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The 551 patent discloses and claims lacosamide, the active ingredient in Vimpat®, a drug that treats epilepsy and other central nervous system disorders. UCB holds New Drug Applications that cover the FDA approval of Vimpat®. The 551 patent is listed in the FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book). Generic drug manufacturers filed Abbreviated New Drug Applications (ANDAs), seeking approval for generic versions of Vimpat®. Pursuant to the governing Hatch-Waxman Act provisions, they certified in their ANDAs that the 551 patent is invalid, unenforceable, or that their proposed generic lacosamide products will not infringe the patent. UCB sued and the generic manufacturers stipulated to infringement of claims 9, 10, and 13 but maintained that these claims are invalid for obviousness-type double patenting, 35 U.S.C. 101, obviousness, and anticipation. The district court concluded that the asserted claims are not invalid. The Federal Circuit affirmed, holding that the district court applied the correct legal standards and that there was no clear error in its underlying fact findings. The district court did not err by focusing its double patenting analysis on the claims’ differences, as well as the claims as a whole. View "UCB, Inc. v. Accord Healthcare, Inc." on Justia Law

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XY’s patents relate to the sorting of X- and Y-chromosome-bearing sperm cells, for selective breeding purposes. Trans Ova provides services related to embryo transfer and in-vitro fertilization for cattle. XY and Trans Ova entered into a five-year licensing agreement in 2004 under which Trans Ova was authorized to use XY’s technology, subject to automatic renewal unless Trans Ova was in material breach. In 2007, Inguran acquired XY and sent a letter purporting to terminate the Agreement because of alleged breaches. For several years, the parties negotiated but failed to resolve their disputes. Trans Ova continued to make royalty payments to XY, which were declined. XY alleges that it became aware of further breaches, including underpayment of royalties and development of improvements to XY’s technology without disclosure of such improvements to XY. XY sued for patent infringement and breach of contract. Trans Ova counterclaimed, alleging patent invalidity, breach of contract, and antitrust violations. The district court granted XY summary judgment on the antitrust counterclaims. A jury found breaches of contract by both parties; that Trans Ova failed to prove that the asserted patent claims were invalid and willfully infringed the asserted claims; and XY was entitled to patent infringement damages. The court denied all of Trans Ova’s requested relief and granted XY an ongoing royalty. The Federal Circuit affirmed except the ongoing royalty rate, which it remanded for recalculation. View "XY, LLC v. Trans Ova Genetics, L.C." on Justia Law

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The Commerce Department's duty orders concerning aluminum extrusions from China cover “aluminum extrusions” described as "parts for final finished products that are assembled after importation.” The scope “includes the aluminum extrusion components that are attached (e.g., by welding or fasteners) to form subassemblies, i.e., partially assembled merchandise” but “excludes finished merchandise containing aluminum extrusions as parts that are fully and permanently assembled and completed at the time of entry.” The orders also exclude goods containing aluminum extrusions that are entered unassembled in a “finished goods kit, a packaged combination of parts that contains all of the necessary parts to fully assemble a final finished good without further finishing, such as cutting or punching, for assembly “as is” into a finished product, except that “[a]nimported product will not be considered a finished goods kit "merely by including fasteners such as screws, bolts.” Whirlpool requested a scope ruling concerning its kitchen appliance door handles with end caps. Commerce found that the handles were within the Orders’ scope. The Federal Circuit held that substantial evidence supports Commerce’s Scope Ruling. The exception for fasteners unambiguously applies only to the finished goods kit exclusion and not to the finished merchandise exclusion; because the finished goods kit exclusion is inapplicable to Whirlpool’s assembled handles, so is the fasteners exception to the finished goods kit exclusion. The court remanded for a determination of whether Whirlpool’s assembled handles meet the requirements for the finished merchandise exclusion. View "Whirlpool Corp. v. United States" on Justia Law

