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Exploring the latest in intellectual property law
IP UPDATE
Exploring the latest in intellectual property law
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Show Your Work: PTO Director’s Procedure for Issuing Instructions Is Reviewable

by | Mar 23, 2023 |

The US Court of Appeals for the Federal Circuit affirmed the district court’s finding under the Administrative Procedure Act (APA) that the substance of the US Patent & Trademark Office (PTO) Director’s instructions is unreviewable but reversed the finding that the cloak of unreviewability extended to the procedure used in issuing the instructions. Apple v. Vidal, Case No. 22-1249 (Fed. Cir. Mar. 13, 2023) (Lourie, Taranto, Stoll, JJ.)

The creation of the inter partes review (IPR) program opened new avenues for reviewing the validity of patents following issuance. Since the program’s inception, Congress has recognized that there is a possibility of parallel proceedings at the Patent Trial & Appeal Board and in the district court, that such proceedings could result in conflicting decisions and reduced efficiency in the system. However, Congress left it to the discretion of the two branches to work out such situations among themselves.

As one lever to overcome these issues, Congress provided the Director with unreviewable discretion in deciding whether to institute an IPR. Recently, the Director attempted to leverage this power to increase efficiencies and reduce gamesmanship by instructing the Board on what to consider when instituting an IPR.

Apple and four other companies challenged these instructions in the district court. Apple argued that the Director’s instructions violated the APA by being contrary to the IPR provisions, arbitrary and capricious, and issued without the notice-and-comment rulemaking required under the APA.

Following a motion to dismiss, the district court concluded that Apple’s challenges were directed at the Director’s actions, making them unreviewable by the court. Apple appealed.

On appeal, the Federal Circuit considered all three of Apple’s APA challenges to the instructions, along with whether Apple had standing to bring the suit. The Court agreed with the district court that the question of whether an instruction violates the APA by being contrary to the IPR provisions or by being arbitrary and capricious is directed to the substance of the Director’s action and is not reviewable: “§ 314(a) invests the Director with discretion on the question whether to institute review . . . : The determination by the Director whether to institute an inter partes review . . . shall be final and nonappealable.” As the Federal Circuit noted, this conclusion rests on the well-supported need for the PTO Director to give guidance to delegatees on how to make institution determinations.

The Federal Circuit disagreed that the announcement procedure the Director used for issuing the instructions to the Board was unreviewable, however. As the Court noted, the procedure employed by an agency to announce guidelines is “quite apart” from the substance of those guidelines. Given this distinction, the Court concluded that the procedure the Director used to announce the instructions was reviewable: “The government here has not shown that anything in § 314(d) or elsewhere in the IPR statute supplies clear and convincing evidence that there was to be no judicial review of the choice of announcement procedure, a matter for which generally applicable standards exist.”

The [...]

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Transfer Motions Take Priority Regardless of Target District

by | Mar 16, 2023 |

The US Court of Appeals for the Federal Circuit granted a writ of mandamus and ordered the district court to decide a motion for intra-district transfer before proceeding to further substantive matters, explaining that both intra-district and inter-district transfer motions must be prioritized. In re: Apple Inc., Case No. 23-120 (Fed. Cir. Mar. 6, 2023) (per curiam) (nonprecedential).

SpaceTime3D sued Apple for patent infringement in February 2022 in the Western District of Texas, Waco Division. In July 2022, Apple moved to transfer the action within the Western District to Austin. The motion was fully briefed by the parties on November 7, 2022. The claim construction hearing was scheduled for November 17, 2022, based on an agreement between the parties. The day before the hearing, Apple moved to stay the hearing and all other proceedings until the district court ruled on Apple’s pending motion to transfer. The district court deferred claim construction, then denied Apple’s stay motion. The district court acknowledged that it was required to prioritize a motion for inter-district transfer but stated that “it does not have to stay the proceedings or decide whether to transfer the case intra-district until closer to trial.” Apple filed a writ of mandamus with the Federal Circuit.

The Federal Circuit noted that although the remedy of mandamus is drastic and should be invoked only in extraordinary situations, it has previously granted mandamus “to correct a clearly arbitrary refusal to act on a longstanding pending transfer motion.” The Federal Circuit stated that under Fifth Circuit law, precedent entitles parties to have their transfer motions prioritized. The Federal Circuit was not swayed by the trial court’s reliance on a statement in an unpublished, nonprecedential Fifth Circuit decision in Sundell v. Cisco Systems, Inc., because the Fifth Circuit did not suggest any discretion in the prioritization of transfer motions based on the type of transfer. The Federal Circuit explained that the Fifth Circuit does not require that inter-district transfer motions be prioritized to the exclusion of intra-district transfer motions. The Federal Circuit granted Apple’s petition for mandamus and ordered the district court to timely decide the transfer motion before proceeding with further substantive matters beyond the claim construction hearing.



