Justia Drugs & Biotech Opinion Summaries

Novartis markets a 0.5 mg daily dose of fingolimod hydrochloride under the brand name Gilenya, for treating relapsing-remitting multiple sclerosis, a debilitating immune-mediated demyelinating disease. There is currently no cure for MS. The disease is managed by reducing or preventing relapses and thereby slowing disability. HEC filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Gilenya. Novartis sued, alleging that HEC’s ANDA infringes all claims of its patent. The Federal Circuit initially affirmed a holding that the patent is not invalid and that HEC’s ANDA infringes that patent.On rehearing, the Federal Circuit reversed. Because the Novartis patent fails to disclose the absence of a loading dose, the district court clearly erred in finding that the negative claim limitation “absent an immediately preceding loading dose” added during prosecution to overcome prior art satisfied the written description requirement of 35 U.S.C. 112(a). The specification nowhere describes “initially” administering a daily dosage. View "Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc." on Justia Law

Congestive heart failure can be treated by resynchronization therapy, using electrical pacing leads to help keep the two sides of the heart contracting with regularity and in sync. According to Niazi's 268 patent, physicians previously accomplished resynchronization by inserting a catheter into the coronary sinus and its branch veins to place pacing leads on the hearts of patients; it can be “difficult to pass a lead” into the coronary sinus and its branch veins using a catheter. The 268 patent describes a double catheter, comprising an outer and inner catheter, for cannulating the coronary sinus “without significant manipulation.” Niazi sued for patent infringement, accusing combinations of St. Jude’s products of directly infringing the 268 patent and accusing St. Jude of inducing infringement.The Federal Circuit reversed the district court’s determination that all but one of the asserted patent claims are invalid as indefinite; when read in light of the intrinsic evidence, a person of ordinary skill in the art would understand the scope of the claims with reasonable certainty. Niazi failed to prove direct infringement—a necessary element of Niazi’s inducement claim. The court affirmed the entry of monetary sanctions and the exclusion of portions of Niazi’s technical expert and damages expert reports because Niazi failed to disclose predicate facts during discovery. The court upheld the exclusion of portions of Niazi’s damages expert report as unreliable. View "Niazi Licensing Corp. v. St. Jude Medical S.C., Inc." on Justia Law

Almirall’s patent relates to methods of treating acne or rosacea with dapsone formulations that include an acrylamide/sodium acryloyldimethyl taurate copolymer (A/SA) thickening agent and the solvent diethylene glycol monoethyl ether (DGME), which allows compositions to be prepared with increased solubilized concentrations of dapsone. A polymeric viscosity builder such as an A/SA, can minimize the yellowing of the composition and can reduce the particle size, and minimize a gritty feel upon application. The Almirral patent includes 62 generalized composition embodiments and eight specific example formulations.On inter partes review, the Patent Trial and Appeal Board agreed that claims 1–8 would have been obvious over prior art at the time the alleged invention was made. The Federal Circuit affirmed. The Board’s decision sets forth factual findings of similarity between carbomers and A/SA agents that support its conclusion that prior art discloses a range for each component of the composition that either fully encompasses or overlaps/abuts the ranges and amounts for those components recited in the challenged claims, sufficient to create a presumption of obviousness. The court upheld the Board’s analysis of whether a skilled artisan would have had a reasonable expectation of success in combining prior art teachings to achieve the claimed invention. View "Almirall, LLC v. Amneal Pharmaceuticals, LLC" on Justia Law

Adapt’s patents-in-suit claim methods of treating opioid overdose by intranasal administration of a naloxone formulation, and devices for intranasal administration. Naloxone—the active ingredient in Adapt’s NARCAN® Nasal Spray—is an opioid receptor antagonist that blocks opioids from reaching the opioid receptors, helping reverse the effects of opioid overdose. Before the priority date of the patents-in-suit, numerous naloxone products had been used to treat opioid overdose. The patents-in-suit are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” “Orange Book.” Teva submitted to the FDA Abbreviated New Drug Application (ANDA) seeking approval to manufacture and sell a generic version of NARCAN®., with a Paragraph IV certification asserting that the patents-in-suit are invalid, unenforceable, and/or not infringed, 21 U.S.C. 355(j)(2)(A)(vii)(IV).Adapt sued Teva for infringement under 35 U.S.C. 271(e)(2). The Federal Circuit affirmed a holding that the asserted claims of the patents-in-suit would have been obvious in view of prior art. The district court’s findings, supported by ample evidence, provide a detailed explanation as to why a skilled artisan would have been motivated to combine the prior art references to arrive at the claimed invention. Prior art, as a whole, did not teach away from the claimed invention. The court rejected Adapt’s argument that its evidence of unexpected results, copying, skepticism, long-felt need, and failure of others indicated nonobviousness. View "Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc." on Justia Law