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The U.S. Department of Commerce determined that certain extruded aluminum door handles for kitchen appliances that are packaged with two plastic end caps and two screws were within the scope of antidumping and countervailing duty orders applicable to aluminum extrusions from China. The duty order describes imports from China of aluminum extrusions that are shapes and forms, produced by an extrusion process, made from specified aluminum alloys, and possessing “a wide variety of shapes and forms” in “a variety of finishes.” Subject aluminum extrusions may be described at the time of importation as parts for final finished products that are assembled after importation, including, but not limited to, window frames, door frames, solar panels, curtain walls, or furniture. The scope includes the aluminum extrusion components that are attached (e.g., by welding or fasteners) to form subassemblies. On remand, Commerce determined, under protest, that the subject products are not included in the scope of the orders. The Federal Circuit reversed. The Trade Court impermissibly substituted its judgment for that of Commerce to conclude that the plastic end caps rendered the handles “assemblies” excluded from the general scope language. The order's scope as a whole supports Commerce’s treatment of the end caps as fasteners. The scope language does not limit fasteners to non-plastic components, but rather provides examples of common fasteners. View "Meridian Products, LLC v. United States" on Justia Law

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D Three’s patents, issued in 2014-2015, are directed to roof mount sealing assemblies. EcoFasten’s allegedly infringing product was available to the public in June 2009. D Three claimed priority from its 2009 Application’s effective filing date, February 2009. The Federal Circuit affirmed summary judgment, holding that the asserted claims could not claim priority from the application because they were broader than the invention disclosed in the application, such that they did not meet the written description requirement, 35 U.S.C. 112(a). The court divided the asserted claims into two categories–– claims that recited a washer and claims that did not––and asked whether “the parent applications disclose roof mount assemblies that (a) do not have a soft washer but also do not limit the type of attachment bracket, and (b) have a soft washer but do not limit its location.” The application’s only disclosure of a washerless assembly “requir[ed a] W[-]pronged attachment bracket 1700,” but the asserted claims disclosed broader configurations of washerless assemblies; the application's assemblies with washers only disclosed washers situated “above the flashing,” but the asserted claims covered assemblies with washers below the flashing. The court invalidated the asserted claims as anticipated. View "D Three Enterprises, LLC v. Sunmodo Corp." on Justia Law

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Mallinckrodt’s 112 patent is directed to methods of distributing nitric oxide gas cylinders for pharmaceutical applications. Inhaled nitric oxide is approved by the FDA for treating neonates with hypoxic respiratory failure, a condition where oxygen levels in the blood are too low. Nitric oxide functions to dilate blood vessels in the lungs and can thereby improve blood oxygenation. Mallinckrodt exclusively supplies inhaled nitric oxide in the United States for pharmaceutical use under the brand name INOmax®. On inter partes review, the Patent and Trademark Office Patent Trial and Appeal Board found claim 9 not unpatentable as obvious under 35 U.S.C. 103 but found claims1-8 and 10-11 unpatentable as obvious. The Federal Circuit reversed as to claim 9 but otherwise affirmed. The Board did not err in applying the printed matter doctrine to claims 1–8 and 10, but its findings regarding the differences between the prior art and claim 9 and its findings on secondary considerations depended on an incorrect interpretation of that claim, and are not supported by substantial evidence. The Board’s uncontested findings regarding prior art render claim 9 obvious under the proper reading of the claim. View "Praxair Distribution Inc. v. Mallinckrodt Hospital Products IP, Ltd." on Justia Law

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Diem and Express filed patent infringement suits against BigCommerce in the Eastern District of Texas. BigCommerce is incorporated in Texas and lists Austin, Texas, where it is also headquartered, as its registered office. Austin lies in the Western District of Texas. BigCommerce has no place of business in the Eastern District. During the discovery phase of the cases, the Supreme Court issued its 2017 decision, “TC Heartland,” which reaffirmed that a domestic defendant corporation “resides” under 28 U.S.C. 1400(b) only in its state of incorporation. BigCommerce moved to dismiss Diem’s case and transfer Express’s case, arguing that it resides only in the Western District. The court denied the motion. The Federal Circuit disagreed, holding that a domestic corporation incorporated in a state having multiple judicial districts “resides” for purposes of the patent-specific venue statute, 28 U.S.C. 1400(b), only in the single judicial district within that state where it maintains a principal place of business, or failing that, the judicial district in which its registered office is located. View "In re: BigCommerce, Inc." on Justia Law

