Nantkwest, Inc. appeals from a decision of the United States District Court for the Eastern District of Virginia granting-in-part and denying-in-part the United States Patent and Trademark Office (“USPTO”) Director’s motion for fees. In its order, the district court granted the Director’s requested witness’ fees but denied the requested attorneys’ fees. The Director appeals the court’s denial of attorneys’ fees. We reverse.
The Board of Trustees of the Leland Stanford Junior University (“Stanford”) appeals from orders of the Patent Trial and Appeal Board (“Board”) in three interference proceedings between Stanford and the Chinese University of Hong Kong (“CUHK”). In all of these proceedings, the Board found that Stanford’s claims were unpatentable for lack of written description. See Quake v. Lo, No. 105,920 (P.T.A.B. Apr. 7, 2014); Lo v. Quake, No. 105,923 (P.T.A.B. Apr. 7, 2014); Lo v. Quake, No. 105,924 (P.T.A.B. Apr. 7, 2014).1 Because we conclude that the Board relied on improper evidence to support its key findings and did not cite to other substantial evidence to support its findings, we vacate the Board’s interference decisions and remand for further proceedings.
Are You A Young Inventor? File A Patent Tips and advice on how young inventors can protect their intellectual property.
by Lauren J. Young
The children really are our future—some of the most innovative ideas and inventions can come from our youth. The creative caliber of young inventors’ scientific ideas was reflected at the May 2017 Intel International Science and Engineering Fair. The world’s largest science competition, it features the projects of nearly 1,800 pre-college students. Students from grades 9 to 12 showcased experiments, applications, and designs from a solar power heater, to a remote control aircraft, to a space debris tracker. And some of these young inventors are thinking ahead on how to apply (and protect) their projects.
“As I move forward into college, I’m really looking into how I can protect the intellectual property on this,” Amber Yang, who won an Intel Foundation Young Scientist Award for her artificial neural network space debris tracker, told Science Friday in a recent interview. “I think, definitely, I will either try to get my work published in a journal or actually pursue a patent so I can begin licensing my work out to companies who might be interested.”
This patent interference contest involves methods of treating hepatitis C by administering compounds having a specific chemical and stereochemical structure, based on the following foundation formula of a five-membered ring having the fluorine substituent in the 2´(down) position:
Storer Br. at 8. The priority decision was based on enablement of this product. The interference was declared between an issued patent (Storer et al.) and a pending application (Clark), both of which were filed before the effective date of the America Invents Act, the statute that abolished the first-to-invent interference rule in favor of a first-to-file rule. By the terms of the Act, § 3(n)(2), the prior, first-to-invent, law applies to this interference.
To establish priority, Storer relied on the disclosure in the provisional specification from which priority was claimed for conception and constructive reduction to practice. In its joint decision on Clark’s motion to deny Storer the benefit of the provisional application and on Clark’s motion to invalidate Storer’s claims on the grounds of lack of enablement and written description,1 the Patent Trial and Appeal Board (PTAB or “Board”) held that Storer’s provisional application was not enabling for the count of the interference, and on that ground the PTAB entered judgment granting priority to Clark.2 Storer appeals that judgment and the underlying decision on Clark’s motions.
We take note that Storer initially filed in the District of Delaware, seeking review of the Board’s decision under 35 U.S.C. § 146. The district court dismissed the case, Idenix Pharmaceuticals. LLC v. Gilead Pharmasset LLC, 2016 WL 6804915, at *1 (D. Del. Nov. 16, 2016), based on this court’s ruling in Biogen MA, Inc. v. Japanese Foundation for Cancer Research, 785 F.3d 648 (Fed. Cir. 2015), that the America Invents Act eliminated the option of district court review under Section 146 for interferences declared after September 15, 2012. Although Storer says that Biogen was incorrectly decided, that decision is binding on this panel. Storer’s appeal of the district court’s dismissal has been stayed pending the outcome of this appeal. Order, Idenix Pharm. LLC v. Gilead Pharmasset LLC, No. 17-1369 (Fed. Cir. Feb. 16, 2017).
The panel affirmed the district court’s order denying defendants’ anti-SLAPP motion to strike a state law claim for breach of implied-in-fact contract in a copyright case.
The plaintiff alleged that the defendants infringed his copyright in a screenplay and used his screenplay idea to create films without providing him compensation as a writer. The panel held that the breach of contract claim did not arise from an act in furtherance of the right of free speech because the claim was based on defendants’ failure to pay for the use of plaintiff’s idea, not the creation, production, distribution, or content of the films. Accordingly, the district court did not err in denying defendants’ motion to strike the state law claim under California’s anti-SLAPP statute.
