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The Court of International Trade held that Sunpreme’s solar modules are covered by the scope of antidumping and countervailing duty orders on U.S. imports of certain solar cells from China and that the Department of Commerce could not instruct U.S. Customs and Border Protection to continue suspending liquidation of Sunpreme’s solar modules entered or withdrawn from warehouse for consumption before the scope inquiry was initiated. The Federal Circuit affirmed, rejecting Sunpreme’s arguments that the orders did not cover its solar modules because they do not contain crystalline silicon photovoltaic cells, do not have an additional semiconductor substrate (p/n junction), and are thin film products. Commerce cannot order the suspension of liquidation pre-scope inquiry for merchandise possibly subject to an unclear or ambiguous duty order; neither can Customs because allowing it to do so would permit Customs in the first instance to clarify or interpret the ambiguity in the duty order so as to place merchandise within its scope. Customs lacks authority to suspend liquidation under those narrow circumstances and Commerce cannot continue an ultra vires suspension of that kind. View "Sunpreme Inc. v. United States" on Justia Law

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Non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin and naproxen, control pain but have undesirable side effects, including gastrointestinal problem. Some practitioners began prescribing acid inhibitors, including PPIs, to reduce the acidity in the gastrointestinal tract. The combination therapy had complications. Stomach acid degraded the PPI before it could reach the small intestine. To address those complications, Dr. Plachetka invented a drug (Vimovo®.) that coordinated the release of an acid inhibitor and an NSAID in a single tablet with a core of an NSAID, an enteric coating around the NSAID that prevents its release before the pH increases to a certain desired level, and an acid inhibitor like PPI around the outside of the enteric coating that actively works to increase the pH to the desired level. Plachetka’s invention contemplates using some uncoated PPI for immediate release. Manufacturers, wanting to market a generic version of Vimovo®, submitted Abbreviated New Drug Applications to the FDA. They stipulated to infringement, except with respect to one ANDA product and alleged that the Vimovo® patents were invalid as obvious over prior art, 35 U.S.C. 103 and for lack of enablement and adequate written description, 35 U.S.C. 112. The Federal Circuit reversed a holding that the Vimovo® patents were valid. The specification provides nothing more than a claim that uncoated PPI might work, even though persons of ordinary skill in the art would not have thought so, and does not satisfy the written description requirement. View "Nuvo Pharmaceuticals, Inc. v. Dr. Reddy's Laboratories Inc." on Justia Law

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BTG’s 438 Patent, entitled “Methods and Compositions for Treating Cancer,” discloses the administration of a therapeutically effective amount of a CYP17 inhibitor, such as abiraterone acetate, in combination with at least one additional therapeutic agent such as an anti-cancer agent or a steroid. The patent defines an “anti-cancer agent” as “any therapeutic agent that directly or indirectly kills cancer cells or directly or indirectly prohibits[,] stops[,] or reduces the proliferation of cancer cells.” BTG sued Amneal, asserting that its Abbreviated New Drug Applications (ANDA) for the generic version of BTG’s abiraterone product ZYTIGA® infringed the patent. On inter partes review, the Patent Trial and Appeal Board found that the patent’s claims would have been obvious under 35 U.S.C. 103. The district court affirmed, accepting the Board’s claim construction and the same combination of prior art. The Federal Circuit affirmed. The Board correctly concluded that the claims cover a therapy in which abiraterone has an anticancer effect, while prednisone either has its own anti-cancer effect or has a palliative/side-effect reduction effect, and that the “prior art provides a reasonable expectation that prednisone could be used as a therapeutic agent in the treatment of prostate cancer.” View "BTG International Ltd. v. Amneal Pharmaceuticals LLC" on Justia Law

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Bradium’s patents, entitled “Optimized Image Delivery over Limited Bandwidth Communication Channels,” are broadly directed to retrieving large-scale images over network communication channels in low bandwidth conditions and to displaying such images on client devices with limited processing power. The preferred embodiment of the invention includes an image server and a client device connected to each other over a network. In two inter partes review proceedings, Patent Trial and Appeal Board found the claims of both patents unpatentable as obvious in light of prior references, 35 U.S.C. 103. The Federal Circuit affirmed, upholding the Board’s construction of “limited bandwidth communications channel” in both proceedings to mean “a communications channel whose bandwidth is limited.” Substantial evidence supports the Board’s obviousness determinations. View "Bradium Technologies LLC v. Iancu" on Justia Law

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The Novartis 131 patent claims methods of using the compound everolimus to treat advanced renal cell carcinoma (RCC). Advanced RCC is a cancer of the kidneys that has spread to other parts of the body. Everolimus is the active ingredient in Novartis’s Afinitor product. West-Ward’s predecessor filed an Abbreviated New Drug Application (ANDA) seeking to manufacture and sell generic versions of Afinitor. Novartis filed an infringement suit in response. The district court ruled that West-Ward failed to prove by clear and convincing evidence that claims 1–3 of the 131 patent are invalid as obvious in light of prior art, 35 U.S.C. 103(a). The Federal Circuit affirmed. While the district court erred in its analysis of whether there was a motivation to combine, a person of ordinary skill would not have reasonably expected success in using everolimus to treat advanced RCC as of February 2001. View "Novartis Pharmaceuticals Corp v. West-Ward Pharmaceuticals International, Ltd." on Justia Law

