Justia U.S. Federal Circuit Court of Appeals Opinion Summaries

Index and Gilead were developing drugs for treating the hepatitis C virus (HCV). Idenix alleged that the imminent FDA approval, and launch, of Gilead’s HCV treatment drug sofosbuvir would infringe Idenix’s 597 patent. After a jury trial, Gilead stipulated to infringement under the district court’s claim construction but argued that the patent was invalid for failure to meet the written description and enablement requirements. The jury found for Idenix, upheld the patent and awarded damages. The district court denied Gilead’s motion with respect to written description but granted judgment as a matter of law on enablement, holding the 597 patent invalid. The Federal Circuit affirmed as to non-enablement and held that the patent is also invalid for lack of written description. Although the level of skill in the art is high, the patent does not provide enough meaningful guidance or working examples, across the full scope of the claim, to allow a person of ordinary skill in the art to determine which nucleosides would be effective against HCV without extensive screening. The immense breadth of screening required amounts to "undue experimentation." Given the conspicuous absence of that compound, a person of ordinary skill in the art would not “visualize or recognize the members of the genus” as including 2'-fluoro-down, and the specification could not demonstrate that the inventor had possession of that embodiment at the time of filing. View "Idenix Pharmaceuticals LLC v. Gilead Sciences Inc." on Justia Law

Fraunhofer’s patents relate to multicarrier modulation for transmitting a main data stream over multiple carrier data streams, which is useful in satellite-based communication networks. In 1998, Fraunhofer gave WorldSpace a Master Agreement for a “worldwide, exclusive, irrevocable license, with the right to sublicense” the technology. SXM entered into a Sublicense Agreement with WorldSpace. Fraunhofer assisted SXM in developing a satellite communication system utilizing Fraunhofer’s technology. In 1999, SXM and Fraunhofer entered into a Technical Consulting Contract, confirming that the patents were exclusively licensed to WorldSpace. Fraunhofer allegedly constructed a system for SXM using the technologies covered by the patents. In 2008, WorldSpace filed for bankruptcy and rejected the Master Agreement. Fraunhofer did not terminate the agreement but filed an administrative claim for amounts unpaid under the Master Agreement. WorldSpace did not terminate the Sublicense Agreement. The bankruptcy court approved a settlement between WorldSpace and SXM, stating that the sublicense would remain in effect. SXM continued to use the technology. In 2015, Fraunhofer sent SXM a letter, alleging that SXM was infringing patents that were covered in the Master Agreement and Sublicense Agreement. Fraunhofer also sent WorldSpace a letter, claiming that the Master Agreement was terminated by rejection in bankruptcy and under German law. Fraunhofer sued SXM, alleging infringement. The district court dismissed, finding that SXM had a valid license to the patents-in-suit. The Federal Circuit vacated, concluding that the license defense cannot be resolved on a motion to dismiss. View "Fraunhofer-Gesellschaft Zur Förderung Der Angewandten Forschung E.V. v. Sirius XM Radio Inc." on Justia Law

Horizon’s patents generally relate to methods and compositions for treating osteoarthritis and share a substantially similar specification; there are method-of-use patents and formulation patents. Both groups of patents are listed in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for Horizon’s PENNSAID® 2% product, a nonsteroidal anti-inflammatory drug (NSAID) and the first FDA-approved twice-daily topical diclofenac sodium formulation for the treatment of pain of osteoarthritis of the knees. Prior art, PENNSAID® 1.5%, also treats osteoarthritis knee pain but differs from PENNSAID® 2% both in the formulation and recommended dosage. Actavis sought to market a generic version of PENNSAID 2% and filed an Abbreviated New Drug Application (ANDA) with certification under 21 U.S.C. 355(j)(2)(A)(vii)(IV), stating that the patents-at-issue were invalid or would not be infringed by Actavis’s generic product. Horizon filed an infringement suit under 35 U.S.C. 271(e)(2)(A). The Federal Circuit affirmed findings of invalidity and noninfringement, upholding claim construction that the terms “impurity A”; “degrades at less than 1% over 6 months”; and “consisting essentially of” are indefinite. Actavis’s ANDA label did not induce infringement of the method-of-use patent. View "HZNP Medicines LLC v. Actavis Laboratories UT, Inc." on Justia Law

