work is properly analyzed as a selection and arrangement of movements, Hanagami “plausibly alleged that the creative choices he made in selecting and arranging elements . . . are substantially similar to the choices Epic made in creating the emote.” Second, the district court erred in dismissing Hanagami’s claim because the choreography in the emote was “short” and a “small component” of the original work. The Ninth Circuit [...]

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