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

Checo sought an increased disability rating for lumbosacral spinal stenosis, including disk bulges, which was rated at a 20% disability. On July 6, 2011, the Board of Veterans’ Appeals denied her request. Checo was homeless, residing in shelters and temporary housing without the ability to receive mail. On September 27, 2011, she contacted the VA to provide a new address, and received a copy of the adverse decision on October 6, 2011; 91 days of the 120-day filing period under 38 U.S.C. 7266 had passed. On December 7, 2011, Checo filed a Notice of Appeal, 33 days late. She wrote: “Due to economic hardship, I’ve been homeless for extensive periods of time since July 2009 … and did not learn about the hearing and subsequent decision until” October 2011. The Clerk of the Veterans Court ordered the Secretary to file a response discussing whether the circumstances warranted equitable tolling of the judicial appeal period. In its response, the Secretary noted that “it appears that [Ms. Checo’s] homelessness was due to circumstances beyond her control” and that homelessness “would have delayed her filing of her NOA.” After the Veterans Court accepted the Secretary’s concession that Checo’s homelessness qualified as an extraordinary circumstance, it dismissed, finding that Checo failed to prove two other necessary elements, due diligence and direct causation,—to warrant equitable tolling. The Federal Circuit vacated. The Veterans Court used an inappropriate due diligence standard and erred in determining that homelessness did not cause the delay.View "Checo v. Shinseki" on Justia Law

The Department of Commerce initiated a CVD investigation, 19 U.S.C. 1671(a), on multi-layered wood flooring from China in response to a petition from domestic producers, limiting its individual examination to companies accounting for the largest volume of imports, and selected Fine Furniture as a mandatory respondent. Commerce sent out questionnaires to analyze an allegation that the government of China subsidized the respondents’ electricity costs. Among other things, Commerce sought draft provincial price proposals for 2006 and 2008 for each province in which the mandatory respondents were located. Fine Furniture provided all of the requested information, while the government of China did not. Commerce determined that the government of China’s decision not to provide information about how electricity rates were determined for each province in which mandatory respondents were located was a failure to cooperate to the best of its ability. Accordingly, Commerce applied an adverse inference to find that the Electricity Program provided a financial contribution specific to the identified respondents. Commerce also applied adverse inferences to determine the benchmark price for electricity. The Court of International Trade held that Commerce did not apply adverse inferences against Fine Furniture, but applied adverse inferences as its method for determining the information requested from, but not provided by, the government of China. The Federal Circuit affirmed. View "Fine Furniture Ltd. v. United States" on Justia Law

Braintree manufactures the SUPREP® Bowel Prep Kit, which helps to prepare patients for colonoscopies. In the late 1990s, two colon cleansing options existed; the safest required patients to drink large volumes of unappetizing isotonic prep formulas, resulting in low patient compliance, and a low-volume, hypertonic prep that could cause severe electrolyte shifts, leading to heart failure, kidney failure, neurological impairment, and even death. Braintree’s patent discloses a combination of magnesium sulfate, potassium sulfate, and sodium sulfate, which can be digested in small volumes to safely and effectively induce colonic purging without causing clinically significant electrolyte shifts. Novel filed an abbreviated new drug application (ANDA) and Braintree responded with a patent infringement case (Hatch- Waxman Act, 35 U.S.C. 271(e)(2)(A). The district court granted summary judgment of infringement based on its construction of four disputed claim terms. The Federal Circuit affirmed a finding Braintree’s patent not invalid, but reversed with respect to construction of the claim term “clinically significant electrolyte shifts” and vacated with respect to infringement.View "Braintree Labs, Inc. v. Novel Labs, Inc." on Justia Law

