Justia Patents Opinion Summaries

Norwich Pharmaceuticals sought to market a generic version of Xifaxan, a drug invented by Salix Pharmaceuticals for treating irritable bowel syndrome with diarrhea and hepatic encephalopathy. Norwich submitted an Abbreviated New Drug Application (ANDA) to the FDA, identified as number 214369. Salix believed this ANDA infringed its patents and sued Norwich in the United States District Court for the District of Delaware. That court found Norwich’s ANDA infringed Salix’s patents related to hepatic encephalopathy, while the patents for irritable bowel syndrome were invalid as obvious. The court’s final judgment barred FDA approval of Norwich’s ’369 ANDA until Salix’s hepatic encephalopathy patents expired in October 2029.Following the judgment, Norwich amended its ’369 ANDA to remove the indication for hepatic encephalopathy and requested the Delaware District Court modify its judgment to allow immediate FDA approval of the amended ANDA. The court denied this motion, reasoning that Norwich could not change its ANDA after final judgment to circumvent the prior ruling. Norwich appealed to the United States Court of Appeals for the Federal Circuit, which agreed the judgment restricted approval of the entire ANDA, including non-infringing indications, until 2029, and affirmed the Delaware District Court’s decision.After the FDA declined to grant final approval of Norwich’s amended ANDA, instead issuing only tentative approval, Norwich sued in the United States District Court for the District of Columbia, arguing the FDA acted arbitrarily and capriciously. The court granted summary judgment to the FDA and Salix. On appeal, the United States Court of Appeals for the District of Columbia Circuit held that the Delaware District Court’s judgment applied to Norwich’s ANDA as amended, so the FDA correctly delayed final approval until October 2029. The appellate court affirmed the district court’s judgment. View "Norwich Pharmaceuticals, Inc. v. Kennedy" on Justia Law

Enanta Pharmaceuticals owned a patent directed to certain chemical compounds and methods for inhibiting coronavirus replication. The patent claimed priority to an earlier provisional application filed in July 2020. In the original provisional application, the relevant chemical group was described as containing two to twelve carbon atoms, while in the later patent, the range was changed to include one to twelve carbon atoms. Before the non-provisional patent was filed, Pfizer publicly disclosed a compound that fell within the scope of Enanta’s later patent claims.Enanta filed suit in the United States District Court for the District of Massachusetts, asserting that Pfizer’s product infringed its patent. Pfizer countered that the patent was invalid because its public disclosure anticipated the patent claims, and argued that Enanta’s patent could not claim priority to the earlier provisional application since the specific chemical group was not adequately supported in the provisional filing. The district court granted summary judgment in Pfizer’s favor, concluding that the change from two to one carbon atoms was not a correctable typographical error, and that the patent could not claim the earlier priority date.On appeal, the United States Court of Appeals for the Federal Circuit reviewed the district court’s decision de novo. The appellate court held that the provisional application did not provide written description support for the later patent’s claims, specifically the inclusion of the one-carbon group, and thus the patent was not entitled to the earlier priority date. As a result, Pfizer’s disclosure anticipated all claims of Enanta’s patent, rendering them invalid. The Federal Circuit affirmed the district court’s grant of summary judgment. View "ENANTA PHARMACEUTICALS, INC. v. PFIZER INC. " on Justia Law

