Justia U.S. Federal Circuit Court of Appeals Opinion Summaries

Senju’s patent covers an ophthalmic solution for eye drops containing Gatifloxacin, an antimicrobial agent, to kill bacteria. Tear dilution and the outer layer of the eye can prevent Gatifloxacin from passing into and treating the aqueous humor. The patent discloses a solution combining Gatifloxacin with disodium edetate, to expand the intercellular spaces of the cornea, accelerating passage of Gatifloxacin solution into the eye. In 2007, Apotex filed an Abbreviated New Drug Application with the FDA (Hatch-Waxman Act, 98 Stat. 1585), requesting approval to manufacture and sell a generic version of the solution. Senju filed an infringement action. The district court held that, though the ANDA product infringed claims 1–3, 6, 7, and 9, claim 7 was invalid as obvious. The Federal Circuit affirmed. In the gap between the court’s 2010 issuance of findings and its December 2011 entry of final judgment, Senju requested reexamination of claims 1–3, 6, 8, and 9; amended claim 6 to include additional limitations; and added new independent claim. In October 2011, the PTO issued a reexamination certificate cancelling claims 1–3 and 8–11, and certifying amended claim 6, new independent claim 12, and new dependent claims as patentable. Before entry of final judgment in the first action, Senju sought a declaratory judgment that Apotex’s manufacture, use, or sale of Gatifloxacin ophthalmic solution infringed claims set forth in the reexamination certificate. The district court dismissed. The Federal Circuit affirmed, finding the suit barred by claim preclusion. View "Senju Pharm. Co., Ltd. v. Apotex, Inc." on Justia Law

In 2009, the U.S. Department of Commerce initiated the Fifth Administrative Review of the Antidumping Duty Order covering TPBI’s polyethylene retail carrier bags imported from Thailand during the 2008–2009 review period, 19 U.S.C. 1673. Commerce calculated the normal value of TPBI’s merchandise based on a constructed value, having determined that the sales in the exporting country of the foreign like product had been made at prices below the cost of production. Commerce found that TPBI’s methodology did not reasonably reflect actual costs because it resulted in products with few or minor physical differences being assigned significantly different costs of manufacturing. Commerce disregarded the below-cost sales. The Court of International Trade affirmed. Finding Commerce’s determinations supported by substantial evidence and in accordance with law, the Federal Circuit affirmed. View "Thai Plastic Bags Indus. Co., Ltd. v. United States" on Justia Law

Shire markets oral pharmaceuticals under the brand name LIALDA®. Its patent, entitled “Mesalazine Controlled Release Oral Pharmaceutical Composition,” concerns controlled-release compositions for treating inflammatory bowel diseases, such as Crohn’s and ulcerative colitis. The active ingredient is 5-aminosalicylic acid, also called mesalazine or mesalamine, which treats inflamed areas in the bowel by direct contact with the intestinal mucosal tissue. It must pass through the stomach and small intestine without being absorbed into the bloodstream and must be administered throughout the entire length of the colon so that the mesalamine contacts all affected tissues. The oral composition must, therefore, contain a high percentage of mesalamine. The patent teaches an inner lipophilic matrix and an outer hydrophilic matrix to address the limitations of the prior art systems. According to the patent, the combination of a lipophilic and hydrophilic matrix in an inner-outer matrix system, respectively, is advantageous because the inner-outer matrix properties cause the mesalamine to be released in a sustained and uniform manner. Watson submitted an Abbreviated New Drug Application seeking approval to sell generic LIALDA®. Shire sued. After construing claim language, the district court found infringement. The Federal Circuit reversed. The district court’s constructions of “inner lipophilic matrix” and “outer hydrophilic matrix” impermissibly broadened the ordinary meaning of the terms. View "Shire Dev., LLC v. Watson Pharm., Inc." on Justia Law