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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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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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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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The Alice Eligibility Two-Step Dance Continues

by | Mar 2, 2023 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s dismissal of a Fed. R. Civ. P. 12(b)(6) motion, holding that patent claims directed to abstract ideas and lacking inventive steps that transform abstract ideas into patent-eligible inventions fail the Alice two-step test and are not patent eligible under 35 U.S.C. § 101. Hawk Tech. Sys., LLC v. Castle Retail, LLC, Case No. 22-1222 (Fed. Cir. Feb. 17, 2023) (Reyna, Hughes, Cunningham, JJ.)

35 U.S.C. § 101 states that laws of nature, natural phenomena and abstract ideas are not patentable. The Supreme Court of the United States in Alice v. CLS Bank Int’l (2014) articulated a two-step test for examining patent eligibility: a patent claim falls outside § 101 if it is directed to a patent-ineligible concept such as an abstract idea and lacks elements sufficient to transform the claim into a patent-eligible application.

Hawk Technology sued Castle Retail alleging infringement of its patent directed to security surveillance video operations in Castle Retail’s grocery stores. The patent relates to a method of viewing multiple simultaneously displayed and stored video images on a remote viewing device of a video surveillance system using result-based functional language. Castle Retail moved to dismiss on the basis that the claims were not patent eligible under § 101. After conducting a technology briefing, the district court granted the motion. The district court ruled that the claims were abstract because surveillance monitoring is a common business practice and the claims recited little more than taking video surveillance and digitizing it for display and storage in a conventional computer system, and the claims did not limit the abstract idea to a new technological improvement in video storage/display that could transform the abstract idea into a patent-eligible invention. Hawk Technology appealed.

The Federal Circuit, reviewing de novo, affirmed. Addressing Alice step one, the Court found that the patent’s required functional results of receiving/digitizing video images, converting images to selected format and storing/displaying/transmitting the images were similar to claims that the Court previously ruled as abstract. The results-oriented claim language failed to concretely recite how the claimed invention improved the functionality of video surveillance systems and was therefore abstract. Regarding Alice step two, the Court analyzed the claim elements, both individually and as an ordered combination in light of the specification, for transformative elements. The Court explained that although the claims recited the purported inventive solution and referenced specific tools/parameters, they neither showed how monitoring and storage was improved nor required anything other than off-the-shelf, conventional computer, network and display technology for gathering, sending and presenting the specified information.

Procedurally, the Federal Circuit found that the motion to dismiss was not decided prematurely because the technology briefing was purely a procedural step conducted in each patent case and there was no evidence that the district court’s decision hinged on new facts constituting matters beyond the pleadings. Hawk had argued that because the district court considered Castle’s testimony and evidence, it was required to convert the [...]

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DC Circuit to Disputes Ancillary to Patent Matters: “You Can’t Sit with Us”

by | Mar 2, 2023 |

For the first time, the US Court of Appeals for the District of Columbia Circuit addressed whether appeals of discovery orders ancillary to a patent suit are within the exclusive jurisdiction of the US Court of Appeals for the Federal Circuit. The DC Circuit joined its sister circuits and held in the affirmative. Fraunhofer-Gesellschaft Zur Förderung Der Angewandten Forschung E.V. v. Sirius XM Radio Inc., Case No. 22-7001 (DC Cir. Feb. 17, 2023) (Srinivasan, Henderson, JJ., Edwards, Sr. J.)

In February 2017, Fraunhofer-Gesellschaft Zur Förderung commenced a civil action for patent infringement against Sirius XM Radio in the District of Delaware. During discovery, Fraunhofer subpoenaed for deposition Sirius XM’s former Chief of Marketing Officer, My-Chau Nguyen, a resident of Washington, DC.

After Nguyen failed to appear for her deposition, she filed a motion in the US District Court for the District of Columbia to quash the subpoena. Fraunhofer responded with a cross-motion to compel Nguyen’s deposition and a motion for sanctions. The DC district court denied Nguyen’s motion to quash, ordered her to sit for deposition, found her in contempt for failing to appear for deposition in the first instance, and expressed an intent to award sanctions upon Fraunhofer’s submission of documentation reflecting fees and costs. Fraunhofer appealed to the DC Circuit.

The DC Circuit first addressed whether it had jurisdiction to consider Nguyen’s challenge to the district court’s order compelling her deposition in light of the fact that Nguyen’s deposition had already been taken at the time of appeal. The Court held that Nguyen’s challenge was moot because “[n]umerous courts have held that an appeal from enforcement of a subpoena becomes moot once the party has complied with the subpoena.” Therefore, the Court reasoned that it lacked jurisdiction to consider Nguyen’s subpoena challenge because she had already complied with the subpoena at the time of the appeal.