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InvestPic’s patent describes and claims systems and methods for performing statistical analyses of investment information. The Federal Circuit previously construed key claim terms and partly vacated the Patent Board’s cancellations of various claims in two reexamination proceedings involving issues of anticipation and obviousness under 35 U.S.C. 102 and 103. SAP subsequently sought a declaration that the patent’s claims are invalid because their subject matter is ineligible for patenting under 35 U.S.C. 101. The district court granted SAP judgment on the pleadings. The Federal Circuit affirmed. Even if the techniques claimed are “[g]roundbreaking, innovative, or even brilliant,” that is not enough for eligibility. Nor is it enough for subject-matter eligibility that claimed techniques be novel and non-obvious in light of prior art, passing muster under 35 U.S.C. 102 and 103. The claims here are nothing but a series of mathematical calculations based on selected information and the presentation of the results of those calculations (in the plot of a probability distribution function). No matter how much of an advance in the finance field the claims recite, the advance lies entirely in the realm of abstract ideas, with no plausibly alleged innovation in the non-abstract application realm. View "SAP America, Inc. v. Investpic, LLC" on Justia Law

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GNC sued ZTE in the Eastern District of Texas alleging infringement of its patents. ZTE moved to dismiss for improper venue under 28 U.S.C. 1406 and 1400(b). While that motion was pending, ZTE sought transfer to the Northern District of Texas or the Northern District of California under 28 U.S.C. 1404(a). The magistrate concluded that venue was proper in the Eastern District of Texas under the 1404(a) convenience analysis but did not rule on the motion to dismiss for improper venue under section 1406(a). The case was assigned to a new judge and a new magistrate, who denied the motion to dismiss, finding that ZTE failed to show it did not have a regular and established place of business in the Eastern District of Texas as required under the second prong of 28 U.S.C. 1400(b). The magistrate placed the burden on the objecting defendant to show improper venue and determined that ZTE had contracted with a call center in Plano, Texas, operated by another company, which constituted a physical place, and that ZTE transacted business there. The district court agreed. The Federal Circuit granted mandamus relief and remanded. The district court incorrectly assigned the burden of proof on venue and failed to fully consider the factors relevant to the question of whether the call center was that of ZTE. View "In re: ZTE (USA) Inc." on Justia Law

Posted in: Civil Procedure

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M-I Drilling, a U.K. company owns five U.S. patents; M-1 LLC, a U.S. company, is an exclusive licensee of the patents, which are claimed to cover pneumatic conveyance systems installed around oil drilling rigs and used to transfer drill cuttings from the oil rigs to ships. DAL, organized under the laws of and with its principal place of business in Brazil, is a subsidiary of Dynamic, a Minnesota corporation. The Brazilian state-owned oil company Petrobras requested proposals for the installation of pneumatic conveyance systems on ships. DAL won the bid and designed, manufactured, and operated conveyance systems from offshore oil drilling rigs onto two U.S.-flagged ships. M-I sued DAL in the District of Minnesota, alleging infringement. The court dismissed the case, finding that, although the alleged infringing activities took place on U.S.-flagged ships that are U.S. territory, the contract between Petrobras and DAL did not identify the ships on which DAL would make installations, so DAL did not purposefully avail itself of the privilege of conducting activities within the U.S. The Federal Circuit reversed. The district court erroneously focused on the contract between Petrobras and DAL. Even if the contract directed where the systems were installed and operated, DAL controlled the specifics of its continued performance. DAL kept the systems operating on the ships. Such deliberate presence of DAL and its systems in the U.S. enhance its affiliation with the forum and “reinforce the reasonable foreseeability of suit there.” View "M-I Drilling Fluids, U.K. Ltd. v. Dynamic Air Ltda." on Justia Law