Simon Tam, lead singer of the rock group “The Slants,” chose this moniker in order to “reclaim” the term and drain its denigrating force as a derogatory term for Asian persons. Tam sought federal registration of the mark “THE SLANTS.” The Patent and Trademark Office (PTO) denied the application under a Lanham Act provision prohibiting the registration of trademarks that may “disparage . . . or bring . . . into contemp[t] or disrepute” any “persons, living or dead.” 15 U. S. C. §1052(a). Tam contested the denial of registration through the administrative appeals process, to no avail. He then took the case to federal court, where the en banc Federal Circuit ultimately found the disparagement clause facially unconstitutional under the First Amendment’s Free Speech Clause.
Held: The judgment is affirmed. 808 F. 3d 1321, affirmed.
JUSTICE ALITO delivered the opinion of the Court with respect to Parts I, II, and III–A, concluding:
1. The disparagement clause applies to marks that disparage the members of a racial or ethnic group. Tam’s view, that the clause applies only to natural or juristic persons, is refuted by the plain terms of the clause, which uses the word “persons.” A mark that disparages a “substantial” percentage of the members of a racial or ethnic group necessarily disparages many “persons,” namely, members of that group. Tam’s narrow reading also clashes with the breadth of the disparagement clause, which by its terms applies not just to “persons,” but also to “institutions” and “beliefs.” §1052(a). Had Congress wanted to confine the reach of the clause, it could have used the phrase “particular living individual,” which it used in neighboring §1052(c). Tam contends that his interpretation is supported by legislative history and by the PTO’s practice for many years of registering marks that plainly denigrated certain groups. But an inquiry into the meaning of the statute’s text ceases when, as here, “the statutory language is unambiguous and the statutory scheme is coherent and consistent.” Barnhart v. Sigmon Coal Co., 534 U. S. 438, 450 (internal quotation marks omitted). Even if resort to legislative history and early enforcement practice were appropriate, Tam has presented nothing showing a congressional intent to adopt his interpretation, and the PTO’s practice in the years following the disparagement clause’s enactment is unenlightening. Pp. 8–12.
2. The disparagement clause violates the First Amendment’s Free Speech Clause. Contrary to the Government’s contention, trademarks are private, not government speech. Because the “Free Speech Clause . . . does not regulate government speech,” Pleasant Grove City v. Summum, 555 U. S. 460, 467, the government is not required to maintain viewpoint neutrality on its own speech. This Court exercises great caution in extending its government-speech precedents, for if private speech could be passed off as government speech by simply affixing a government seal of approval, government could silence or muffle the expression of disfavored viewpoints.The Federal Government does not dream up the trademarks registered by the PTO. Except as required by §1052(a), an examiner may not reject a mark based on the viewpoint that it appears to express. If the mark meets the Lanham Act’s viewpoint-neutral requirements, registration is mandatory. And once a mark is registered, the PTO is not authorized to remove it from the register unless a party moves for cancellation, the registration expires, or the Federal Trade Commission initiates proceedings based on certain grounds. It is thus far fetched to suggest that the content of a registered mark is government speech, especially given the fact that if trademarks become government speech when they are registered, the Federal Government is babbling prodigiously and incoherently. And none of this Court’s government-speech cases supports the idea that registered trademarks are government speech. Johanns v. Livestock Marketing Assn., 544 U. S. 550; Pleasant Grove City v. Summum, 555 U. S. 460; and Walker v. Texas Div., Sons of Confederate Veterans, Inc., 576 U. S. ___, distinguished. Holding that the registration of a trademark converts the mark into government speech would constitute a huge and dangerous extension of the government-speech doctrine, for other systems of government registration (such as copyright) could easily be characterized in the same way. Pp. 12–18.
JUSTICE ALITO, joined by THE CHIEF JUSTICE, JUSTICE THOMAS, and JUSTICE BREYER, concluded in Parts III–B, III–C, and IV:
(a) The Government’s argument that this case is governed by the Court’s subsidized-speech cases is unpersuasive. Those cases all involved cash subsidies or their equivalent, e.g., funds to private parties for family planning services in Rust v. Sullivan, 500 U. S. 173, and cash grants to artists in National Endowment for Arts v. Finley, 524 U. S. 569. The federal registration of a trademark is nothing like these programs. The PTO does not pay money to parties seeking registration of a mark; it requires the payment of fees to file an application and to maintain the registration once it is granted. The Government responds that registration provides valuable non-monetary benefits traceable to the Government’s resources devoted to registering the marks, but nearly every government service requires the expenditure of government funds. This is true of services that benefit everyone, like police and fire protection, as well as services that are utilized by only some, e.g., the adjudication of private lawsuits and the use of public parks and highways. Pp. 18–20.