Next, the Court addressed whether it had jurisdiction to assess the merits of Nguyen’s challenge to the district court’s finding of contempt and intent to award sanctions. The Court determined that it did not have subject matter jurisdiction to consider these issues.  The Court explained that because “the underlying litigation between Fraunhofer and Sirius XM in the District of Delaware arises under an Act of Congress relating to patents[,]” Nguyen’s discovery dispute in the DC district court was “ancillary to a patent suit.” The DC Circuit reasoned that only the Federal Circuit is vested with jurisdiction over appeals “arising under . . . any Act of Congress related to patents[.]” (28 U.S.C. § 1295(a)(1).) Holding similarly to other circuits, the Court concluded that because Nguyen’s discovery dispute was ancillary to a patent matter, the ability to decide the merits of her appeal was solely within the province of the Federal Circuit.

The DC Circuit found that it did not have the authority to transfer Nguyen’s challenges to the Federal Circuit, however. The DC Circuit concluded that it was forced to dismiss rather than transfer because “this appeal could not have been brought [...]

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When It Comes to Claim Construction, Prosecution History and Specification Rule

by | Feb 23, 2023 |

Addressing claim constructions across two patents that ultimately led to noninfringement findings by a district court, the US Court of Appeals for the Federal Circuit affirmed one construction because it was supported by the prosecution history but reversed another because it was unsupported by the specification. SSI Techs., LLC v. Dongguan Zhengyang Elec. Mech. Ltd., Case Nos. 21-2345, 22-1039 (Fed. Cir. Feb. 13, 2023) (Reyna, Bryson, Cunningham, JJ.)

SSI owns two patents directed to sensors for determining the characteristics of fluid in a container such as a fuel tank. One patent, referred to as the transducer patent, describes an exemplary sensor system containing a “level” transducer and a “quality” transducer. The two transducers use ultrasonic sound waves and time of flight to determine both a level of fluid in a given tank and a quality (i.e., concentration of diesel exhaust fluid). The other patent, referred to as the filter patent, describes a similar system but attempts to address the problem of erratic measurement results that may occur because of air bubbles embedded in the fluid. This patent claims a “filter” covering the sensing area that substantially prohibits gas bubbles from entering the sensing area.

Dongguan Zhengyang Electronic Mechanical (DZEM) produces systems that determine the quality and volume of diesel exhaust fluid that are used in emission-reduction systems for diesel truck engines. SSI accused DZEM of infringing both patents. In the district court action, DZEM brought a motion for summary judgment of noninfringement based on the court’s construction of certain terms that appear in the asserted claims. With reference to the transducer patent, the claims recite the need to “determine whether a contaminant exists in the fluid based on . . . a dilution of the fluid [] detected while the measured volume of the fluid decreases.” The district court determined that this claim element required that the contaminant determination actually consider the measured volume of the fluid. The district court predicated its determination on the prosecution history, having found that this term was amended to include the disputed term and that the applicant’s intention was to incorporate the specific error-detection capability recited in the specification. The parties had previously agreed that the DZEM products did not base the contamination determination on any consideration of the measured volume. As a result, the district court granted DZEM’s motion for summary judgment of noninfringement on the transducer patent.

Regarding the filter patent, the district court adopted DZEM’s construction of the term “filter,” which was “a porous structure defining openings, and configured to remove impurities larger than said openings from a liquid or gas passing through the structure.” DZEM’s accused sensors includes a rubber cover with four apertures. The district court found that the rubber cover was not “porous” because the apertures were “relatively large” when compared with the disclosed embodiments in the specification. As a result, the court granted DZEM’s motion for summary judgment of noninfringement on the filter patent. SSI appealed.

SSI challenged both constructions. Regarding the transducer patent, SSI argued that [...]

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No First Place Trophy Here: Public Demo at Trade Show Found Invalidating

by | Feb 23, 2023 | ,

Addressing the public use bar of pre-America-Invents-Act (AIA) 35 U.S.C. § 102(b), the US Court of Appeals for the Federal Circuit affirmed a district court’s decision to invalidate a patent because the patent owner’s disclosure of a prior art device at a trade show more than one year before the patent’s priority date was an invalidating prior public use. Minerva Surgical, Inc. v. Hologic, Inc., Case No. 21-2246 (Fed. Cir. Feb. 15, 2023) (Prost, Reyna, Stoll, JJ.)