B.E. sued Facebook for infringement of B.E.’s 314 patent. Approximately a year into the case, Facebook and two other parties B.E. had accused of infringement, Microsoft and Google, filed petitions for inter partes review of the asserted claims. The district court stayed its proceedings. The Patent Board instituted review and held the claims unpatentable. The Federal Circuit affirmed. Facebook then moved in the district court for a dismissal with prejudice and costs under Rule 54(d). B.E. agreed that dismissal was appropriate but argued that the claims should be dismissed for mootness, rather than with prejudice. The district court agreed with B.E., issuing an Order holding that, in light of the cancellation of claims, B.E. no longer had a basis for the lawsuit. The court ultimately awarded costs under Rule 54(d). The Clerk of Court held a hearing and taxed $4,424.20 in costs against B.E.; the court affirmed, holding that, although the case was dismissed for mootness, Facebook “obtained the outcome it sought: rebuffing B.E.’s attempt to alter the parties’ legal relationship.” The Federal Circuit affirmed, finding Facebook to be the prevailing party in B.E.’s lawsuit. View "B.E. Technology, L.L.C. v. Facebook, Inc." on Justia Law

Non-small cell lung cancer (NSCLC) was the leading cause of cancer deaths in 2000. The standard for treating NSCLC was chemotherapy, which ameliorated some lung cancer-related symptoms, but was limited in use due to toxicity. In response to a need for a therapy that would effective and well-tolerated, investigators pursued targeted therapies as alternatives to chemotherapy. A great majority of alternative therapies for NSCLC failed in clinical trials. One compound that ultimately gained FDA approval was erlotinib. OSI markets erlotinib under the name Tarceva®, which is covered by the 221 patent, which issued in 2005. On inter partes review, the Patent Board found certain claims unpatentable under 35 U.S.C. 103, in light of prior art and the 10-K disclosure filed by OSI with the Securities and Exchange Commission. The Federal Circuit reversed. Substantial evidence did not support the Board’s finding that the asserted combinations of prior art or prior art and the 10-K disclosures each would have provided a person of ordinary skill with a reasonable expectation of success in using erlotinib to treat NSCLC in a mammal. View "OSI Pharmaceuticals, LLC v. Apotex Inc" on Justia Law

AAM’s 911 patent generally relates to a method for manufacturing driveline propeller shafts with liners that are designed to attenuate vibrations transmitted through a shaft assembly. Propshafts are employed in automotive vehicles to transmit rotary power in a driveline. The patent identified a need for an improved method for damping various types of vibrations in a hollow shaft; AAM argued that the inventive concept to which the claims are directed is the tuning of a liner in order to produce frequencies that dampen the shell mode and bending mode vibrations simultaneously. In AAM’s infringement action against Neapco, the district court granted Neapco summary judgment, holding that the asserted claims are patent-ineligible under 35 U.S.C. 101. The Federal Circuit affirmed. The claims’ direction to tune a liner to attenuate to different vibration modes amounted to merely instructing one to apply Hooke’s law to achieve the desired result of attenuating certain vibration modes and frequencies without providing a particular means of how to craft the liner and propeller shaft in order to do so. Hooke’s law is a natural law, an equation that describes the relationship between an object’s mass, its stiffness, and the frequency at which the object vibrates. View "American Axle & Manufacturing, Inc. v. Neapco Holdings LLC" on Justia Law

Honeywell’s patent, directed to fluoroalkene compounds used in refrigeration systems and other applications, issued in October 2015 and recites a chain of priority applications dating back to 2002, all of which were incorporated by reference. During prosecution of the patent, Honeywell filed a preliminary amendment that canceled all 20 claims recited in the original application and added 20 new claims directed to different subject matter: automobile air conditioning systems. The Patent Trial and Appeal Board initiated post-grant review proceedings, finding that the claims of the patent were only entitled to a priority date of March 2014—the filing date of the application that led to the patent—rather than the 2002 priority date that would result if the priority chain adequately supported the claims. PGR proceedings are available only for patents having at least one claim with an effective filing date on or after March 16, 2013. There were several prior art references dated from the period between 2002 and 2014. The Federal Circuit vacated the Board’s refusal to grant Honeywell leave to seek a Certificate of Correction to correct the challenged patent. The Board abused its discretion by assuming the authority that 35 U.S.C. 255 expressly delegates to the Director: to determine when a Certificate of Correction is appropriate. View "Honeywell International Inc. v. Arkema Inc." on Justia Law