(b) Also unpersuasive is the Government’s claim that the disparagement clause is constitutional under a “government-program” doctrine, an argument which is based on a merger of this Court’s government-speech cases and subsidy cases. It points to two cases involving a public employer’s collection of union dues from its employees, Davenport v. Washington Ed. Assn., 551 U. S. 177, and Ysursa v. Pocatello Ed. Assn., 555 U. S. 353, but these cases occupy a special area of First Amendment case law that is far removed from the registration of trademarks. Cases in which government creates a limited public forum for private speech, thus allowing for some content- and speaker-based restrictions, see, e.g., Good News Club v. Milford Central School, 533 U. S. 98, 106–107; Rosenberger v. Rector and Visitors of Univ. of Va., 515 U. S. 819, 831, are potentially more analogous. But even in those cases, viewpoint discrimination is forbidden. The disparagement clause denies registration to any mark that is offensive to a substantial percentage of the members of any group. That is viewpoint discrimination in the sense relevant here: Giving offense is a viewpoint. The “public expression of ideas may not be prohibited merely because the ideas are themselves offensive to some of their hearers.” Street v. New York, 394 U. S. 576, 592. Pp. 20–23.
(c) The dispute between the parties over whether trademarks are commercial speech subject to the relaxed scrutiny outlined in Central Hudson Gas & Elect. v. Public Serv. Comm’n of N. Y., 447 U. S. 557, need not be resolved here because the disparagement clause cannot withstand even Central Hudson review. Under Central Hudson, a restriction of speech must serve “a substantial interest” and be “narrowly drawn.” Id., at 564–565 (internal quotation marks omitted). One purported interest is in preventing speech expressing ideas that offend, but that idea strikes at the heart of the First Amendment. The second interest asserted is protecting the orderly flow of commerce from disruption caused by trademarks that support invidious discrimination; but the clause, which reaches any trademark that disparages any person, group, or institution, is not narrowly drawn. Pp. 23–26.
JUSTICE KENNEDY, joined by JUSTICE GINSBURG, JUSTICE SOTOMAYOR, and JUSTICE KAGAN, agreed that 15 U. S. C. §1052(a) constitutes viewpoint discrimination, concluding:
(a) With few narrow exceptions, a fundamental principle of the First Amendment is that the government may not punish or suppress speech based on disapproval of the ideas or perspectives the speech conveys. See Rosenberger v. Rector and Visitors of Univ. of Va., 515 U. S. 819, 828–829. The test for viewpoint discrimination is whether—within the relevant subject category—the government has singled out a subset of messages for disfavor based on the views expressed. Here, the disparagement clause identifies the relevant subject as “persons, living or dead, institutions, beliefs, or national symbols,” §1052(a); and within that category, an applicant may register a positive or benign mark but not a derogatory one. The law thus reflects the Government’s disapproval of a subset of messages it finds offensive, the essence of viewpoint discrimination. The Government’s arguments in defense of the statute are unpersuasive. Pp. 2–5.
(b) Regardless of whether trademarks are commercial speech, the viewpoint based discrimination here necessarily invokes heightened scrutiny. See Sorrell v. IMS Health Inc., 564 U. S. 552, 566. To the extent trademarks qualify as commercial speech, they are an example of why that category does not serve as a blanket exemption from the First Amendment’s requirement of viewpoint neutrality. In the realm of trademarks, the metaphorical marketplace of ideas becomes a tangible, powerful reality. To permit viewpoint discrimination in this context is to permit Government censorship. Pp. 5–7.
ALITO, J., announced the judgment of the Court and delivered the opinion of the Court with respect to Parts I, II, and III–A, in which ROBERTS, C. J., and KENNEDY, GINSBURG, BREYER, SOTOMAYOR, and KAGAN, JJ., joined, and in which THOMAS, J., joined except for Part II, and an opinion with respect to Parts III–B, III–C, and IV, in which ROBERTS, C. J., and THOMAS and BREYER, JJ., joined. KENNEDY, J., filed an opinion concurring in part and concurring in the judgment, in which GINSBURG, SOTOMAYOR, and KAGAN, JJ., joined. THOMAS, J., filed an opinion concurring in part and concurring in the judgment. GORSUCH, J., took no part in the consideration or decision of the case.
