Articles Posted in Drugs & Biotech

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When an artery is damaged or inflamed, the body releases the enzyme myeloperoxidase (MPO). Prior art taught that MPO could be detected in an atherosclerotic plaque or lesion that required a surgically invasive method; could be indirectly detected in blood; or could be detected in blood with results that were not predictive of cardiovascular disease. Cleveland Clinic purportedly discovered how to “see” MPO in blood and correlate that to the risk of cardiovascular disease. True Health, a diagnostic laboratory, purchased the assets of Diagnostics, which had contracted with Cleveland Clinic to perform MPO testing. Rather than continue that relationship, True Health performed its own MPO testing. Cleveland Clinic sued, asserting infringement of the patents. The district court found all the claims patent-ineligible under 35 U.S.C. 101; dismissed the contributory and induced infringement claims of the 260 patent; denied leave to amend; and held that it was proper to consider section 101 at the motion to dismiss stage.. The court found that the claims were directed to a law of nature, with no saving inventive concept. The Federal Circuit affirmed. Cleveland Clinic provided no proposed construction of any terms or proposed expert testimony that would change the analysis. The claims, whether considered limitation-by-limitation or as a whole, do not sufficiently transform the natural existence of MPO in a bodily sample and its correlation to cardiovascular risk into a patentable invention. View "Cleveland Clinic Foundation v. True Health Diagnostics. LLC" on Justia Law

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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

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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

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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

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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

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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

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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

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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

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Shire sued Watson for infringing the 720 patent by filing an Abbreviated New Drug Application (ANDA) with the FDA seeking to market a generic version of Shire’s drug, LIALDA®. The patent is directed to a controlled-release oral pharmaceutical composition of mesalamine used to treat inflammatory bowel diseases. The district court rejected Watson’s invalidity arguments that the patent lacked written description and enablement, and held that Watson infringed two claims. On appeal, and again after remand from the Supreme Court, the Federal Circuit stated that the matrix compositions are “limited by the Markush groups” added during prosecution “to overcome the examiner’s rejection of the claims as obvious” and that “the correct construction requires that the inner volume contain substances from the group described for the inner lipophilic matrix (which are all lipophilic substances), and that the outer volume separately contain substances from the group described for the outer hydrophilic matrix (which are all hydrophilic).” On remand, the district court concluded that Watson’s ANDA Product satisfied the “inner lipophilic matrix” and “outer hydrophilic matrix” limitations and satisfied the Markush limitations because the excipients falling outside the respective Markush groups were “unrelated” to the invention since they did not drive the water-affinity property of their respective matrices. The Federal Circuit reversed and remanded with instructions to enter judgment of non-infringement. Watson’s ANDA Product does not satisfy the Markush group requirements. View "Shire Development, LLC v. Watson Pharmaceuticals, Inc." on Justia Law

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Cumberland Pharmaceuticals owns the 445 patent, which describes acetylcysteine compositions substantially free of chelating agents. It is listed in the Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) as covering Cumberland’s chelating-agent-free formulation of Acetadote®, an intravenous antidote for overdoses of acetaminophen. When Mylan filed an abbreviated new drug application to market its own chelating-agent-free acetylcysteine formulation, Cumberland filed a patent-infringement action. Mylan stipulated to infringement but asserted invalidity based on derivation of the claimed invention from someone at the FDA and obviousness. The district court rejected both challenges, finding that Mylan proved neither that anyone at the FDA conceived of the claimed invention before the named inventor nor that there was a reasonable expectation that the claimed formulations, without any chelating agents, would succeed. The Federal Circuit affirmed. Mylan offered evidence that there is no need to chelate trace metal ions because degradation may be effectively avoided by an inert vial atmosphere together with modern manufacturing practices that leave very low levels of metal contaminants, but the evidence did not establish that relevant skilled artisans would have reasonably expected success for those reasons in 2005. The district court had sufficient evidence to find otherwise. View "Cumberland Pharmaceuticals, Inc. v. Mylan Institutional LLC" on Justia Law