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

Robinson became the Associate Director of the Phoenix Veterans Administration Health Care System in 2012, having started his VA career in 1987. Robinson was aware of scheduling issues, including that it often took more than 30 days for patients to receive new-patient appointments. In 2014, the Chairman of the U.S. House Committee on Veterans’ Affairs alleged that veterans died while on “secret” waitlists at the Phoenix VA. Based on an investigation by the Office of the Inspector General and the Department of Justice, Robinson’s removal was proposed for “failure to provide oversight.” The Deciding Official did not take action. Robinson remained on administrative leave for two years, returning to duty in January 2016. The Senate Committee on Veterans’ Affairs questioned why many senior executives were placed on paid leave instead of removed from office. In March 2016, a second proposal for Robinson’s removal issued. The Deciding Official sustained all charges. Robinson was removed. The Merit Systems Protection Board affirmed the removal, finding that Robinson was negligent in the performance of his duties and failed to provide accurate information to his supervisors but did not sustain a whistleblowing retaliation charge. The Federal Circuit affirmed the decision as supported by substantial evidence, rejecting Robinson’s claim that he was treated differently than other supervisors. Robinson had notice and a pre-termination opportunity to be heard. Robinson had a duty to ensure compliance with VA policy but the record demonstrated that he did not. View "Robinson v. Department of Veterans Affairs" on Justia Law

A.M. received a human papillomavirus vaccine in 2007. Shortly thereafter, she developed autoimmune limbic encephalitis and an intractable seizure disorder, resulting in cognitive impairment. Her mother (McCulloch) sought compensation under the Vaccine Act, 42 U.S.C. 300aa. A special master awarded compensation for A.M.’s injury and accepted the parties' agreement on the amounts and mechanisms of compensation. Neither party sought review. Months later McCulloch sought an award of attorneys’ fees and costs under section 300aa15(e)(1). A special master awarded fees and costs and included amounts to cover the expenses, under Florida guardianship law, of maintaining the guardianship for A.M,-- a required condition for receiving the full payments under the merits judgment. The Claims Court upheld inclusion of those amounts, but cited section 300aa-15(a), the provision governing merits awards of compensation, instead of 300aa-15(e), the fees/costs provision on which the special master relied. The Federal Circuit affirmed while acknowledging that the Claims Court improperly reopened a final merits judgment by awarding money under section 300aa-15(a). Nonetheless, it was appropriate for the special master to award guardianship-maintenance expenses under that section because McCulloch incurred a continuing liability to pay such expenses as a condition of receiving, for her daughter, the compensation awarded on the merits in this proceeding. View "McCulloch v. Secretary of Health and Human Services" on Justia Law

The 779 Patent, entitled “Process for Preparing Morphinan-6-One Products with Low Levels of α,β-Unsaturated Ketone Compounds,” generally relates to compounds known as “morphinan alkaloids,” such as “oxymorphone,” which have “great medical importance” and “are used extensively for pain relief.” Endo, which licenses the patent, sued, alleging that two Abbreviated New Drug Applications filed by Actavis infringed claims in the patent. The Federal Circuit affirmed an infringement finding, concluding that Actavis failed to prove by clear and convincing evidence that any of the asserted claims were invalid as obvious or anticipated. The district court correctly construed 14-hydroxymorphinone as 14-hydroxymorphinone hydrochloride. The claims were not obvious under 35 U.S.C. 103(a); a person of ordinary skill in the art would not have a reasonable expectation of success in combining the prior art. View "Endo Pharmaceuticals Inc. v. Actavis, LLC" on Justia Law

Under the Medicare administrative contractor (MAC) program, 42 U.S.C. 1395kk1, the Centers for Medicare & Medicaid Services (CMS) use contractors to administer Medicare claims and benefits. CMS must use competitive procedures when entering into contracts with MACs, taking into account performance quality, price, and other factors. In 2010, CMS prepared solicitations to replace the original MAC contracts and implemented a policy in the solicitations for several jurisdictions, placing a limit on the amount of MAC contract responsibility that any single entity could win in a prime contractor capacity. CMS would not award more than 26% of the national A/B Medicare workload to any single contractor or more than 40% of the national A/B Medicare workload to any one set of affiliates. An “Exception” stated that, for the sake of continuity of service, CMS retained the discretion to award a particular prime contract to a particular contractor, even where doing so would exceed the policy workload. Because of the policy, with NGS’s current contracts, NGS cannot win the MAC contract for Jurisdiction H. NGS filed a pre-award protest. The Government Accountability Office rejected the protest. The Claims Court affirmed. The Federal Circuit reversed. The policy precludes “full and open competition through the use of competitive procedures,” 41 U.S.C. 3301(a)(1). Congress outlined the circumstances under which an agency may avoid the full and open competition requirement. The court rejected the government’s argument that the workload caps fall within an exception for “procurement procedures otherwise expressly authorized by statute.” View "National Government Services, Inc. v. United States" on Justia Law

Kalle's sausage casings, imported from Germany, are comprised of a woven textile sheet that is coated with a layer of plastic on one side. The plastic coating is thin and “only fills the interstitial spaces between the textile fibers” to ensure that the casing’s “textile character remains recognizable.” The textile gives the casing its strength and shape and allows the casing to “absorb dyes and aroma substances.” The plastic coating helps prevent moisture transmission. After the textile sheet is coated in plastic, it is trimmed, folded to form a tube, and fixed with a seam for importation as flattened tubes wound around a cardboard core. The casings were liquidated by U.S. Customs and Border Protection under Harmonized Tariff Schedule of the United States (HTSUS) subheading 6307.90.98, as “[o]ther made up articles, including dress patterns,” subject to a duty of 7%. Kalle argued that the casings should be classified under subheading 3917.39.0050, which covers “[t]ubes, pipes and hoses and fittings therefor (for example, joints, elbows, flanges), of plastics,” subject to a duty of 3.1%, emphasizing that Note 8 includes “sausage casings and other lay-flat tubing.” The Trade Court granted the government summary judgment. The Federal Circuit affirmed. The casings are not “completely embedded,” or entirely fixed in a surrounding mass of plastic. The court distinguished “impregnated” fabrics. View "Kalle USA, Inc. v. United States" on Justia Law