M.L. was born in 2003. At his 15-month well-child visit, his pediatrician noted that M.L. was walking and generally developing normally but did not “want to talk.” In 2005, M.L. received several immunizations, including the DTaP vaccination. Hours later, M.L. allegedly began experiencing an abnormally high fever and swelling. He was admitted to the hospital with a diagnosis of “vaccine adverse reaction with secondary fever, angiodema, and anaphylactoid reaction.” The morning after his discharge, M.L.’s mother called an ambulance because M.L. was exhibiting signs of hypothermia and seizure-like episodes. In the months that followed, M.L.’s vocabulary allegedly decreased. An MRI of M.L.’s brain with and without contrast was normal. After observing M.L.’s developmental delays and repetitive behaviors, a pediatric neurologist placed M.L. in the autism spectrum disorder category. A special master rejected claims under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. 300aa-1 to -34, and the Claims Court affirmed. The Federal Circuit affirmed. While the DTaP vaccination likely caused the initial anaphylactic reaction, there was no reliable medical theory that the M.L.’s anaphylaxis caused a focal brain injury. View "LaLonde v. Sec'y of Health & Human Servs." on Justia Law

New York based Stone Lion manages a hedge fund that focuses on credit opportunities. Lion, a United Kingdom private equity firm, invests primarily in companies that sell consumer products. Lion has two marks registered with the Patent and Trademark Office and started using the marks in the U.S. in 2005. Lion filed applications for “LION CAPITAL” and “LION” in 2005 and 2007, respectively, for services including “financial and investment planning and research,” “investment management services,” “capital investment consultation,” “equity capital investment,” and “venture capital services” Lion has priority over Stone Lion with respect to those marks. In August 2008, Stone Lion filed an intent-to-use application for the mark “STONE LION CAPITAL,” proposing to use the mark in connection with “financial services, namely investment advisory services, management of investment funds, and fund investment services.” Lion opposed the registration under section 2(d) of the Lanham Act, 15 U.S.C. 1052(d), alleging that the proposed mark would likely cause confusion with Lion’s registered marks when used for Stone Lion’s recited financial services. The Trademark Trial and Appeal Board conducted the likelihood of confusion inquiry pursuant to 13 factors and refused registration. The Federal Circuit affirmed, finding that the Board had substantial evidence to support its conclusion. View "Stone Lion Capital Partners, LP v. Lion Capital, LLP" on Justia Law

In 2006, Allen and Gillman agreed to adapt Allen’s electronic payment system, then used in the automotive industry, to process health care claims. Their contracts provided that Allen’s company, StoneEagle, owned the new system technology. StoneEagle licensed the technology to Talon, which was responsible for marketing. Allen applied for a patent on the system, listing himself as the sole inventor. Gillman had some role in drafting the application and in the application process. Although not listed as an inventor, Gillman had an ownership interest in the patent application until at least July 2010, when he assigned his interest to StoneEagle. The patent issued in September 2010. By 2011, the relationship had soured. StoneEagle sought a declaratory judgment that Allen was the sole inventor and owner of the patent and asserted state law trade secret misappropriation claims. The court issued a preliminary injunction prohibiting use or disclosure of StoneEagle’s trade secrets and confidential information. StoneEagle terminated the license agreement, but Talon and Gillman allegedly started a competing venture. The district court denied a contempt order and clairifed the injunction. The Federal Circuit remanded with instructions to dismiss, finding that the court lacked jurisdiction over the case when StoneEagle initiated the lawsuit because it did not did not allege an actual controversy concerning inventorship. View "Stoneeagle Servs., Inc. v. Gillman" on Justia Law

The Federal Grant and Cooperative Agreement Act, 31 U.S.C. 6301, states that an executive agency must use: “a procurement contract . . . when . . . the principal purpose … is to acquire … property or services for the direct benefit or use” of the government and must adhere to the Competition in Contracting Act and the Federal Acquisition Regulation However, an “agency shall use a cooperative agreement . . . when . . . the principal purpose … is to transfer a thing of value … to carry out a public purpose of support or stimulation … instead of acquiring . . . property or service” and can avoid procurement laws. Under Section 8 of the Housing Act, HUD provides rental assistance, including entering Housing Assistance Program (HAP) contracts and paying subsidies directly to private landlords. A 1974 amendment gave HUD the option of entering an Annual Contributions Contract (ACC) with a Public Housing Agency (PHA), which would enter into HAP contracts with owners and pay subsidies with HUD funds. In 1983, HUD’s authority was amended. HUD could administer existing HAP contracts, and enter into new HAP contracts for existing Section 8 dwellings by engaging a PHA if possible, 42 U.S.C. 1437f(b)(1). Later, HUD began outsourcing services and initiated a competition to award a performance-based ACC to a PHA in each state, with the PHA to assume “all contractual rights and responsibilities of HUD.” After making an award, HUD chose to re-compete, seeking greater savings, expressly referring to “cooperative agreements,” outside the scope of procurement law. The Government Accountability Office agreed with protestors that the awards were procurement contracts. HUD disregarded that recommendation. The Claims Court denied a request to set aside the award. The Federal Circuit reversed, finding that the awards are procurement contracts, not cooperative agreements.View "CMS Contract Mgmt. Servs. v. United States" on Justia Law

