Leonel Romero-Ochoa was convicted by jury of burglary, unlawful imprisonment, assault, and multiple counts of rap all arising from an incident in which he broke into a woman's home, beat her, and raped her twice. At trial, Romero-Ochoa wanted to admit evidence that the victim was a U-visa applicant, which would grant her temporary legal resident status if she was the victim of a qualifying crime and helps law enforcement investigate or prosecute that crime. The trial court excluded the U-visa evidence. Romero-Ochoa argued that exclusion violated his constitutional rights to present a defense and confront witnesses. The Court of Appeals agreed and revered all but the unlawful imprisonment conviction, holding the constitutional error was harmless beyond a reasonable doubt as to that conviction but not the others. The Washington Supreme Court granted the State's petition for review, which raised only the harmless error issue. The Supreme Court reversed, finding any error excluding the U-visa evidence was harmless as to all of Romero-Ochoa's convictions. The convictions were reinstated, and the matter remanded to the Court of Appeals to consider the claim of sentencing error that was not previously reached. View "Washington v. Romero-Ochoa" on Justia Law

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

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

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

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

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

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

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

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

MRT filed suit against Microsoft, alleging patent infringement stemming from MRT's development of a technology to protect electronic files from content piracy. The Ninth Circuit held that claim preclusion barred the claims in this suit that accrued at the time of MRT's patent-infringement action, because these claims arose from the same events—Microsoft's alleged misappropriation of MRT's software—as the prior patent infringement claims. Furthermore, they merely offer different legal theories for why Microsoft's alleged conduct was wrongful. Accordingly, the panel affirmed the dismissal of these claims. However, the panel held that, under Howard v. City of Coos Bay, 871 F.3d 1032 (9th Cir. 2017), claim preclusion did not bar MRT from asserting copyright infringement claims that accrued after it filed its patent-infringement suit: namely, claims arising from the sale of Microsoft products after MRT filed its patent-infringement suit. Therefore, the panel reversed the district court's dismissal of these copyright infringement claims and remanded for further proceedings. View "Media Rights Technologies, Inc. v. Microsoft Corp." on Justia Law