Ironburg Inventions Ltd. owns a patent for a video game controller featuring additional, resilient controls on the back of the device. Ironburg alleged that Valve Corporation’s Steam Controller infringed several claims of this patent. Valve responded by filing an inter partes review (IPR) petition in 2016 challenging the patent, and later amended its invalidity contentions in district court proceedings to include new grounds based on prior art references that had been asserted by a third party, Collective Minds Gaming Co. Ltd., in a separate IPR.The United States District Court for the Western District of Washington granted Ironburg’s motion for IPR estoppel under 35 U.S.C. § 315(e)(2), barring Valve from asserting two invalidity grounds—one based on the Kotkin reference and another combining Willner, Koji, and Raymond—finding they could have been discovered by a skilled searcher conducting a diligent search. After a jury verdict for Ironburg and an initial appeal, the United States Court of Appeals for the Federal Circuit vacated and remanded, instructing the district court to place the burden on Ironburg and to evaluate whether the grounds were reasonably discoverable.On remand, the district court again estopped Valve from raising both grounds. The United States Court of Appeals for the Federal Circuit reviewed the evidence and found that the district court erred. Specifically, the district court relied on insufficient evidence to estop the Kotkin ground, as the search results from Valve’s agent included thousands of references without further narrowing. For the Willner-Koji-Raymond ground, the district court failed to properly account for hindsight bias in the evidence presented. The Federal Circuit reversed the district court’s estoppel rulings and remanded for proceedings consistent with its opinion, instructing the district court to reconsider the invalidity of the patent in light of both grounds. View "IRONBURG INVENTIONS LTD. v. VALVE CORPORATION " on Justia Law

The dispute centers on three patents owned by the appellant, which describe a method for displaying information to facilitate the return of lost or stolen computers. The patented method involves powering on a computer and automatically displaying a screen with return information, either before or alongside the lock screen, and includes the ability to remotely initiate or change the displayed information without assistance from a user with the computer. The appellant alleged that certain devices sold by LG Electronics, featuring Google or Microsoft’s “Find My Device” software, infringed these patents.Following the appellant’s lawsuit in the United States District Court for the Western District of Texas, Google and Microsoft initiated six inter partes review (IPR) proceedings before the United States Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB), contesting the validity of the patents based on prior art. The PTAB instituted review despite the appellant’s arguments referencing a parallel district court action and concerns about duplicative proceedings. LG, named as a real party in interest, filed a “Sotera stipulation,” agreeing not to pursue in district court any grounds raised in the IPRs, which the PTAB considered in its decision to institute review.The United States Court of Appeals for the Federal Circuit reviewed the PTAB’s final written decisions, which found all challenged claims unpatentable. The Federal Circuit held that it lacked jurisdiction to review challenges tied to the PTAB’s institution decision, specifically regarding the impact of LG’s violation of the Sotera stipulation. On the merits, the court affirmed the PTAB’s construction of the “without assistance” claim limitation, finding no error and concluding that the prior art disclosed the disputed method. The court also determined that the PTAB’s analysis of secondary considerations of non-obviousness was supported by substantial evidence. The court dismissed the appeal in part and affirmed in part, awarding costs against the appellant. View "HAFEMAN v. GOOGLE LLC " on Justia Law

Amarin Pharma, Inc. developed and marketed Vascepa, a drug containing icosapent ethyl. Initially, the Food and Drug Administration (FDA) approved Vascepa for treating severe hypertriglyceridemia (the SH indication). Later, the FDA approved a new use: reducing cardiovascular risk in certain patients (the CV indication), for which Amarin held two method-of-use patents. Hikma Pharmaceuticals USA Inc., a generic manufacturer, sought to market a generic icosapent ethyl. After Amarin’s SH-indication patents were invalidated by a district court, Hikma pursued FDA approval for a “skinny label” generic, carving out the patented CV indication. The FDA approved Hikma’s application with the label limited to the SH indication.Amarin sued Hikma in the United States District Court for the District of Delaware, alleging that Hikma actively induced infringement of Amarin’s CV-indication patents. Amarin argued that various statements in Hikma’s skinny label, patient information leaflet, website, and press releases encouraged infringement. The District Court granted Hikma’s motion to dismiss, finding that the statements did not constitute active encouragement of infringement. The United States Court of Appeals for the Federal Circuit reversed, holding it plausible that a physician could read Hikma’s statements as instructions or encouragement to prescribe the drug for the patented use.The Supreme Court of the United States reviewed the case and held that Amarin failed to state a claim for active inducement under 35 U.S.C. §271(b). The Court clarified that liability requires affirmative “active steps” to encourage infringement, not merely statements that could be read as encouragement. The Court found Hikma’s statements either reflected legal compliance or ordinary industry practice, or were too vague or passive to plausibly constitute active inducement. The Supreme Court reversed the Federal Circuit’s judgment and remanded for further proceedings. View "Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc." on Justia Law