Minerva sued Hologic for infringement of a patent directed to surgical devices for a procedure called endometrial ablation, which stops or reduces abnormal uterine bleeding. The patent had a priority date of November 7, 2011, and the asserted claim included the term “the inner and outer elements have substantially dissimilar material properties” (SDMP term). The district court construed the SDMP term to mean that the “inner and outer frame elements have different thickness and different composition.”

On completion of discovery, Hologic moved for summary judgment of invalidity, arguing that the asserted patent claims were anticipated under the public use bar of pre-AIA § 102(b). According to Hologic, more than a year before the patent’s priority date, Minerva brought a device called Aurora to the 38th Global Congress of Minimally Invasive Gynecology sponsored by the American Association of Gynecologic Laparoscopists (AAGL 2009)—an event dubbed the “Super Bowl of the industry.” During the AAGL 2009 conference, Minerva had a booth with 15 fully functional Aurora devices, gave a presentation discussing the Aurora devices and distributed brochures. In light of the record, the district court granted summary judgment that the asserted claims were anticipated under the public use bar. Minerva appealed.

Minerva raised three arguments on appeal. First, Minerva argued that disclosure of the Aurora device at AAGL 2009 was not a “public use” because Minerva “merely displayed” the device. Second, Minerva argued that there was no disclosure of the “invention” of the asserted claim because the Aurora device disclosed at AAGL 2009 lacked the SDMP term. Third, Minerva argued that the invention was not “ready for patenting” because Minerva was still improving the SDMP technology at the time of AAGL 2009, so the device did not function for its intended purpose of ablating “live human” tissue. The Federal Circuit addressed each argument in turn.

The Federal Circuit found that the district court had correctly determined that the Aurora device at AAGL 2009 was a “public use” since it was shown to individuals other than the inventor under no limitation, restriction or obligation of confidentiality. The undisputed record showed that Minerva pitched the Aurora device to various sophisticated industry members, who were allowed, without confidentiality obligations, to scrutinize the Aurora device closely enough to recognize and understand the SDMP technology Minerva later sought to patent.

The Federal Circuit also concluded that the Aurora device disclosed the SDMP term. The Court found that the inventors conceived of the SDMP technology before AAGL 2009 and that documentation about the Aurora device from before and shortly after the event [...]

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Patenting a Nice Cool Glass of Nicotinamide Riboside? Claims Covering Milk Invalid under § 101

by | Feb 23, 2023 |

The US Court of Appeals for the Federal Circuit found that claims covering a naturally occurring composition were not patent eligible under 35 U.S.C. § 101 merely because one component of the composition had been “isolated.” ChromaDex, Inc. v. Elysium Health, Inc., Case No. 2022-1116 (Fed. Cir. Feb. 13, 2023) (Chen, Prost, Stoll, JJ.)

ChromaDex sued Elysium (a former ChromaDex customer) for infringement of its patent directed to dietary supplements containing nicotinamide riboside (NR). Elysium moved for summary judgment, arguing that the asserted claims were invalid under the § 101 prohibition against patenting natural phenomena. After the district court granted summary judgment, ChromaDex appealed.

The asserted claims were directed to a composition comprising:

  • Isolated NR
  • One or more of tryptophan, nicotinic acid or nicotinamide
  • One of 22 carriers
  • Increased NAD+ biosynthesis after eating.

Both parties conceded that milk satisfies every element of the asserted claims with the exception that its NR is not “isolated.” Both parties also conceded that milk is a naturally occurring material and thus not patent eligible under § 101.

On these facts, the issue presented was whether the claim limitation that the NR must be “isolated” (which does not occur in nature) was sufficient to make the claims patent eligible. The Federal Circuit responded “no.”

The Federal Circuit analyzed the asserted claims under two tests: the “markedly different characteristics” test set out in Chakrabarty, and the Alice two-step test (unsure whether Chakrabarty remains controlling precedent).

Under the Chakrabarty test, a claimed composition is not a natural phenomenon if it has “markedly different characteristics” from what occurs in nature. The Federal Circuit found that ChromaDex’s claimed composition had no markedly different characteristics from natural milk. While ChromaDex argued that isolation potentially allowed for unnaturally high concentrations of NR, the claims did not require such concentrations. The claims included compositions structurally and functionally identical to milk and therefore failed the “markedly different characteristics” Chakrabarty test.

Proceeding to the two-part Alice test, under step 1 the Federal Circuit found that the claims were directed to a product of nature because there were no structural differences between the claimed composition and natural milk. Under step two, the Court found that there was no “inventive step” because the claims were merely directed to increasing NAD+ biosynthesis, which was a natural principle that resulted from drinking milk.

Practice Note: During claim drafting, care should be taken to avoid claims that encompass all structural and functional components of a naturally occurring material.



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