by
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

by
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

by
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

by
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

by
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

by
The Supreme Judicial Court affirmed a summary judgment entered in the Business and Consumer Docket in favor of Copay Italia S.p.A. on Puritan Medical Products Company’s claim that Copay violated Maine’s Actions for Bad Faith Assertion of Patent Infringement statute, Me. Rev. Stat. 14, 8701-8702, holding that Puritan’s claim was preempted by federal patent law. Although the lower court granted summary judgment for Copan after finding no genuine issues of material fact and determining that Copay was entitled to judgment as a matter of law, Copan filed a cross-appeal challenging the court’s conclusion that Puritan’s claim was not preempted by federal law. The Supreme Judicial Court affirmed, holding (1) in its preemption analysis, the trial court conflated the test for federal preemption with the test for federal jurisdiction; and (2) federal patent law preempted Puritan’s state law claim, and therefore, summary judgment in favor of Copay was properly granted on that basis. View "Puritan Medical Products Co. v. Copan Italia S.p.A." on Justia Law

by
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

by
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

by
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

by
WesternGeco owns patents for a system used to survey the ocean floor. ION sold a competing system, built from components manufactured in the U.S., then shipped abroad for assembly into a system indistinguishable from WesternGeco’s. WesternGeco sued for patent infringement, 35 U.S.C. 271(f)(1) and (f)(2). The jury awarded WesternGeco royalties and lost profits under section 284. The Supreme Court reversed the Federal Circuit, holding that WesternGeco’s award for lost profits was a permissible domestic application of section 284 of the Patent Act, not an impermissible extraterritorial application of section 271. To determine whether the case involves a domestic application of the statute, courts must identify the statute’s "focus” and ask whether the conduct relevant to that focus occurred in U.S. territory. If so, the case involves a permissible domestic application of the statute. When determining the statute’s focus, the provision at issue must be assessed in concert with other provisions. Section 284, the general damages provision, focuses on “the infringement.” The “overriding purpose” is “complete compensation” for infringements. Section 271 identifies several ways that a patent can be infringed; to determine section 284’s focus in a given case, the type of infringement must be identified. Section 271(f)(2) was the basis for WesternGeco’s claim and damages. That provision regulates the domestic act of “suppl[ying] in or from the United States,” and vindicates domestic interests, The focus of section 284 in a case involving infringement under section 271(f)(2) is the act of exporting components from the U.S., so the relevant conduct occurred in the U.S. Damages are not the statutory focus but are merely the means by which the statute remedies infringements. The overseas events giving rise to the lost-profit damages here were merely incidental to the infringement. View "WesternGeco LLC v. ION Geophysical Corp." on Justia Law