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

The Jazz patents relate to a drug distribution system for tracking prescriptions of a “sensitive drug.” “A sensitive drug is one which can be abused, or has addiction properties or other properties that render the drug sensitive.” One such sensitive drug is Xyrem®. Jazz exclusively markets Xyrem®, which the FDA has approved to treat symptoms associated with narcolepsy. The active ingredient in Xyrem®, gamma-hydroxybutyrate (GHB), may also be illicitly used as a “date-rape drug.” Under the Controlled Substances Act any approved drug product containing GHB is classified as a Schedule III depressant, so the FDA approved Xyrem® under “restricted distribution regulations contained in [21 C.F.R. 314.500] (Subpart H) to assure safe use of the product.” On inter partes review, the Patent Board found certain claims invalid as obvious. The Federal Circuit affirmed, upholding a conclusion that implementing prior art, consisting of background materials and the meeting minutes, transcript, and slides on the FDA website, on multiple computers “would have been a predictable use of a known distributed data system according to its established function.” View "Jazz Pharmaceuticals, Inc.. v. Amneal Pharmaceuticals, LLC" on Justia Law

Endo holds the approved New Drug Application for Aveed®, a testosterone undecanoate intramuscular injection. Bayer owns the 640 and 395 patents listed in the Orange Book for Aveed®. Custopharm’s predecessor submitted an Abbreviated New Drug Application (ANDA) to the FDA for approval to produce and market a generic version of Aveed® and made a Paragraph IV certification and gave notice of the certification to Endo and Bayer in October 2014. Endo and Bayer brought an action alleging infringement of the 640 and 395 patents. Custopharm stipulated to infringement; Endo and Bayer limited their asserted claims to claim 2 of the 640 patent and claim 18 of the 395 patent. After a bench trial on invalidity, the district court concluded that Custopharm had not proven that the claims were invalid under 35 U.S.C. 103. The Federal Circuit affirmed. Custopharm failed to meet its burden of showing that a skilled artisan would combine a lowered dose with the injection schedule in the manner claimed. View "Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc." on Justia Law

Tre Milano challenged the validity of claims 1–5 and 11, and did not challenge the validity of claims 6–10 and 12–15 of the 118 Patent, which covers a device that automates the curling of hair. A strand of hair is fed into a chamber of the device, the hair is wound around a rotating curling member in the chamber, the wound hair is heated to preserve the curl, and the curled hair slides off the curling member and exits the chamber so that the curvature of the curls created by the device can be substantially maintained. The Patent Trial and Appeal Board instituted Inter partes review of all of the claims that were challenged. The Federal Circuit concluded that the Board erred in its finding of anticipation by erroneously construing two claim terms: “the length of hair can pass through the secondary opening” and “free end,” broadening the claims beyond the description in the 118 Patent specification. On the correct claim construction, the claims are not anticipated by prior art, 35 U.S.C. 102(b). View "TF3 Ltd. v. Tre Milano, LLC" on Justia Law

Plaintiffs each entered into agreements to provide services to Voice of America (VOA), a U.S. government-funded broadcast service. The agreements were a series of individual purchase order vendor (POV) contracts that each plaintiff entered into over several years with the Broadcasting Board of Governors (BBG), which oversees VOA. In 2014, the Office of Inspector General for the U.S. Department of State issued a report that was critical of the BBG’s use of POV contracts, concluding that the BBG was using such contracts in some cases to obtain personal services. Plaintiffs filed a class action complaint alleging that, along with other individuals who have served as independent contractors for VOA, they should have been retained through personal services contracts or appointed to positions in the civil service. If their contracts had been classified as personal services contracts or they had been appointed to civil service positions, they alleged, they would have enjoyed enhanced compensation and benefits. The Claims Court dismissed and denied their request for leave to file a proposed second amended complaint. The Federal Circuit affirmed, rejecting several contract-based claims, seeking damages for the loss of the additional compensation and benefits to which Plaintiffs contend they were entitled. Plaintiffs have set forth no viable theory of recovery. View "Lee v. United States" on Justia Law

Raytheon produces infrared imaging equipment, including infrared cameras, which enable people to see in the dark and through obstructions such as smoke. Indigo’s founders included three former Raytheon employees. By 2000, Indigo was manufacturing and selling infrared cameras. In 2007, Raytheon sued, alleging patent infringement and trade secret misappropriation under California and Texas law. The district court granted Indigo summary judgment, finding Raytheon’s trade secrets claims time-barred. The parties settled Raytheon’s patent claims. The Federal Circuit reversed, reasoning that there were factual questions regarding when Raytheon should have become aware of its misappropriation cause of action and vacated the denial of Indigo’s motion for attorney fees under the under the Texas Theft Liability Act (TTLA). On remand, a jury ruled in Indigo’s favor on all 31 alleged trade secrets. Raytheon unsuccessfully moved for judgment as a matter of law, contending that it had conclusively established misappropriation of two trade secrets. Indigo moved for attorney fees under the TTLA arguing Raytheon had withdrawn its TTLA claim to avoid an adverse ruling that California law, rather than Texas law, governed Raytheon’s misappropriation claims. Denying Indigo’s motion, the district court observed that Raytheon’s continued pursuit of its misappropriation claims under California law established that Raytheon’s withdrawal of its TTLA claim was not motivated by a desire to avoid an unfavorable ruling. The Federal Circuit affirmed both the judgment of no liability in favor of Indigo and the denial of attorney fees. View "Raytheon Co. v. Indigo Systems Corp." on Justia Law