Outdry Technologies Corp. (“Outdry”) appeals from the Patent Trial and Appeal Board’s (“Board”) inter partes review decision holding that claims 1–15 of U.S. Patent No. 6,855,171 (“the ’171 patent”) would have been obvious over a combination of prior art. For the reasons discussed below, we affirm.
The Cleveland Clinic Foundation and Cleveland Heartlab, Inc. accused True Health Diagnostics LLC of infringement of three patents that claim methods for testing for myeloperoxidase in a bodily sample and a fourth patent that claims a method for treating a patient that has cardiovascular disease. The United States District Court for the Northern District of Ohio found that the asserted claims of the three testing patents are not directed to patent-eligible subject matter and that Cleveland Clinic failed to state a claim of contributory or induced infringement of the fourth patent. For the reasons explained below, we affirm.
EmeraChem Holdings, LLC (“EmeraChem”) appeals from a decision of the Patent Trial and Appeal Board (“Board”) that claims 1–14 and 16–20 of U.S. Patent No. 5,599,758 (“the ’758 patent”) would have been obvious over U.S. Patent No. 5,451,558 (“Campbell ’558”), Japanese Patent Application No. 62-106826 (“Saito”), and U.S. Patent No. 5,362,463 (“Stiles”). For the reasons set forth below, we affirm the Board’s decisions as to claims 1–2, 4– 14, and 17–19 and vacate and remand as to claims 3, 16, and 20.
The Biologics Price Competition and Innovation Act of 2009 (BPCIA or Act) provides an abbreviated pathway for obtaining Food and Drug Administration (FDA) approval of a drug that is biosimilar to an already licensed biological product (reference product). 42 U. S. C. §262(k). It also provides procedures for resolving patent disputes between biosimilar manufacturers (applicants) and manufacturers of reference products (sponsors). §262(l). The Act treats the mere submission of a biosimilar application as an “artificial” act of infringement, enabling parties to bring patent infringement actions at certain points in the application process even if the applicant has not committed a traditional act of patent infringement. See 35 U. S. C. §§271(e)(2)(C)(i), (ii).
Under §262(l)(2)(A), an applicant seeking FDA approval of a biosimilar must provide its application and manufacturing information to the sponsor within 20 days of the date the FDA notifies the applicant that it has accepted the application for review. This triggers an exchange of information between the applicant and sponsor designed to create lists of relevant patents and flesh out potential legal arguments. §262(l)(3). The BPCIA then channels the parties into two phases of patent litigation. In the first, the parties collaborate to identify patents on the lists for immediate litigation. The second phase—triggered when the applicant, pursuant to §262(l)(8)(A), gives the sponsor notice at least 180 days before commercially marketing the biosimilar—involves any listed patents not litigated in the first phase. The applicant has substantial control over the timing and scope of both phases of litigation. Failure to comply with these procedural requirements may lead to two consequences relevant here. Under §262(l)(9)(C), if an applicant fails to provide its application and manufacturing information to the sponsor under §262(l)(2)(A), then the sponsor, but not the applicant, may immediately bring an action “for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.” And under §262(l)(9)(B), if an applicant provides the application and manufacturing information but fails to complete a subsequent step in the process, the sponsor, but not the applicant, may bring a declaratory-judgment action with respect to any patent included on the sponsor’s list of relevant patents.
Neupogen is a filgrastim product marketed by Amgen, which claims to hold patents on methods of manufacturing and using filgrastim. Sandoz sought FDA approval to market a biosimilar filgrastim product under the brand name Zarxio, with Neupogen as the reference product. A day after the FDA informed Sandoz that its application had been accepted for review, Sandoz notified Amgen that it had submitted an application and that it intended to market Zarxio immediately upon receiving FDA approval. It later informed Amgen that it did not intend to provide the application and manufacturing information required by §262(l)(2)(A) and that Amgen could sue immediately for infringement under §262(l)(9)(C).
Amgen sued Sandoz for patent infringement and also asserted that Sandoz engaged in “unlawful” conduct in violation of California’s unfair competition law. This latter claim was predicated on two alleged violations of the BPCIA: Sandoz’s failure to provide its application and manufacturing information under §262(l)(2)(A), and its provision of notice of commercial marketing under §262(l)(8)(A) prior to obtaining licensure from the FDA. Amgen sought injunctions to enforce both BPCIA requirements. Sandoz counterclaimed for declaratory judgments that the asserted patent was invalid and not infringed and that it had not violated the BPCIA.
