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

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

Specific elements from within a television show—as opposed to the title of the show itself—can receive trademark protection. The Fifth Circuit affirmed the district court's grant of summary judgment to Viacom on its trademark infringement and unfair competition claims related to the common law trademark of The Krusty Krab. The Krusty Krab is a fictional restaurant in the "SpongeBob SquarePants" animated television series, and IJR took steps to open seafood restaurants using the same name. The court held that The Krusty Krab's key role in "SpongeBob SquarePants" coupled with the consistent use of the mark on licensed products established ownership of the mark because of its immediate recognition as an identifier of the source for goods and services; Viacom's mark has acquired distinctiveness through secondary meaning as a matter of law; and Viacom met its burden by proving that IJR's use of The Krusty Krab created a likelihood of confusion as to source, affiliation, or sponsorship. View "Viacom International, Inc. v. IJR Capital Investments, LLC" on Justia Law

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

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

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

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

Anacor’s patent, entitled “Boron-containing Small Molecules,” is directed to the use of 1,3-dihydro-5- fluoro-1-hydroxy-2, 1-benzoxaborole, also known as tavaborole, to topically treat fungal infections that develop under fingernails and toenails. The patent teaches that tavaborole can be used to treat onychomycosis, a fungal infection that is responsible for approximately half of all nail disorders in humans. On inter partes review, the Patent Board found all of the claims of the patent unpatentable for obviousness. The Federal Circuit affirmed. Anacor was not denied its procedural rights with respect to the theory of obviousness the Board adopted or any evidence it relied on. The Board understood that the petitioner’s theory was “not based on structural similarities alone,” but was “based on the combination of structural similarity and functional similarity” and agreed with the petitioner that “a person of ordinary skill in the art would have expected that tavaborole, which shares functional activity with the compounds of Brehove, would have shared other activities as well, such as the inhibition of additional fungi responsible for onychomycosis.” View "Anacor Pharmaceuticals, Inc. v. Iancu" on Justia Law

Defendants produce or sell patented drug products containing the antiviral agent tenofovir alafenamide fumarate (TAF), which is used in the treatment of AIDS. Healthcare provides medical care to persons afflicted with AIDS, including providing antiviral drugs, including the TAF products that Healthcare buys from Defendants. Healthcare sought declarations of invalidity for patents purportedly covering TAF and various combination products so that it could partner with generic makers and purchase generic TAF on the expiration of the five-year New Chemical Entity exclusivity s(21 U.S.C. 355(j)(5)(F)(ii)). Healthcare filed suit two months after the FDA approved Genvoya®—the first TAF-containing product to receive FDA approval; other TAF products were still undergoing clinical trials. No unlicensed source was offering a TAF product or preparing to do so. Healthcare told the court that “none of the generic makers wanted to enter the market because there was the fear of liability.” The court ruled that Healthcare’s actions in encouraging others to produce generic TAF products and interest in purchasing such products did not create an actual controversy under the Declaratory Judgment Act. The Federal Circuit affirmed. The declaratory requirement of immediacy and reality is not met by litigation delay. Healthcare has not otherwise shown that there is a controversy of sufficient immediacy and reality to create declaratory judgment jurisdiction. Liability for inducing infringement requires that there be direct infringement. An interest in buying infringing product is not an adverse legal interest for declaratory jurisdiction. View "AIDS Healthcare Foundation, Inc. v. Gilead Sciences, Inc." on Justia Law

By 2000, Altaire was manufacturing R-phenylephrine hydrochloride products, used to dilate patients’ pupils. In 2011, Altaire and Paragon agreed to pursue FDA approval. Paragon submitted a new drug application (NDA). The FDA recommended that Paragon consider adding a chiral purity test. Altaire measured the optical rotation of Lots 11578 and 11582, 2.5% and 10% phenylephrine hydrochloride ophthalmic solution products. Paragon submitted a supplementary NDA, which was FDA-approved. Altaire also conducted high-performance liquid chromatography testing on the two lots (TMQC-247). Paragon proposed an amendment to the Agreement to address filing a patent application. Altaire responded that: “the formulation, processes[,] and controls ... were developed solely by [Altaire’s Chief Executive] … and are . . . the proprietary and confidential information of Altaire”; the Agreement “does not contemplate ... a patent application.” Paragon did not respond but filed a patent application, entitled “Methods and Compositions of Stable Phenylephrine Formulations.” While the application was being prosecuted, Paragon requested “all the work [Altaire] ha[s] on chiral purity” for its annual FDA report. Altaire provided a report. Altaire later sued, alleging that Paragon breached a nondisclosure agreement; Paragon counterclaimed. Altaire sought a declaratory judgment of invalidity of the patent and sought post-grant review, arguing that the Asserted Claims would have been obvious over Lots #11578 and #11581. The Patent Board rejected the argument. The Federal Circuit reversed. The Board erred in refusing to consider a declaration by Altaire’s Chief Executive concerning the TMQC-247 and optical rotation test data. View "Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc." on Justia Law