The Inholders own patented mining and homestead claims within the Santa Fe National Forest. The 2011 Las Conchas Fire caused widespread destruction of vegetation within the forest. Forest Roads 89 and 268, which the Inholders had used to access their properties, were severely damaged by subsequent flooding. The Forest Service notified them that the roads were “impassible” and that it would provide them with limited access: “a combination of driving and hiking over specific routes and under specific weather conditions.” Later, the Service sent a letter stating that “public safety would be highly threatened by use of” the roads; that it would close the roads to public access for the foreseeable future; that because of continuing terrain instability, any reconstruction would likely be destroyed by future flooding; and, even if reconstruction were possible, the Service could not justify expending public funds when there is no general public need. The Service suggested that the Inholders work “collectively” to reconstruct the roads. The Inholders claimed that they held statutorily-granted easements. The USDA disagreed, citing 90 Stat. 2743, but acknowledged that the Inholders had a right to access their properties, “subject to reasonable regulations.” The Inholders claimed a compensable taking. The Federal Circuit affirmed the Claims Court’s dismissal, finding that the Inholders had not adequately pled a physical taking and that any regulatory taking claim was not ripe because the Inholders had not applied for a permit to reconstruct the roads. View "Martin v. United States" on Justia Law

Polara entered the accessible pedestrian signal systems (APS market) with an eight-wire system, the Navigator. Because many intersections only have two wires, installation of eight-wire systems could be difficult and labor-intensive. In 2000-2001, Polara engineers began designing a two-wire version of the Navigator, which led to the 476 patent, relating to a two-wire control system for push-button crosswalk stations for a traffic-light-controlled intersection with visual, audible, and tactile accessible signals. The patent discloses using “existing underground wire pairs to transmit power and data signals in order to generate the accessible signal functions for both sighted and visually impaired pedestrians.” Polara filed the application in August 2004. In September 2003, Polara began selling the Navigator-2, a two-wire APS system. In Polara’s infringement suit, the Federal Circuit rejected claims of invalidity and no willful infringement, based on prior public use and prior art, 35 U.S.C. 282. The court vacated an enhanced damages award and remanded for a more complete explanation, including a discussion of the public use defense, for the court’s exercise of its discretion, 35 U.S.C. 284. View "Polara Engineering Inc. v. Campbell Co." on Justia Law

The parties manufacture power supply controller chips--integrated circuits used in power supplies, such as chargers that transform AC electricity from an outlet into DC electricity, to power electronic devices. A switching regulator directs the transistor in the circuit when to turn on and off, to provide the desired amount of power. Power’s patents cover switching regulators. Prior-art regulators were inefficient during low power periods, creating loud noise and delivering power in an intermittent fashion. Power’s 079 patent addressed this problem by reducing the frequency of on/off cycles rather than by skipping cycles altogether, using feedback signals. Power’s 908 patent covers a power supply controller--an integrated circuit that can perform a variety of power-regulation functions. A jury found Fairchild literally infringed claims of the 079 patent and infringed two claims of the 908 patent under the doctrine of equivalents. Another jury awarded damages of roughly $140 million, finding that the entire market value rule applied in calculating damages for infringement of the 079 patent. The Federal Circuit affirmed judgments of infringement but vacated the award, concluding that the entire market value rule cannot be used to calculate damages. Power did not show that the patented feature was the sole driver of consumer demand, i.e., that it alone motivated consumers to buy the accused products. View "Power Integrations, Inc. v. Fairchild Semiconductor International, Inc." on Justia Law

Adidas sought inter partes review of Nike's 598 and 749 patents, arguing (ground 1) that each challenged claim would have been obvious based on the Reed and Nishida references and (ground 2) that each claim would have been obvious based on the Castello, Fujiwara, and Nishida references. The Patent Trial and Appeal Board instituted inter partes review and held that Adidas had not met its burden of demonstrating any of the claims would have been obvious based on ground 1 without addressing the merits of ground 2 or suggesting that its conclusions as to ground 1 would be dispositive as to ground 2. After the Supreme Court issued its 2018 "SAS" decision, Adidas sought remand, arguing that SAS requires that the Board institute on all grounds raised in the Petition. The Patent Office recently issued public guidance indicating that, in light of SAS, if a trial is instituted, the Board will institute review on all challenges raised in the petitions. The Federal Circuit ordered a remand, quoting the Court: “the petitioner’s contentions, not the Director’s discretion, define the scope of the litigation all the way from institution through to conclusion.” View "Adidas AG v. Nike, Inc." on Justia Law

Triptans are selective serotonin receptor agonists, developed in the 1980s. When Zolmitriptan became available in the U.S. in oral tablet form in 1999 under the name Zomig® it was among several triptans on the market or under development. AstraZeneca owns the 237 and 767 patents, which relate to formulations of zolmitriptan for intranasal administration, and the New Drug Application for Zomig® (zolmitriptan) Nasal Spray, approved by the FDA for treatment of migraines. The patents are listed in connection with Zomig® Nasal Spray in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). In 2012, AstraZeneca and Impax entered into an agreement, granting Impax an exclusive license to AstraZeneca’s patents covering the Zomig® products, for the payment of $130 million and additional payments at varying royalty rates. In 2014, Lannett notified AstraZeneca that it had filed an Abbreviated New Drug Application, seeking approval for a generic version of Zomig® Nasal Spray, with a Paragraph IV certification (21 U.S.C. 355(j)(2)(A)(vii)(IV)), alleging noninfringement or invalidity of the 237 and 767 patents. In the subsequent infringement suit, 35 U.S.C. 271(e)(2)(A), the district court issued its claim construction opinion, the parties stipulated to infringement, and the court held that Lannett failed to prove by clear and convincing evidence that the asserted claims were invalid or would have been obvious over prior art. The Federal Circuit affirmed, upholding the entry of an injunction. View "Impax Laboratories Inc. v. Lannett Holdings Inc." on Justia Law