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Presidio's 639 patent describes and claims single-layer ceramic capacitors with certain features. Competitor AVX, which manufactures and sells various electronic components, including capacitors, petitioned for an inter partes review (IPR), under 35 U.S.C. 311−319, of all 21 claims of the 639 patent, asserting obviousness (35 U.S.C. 103). The Patent Trial and Appeal Board instituted a review (35 U.S.C. 314), held claims 13–16 and 18 unpatentable, but held that AVX failed to establish unpatentability of all other claims. Presidio did not appeal the as to the unpatentable claims. AVX appealed as to the upheld claims. Presidio responded to AVX on the merits and argued that AVX lacked Article III standing. The Federal Circuit dismissed the appeal, rejecting AVX’s estoppel and “competitor standing” theories and concluding that AVX lacks standing. A person does not need Article III standing to file an IPR petition and obtain a Board decision, because Article III requirements do not apply to administrative agencies, but AVX has no present or nonspeculative interest in engaging in conduct arguably covered by the patent claims at issue. AVX has not shown that it is engaging in or has nonspeculative plans to engage in, conduct arguably covered by the upheld claims of the patent. View "AVX Corp. v. Presidio Components, Inc." on Justia Law

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Segway filed a complaint (19 U.S.C. 337) with the International Trade Commission based on infringement of six patents and two trademarks--stylized and non-stylized SEGWAY marks, which cover “motorized, self-propelled, wheeled personal mobility devices, namely, wheelchairs, scooters, utility carts, and chariots.” The complaint alleged that Swagway’s self-balancing hoverboard products, marketed under the names SWAGWAY and SWAGTRON infringed Segway’s marks. Swagway proposed a consent order stipulating that Swagway would not sell or import “SWAGWAY-branded personal transporter products ... all components thereof, packaging and manuals.” Segway opposed the proposal as addressing only a subset of the claims and products at issue. After a hearing, the ALJ found that the accused products did not infringe certain patents and that use of the SWAGWAY designation, but not the SWAGTRON designation, infringed the trademarks. The Commission determined not to review the ALJ’s denial of Swagway’s consent order motion. The Federal Circuit upheld that determination and the trademark infringement determination based on the evidence supporting factors other than likelihood of confusion, including the degree of similarity between the two marks in appearance, the pronunciation of the words, and the strength of the SEGWAY marks. View "Swagway, LLC v. International Trade Commission" on Justia Law

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Amgen created and commercialized two related biologic products, filgrastim (Neupogen®) and pegfilgrastim (Neulasta®), indicated for treating neutropenia, a deficiency of white blood cells. Neutropenia often results from exposure to certain chemotherapeutic regimens or radiation therapy during cancer treatment. In 2014, Sandoz submitted to the FDA an abbreviated Biologics License Application (aBLA) to market a biosimilar filgrastim product. While Sandoz’s aBLA referenced Neupogen®, Sandoz elected not to provide Amgen with its aBLA or manufacturing information. Amgen sought a declaratory judgment that Sandoz’s proposed biosimilar would infringe its patent, Biologics Price Competition and Innovation Act, 35 U.S.C. 271(e)(2)(C); 42 U.S.C. 262(l)(9)(C) Sandoz received FDA approval for its filgrastim biosimilar, Zarxio®. After Sandoz launched Zarxio®, Amgen amended its complaint to plead infringement under 35 U.S.C. 271(e)(2)(C)(ii), (g). In 2015, Sandoz submitted an aBLA to market a biosimilar pegfilgrastim product referencing Neulasta®. Amgen filed a complaint, alleging infringement of that patent. Sandoz has not yet received approval for its proposed pegfilgrastim biosimilar. The Federal Circuit affirmed summary judgment of noninfringement, upholding the district court’s construction of “disease treating-effective amount of at least one chemotherapeutic agent” as limited to “[a]n amount sufficient to treat a disease for which at least one chemotherapeutic agent is prescribed.” View "Amgen Inc. v. Sandoz Inc." on Justia Law

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The Department of Commerce imposed an antidumping duty on crystalline silicon photovoltaic cells, whether or not assembled into modules, from China. Commerce assigned Sumec Hardware a separate rate, 24.48%, assigning Sumec’s China-wide entity a margin of 249.96%. In 2015, Hardware's margin was amended to 13.18% pursuant to the U.S. Trade Representative’s decision to implement a related World Trade Organization determination. Commerce later reconsidered and assigned Hardware the China-wide rate. The Trade Court affirmed. Commerce then published a Timken notice, suspended liquidation of entries in accordance with the decision, and later instructed Customs to collect cash deposits on subject merchandise exported by Hardware at the China-wide rate of 238.95% for any entries made after October 15, 2015. In March 2016, Commerce issued liquidation instructions, ordering Customs to liquidate all Hardware entries “at the cash deposit . . . rate in effect.” Sumec sought an injunction, alleging that Commerce should have set the “date for the change in liquidation rate as the date of publication of the Timken [n]otice,” (November 23, 2015) rather than October 15, and that Hardware made entries during this 39-day period, which should have been subject to the 13.18% separate rate. The Federal Circuit affirmed the denial of Sumec’s Motion; Sumec failed to demonstrate irreparable harm. View "Sumecht NA, Inc. v. United States" on Justia Law

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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