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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

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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

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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

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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

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Plaintiffs filed a patent infringement suit in the District of Delaware against HTC, a Taiwanese corporation with its principal place of business in Taiwan, and its wholly owned U.S. based subsidiary, HTC America, a Washington corporation with its principal place of business in Seattle. HTC and HTC America moved to dismiss for improper venue or, in the alternative, to transfer the case to the Western District of Washington pursuant to 28 U.S.C. 1404(a) or 1406(a). The district court found that venue was not proper as to HTC America but was proper as to HTC. Plaintiffs voluntarily dismissed their suit against HTC America without prejudice. HTC filed a mandamus petition seeking dismissal for improper venue. The Federal Circuit denied relief, rejecting HTC’s attempts to characterize the legal issue as “unsettled.” Suits against alien defendants are outside the operation of the federal venue laws. View "In re: HTC Corp." on Justia Law

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Income earned by Americans typically is taxed in the U.S., regardless of where it is earned. European countries only tax income earned within their borders. To address possible “double taxation” the U.S. generally provides credits for taxes paid to foreign governments; European systems typically exempt from taxation income earned abroad. Congress, believing that the exemption method puts American companies at a trade disadvantage, has enacted various tax regimes, then received push-back from its European trading partners, who claimed each was an effective export subsidy. The 2000 ETI Act, intended to ease the burden of the tax revisions on domestic producers, was rejected in the World Trade Organization (WTO). Congress responded with the 2004 American Jobs Creation Act (AJCA), 118 Stat. 1418. Section 101 repeals the ETI provision that excluded extraterritorial income from taxation, effective for “transactions after December 31, 2004.” Section 101(d), provides: In the case of transactions during 2005 or 2006, the amount includible in gross income by reason of the amendments made by this section shall not exceed the applicable percentage of the amount which would have been so included but for this subsection. In 2005, WTO found that the ACJA improperly maintained prohibited ETI subsidies through transitional and grandfathering measures. Congress repealed section 101(f), effective for “taxable years beginning after” May 17, 2006. It did not repeal or revise section 101(d). Pursuant to a 2006 Agreement, DWA recognized qualifying extraterritorial income for 2006, invoked section 101(d), and excluded 60% from gross income. The IRS allowed the exclusion. DWA subsequently sought refunds for 2007-2009, claiming the section 101(d) exclusion. The Federal Circuit, disagreeing with the IRS and the Claims Court, held that section 101(d) unambiguously provides transitional relief for all extraterritorial income received from transactions entered into in 2005 and 2006, even income received in later years. View "DWA Holdings LLC v. United States" on Justia Law

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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

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Alimanestianu, a U.S. citizen, was killed in the 1989 bombing of Flight 772 by the Abu Nidal Organization. The State Department determined that the Libyan government sponsored the bombing. Libya was protected from suit in the U.S. under the Foreign Sovereign Immunities Act (FSIA); in 1996, FSIA was amended to permit claims for personal injury or death caused by acts of foreign sovereigns designated as state sponsors of terrorism, 28 U.S.C. 1605(a)(7). Libya had been designated in 1979. In 2002, the Alimanestianus and others sued Libya and obtained summary judgment in 2008, awarding $6.9 billion in total; the Alimanestianus received $1.297 billion. While the defendants appealed, the United States entered into a Claims Settlement Agreement with Libya. Libya agreed to deposit $1.5 billion into a humanitarian fund, $681 million of which was for claims by U.S. nationals for wrongful death or physical injury in pending case as “a full and final settlement.” The Foreign Claims Settlement Commission subsequently awarded the Alimanestianus $10 million. The Federal Circuit rejected a claim that vacating their judgment constituted a compensable taking. The court considered the Penn Central factors: the Executive has an overwhelming interest in conducting foreign affairs; the plaintiffs have no evidence that they had an investment-backed expectation in their claims and nonfinal judgment; plaintiffs’ claim that the Commission’s award was less than their nonfinal judgment does not refute that they received more than they would have without government action. View "Alimanesianu v. United States" on Justia Law

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Plaintiffs leased part of Love Field airport from the City of Dallas and constructed a six-gate airline terminal. Plaintiffs claim that the Wright Amendment Reform Act of 2006 (WARA), 120 Stat. 2011, effected a regulatory taking of their leases and a physical taking of the terminal because the statute codified a private agreement in which Dallas agreed to bar the use of plaintiffs’ gates for commercial air transit and to acquire and demolish plaintiffs’ terminal. The Claims Court found that WARA's enactment constituted a per se regulatory taking of plaintiffs’ leaseholds under Supreme Court precedent, Lucas, and a regulatory taking of the leaseholds under Penn Central, and a physical taking of the terminal. The Federal Circuit reversed. Noting the history of regulation of Love Field and limitations in place before WARA, the court stated there can be no regulatory taking because plaintiffs cannot demonstrate that their ability to use their property for commercial air passenger service pre-WARA had any value. Plaintiffs’ reasonable, investment-backed expectations are limited by the regulatory regime in place when they acquired the leases. Rejecting a claim of physical taking the court reasoned that a requirement that federal funds not be used for removal of plaintiffs’ gates explicitly distances the federal government from Dallas’ intended action. View "Love Terminal Partners, L.P. v. United States" on Justia Law

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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