Justia Drugs & Biotech Opinion Summaries

Incyte Corporation and Incyte Holdings Corporation (collectively, Incyte) own U.S. Patent No. 9,662,335, which claims deuterated versions of ruxolitinib, a Janus kinase (JAK) modulator used to treat autoimmune disorders. Sun Pharmaceutical Industries, Ltd. and Sun Pharmaceutical Industries, Inc. (collectively, Sun) secured FDA approval for an oral deuterated ruxolitinib product, branded as Leqselvi, to treat alopecia areata (AA) and planned to launch it in October 2024. Incyte sued Sun for allegedly infringing the ’335 patent and moved for a preliminary injunction to prevent Sun from launching Leqselvi.The United States District Court for the District of New Jersey granted Incyte’s motion for a preliminary injunction, finding that Incyte would suffer irreparable harm if Sun launched Leqselvi. The district court based its decision on the theory that Sun’s launch would give it an unjust head start in the AA market, diminishing the value of Incyte’s investments in developing its own topical deuterated ruxolitinib product.Sun appealed the district court’s decision to the United States Court of Appeals for the Federal Circuit. The Federal Circuit reviewed the grant of the preliminary injunction for an abuse of discretion, focusing on whether the district court made a clear error in its irreparable harm analysis. The Federal Circuit found that the district court clearly erred in its finding of irreparable harm, as it was based on the incorrect assumption that Incyte would be first to market if the injunction were granted. The court noted that Sun’s multi-year head start was inevitable regardless of the injunction, as Incyte’s product would not launch until several years after the ’335 patent expired.The Federal Circuit reversed the district court’s order granting the preliminary injunction, concluding that Incyte failed to provide non-speculative evidence of irreparable harm. View "INCYTE CORPORATION v. SUN PHARMACEUTICAL INDUSTRIES, LTD. " on Justia Law

Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited (collectively, "Jazz") manufacture and sell sodium oxybate products, Xyrem and Xywav, for treating narcolepsy and idiopathic hypersomnia (IH). Avadel CNS Pharmaceuticals, LLC ("Avadel") sought FDA approval for Lumryz, a sodium oxybate product, for treating narcolepsy. Jazz sued Avadel, alleging that Avadel's FDA submission infringed Jazz's U.S. Patent 11,147,782. The district court found in favor of Jazz, issuing a permanent injunction against Avadel from seeking FDA approval for Lumryz for IH and from marketing Lumryz for that indication.The U.S. District Court for the District of Delaware initially ruled that Avadel's submission of its New Drug Application (NDA) constituted infringement under 35 U.S.C. § 271(e)(2). The court issued a permanent injunction prohibiting Avadel from seeking FDA approval for Lumryz for IH, offering open-label extensions (OLEs) to clinical trial participants, and initiating new clinical trials. Avadel appealed, arguing that the injunction was overly broad and that certain activities were protected under the safe-harbor provision of 35 U.S.C. § 271(e)(1).The United States Court of Appeals for the Federal Circuit reviewed the case. The court reversed the injunction prohibiting Avadel from initiating new clinical trials and offering OLEs, finding these activities to be protected under the safe-harbor provision. The court vacated the injunction preventing Avadel from seeking FDA approval for new indications of Lumryz, remanding the issue to the district court for further consideration. The court instructed the district court to determine whether Avadel's submission of a paper NDA for additional indications would constitute an act of infringement under 35 U.S.C. § 271(e)(2) and to reassess the eBay factors if necessary. View "JAZZ PHARMACEUTICALS, INC. v. AVADEL CNS PHARMACEUTICALS, LLC " on Justia Law

