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

Skechers challenged the district court's issuance of a preliminary injunction prohibiting it from selling shoes that allegedly infringe and dilute adidas America, Inc.’s Stan Smith trade dress and Three-Stripe trademark. The panel affirmed in part, holding that the district court did not abuse its discretion in issuing the preliminary injunction as to adidas's claim that Skechers's Onix shoe infringes on adidas's unregistered trade dress of its Stan Smith shoe. However, the panel reversed in part, holding that the district court erred in issuing a preliminary injunction as to adidas's claim that Skechers's Cross Court shoe infringes and dilutes its Three-Stripe mark. View "adidas America, Inc. v. Skechers USA, Inc." on Justia Law

WesternGeco’s patents are directed to technologies for controlling the movement and positioning of a series of streamers towed in an array behind a ship, emitting acoustic signals and detecting the returning signals that reflect from the ocean floor. The collected data can be used to map the subsurface geology, helping oil companies analyze underwater natural resource formations and explore for oil and gas beneath the ocean floor. Conventional marine seismic survey systems use long streamers that are towed behind ships in open-water conditions. Vessel movements, weather, and other conditions can cause the streamers to tangle or drift apart. In inter partes review proceeding, the Patent Trial and Appeal Board issued six final written decisions, finding all of the instituted claims in the six proceedings to be unpatentable as anticipated or obvious. It rejected WesternGeco’s arguments that the IPR proceedings were time-barred under 35 U.S.C. 315(b). The Federal Circuit affirmed, as supported by substantial evidence, the Board’s unpatentability determinations, and its conclusion that the proceedings were not time-barred. The relationship at issue is not sufficiently close such that an infringement proceeding would have given an unrelated company a full and fair opportunity to litigate the validity of the claims of the WesternGeco Patents. View "WesternGeco LLC v. ION Geophysical Corp." on Justia Law

The claims relate to methods of removing hair using nanoparticles to damage hair follicles. GHC is the named applicant on the 575 application. Sienna owns the 941 patent. In 2015, at GHC’s suggestion, the Board declared an interference and identified claim 1 of the 941 patent as the sole count. Claim 1 is directed to a method of localizing thermal damage to a hair follicle by applying a composition comprising a plurality of unassembled plasmonic nanoparticles to a skin surface. The Board identified claims 65–67 of the 575 application and claims 1–20 of the 941 patent as corresponding to that count. Sienna argued that claims of the 575 application were unpatentable for failure to meet the written description requirement. The Board found claims 65–67 lack written description support and are unpatentable under 35 U.S.C. 112 and denied GHC’s motion to add new claim 74, determining that GHC did not show interference-in-fact with Sienna claim or correspondence to Count 1, and failed to provide supporting evidence that this claim was patentable. The Federal Circuit vacated. Substantial evidence supports a finding of a lack of sufficient of written description but the Board erred in denying the motion to amend; its determination that GHC had not established claim 74 interferes with any of Sienna’s claims was not in accordance with controlling precedent. View "General Hospital Corp. v. Sienna Biopharmaceuticals, Inc." on Justia Law

The patent is titled “Water Heating Apparatus for Continuous Heated Water Flow and Method for Use in Hydraulic Fracturing.” The inventor, Hefley, HOTF's founder, filed the earliest provisional application in 2009; the critical date for analyzing the on-sale and public-use bars under 35 U.S.C. 1023 is September, 2008. Before the critical date, Hefley and his companies performed on-the-fly heating of water on at least 61 frac jobs using the patented system and collected over $1.8 million for those services. Hefley knew that the patent process required that he file his application within one year of the first offer for sale or public use. Hefley did not disclose any of the frac jobs to the PTO. The patent issued in May 2012. Energy, HOTF's competitor, began using its accused process of heating water on frac jobs in 2012. Energy alleged that HOTF tortiously interfered with its prospective business relationship by alleging that Energy’s water heaters infringed a patent. The court granted Energy summary judgment. A jury found HOTF represented in bad faith that it possessed a valid patent, knowingly engaged in unlawful sales or advertising practices, and unlawfully interfered with Energy’s contractual rights and prospective business relationship. The court granted declaratory judgment against Hefley on inequitable conduct, finding that even if the prior frac jobs were experimental, they were focused on economic viability, not how to meet the claims of the patent. The Federal Circuit affirmed that the patent is unenforceable due to inequitable conduct and the findings of tortious interference but vacated the denial of attorneys’ fees. View "Energy Heating, LLC. v. Heat On-the-Fly, LLC" on Justia Law