A dispute arose between two companies over patents related to wireless communications for building automation systems. The plaintiff alleged that the defendant’s smart thermostat products infringed four patents, which addressed improvements in wireless network architecture, power and bandwidth usage, and data redundancy within building control systems. At trial, a jury found that the defendant had infringed at least one of the asserted patents (without specifying which), determined that the claims of one patent were not limited to well-understood or routine technology, found another patent’s claims invalid, and awarded the plaintiff lump sum damages.In the United States District Court for the Eastern District of Texas, the defendant moved to dismiss based on patent ineligibility under 35 U.S.C. § 101, but the court denied these motions for the patents at issue, except for one where factual disputes precluded summary judgment. The court also denied the defendant’s post-trial motions, including challenges to the verdict form, jury instructions related to patent eligibility, and motions to exclude expert testimony. The plaintiff, in turn, appealed the district court’s limitation on prejudgment interest.The United States Court of Appeals for the Federal Circuit reviewed the case and determined that the district court’s verdict form, which combined all asserted patents into a single infringement question, violated the defendant’s right to a unanimous verdict. The appellate court vacated both the infringement and damages judgments and remanded for a new trial on those issues. The court also vacated and remanded the § 101 eligibility determination for one patent, requiring further proceedings under the Alice framework. However, the court affirmed the district court’s findings that the asserted claims of two other patents were not directed to abstract ideas and that substantial evidence supported the jury’s verdict of infringement on one patent. Remaining evidentiary and interest issues were dismissed as moot. View "OLLNOVA TECHNOLOGIES LTD. v. ECOBEE TECHNOLOGIES ULC " on Justia Law

AGI SureTrack LLC brought suit against Farmers Edge Inc. and its U.S. subsidiary, alleging infringement of several patents relating to automated systems and methods for capturing, processing, and sharing farming data. The core patented technology involved using a relay device with generic computer components to collect real-time data from various farming equipment, process this information, and share it via an online exchange. The patent claims described a system using a microprocessor, bus connector, GPS receiver, and memory storage, together with software that records and interprets data from farming implements.The United States District Court for the District of Nebraska granted summary judgment in favor of Farmers Edge. The court found that the asserted patent claims were directed to patent-ineligible subject matter under 35 U.S.C. § 101. Specifically, the court concluded that the claims merely used generic computer components to collect and process data and did not constitute an inventive concept. The district court also ruled that the case was not exceptional and denied Farmers Edge’s request for attorney’s fees under 35 U.S.C. § 285.On appeal, the United States Court of Appeals for the Federal Circuit reviewed both AGI’s challenge to the finding of patent ineligibility and Farmers Edge’s cross-appeal regarding exceptionality. The Federal Circuit affirmed the district court’s determination that the asserted patents were not patent-eligible, holding that the claims were directed to an abstract idea and lacked any inventive concept beyond conventional technology. However, the appellate court vacated the district court’s summary determination that the case was not exceptional, finding the lower court failed to provide adequate reasoning or allow both parties to present argument on the issue. The case was remanded for further proceedings on exceptionality and attorney’s fees. View "AGI SURETRACK LLC v. FARMERS EDGE INC. " on Justia Law

Two companies, both joint owners of several patents related to warm-mix asphalt paving, entered into a licensing agreement in 2008 granting an exclusive, worldwide, royalty-bearing license to another company (and, after a reorganization, its successor). The agreement allowed the licensee to manufacture, use, sell, and sublicense the patented products, but required that sublicensing terms be subject to the patent owners’ prior review and approval (not to be unreasonably withheld). The patent owners retained certain rights, including the right to sue for infringement (with shared or independent control depending on the circumstances), receive royalties, and veto sublicenses. The patent owners also kept limited rights to practice the invention for research and to use products purchased from the licensee.In 2024, the patent owners sued two defendants, alleging infringement of the six patents. The defendants moved to dismiss for lack of Article III standing. The United States District Court for the District of Delaware granted the motion, finding that the patent owners had transferred away all exclusionary rights through the license, and that their retained right to sue was not sufficient for constitutional standing. The district court relied on previous decisions holding that a bare right to sue, separated from other substantial patent rights, did not confer standing.On appeal, the United States Court of Appeals for the Federal Circuit reversed. The Federal Circuit held that the patent owners retained an exclusionary right sufficient for Article III standing, namely the right to sue for infringement that was not rendered illusory by the licensee’s rights. The court concluded that the combination of the right to sue, the right to veto sublicenses, and the continuing royalty interest demonstrated a concrete, non-illusory exclusionary interest. The case was remanded for further proceedings. View "A.L.M. HOLDING COMPANY v. ZYDEX INDUSTRIES PRIVATE LTD. " on Justia Law