Regeneron Pharmaceuticals, Inc. holds a Biologics License Application (BLA) for EYLEA®, a therapeutic product containing aflibercept, a VEGF antagonist used to treat angiogenic eye diseases. Regeneron also owns U.S. Patent No. 11,084,865, which covers VEGF-trap formulations suitable for intravitreal injection. Several companies, including Samsung Bioepis Co., Ltd. (SB), filed abbreviated Biologics License Applications (aBLAs) seeking approval to market EYLEA® biosimilars. Regeneron sued these companies, including SB, for patent infringement in the Northern District of West Virginia.The district court consolidated the cases and granted Regeneron’s motion for a preliminary injunction against SB, enjoining it from marketing its biosimilar product in the U.S. without a license from Regeneron. The court found it had personal jurisdiction over SB based on SB’s aBLA filing and its distribution agreement with Biogen, which indicated plans for nationwide marketing, including West Virginia. The court also found that Regeneron was likely to succeed on the merits, as SB had not raised a substantial question of invalidity of the ’865 patent for obviousness-type double patenting or lack of written description.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the district court’s decision. The appellate court agreed that the district court had personal jurisdiction over SB, as SB’s actions indicated plans to market its biosimilar nationwide. The court also upheld the district court’s findings that SB had not raised a substantial question of invalidity for the ’865 patent. The court found that the patent’s specific stability and glycosylation requirements were patentably distinct from the reference patent and adequately supported by the specification. The court also agreed that Regeneron had established a causal nexus between SB’s infringement and the irreparable harm it would suffer without an injunction. View "REGENERON PHARMACEUTICALS, INC. v. MYLAN PHARMACEUTICALS INC. " on Justia Law

Apicore owns, and Mylan Is the exclusive licensee of, the 992, 616, and 050 patents, which relate to isosulfan blue (ISB), a triarylmethane dye used to map lymph nodes. The 992 and 616 patents (together, “the process patents”) are directed to a process for preparing ISB by reacting isoleuco acid with silver oxide in a polar solvent, followed by reaction with a sodium solution. In response to Aurobindo’s FDA application to market a generic version of Myland’s drug, Lymphazurin®, Apricore and Myland obtained a preliminary injunction precluding Aurobindo from making, using, selling, offering to sell, and importing the accused ISB product that allegedly infringes the patents. The Federal Circuit affirmed. While the district court’s “equivalents analysis” was deficient and there remains a substantial question concerning infringement, so that the court’s grant of a preliminary injunction based on the process patents constituted an abuse of discretion, the injunction stands under the 050 patent. View "Mylan Institutional LLC v. Aurobindo Pharma Ltd." on Justia Law

The Leahy-Smith America Invents Act did not change the statutory meaning of “on sale” under 35 U.S.C. 102, in a case involving patents that were ready for patenting and subject to an invalidating contract for sale prior to the critical date of January 30, 2002. Teva had invoked the provision as a defense in a suit charging infringement based on Teva’s filing of an Abbreviated New Drug Application (ANDA). The district court upheld, as valid, Helsinn’s patents, directed to intravenous formulations of palonosetron for reducing chemotherapy-induced nausea and vomiting, and rejected Teva’s “on sale” defense. In reversing, the Federal Circuit noted that the invention worked for its intended purpose, that the evidence that the formulation was ready for patenting was “overwhelming,” and that there was no tenable argument that, before the critical date, Helsinn was unable to file a patent application that met the requirements of 35 U.S.C. 112. The district court clearly erred by applying too demanding a standard. The completion of Phase III studies and final FDA approval are not pre-requisites for the invention here to be ready for patenting. View "Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc." on Justia Law

Navartis’s 283 patent relates to a solid pharmaceutical composition suitable for oral administration, comprising a sphingosine-1 phosphate (S1P) receptor agonist and a sugar alcohol, which the patent explains is useful for the treatment of certain autoimmune diseases such as multiple sclerosis. According to the specification, S1P receptor agonists generally exhibit properties that make formulations suitable for oral administration of a solid composition difficult to create. However, “solid compositions comprising a sugar alcohol provide formulations which are particularly well suited to the oral administration of S1P receptor agonists." They also “provide a convenient means of systemic administration of S1P receptor agonists, do not suffer from the disadvantages of liquid formulations for injection or oral use, and have good physiocochemical and storage properties.” On inter partes review, the Patent Trial and Appeal Board found all original claims of the 283 patent and proposed substitute claims unpatentable as obvious. The Federal Circuit affirmed. The Board discussed independent grounds supporting the motivation to combine prior art, fingolimod and mannitol, in a solid oral composition. View "Novartis AG v. Torrent Pharmaceuticals, Limited" on Justia Law

