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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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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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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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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 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

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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

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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

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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