While the case was pending, the FDA licensed Zarxio, and Sandoz provided Amgen a further notice of commercial marketing. The District Court subsequently granted partial judgment on the pleadings to Sandoz on its BPCIA counterclaims and dismissed Amgen’s unfair competition claims with prejudice. The Federal Circuit affirmed in part, vacated in part, and remanded. The court affirmed the dismissal of Amgen’s state-law claim based on Sandoz’s alleged violation of §262(l)(2)(A), holding that Sandoz did not violate the BPCIA in failing to disclose its application and manufacturing information and that the BPCIA provides the exclusive remedies for failure to comply with this requirement. The court also held that under §262(l)(8)(A) an applicant must provide notice of commercial marketing after obtaining licensure, and that this requirement is mandatory. It thus enjoined Sandoz from marketing Zarxio until 180 days after the date it provided its second notice.
Held: Section 262(l)(2)(A) is not enforceable by injunction under federal law, but the Federal Circuit on remand should determine whether a state-law injunction is available. An applicant may provide notice under §262(l)(8)(A) prior to obtaining licensure. Pp. 10–18.
(a) Section 262(l)(2)(A)’s requirement that an applicant provide the sponsor with its application and manufacturing information is not enforceable by an injunction under federal law. The Federal Circuit reached the proper result on this point, but its reasoning was flawed. It cited §271(e)(4), which expressly provides the “only remedies” for an act of artificial infringement. In light of this language, the court reasoned that no remedy other than those specified in the text—such as an injunction to compel the applicant to provide its application and manufacturing information—was available. The problem with this reasoning is that Sandoz’s failure to disclose was not an act of artificial infringement remediable under §271(e)(4). Submitting an application constitutes an act of artificial infringement; failing to disclose the application and manufacturing information required by §262(l)(2)(A) does not.
Another provision, §262(l)(9)(C), provides a remedy for an applicant’s failure to turn over its application and manufacturing information. It authorizes the sponsor, but not the applicant, to bring an immediate declaratory-judgment action for artificial infringement, thus vesting in the sponsor the control that the applicant would otherwise have exercised over the scope and timing of the patent litigation and depriving the applicant of the certainty it could have obtained by bringing a declaratory-judgment action prior to marketing its product. The presence of this remedy, coupled with the absence of any other textually specified remedies, indicates that Congress did not intend sponsors to have access to injunctive relief, at least as a matter of federal law, to enforce the disclosure requirement. See Great-West Life & Annuity Ins. Co. v. Knudson, 534 U. S. 204, 209. Statutory context further confirms that Congress did not authorize courts to enforce §262(l)(2)(A) by injunction. Pp. 10–13.
(b) The Federal Circuit should determine on remand whether an injunction is available under state law to enforce §262(l)(2)(A). Whether Sandoz’s conduct was “unlawful” under California’s unfair competition statute is a question of state law, and the Federal Circuit thus erred in attempting to answer that question by referring only to the BPCIA. There is no dispute about how the federal scheme actually works on the facts of this case: Sandoz failed to disclose the requisite information under §262(l)(2)(A), and was accordingly subject to the consequence specified in §262(l)(9)(C). As a result, there is nothing to decide on this point as a matter of federal law. The court on remand should determine whether California law would treat noncompliance with §262(l)(2)(A) as “unlawful,” and whether the BPCIA pre-empts any additional state-law remedy for failure to comply with §262(l)(2)(A). Pp. 13–15.
(c) An applicant may provide notice of commercial marketing before obtaining a license. Section 262(l)(8)(A) states that the applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).” Because the phrase “of the biological product licensed under subsection (k)” modifies “commercial marketing” rather than “notice,” “commercial marketing” is the point in time by which the biosimilar must be “licensed.” Accordingly, the applicant may provide notice either before or after receiving FDA approval. Statutory context confirms that §262(l)(8)(A) contains a single timing requirement (180 days before marketing), rather than the two requirements posited by the Federal Circuit (after licensing, and 180 days before marketing). “Had Congress intended to” impose two timing requirements in §262(l)(8)(A), “it presumably would have done so expressly as it did in the” adjacent provision, §262(l)(8)(B). Russello v. United States, 464 U. S. 16, 23. Amgen’s contrary arguments are unpersuasive, and its various policy arguments cannot overcome the statute’s plain language. Pp. 15–18.
794 F. 3d 1347, vacated in part, reversed in part, and remanded.
THOMAS, J., delivered the opinion for a unanimous Court. BREYER, J., filed a concurring opinion.