The case concerns a patent dispute involving a company that owns a patent for a unified electronic banking system. After most of the patent’s claims were found unpatentable in an inter partes review (IPR) before the Patent and Trademark Office, only four claims remained. The company then sued a bank in the United States District Court for the Southern District of Florida, alleging infringement of these remaining claims. The allegations were supported by claim charts and references to the bank’s online services.The district court first struck the original complaint as a “shotgun pleading” and allowed an amended complaint. The amended complaint was also challenged by the defendant, who argued that the remaining claims were invalid for obviousness and, alternatively, for claiming ineligible subject matter, and that the infringement allegations were inadequate. The district court dismissed the case with prejudice, finding the asserted claims invalid for obviousness as they did not add anything patentably distinct from those already invalidated in the IPR, and also held that infringement was not adequately pleaded. The court denied leave to further amend the complaint and subsequently awarded attorneys’ fees to the defendant under 35 U.S.C. § 285, finding the case “exceptional,” and imposed sanctions on plaintiff’s counsel under 28 U.S.C. § 1927 for alleged bad faith litigation.On appeal, the United States Court of Appeals for the Federal Circuit affirmed the dismissal of the complaint, upholding the finding that the patent claims at issue were invalid for obviousness. However, the appellate court reversed the awards of attorneys’ fees and sanctions, holding that the record did not support a finding that the case was exceptional or that counsel acted in bad faith, as required by the respective statutes. Each party was ordered to bear its own costs. View "MCOM IP, LLC v. CITY NATIONAL BANK OF FLORIDA " on Justia Law

Actelion Pharmaceuticals Ltd, holder of patents for pharmaceutical compositions involving epoprostenol, alleged that Mylan Pharmaceuticals Inc.’s proposed generic drug infringed its patents by manufacturing a bulk solution with a pH of 13 or higher, as claimed in the patents. The dispute centered on whether Mylan’s bulk solution met this pH threshold, either literally or under the doctrine of equivalents. Actelion argued that pH should be measured at the solution’s actual (refrigerated) temperature, while Mylan maintained that its product’s pH, when measured at industry standard temperature, did not meet the claimed threshold.The United States District Court for the Northern District of West Virginia held a bench trial after remand from the United States Court of Appeals for the Federal Circuit, which had previously vacated a judgment based on incorrect claim construction. On remand, the district court construed “a pH of 13 or higher” to mean a pH measurement of 12.98 or higher at standard temperature (25±2°C), relying on both intrinsic and extrinsic evidence. The court found no literal infringement, as Mylan’s bulk solution did not meet this threshold at standard temperature. It also ruled that Actelion was barred from asserting infringement by an equivalent due to prosecution history estoppel and the disclosure-dedication rule, and that Actelion had not proven equivalence.On appeal, the United States Court of Appeals for the Federal Circuit reviewed claim construction de novo and factual findings for clear error. The court affirmed the district court’s claim construction, finding that “a pH of 13 or higher” refers to standard-temperature measurement, supported by industry standards and patent evidence. It also upheld the district court’s application of prosecution history estoppel and the disclosure-dedication rule, barring Actelion’s equivalents argument. The judgment for Mylan was affirmed. View "ACTELION PHARMACEUTICALS LTD v. MYLAN PHARMACEUTICALS INC. " on Justia Law