Bivalirudin is a synthetic peptide used to prevent blood clotting in patients undergoing cardiac catheterization. Bivalirudin’s pharmacological properties were known before the filing of Medicines’ 727 and 343 patents and were covered by Medicines’ 404 patent, which expired in 2015. The claimed inventions of the 727 and 343 patents are directed to minimizing impurities in batches of bivalirudin, an active ingredient, typically distributed as a dry powder that must be compounded with a base before being administered to a patient as an intravenous injection. Medicines received FDA approval to market a base-compounded bivalirudin drug product in 2000, and has sold the approved product since 2001 under the tradename ANGIOMAX®, before the critical date of the 727-343 patents. Mylan submitted an Abbreviated New Drug Application, seeking to market a generic version of ANGIOMAX. The district court held that the 343 patent was not infringed because Mylan did not satisfy the “efficient mixing” limitation of asserted claims and that the 727 patent was infringed because its asserted claims did not include an “efficient mixing” limitation. Without addressing the validity of the patents, the Federal Circuit reversed as to the 727 patent and affirmed as to the 343 patent. Both include a “batches” limitation that requires batch consistency, which, according to the patents, is achieved through efficient mixing. Efficient mixing is required by the asserted claims of both patents. View "The Medicines Co. v. Mylan, Inc." on Justia Law

The 631 application, entitled “Glenoid Implant for Minimally Invasive Shoulder Replacement Surgery,” describes an invention related to “rotator cuff sparing procedures and associated devices for shoulder replacement surgery.” The application improves on the prior art by offering “simple and less invasive perpendicular access to the humeral and glenoid joint surfaces,” which “spares the rotator cuff tendons and allows for a quicker and more functional recovery.” The surgery described in the application involves two main steps. First, the surgeon removes “a minimal amount of bone from the peripheral surface of the glenoid”—a process called reaming. Second, the surgeon places an implant in the reamed cavity. The Patent Trial and Appeal Board concluded that several claims were anticipated by prior art, 35 U.S.C. 102(b). The Federal Circuit reversed; the finding of anticipation was not supported by substantial evidence. View "In re: Chudik" on Justia Law

LAB’s 903 patent claims a method of “arresting or regressing” penile fibrosis, which can result in erectile dysfunction and penile deformation, by the long-term, daily administration of type 5 phosphodiesterase (PDE5) inhibitors. At Eli Lilly’s request, the Patent Trial and Appeal Board conducted inter partes review. The patent claimed priority from a 2002 Provisional Application. The Board first rejected LAB’s argument for the earlier priority date, construed three terms, and concluded that the claim limitation requiring the delivery of a dosage of up to 1.5 mg/kg/day for at least 45 days “would meet the claim requirement of a continuous, long-term regimen,” and that the combination of three prior references rendered the claims unpatentable as obvious. The Federal Circuit vacated, finding two claim constructions erroneous and that the Board did not make factual findings as to whether there was an apparent reason to combine the references to treat penile fibrosis and whether a person of skill in the art would have had a reasonable expectation of success from such a combination. In a separate opinion, the court specifically addressed one prior reference, Whitaker, stating that it may “suggest” long-term daily treatment by noting the beneficial effects of daily treatment (better erectile response and decreased side effects), but that is not enough. Whitaker does not disclose the claimed treatment regimen with sufficient clarity to satisfy the demanding standard for anticipation. View "Eli Lilly & Co, v. Los Angeles Biomedical Research Institute" on Justia Law

LAB’s 903 patent claims a method of “arresting or regressing” penile fibrosis, which can result in erectile dysfunction and penile deformation, by the long-term, daily administration of type 5 phosphodiesterase (PDE5) inhibitors. At Eli Lilly’s request, the Patent Trial and Appeal Board conducted inter partes review. The patent claimed priority from a 2002 Provisional Application. The Board first rejected LAB’s argument for the earlier priority date, finding that the specification of the provisional application did not disclose the dosage limitation, then construed: “an individual with at least one of penile tunical fibrosis and corporal tissue fibrosis”; “arresting or regressing the at least one of the penile tunical fibrosis and corporal tissue fibrosis”; and “continuous long-term regimen.” The Board concluded that the claim limitation requiring the delivery of a dosage of up to 1.5 mg/kg/day for at least 45 days “would meet the claim requirement of a continuous, long-term regimen,” and that the combination of three prior references rendered the claims unpatentable as obvious. The Federal Circuit vacated, finding two claim constructions erroneous and that the Board did not make factual findings as to whether there was an apparent reason to combine the references to treat penile fibrosis and whether a person of skill in the art would have had a reasonable expectation of success from such a combination. View "Los Angeles Biomedical Research Institute v. Eli Lilly & Co." on Justia Law