Amarin markets Vascepa®, a prescription drug consisting of eicosapentaenoic acid in ethyl ester form, synthetically produced from fish oil, intended to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Vascepa® is the only FDA-approved purified ethyl ester E-EPA product sold in the U.S. Amarin filed a complaint with the International Trade Commission (ITC) under 19 U.S.C. 1337 (Tariff Act), alleging that certain companies were falsely labeling and deceptively advertising their imported synthetically produced omega-3 products as “dietary supplements,” where the products are actually “new drugs” under the Food, Drug, and Cosmetic Act (FDCA) that have not been approved for use in the U.S. Amarin claimed that their importation and sale was an unfair act or unfair method of competition because it violates the Lanham Act, 15 U.S.C. 1125(a), and the Tariff Act “based upon" FDCA standards. The FDA urged the Commission not to institute an investigation and to dismiss Amarin’s complaint, arguing that the FDCA prohibits private enforcement actions and precludes any claim that would “require[] the Commission to directly apply, enforce, or interpret the FDCA.” The ITC and Federal Circuit agreed.Amarin’s allegations are based entirely on FDCA violations; such claims are precluded by the FDCA, where the FDA has not yet provided guidance as to whether violations have occurred. Although Amarin claimed violations of the Tariff Act, its claims constituted an attempt to enforce the FDCA. View "Amarin Pharma, Inc. v. International Trade Commission" on Justia Law

ThermoLife, the exclusive licensee of four Stanford University patents, claiming methods and compositions involving the amino acids arginine and lysine, to be ingested to enhance vascular function and physical performance, filed an infringement suit against several defendants. Stanford was a co-plaintiff. A bench trial was held and the district court found all asserted claims invalid and later granted defendants’ motions for attorney’s fees under 35 U.S.C. 285, which authorizes an award to a prevailing party in “exceptional” cases. The court found the cases exceptional, not based on an assessment of the validity position taken by plaintiffs or how they litigated but on its conclusion that plaintiffs were unjustified in alleging infringement in the first place, having failed to do an adequate pre-filing investigation. The Federal Circuit affirmed. These are unusual cases in that the basis for the fee award had nothing to do with the only issues litigated to reach the merits judgment: Infringement had not been adjudicated and even discovery on infringement had been postponed so that validity could be litigated first. Nevertheless, there was no abuse of discretion in the district court’s determination of exceptionality based on plaintiffs’ inadequate pre-suit investigation of infringement. View "ThermoLife International, LLC v. GNC Corp." on Justia Law

TT’s patent “relates to displaying market information on a screen.” According to the specification, “traders are often interested in analyzing other pieces of highly relevant information that are not normally provided in an electronic exchange’s data feed nor displayed by a trading screen.” Traders may “make quick mental calculations, use charting software, or look to other sources to provide additional insight beyond what is normally provided.” The specification discloses “generating values that are derivatives of price and then displaying these values along an axis on a screen,” particularly profit and loss. Petitioners sought review under the Transitional Program for Covered Business Method Patents (CBM review), 125 Stat. 284, 329–31. The Patent Trial and Appeal Board held, and the Federal Circuit affirmed, that the patent meets the criteria for CBM review and the claims are ineligible under 35 U.S.C. 101. Merely providing a trader with new or different information in an existing trading screen is not a technical solution to a technical problem. The purported advance is a process of gathering and analyzing information of specified content, then displaying the results, and not any particular assertedly inventive technology for performing those functions. The claims are directed to an abstract idea. View "Trading Technologies International, Inc. v. IBG LLC" on Justia Law

Rubies imports and sells traditional Christmas Santa Claus costumes, including the “Premier Plush 9 Piece Santa Suit,” which consists of a jacket, pants, gloves, a toy sack, a beard, a wig, a hat, a belt, and shoe covers. Rubies requested a binding pre-importation ruling from U.S. Customs and Border Protection on the tariff classification of the Santa Suit. Customs issued a Ruling Letter HQ, classifying the Santa Suit under several tariff classifications of the Harmonized Tariff Schedule of the United States (HTSUS). Rubies contended that all nine pieces fell under HTSUS chapter 95 as “[f]estive . . . articles,” requiring duty-free entry. The Court of International Trade upheld the tariff classification. The Federal Circuit affirmed. The merchandise is excluded from classification as “festive articles” by the notes to HTSUS chapter 95, referring to “fancy dress of textile material.” View "Rubies Costume Co. v. United States" on Justia Law

Eli Lilly’s patent relates to administering folic acid and a methylmalonic acid (MMA) lowering agent, such as vitamin B12, before administering pemetrexed disodium, a chemotherapy agent, in order to reduce the toxic effects of pemetrexed, an antifolate. In inter partes review, the Patent Trial and Appeals Board rejected arguments that certain claims were unpatentable as obvious, 36 U.S.C. 101. The Federal Circuit affirmed. Substantial evidence supports the Board’s finding that the prior art did not provide a motivation for a skilled artisan to administer an MMA lowering agent, such as vitamin B12, in addition to folic acid. View "Neptune Generics, LLC v. Eli Lilly & Co." on Justia Law