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At issue were legal questions concerning the meaning of a regulation and the scope of the Board of Veterans’ Appeals’ remedial obligations under U.S. Code Title 38 and the Federal Circuit’s previous decision in Pirkl v. Shinseki, 718 F.3d 1379 (Fed. Cir. 2013) (Pirkl I). This case centered on clear and unmistakable (CUE) error in a disability decision from long ago. After Pirkl I was decided, the Board on remand dismissed Appellant’s appeal of a decision not to give relief for a 1953 CUE past the effective date of a 1956 rating reduction. The Court of Appeals for Veterans Claims affirmed. The Federal Circuit vacated the Veterans Court’s decision and remanded the case after addressing the remedy required for a CUE error in a disability rating decision, holding that the Veterans Court mistakenly interpreted a key regulation and took too narrow a view of the legally required corrective remedy for the rating decision error. View "Pirkl v. Wilkie" on Justia Law

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At issue in this case was the relative priority of statutes and regulations governing the procurement process for the Department of Veterans Affairs (VA). The Federal Circuit affirmed the decision of the United States Court of Federal Claims concluding that section 502 of the Veterans Benefits, Health Care, and Information Technology Act of 2006, Pub. L. No. 109-461, 120 Stat. 30403, 3431-35 (VBA), requires the VA to consider awarding contracts for prescription eyewear based on competition restricted to veteran-owned small businesses before procuring this eyewear from any other source, including any nonprofit agency for the blind or significantly disabled designated as such under that Javits-Wagner-O’Day Act, 41 U.S.C. 8504. After considering the plain language of the VBA, as well as the legislative history and Congress’s intention in enacting it, the Federal Circuit held (1) the Claims Court properly exercised subject-matter jurisdiction over this action; and (2) the Claims Court did not err in its substantive legal analysis, and the VA is required to undertake the “rule of two” analysis as required under the VBA - even when goods and services are on the list. View "PDS Consultants, Inc. v. United States" on Justia Law

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The Federal Circuit affirmed the decision of the United States District Court of the District of Delaware invalidating all asserted claims of patents directed to COPAXONE® 40mg/mL, holding that the district court correctly held that the asserted claims were invalid as obvious under 35 U.S.C. 103. The patents at issue, collectively referred to as the “Copaxone patents,” shared a common specification and claim priority to the same two provision applications. The Copaxone patents described and claimed COPAXONE® 40 mg/mL, a product marketed for treatment of patients with relapsing forms of multiple sclerosis. This appeal arose out of five consolidated district court cases. Appellants sued Appellees, general drug manufacturers who sought to engage in the manufacture and sale of generic versions of COPAXONE® 40 mg, three times a week dosage, alleging that Appellees’ respective Abbreviated New Drug Applications infringed claims of the subject patents. The district court held all asserted claims of the Copaxone patents invalid as obvious under section 103. The Federal Circuit affirmed, holding that the district court did not err in invalidating all asserted claims of the Copaxone patents as obvious. View "Teva Pharmaceuticals USA, Inc. v. Sandoz Inc." on Justia Law

Posted in: Patents

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The Federal Circuit affirmed the final written decisions of the Patent Trial and Appeal Board finding the claims of U.S. Patent Nos. 8,232,250, 8,399,413, and 8,969,302 unpatentable as obvious in three inter partes review proceedings, holding that the Board did not err in finding the claims of the patents unpatentable as obvious. Yeda Research and Development Co., Ltd was the assignee of the patents at issue, all entitled “Low Frequency Glatiramer Acetate Therapy.” The so-called “Copaxone patents” shared a common specification and claim priority to the same two provisional applications. Mylan Pharmaceuticals, Inc. filed petitions for inter partes review challenging all claims of the Copaxone patents on grounds pursuant to 35 U.S.C. 102 and 103. The Board concluded that the claims were unpatentable as obvious. The Federal Circuit affirmed, holding that the Board’s actions were in accordance with law and supported by substantial evidence. View "Yeda Research & Development Co. v. Mylan Pharmaceuticals Inc." on Justia Law

Posted in: Patents

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Roche’s 723 patent, titled “Detection of a Genetic Locus Encoding Resistance to Rifampin in Microbacterial Cultures and in Clinical Specimens,” is directed to methods for detecting the pathogenic bacterium Mycobacterium tuberculosis, a major cause of tuberculosis. In 1994, before the priority date of the 723 patent, the general method of MTB detection in a tuberculosis patient was known as sputum examination by the acid-fast bacilli smear. The diagnostic test of the 723 patent involves subjecting DNA extracted from a biological sample taken from a patient to amplification by polymerase chain reaction using a short, single-stranded nucleotide sequence that can hybridize (bind) to at least one of the eleven position-specific signature nucleotides in the MTB rpoB gene. The Federal Circuit affirmed summary judgment, holding that the patent’s claims are directed to patent-ineligible subject matter and are therefore invalid under 35 U.S.C. 101. Roche’s discovery of the signature nucleotides on the MTB rpoB gene and the designing of corresponding primers are valuable contributions to science and medicine, allowing for faster detection of MTB in a biological sample and testing for rifampin resistance but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the section 101 inquiry. The primers can be found in nature. View "Roche Molecular Systems, Inc. v. Cepheid" on Justia Law

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The district court entered judgment on the pleadings, finding the Tab Patents, titled “System and Methods for Improved Spreadsheet Interface With User-Familiar Objects,” patent-ineligible under 35 U.S.C. 101, as directed to abstract concepts and failing to provide an inventive concept. The patents claim systems and methods for making complex electronic spreadsheets more accessible by providing familiar, user-friendly interface objects—specifically, notebook tabs—to navigate through spreadsheets while circumventing the arduous process of searching for, memorizing, and entering complex commands. The Federal Circuit reversed in part, finding all but one claim to be patent eligible. The claims are not abstract, but rather are directed to a specific improved method for navigating through complex three-dimensional electronic spreadsheets. The asserted claims of one patent, reciting methods for tracking changes to data in spreadsheets, are directed to the abstract idea of collecting, recognizing, and storing changed information; nothing in these claims that provides an inventive concept sufficient to render the claims patent eligible. View "Data Engine Technologies LLC v. Google LLC" on Justia Law

