The claims at issue involve testing methods for fetal aneuploidies, conditions in which a fetus either has an abnormally high number of chromosomes (e.g., Down’s syndrome) or an abnormally low number (e.g., Turner’s syndrome). Previously, physicians diagnosed fetal aneuploidies using invasive amniocentesis or chorionic villus sampling or less invasive methods, such as ultrasonography and biochemical marker detection that had suboptimal accuracy. In three interference proceedings between Stanford and Chinese University, the Patent Trial and Appeal Board found that Stanford’s claims were unpatentable for lack of written description. The Federal Circuit vacated, finding that the Board relied on improper evidence and did not cite other substantial evidence to support its key findings. Whether a patent claim satisfies the written description requirement, 35 U.S.C. 112, depends on whether the description clearly allows persons of ordinary skill in the art to recognize that the inventor invented what is claimed. On remand, the Board should examine whether a person of ordinary skill would have understood that the patent’s specification disclosed random MPS sequencing and would have known, as of the priority date, that the specification’s reference to Illumina products meant random MPS sequencing as recited in the claims, by examining the record evidence as to pre-filing date art-related facts on Illumina products. View "Stanford University v. Chinese University of Hong Kong" on Justia Law

The patent, covering methods of treating hepatitis C by administering compounds having a specific chemical and stereochemical structure, issued on a final application filed on June 27, 2003, by the inventor, Storer. In an interference proceeding, Storer was initially declared the senior party based on the “S1” provisional application's June 28, 2002 filing date. Clark’s Application was filed September 12, 2007, with priority claimed to a provisional application filed on May 30, 2003. Both were filed before the effective date of the America Invents Act, which abolished the first-to-invent interference rule in favor of a first-to-file rule. Clark moved to deny Storer the priority date of the S1 application and to invalidate Storer’s claims, arguing that the S1 application did not enable compounds having the 2´F(down) substituent. Storer argued that these compounds were generically disclosed in the S1 application, and were readily obtained based on the disclosure in the S1 provisional and prior art. The Board awarded priority to Clark. The Federal Circuit affirmed; substantial evidence supports the Board’s finding that “a high amount of experimentation is necessary to synthesize” the target compound. The record showed sufficient variability and unpredictability to support a conclusion that Storer’s provisional application did not enable the interference subject matter. View "Storer v. Clark" on Justia Law

Plaintiff filed suit against various defendants in the film industry, alleging copyright and state law claims, including breach of implied-in-fact contract and declaratory relief. Plaintiff alleged that defendants used his screenplay idea to create "The Purge" films without providing him compensation or credit as a writer. The Ninth Circuit affirmed the denial of defendants' anti-SLAPP motion to strike the state law claims. In this case, plaintiff's implied-in-fact contract claim did not arise from protected free speech activity 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. The panel also held that defendants' failure to pay was not conduct in furtherance of the right to free speech. View "Jordan-Benel v. Universal City Studios, Inc." on Justia Law

The rock group “The Slants,” chose that name to dilute the term’s denigrating force as a derogatory term for Asians. The Patent and Trademark Office (PTO) denied an application for registration of the name under 15 U.S.C. 1052(a), which prohibits the registration of trademarks that may “disparage . . . or bring . . . into contemp[t] or disrepute” any “persons, living or dead.” The Supreme Court affirmed the Federal Circuit in finding the clause unconstitutional. The Court first rejected an argument that the clause applies only to natural or juristic persons. The Court then held that the clause is subject to the Free Speech Clause, which does not regulate government speech. Trademarks are private, not government speech. "If trademarks become government speech when they are registered, the Federal Government is babbling prodigiously and incoherently.” 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. The “public expression of ideas may not be prohibited merely because the ideas are themselves offensive to some of their hearers.” The disparagement clause cannot withstand even “relaxed” review. It does not serve a “substantial interest,” nor is it “narrowly drawn.” View "Matal v. Tam" on Justia Law

Outdry’s 171 patent claims methods of waterproofing leather, particularly for the manufacture of shoes, clothes, or leather accessories. The specification discloses prior art methods of waterproofing leather shoes, including sewing a fabric lining and a semipermeable film to the interior surface of the leather or gluing a semi-permeable membrane inside the leather around the membrane’s perimeter, but states those methods allowed a water cushion to form in which water penetrates the leather and becomes trapped between the membrane and interior surface of the leather. The 171 patent sought to overcome this issue by “directly pressing” a semi-permeable membrane onto the leather via a dotted glue pattern. The Patent Board found that the claims would have been obvious over a combination of prior art. The Federal Circuit affirmed, upholding the Board’s construction of “directly pressing” and finding that a prior reference discloses “directly pressing” and “a process for waterproofing leather.” The Board’s fact finding regarding motivation to combine is supported by substantial evidence. View "Outdry Technologies Corp. v. Geox S.P.A." on Justia Law

When an artery is damaged or inflamed, the body releases the enzyme myeloperoxidase (MPO). Prior art taught that MPO could be detected in an atherosclerotic plaque or lesion that required a surgically invasive method; could be indirectly detected in blood; or could be detected in blood with results that were not predictive of cardiovascular disease. Cleveland Clinic purportedly discovered how to “see” MPO in blood and correlate that to the risk of cardiovascular disease. True Health, a diagnostic laboratory, purchased the assets of Diagnostics, which had contracted with Cleveland Clinic to perform MPO testing. Rather than continue that relationship, True Health performed its own MPO testing. Cleveland Clinic sued, asserting infringement of the patents. The district court found all the claims patent-ineligible under 35 U.S.C. 101; dismissed the contributory and induced infringement claims of the 260 patent; denied leave to amend; and held that it was proper to consider section 101 at the motion to dismiss stage.. The court found that the claims were directed to a law of nature, with no saving inventive concept. The Federal Circuit affirmed. Cleveland Clinic provided no proposed construction of any terms or proposed expert testimony that would change the analysis. The claims, whether considered limitation-by-limitation or as a whole, do not sufficiently transform the natural existence of MPO in a bodily sample and its correlation to cardiovascular risk into a patentable invention. View "Cleveland Clinic Foundation v. True Health Diagnostics. LLC" on Justia Law