In 1997 MIDCO alleged that Elekta’s GammaKnife, GammaPlan, and SurgiPlan products infringed its patent, “Method and Apparatus For Video Presentation From Scanner Imaging Sources,” directed to both a method and apparatus for generating a video image from separate scanner imaging sources. Previously, images were not in a common format, and there was no method for comparing and using images from various scanners. In discovery, MIDCO focused on claim 1 and neglected the method claims. The court only construed terms from apparatus claims and dismissed the method claims without prejudice. Its construction included analog-to-digital and software based digital-to-digital conversion. A jury awarded $16 million. The Federal Circuit found that the disclosure did not encompass digital-to-digital conversion. On remand, MIDCO unsuccessfully attempted to revive the method claims. The court entered judgment for Elekta. The Federal Circuit affirmed. MIDCO licensed the patent; Brain Life sued defendants, including Elekta, claiming that Elekta’s GammaKnife, GammaPlan, SurgiPlan, and ERGO++ systems infringed the method claims. The court granted Elekta summary judgment, finding no material difference between current products and those previously adjudicated noninfringing. Brain Life argued that similarity did not bar allegations of infringement of method claims. The court found that, once judgment entered in its favor, Elekta developed and sold products with an understanding that they did not infringe; MIDCO chose not to pursue method claims in the first litigation. Concerning other defendants, the court concluded that the method claims were broader than the apparatus claims and included digital-to-digital conversion. With respect to Brain Life, the Federal Circuit held that its claims were not barred by claim or issue preclusion, but that the Kessler Doctrine bars most of them. View "Brain Life, LLC v. Elekta Inc." on Justia Law

Biggers had been employed by the Navy for 29 years and in 2007 was Security Manager for the Naval Facilities Engineering Service Center. The position required him to maintain a top secret security clearance. In 2008, a duty officer found that an outer vault door of the Secret Internet Protocol Router Network room was left open. Biggers notified the Commanding Officer of the potential violation. After an investigation, the Command Evaluator recommended that all security personnel (including Biggers) have their access to classified material suspended because “the investigation revealed numerous systemic problems, violations and deficiencies.” Biggers’ security clearance was suspended pending a final determination by the Department of Navy Central Adjudication Facility (DONCAF) pursuant to 5 U.S.C. 7513. Ultimately, DONCAF concluded that the information provided by Biggers and the Center “sufficiently explained, mitigated, or provided extenuating circumstances,” and Biggers was found eligible for a Top Secret clearance and assignment to a sensitive position and returned to duty status.. His suspension had lasted nine months. The Navy did not provide back pay or treat him as employed for calculation of retirement benefits. Biggers alleged that the suspension was motivated by retaliatory animus arising from his participation in an EEOC proceeding. An AJ determined that the Merit Systems Protection Board may not review the merits of a security clearance revocation or suspension. The Federal Circuit affirmed, holding that Biggers was not entitled to back pay. View "Biggers v. Dep't of the Navy" on Justia Law

Plaintiffs are or were air-traffic-control specialists or traffic-management coordinators with the Federal Aviation Administration and alleged that the FAA’s policies governing how to compensate them when they worked overtime did not comply with the time-and-a-half- payment requirement of the Fair Labor Standards Act 29 U.S.C. 207. They sought damages under 29 U.S.C. 216(b) and invoked jurisdiction under the Tucker Act, 28 U.S.C.1491. The Claims Court ruled in their favor, holding that the agency’s personnel policies are contrary to the FLSA and are not authorized by any other provision of law. The Federal Circuit vacated, holding that the FAA has such authority under the federal personnel laws, 5 U.S.C. 5543 and 6120-6133. The court remanded for determination of whether the challenged FAA policies are fully, or only partly, within the authority of those title 5 exemptions from the FLSA. View "Abbey v. United States" on Justia Law