Gilead owns patents directed to antiviral compounds and methods for their use. The 375 and 483 patents list the same inventors and their written descriptions disclose similar content, but they do not claim priority to a common application and have different expiration dates. Gilead sued Natco for infringement of the 483 patent after Natco filed an FDA request for approval to market a generic version of one of Gilead’s drugs that is allegedly covered by the 483 patent. Natco asserted that the 483 patent was invalid for obviousness-type double patenting over the 375 patent. Gilead argued that the 375 patent cannot serve as a double patenting reference against the 483 patent because, even though the 483 patent’s expiration date is 22 months after the 375 patent’s expiration date, the 375 patent issued after the 483 patent. The district court, pursuant to a stipulation, granted Gilead final judgment on infringement. The Federal Circuit vacated and remanded. Because the obviousness-type double patenting doctrine prohibits an inventor from extending his right to exclude through claims in a later-expiring patent that are not patentably distinct from the claims of the inventor’s earlier-expiring patent, the 375 patent qualifies as an obviousness-type double patenting reference for the 483 patent. View "Gilead Sciences, Inc. v. Natco Pharma. Ltd." on Justia Law

Plaintiffs’ patent concerns the anti-hypertension drug with the brand name Tarka,® a combination of the angiotensin converting enzyme (ACE) inhibitor trandolapril, and the calcium channel blocker (also called “calcium antagonist”) verapamil hydrochloride. The FDA approved a New Drug Application (NDA) for a Tarka® product in 1996. In 2007 Glenmark filed an abbreviated new drug application (ANDA) for a generic counterpart Tarka. Since the patent had not expired, Glenmark filed a Hatch-Waxman “Paragraph IV Certification.” Plaintiffs filed an infringement suit. Launch of Glenmark’s generic product was stayed for 30 months under 21 U.S.C. 355(j)(5(B)(iii). After the stay expired in 2010, Plaintiffs sought a preliminary injunction, which the district court denied. In June 2010 Glenmark launched its generic product “at-risk,” while litigation proceeded. Glenmark admitted infringement and the jury held that the patent had not been proved invalid. The jury awarded $15,200,000 in lost profits and $803,514 in price erosion damages. The Federal Circuit affirmed, rejecting claims that the patent was invalid, that Glenmark was entitled to a new trial based on a prejudicial jury instruction on evidence spoliation, and that no damages should be awarded due to lack of standing of certain Plaintiffs. View "Sanofi-Aventis Deutschland GMBH v. Glenmark Pharm., Inc." on Justia Law

Rapid-prototyping “additive technology” creates parts by building layer upon layer of plastics, metals, or ceramics. Subtractive technology starts with a block and cuts away layers. Additive technology include SL, fused deposition modeling, laser sintering, 3D printing, direct metal laser sintering, and digital light processing. 3DS is the sole U.S. supplier of SL machines, which use an ultraviolet laser to trace a cross section of an object on a vat of liquid polymer resin. The laser solidifies the resin it touches, while untouched, areas remain liquid. After one cross-section has solidified, the newly formed layer is lowered below the surface of the resin. The process is repeated until the object is completed. Users of SL machines often own many machines with varying sizes, speeds, and accuracy levels. 3DS began equipping some of its SL machines with wireless technology that allows a receiver to communicate with a transmitter on the cap of a resin bottle. A software-based lockout feature shuts the machine off upon detection of a resin not approved by 3DD. 3DS has approved two of Desotech’s resins and entered into negotiations for approval of additional resins. After negotiations broke down, Desotech sued, alleging tying, unreasonable restraint of trade, and attempted monopolization under the Sherman Act; tying under the Clayton Act; patent infringement; and violations of the Illinois Antitrust and Uniform Deceptive Trade Practices Acts. The district court granted 3DS summary judgment on the antitrust claims and certain state-law claims. The parties stipulated to dismissal of the remaining claims. The Federal Circuit affirmed. View "DSM Desotech Inc. v. 3D Sys. Corp." on Justia Law