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After the Army awarded a contract for computer hardware to Appellees, including Dell, Blue Tech, and Red River, 21 unsuccessful bidders filed protests, claiming the Army’s evaluations were unreasonable because the proposal deficiencies the Army considered disqualifying were minor or “clerical errors and misunderstandings” resulting from Solicitation ambiguities that could have been resolved through clarifications. The Army instituted a corrective action to reopen procurement and conduct additional discussions with offerors. Appellees challenged the decision. The Court of Federal Claims granted Appellees judgment on the administrative record and enjoined the Army from proceeding with its corrective action. The Federal Circuit reversed. The Claims Court did not apply the proper legal standard and the Army’s corrective action was reasonable under the correct standard. The Claims Court applied a “more exacting [standard] than the APA’s ‘rational basis’ review threshold for procurement protests, and impermissibly restrict[ed] the great deference the Tucker Act requires courts to afford agency procurement officials” by its use of a “narrowly targeted” standard. The Army’s proposed corrective action to reopen procurement and allow proposals to be revised is rationally related to the procurement’s defects, i.e., failure to conduct discussions and spreadsheet ambiguities. View "Dell Federal Systems, L.P. v. United States" on Justia Law

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Real Foods sought registration of two marks: “CORN THINS,” for “crispbread slices predominantly of corn, namely popped corn cakes”; and “RICE THINS,” for “crispbread slices primarily made of rice, namely rice cakes.” Frito-Lay opposed the registrations, arguing that the proposed marks should be refused as either generic or descriptive without having acquired distinctiveness. The U.S. Patent and Trademark Office’s Trademark Trial and Appeal Board refused registration of the applied-for marks, finding the marks “are merely descriptive and have not acquired distinctiveness,” dismissing Frito-Lay’s “genericness claim. The Federal Circuit affirmed. Substantial evidence supports the finding that the proposed marks are highly descriptive. The terms “corn” and “rice,” both of which are grains, describe the primary ingredient in Real Foods’ respective goods; the term thins describes physical characteristics of the corn and rice cakes. Viewing the marks as composites does not create a different impression. Real Foods “has not demonstrated that its applied-for marks have acquired distinctiveness. Real Foods did not demonstrate that its applied-for marks have acquired distinctiveness. The court remanded in part, finding that the Board erred in its analysis of genericness. View "Real Foods Pty Ltd. v. Frito-Lay North America, Inc." on Justia Law

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Robinson served in the Marine Corps in the 1960s, with a deployment in Vietnam. He subsequently experienced heart problems. In 20016, Robinson saw his VA cardiologist, Dr. Sadoughian, who recommended diagnostic testing, but the testing was not performed. Nine months later, Robinson returned after a week in the hospital with blood clots in his leg. Dr. Sadoughian again recommended testing. Robinson received the prescribed testing in April 2007, 14 months after his initial recommendation. The results indicated “[c]oronary artery disease with prior inferior wall myocardial infarction.” In August 2010 the VA amended its regulations to add coronary artery disease to its list of conditions that are presumptively service-connected for veterans who were exposed to certain herbicides, 38 C.F.R. 3.309(e). In 2011, the VA retroactively granted disability benefits to Robinson for that disease following a “Nehmer” review. The Board of Veterans’ Appeals denied Robinson’s claim for an earlier effective date because the April 2007 test results were the earliest medical evidence demonstrating that he satisfied the criteria the disability rating. Robinson argued that he should not be penalized for the delay in scheduling tests and that he would have received an earlier effective date if the VA had provided him with prompt treatment as required by section 17.33(a)(2). The Board concluded that section 17.33 applies only to treatment and has no bearing on effective date criteria. The Veterans Court and Federal Circuit affirmed, noting that the record did not indicate what caused the testing delay or whether Robinson would have satisfied the disability rating requirements earlier. View "Robinson v. Wilkie" on Justia Law

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In 1997-2011, NAI filed eight patent applications. In each continuing application, NAI included a statement (35 U.S.C. 120) claiming priority to the filing date of the first application, which issued in 1999, as the 596 patent. While the fourth application was pending NAI filed the 2003 provisional application and the fifth application, claiming priority to the fourth through first applications and to the 2003 provisional application. The sixth application, filed in 2008, during the fifth application’s pendency, claimed priority to the fifth application, and the fifth application claimed priority to the fourth, and so on. After filing its sixth application, NAI amended the fifth application to delete the benefit claim to the fourth through the first applications and to claim priority to only the 2003 provisional application. The sixth through the eighth applications subsequently issued as patents, but with a statement seeking the benefit of the fifth through the first applications, and the 2003 provisional application. On inter partes reexamination of the 381 patent (from the eighth application), NAI insisted that the sixth application maintained priority back to the first application because it was irrelevant what happened to the fifth application once the sixth application became entitled to the first application’s filing date. The examiner rejected the reexamined claims in view of prior art including the 596 patent, issued from the first application. The Federal Circuit affirmed. Because the eighth application claimed priority to the first application via the fifth application, the 381 patent was not entitled to the benefit of the fourth through the first applications. Under NAI’s theory it could gain patent term on its fifth application while simultaneously shielding its child applications (including the eighth application) from their former parents; NAI cannot have it both ways. View "Natural Alternatives International, Inc. v. Iancu" on Justia Law