Gamon owns the 646 and 645 patents, which each claim the ornamental design for a gravity feed dispenser display (a can dispenser). On inter partes review, the Patent Trial and Appeal Board held that Campbell did not demonstrate that the claimed designs of the patents would have been obvious over the Linz and Samways patents. The Federal Circuit vacated in part. Substantial evidence does not support the Board’s finding that Linz is not a proper primary reference. Linz’s design is made to hold a cylindrical object in its display area. Affirming in part, the court noted that Samways has a dual dispensing area, compared to the single dispensing area of the claimed designs, and has a front label area with different dimensions that extends across both dispensing areas. Given these differences, substantial evidence supports the Board’s finding that Samways does not create basically the same visual impression as the claimed designs. View "Campbell Soup Co. v. Gamon Plus, Inc." on Justia Law

Sipco’s patent explains communicating information from a previously unconnected, remote device to a central location. Rather than set up a direct communication link, the invention sets up a two-step communication path through intermediate nodes to use the nodes’ already-provided link (e.g., a public-switched telephone network (PSTN)) to the central location. The remote device communicates wirelessly to an intermediate node. For example, a user may wish to replace his bank and credit cards with a remote transmitting unit, having buttons each associated with a bank or credit card. When the user depresses a button, the remote unit transmits the user’s account and PIN information to, for example, the ATM, which then transmits the information over, for example, a PSTN to the central location.The Patent Board found that the patent was not exempt from covered business method (CBM) review under the “technological invention” exception and found five claims patent-ineligible under 35 U.S.C. 101 and unpatentable for obviousness under 35 U.S.C. 103. The Federal Circuit vacated. The Board must consider “whether the claimed subject matter as a whole recites a technological feature that is novel and unobvious over the prior art; and solves a technical problem using a technical solution.” The court reversed the Board’s claim construction of “low power transceiver” and its finding that the patent does not satisfy the second part of the regulation defining “technological invention.” The court remanded for the Board to address section 42.301(b)’s first part. View "Sipco, LLC v. Emerson Electric Co." on Justia Law

In September 2010, IntraCellular filed the application leading to the 077 patent. In October 2012, the Patent Office issued a non-final office action including rejections under 35 U.S.C. 103 and 112. Intra-Cellular argued against section 103 rejections without amendment. In April 2013, the Patent Office mailed a final Office action, allowing no claims. In July 2013, on the last day for filing a “reply” to the final Office action without accruing applicant delay, 36 U.S.C. 154(b)(2)(C)(ii), Intra-Cellular responded with “Amendments and Response,” repeating the same arguments and adding a new claim. Nine days later, the Patent Office mailed an Advisory Action: Intra-Cellular’s after-final submission overcame some of the previous rejections but failed to overcome the section 103 rejection for the prior reasons of record. The examiner suggested amending or cancelling certain claims. Ten days later, Intra-Cellular filed its second after-final submission adopting all of those suggestions. A Notice of Allowance was mailed on August 20, 2013. In January 2017, the Patent Office issued a determination that the patent was entitled to 264 days of patent term adjustment ( for agency delays, after subtracting 21 days for applicant delay based on the time it took Intra-Cellular to file its second after-final submission after the response deadline, reasoning that Intra-Cellular’s first after-final submission did not constitute a proper “reply” under 37 CFR 1.704(b). The clock stopped with the second after-final submission, 21 days later. The Federal Circuit affirmed that determination. While timely, Intra-Cellular’ initial response continued to argue the merits of the final rejections, failing to comply with regulatory requirements for what constitutes a proper “reply” to a final Office action. View "Intra-Cellular Therapies, Inc. v. Iancu" on Justia Law