Bowers served in the Army National Guard 1972-1978, with a continuous period of active duty for training from August 1972 to February 1973. His records do not reflect that he incurred any injury or disease during service. In 2009, shortly after his diagnosis with Lou Gehrig’s disease (ALS), Bowers sought benefits for ALS and secondary conditions. A VA Regional Office denied the claim, finding that his ALS was not incurred or aggravated in service. The Board of Veterans’ Appeals rejected his argument that he was entitled to presumptive service connection for ALS under 38 C.F.R. 3.318, noting that reserve duty and active duty for training of the type Bowers performed does not generally entitle an individual to evidentiary presumptions. While his appeal to the Veterans Court was pending, Bowers died and his wife was substituted as the appellant. The Veterans Court affirmed, finding that Bowers did not achieve “veteran status,” and was not entitled to presumptive service connection. The Federal Circuit affirmed. View "Bowers v. Shinseki" on Justia Law

Following a request from ICP, U.S. Customs and Border Protection issued New York Ruling Letter D86228 classifying ICP’s white sauce as “sauces and preparations therefor” under the Harmonized Tariff Schedule of the United States (HTSUS) 2103.90.9060 Years later, Customs issued a notice of action reclassifying all pending and future entries of white sauce as “[b]utter and ... dairy spreads” under HTSUS 0405.20.3000, which increased the tariff by about 2400%. After protesting and paying duties on a single entry, ICP filed a claim in the Court of International Trade, alleging that the notice of action improperly revoked the Ruling Letter without following procedures required by 19 U.S.C. 1625(c). The court ordered Customs to reliquidate the merchandise under the “[s]auces and preparations therefor” heading required by the Ruling Letter. The Federal Circuit affirmed. View "Int'l Custom Prods. v. United States" on Justia Law

Generic drug manufacturers submitted Abbreviated New Drug Applications for FDA approval to manufacture and sell of generic versions of Boniva® before expiration of Roche’s patents, which are directed to methods of treating osteoporosis by monthly administration of ibandronate, one of a class of compounds known as bisphosphonates. Bisphosphonates generally have a low bioavailability when administered and oral administration of bisphosphonates can result in adverse esophageal and gastrointestinal side effects. Patients taking bisphosphonates previously had to take the bisphosphonate tablet in a fasting state at least 30 minutes before eating or drinking, which created compliance problems. Roche sued, alleging infringement under 35 U.S.C. 271(e)(2) based on the ANDA filings. The Federal Circuit affirmed the district court’s denial of the preliminary injunction. The district court entered summary judgment of invalidity of certain claims due to obviousness under 35 U.S.C. 103(a), finding that once monthly oral dosing of ibandronate was established in prior art and that the combination of prior art references suggested a dosage f about 150 mg per month, or at least indicated that a monthly dose of 150 mg was obvious to try. The Federal Circuit affirmed. View "Hoffmann-La Roche Inc. v. Apotex Inc." on Justia Law

In 2006, the U.S. Army Contracting Agency solicited bids for repair, maintenance, and construction services at Fort Rucker, Alabama, with indefinite delivery and quantity terms. The mechanism for pricing such jobs involves identification of costs and multiplication by certain “coefficients” set in the contract. It was well known that construction costs in the region had increased after Hurricane Katrina, 15 months before the government solicited bids. The Army awarded the contract to Lakeshore in 2007. In 2008, Lakeshore began 78 construction projects at Fort Rucker. When the Army exercised its option to extend the contract, it increased payments based on the contract’s price-adjustment clause. Lakeshore began 74 more delivery orders. After two years under the contract, Lakeshore concluded that it had incurred higher costs than were covered by payments under the contract and requested an equitable adjustment. The government denied the request. Acting under the Contract Disputes Act, 41 U.S.C. 7101, the contracting officer denied a claim for recovery of $1,996,152.40. The Claims Court rejected claims of breach of contract, breach of the covenant of good faith and fair dealing, breach of implied warranty, and mistake on summary judgment, stating that the government was not obliged to provide accurate local prices or to bear “economic consequences if one or more prices in the guide proved inaccurate.” The Federal Circuit affirmed. View "Lakeshore Eng'g Servs., Inc. v. United States" on Justia Law