EmeraChem’s 758 patent claims methods for regenerating a devitalized catalyst/absorber that has absorbed and oxidized nitrates and nitrites after exposure to pollutants in the combustion gases of engines by passing a regeneration gas over the catalyst without removing the catalyst. The application was filed in 1994; the patent issued in 1997, naming Guth and Campbell as co-inventors. The 758 patent incorporates Campbell 558 in its entirety. The application for Campbell 558 was filed months before the 758 application; the patent issued in 1995, disclosing a catalyst/absorber used to absorb and oxidize pollutants from exhaust gas but requiring removal of the catalyst/absorber. Campbell, Danziger, Guth, and Padron are its named co-inventors. Volkswagen sought inter partes review of the 758 patent, alleging anticipation of various claims and that various claims would have been obvious under 35 U.S.C. 103(a) over the combination of Campbell 558 and a prior reference. The Patent Board found that certain claims of the 758 patent would have been obvious over Campbell and another reference. The Federal Circuit affirmed as to several claims and vacated with respect to others. Campbell’s Declaration was insufficient to demonstrate that the cited portions of Campbell are not “by another.” The Board did not err in holding Campbell is section 102(e) prior art. The court remanded for clarification of whether the Board adopted a new rationale for unpatentability in its final written decision. View "EmeraChem Holdings, LLC v. Volkswagen Group of America, Inc." on Justia Law

The Biologics Price Competition and Innovation Act, concerning FDA approval of a drug that is biosimilar to an already-licensed biological “reference product,” 42 U.S.C. 262(k), treats submission of a biosimilar application as an “artificial” patent infringement. An applicant must provide its biosimilar application and manufacturing information to the reference product’s sponsor. The parties collaborate to identify patents for immediate litigation. Second phase litigation is triggered when the applicant gives the sponsor notice at least 180 days before commercially marketing the biosimilar. Amgen claims patents on methods of manufacturing and using filgrastim. Sandoz sought FDA approval to market a biosimilar, Zarxio, and notified Amgen that it had submitted an application, that it intended to market Zarxio immediately upon receiving FDA approval, and that it did not intend to provide application and manufacturing information. Amgen sued for patent infringement and asserted that Sandoz engaged in “unlawful” conduct under California law by failure to provide its application and manufacturing information and by notification of commercial marketing before obtaining FDA licensure. The FDA licensed Zarxio. Sandoz provided Amgen another notice of commercial marketing. The Supreme Court unanimously held that section 262(l)(2)(A) is not enforceable by injunction under federal law, but the Federal Circuit should determine whether a state-law injunction is available. Submitting an application constitutes artificial infringement; failing to disclose the application and manufacturing information does not. Section 262(l)(9)(C) provides a remedy for failure to turn over the application and manufacturing information, authorizing the sponsor, but not the applicant, to bring an immediate declaratory-judgment action, thus vesting in the sponsor the control that the applicant would otherwise have exercised over the scope and timing of the patent litigation. An applicant may provide notice under section 262(l)(8)(A) before obtaining FDA licensure. View "Sandoz Inc. v. Amgen Inc." on Justia Law

One-E-Way filed a complaint with the International Trade Commission, alleging infringement of its patents, which disclose a wireless digital audio system designed to let people use wireless headphones privately, without interference, even when multiple people are using wireless headphones in the same space. The specification explains that previous wireless digital audio systems did not provide “private listening without interference where multiple users occupying the same space are operating wireless transmission devices.” The Commission found the claim term “virtually free from interference” indefinite and invalidated the asserted claims of One-E-Way’s patents. The Federal Circuit reversed, finding that the term “virtually free from interference,” as properly interpreted in light of the specification and prosecution history, would inform a person of ordinary skill in the art about the scope of the invention with reasonable certainty. View "One-E-Way, Inc. v. International Trade Commission" on Justia Law

CAC’s patent includes both system and method claims directed to “provid[ing] financing for allowing a customer to purchase a product selected from an inventory of products maintained by a dealer.” In one embodiment, the products are vehicles for sale at a car dealership. The invention involves “maintaining a database of the dealer’s inventory,” gathering financing information from the customer, and “presenting a financing package to the dealer for each individual product in the dealer’s inventory.” Westlake petitioned for Covered Business Method (CBM) review, asserting that all claims were ineligible for patenting under 35 U.S.C. 101. Three months after the Board instituted review of some claims, the Supreme Court vacated precedent on which the Board had relied. In view of the developments in section 101 jurisprudence, Westlake filed a second petition, challenging the remaining claims. In its decision to institute review, the Board rejected CAC’s argument that the existence of the first CBM proceeding estopped Westlake from challenging claims the remaining claims under 35 U.S.C. 325(e)(1). The Board’s determination was based on the fact that the first proceeding had not yet resulted in a final written decision. The Federal Circuit agreed that estoppel did not apply and that the challenged claims were unpatentable. View "Credit Acceptance Corp. v. Westlake Services" on Justia Law