Novartis markets a 0.5 mg daily dose of fingolimod hydrochloride under the brand name Gilenya. The medication is used to treat relapsing-remitting multiple sclerosis, a debilitating immune-mediated demyelinating disease in which the immune system attacks the myelin coating the nerves in the central nervous system. Most MS patients initially present as RRMS patients, but many eventually develop a secondary progressive form of MS, causing them to experience growing disability. There is currently no cure for MS. The disease is managed by reducing or preventing relapses and thereby slowing disability.HEC filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Gilenya. Novartis sued, alleging that HEC’s ANDA infringes all claims of the 405 patent. The Federal Circuit affirmed a holding that the patent is not invalid and that HEC’s ANDA infringes. The 405 claims do not fail the written description requirement of 35 U.S.C. 112(a). The district court did not clearly err in finding that a skilled artisan would read the 405 patent’s disclosure to describe the “absent an immediately preceding loading dose” negative limitation. View "Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc." on Justia Law

AstraZeneca’s asserted patents are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book), as covering AstraZeneca’s Symbicort® pressurized metered-dose inhaler (pMDI). The Symbicort® pMDI is approved for the treatment of asthma and chronic obstructive pulmonary disease (COPD). AstraZeneca has marketed a dry powder inhaler version of Symbicort® (Symbicort® Turbuhaler) since the early 1990s. Both the Symbicort® pMDI and the Symbicort® Turbuhaler administer two active ingredients to the lungs—formoterol, a bronchodilator that opens the airway, and budesonide, a steroid that reduces inflammation in the lungs. Mylar's predecessor submitted an Abbreviated New Drug Application (ANDA) to the FDA, seeking approval to manufacture and sell a generic version of Symbicort® pMDI.AstraZeneca sued Mylan for infringement. After claim construction, Mylan stipulated to infringement. The district court entered judgment accordingly, then held a bench trial and determined that Mylan failed to prove that the asserted claims are invalid as obvious. The Federal Circuit vacated the judgment of infringement, disagreeing with the district court’s claim construction of “0.001%,” the claimed amount of the excipient PVP, on which the stipulated judgment of infringement was based. The court affirmed the determination of nonobviousness, finding no clear error in the district court’s finding that the prior art taught away from the claimed invention. View "AstraZeneca AB v. Mylan Pharmaceuticals Inc." on Justia Law

In the 1980s, researchers suggested using mifepristone to treat Cushing’s syndrome, a disease caused by excessive cortisol levels. More than 20 years later, Corcept initiated the first major clinical trial of mifepristone and obtained FDA approval for Korlym, a mifepristone tablet, with postmarketing requirements (21 U.S.C. 355(o)(3)), including a drug-drug interaction clinical trial involving co-administration of ketoconazole. The FDA approved the prescribing information for Korlym on its label, which warned against using mifepristone “with strong CYP3A inhibitors” and limited the “mifepristone dose to 300 mg per day when used with strong CYP3A inhibitors.” Corcept conducted the drug-drug interaction study, then obtained the 214 patent relating to methods of treating Cushing’s syndrome by co-administering mifepristone and a strong CYP3A inhibitor.Corcept asserted the 214 patent against Teva, Teva sought post-grant review, arguing that certain claims would have been obvious in light of Korlym’s label and the FDA memo describing the required drug interaction study (Lee). The Federal Circuit affirmed the Patent Trial and Appeal Board’s rejection of the obviousness claims. The Board did not err by requiring Teva to show a reasonable expectation of success for a specific mifepristone dosage. The general working conditions disclosed in Lee did not encompass the claimed invention. A skilled artisan would not have expected monotherapy and coadministration dosages to behave similarly. View "Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc." on Justia Law

Arbutus's patent, directed to “stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP,” describes the invention as “novel, serum-stable lipid particles comprising one or more active agents or therapeutic agents, methods of making the lipid particles, and methods of delivering and/or administering the lipid particles (e.g., for the treatment of a disease or disorder)”; “[t]he present invention is based, in part, upon the surprising discovery that lipid particles comprising … provide advantages when used for the in vitro or in vivo delivery of an active agent, such as a therapeutic nucleic acid (e.g., an interfering RNA)”; the particles are “stable in circulation, e.g., resistant to degradation by nucleases in serum and are substantially non-toxic” to humans.On inter partes review, the Patent Trial and Appeal Board held that the claims of the patent are not unpatentable as obvious. The Federal Circuit affirmed, first holding that that Moderna could pursue its appeal based on the risk of an infringement suit. Substantial evidence—including prior art and expert testimony—supports a finding that optimizing the four interdependent lipid components in prior art nucleic acid-lipid particles would not have been routine, and Moderna’s proposed adjustments to the lipid components are hindsight driven. View "ModernaTx, Inc. v. Arbutus Biopharma Corp." on Justia Law

Arbutus’s 435 patent, directed to “stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP,” issued in 2016. The patent recognized that there remained “a strong need in the art for novel and more efficient methods and compositions for introducing nucleic acids such as siRNA into cells.” On inter partes review (IPR), the Patent Board found that Moderna proved by a preponderance of the evidence that 10 claims were anticipated by a formulation in a publication but that Moderna failed to prove that the remaining claims were anticipated, or that those claims would have been obvious over the prior art.The Federal Circuit dismissed Moderna’s appeal and otherwise affirmed. Under the IPR statute, there is no standing requirement for petitioners to request the institution of IPR by the Board; the statute does not eliminate the Article III injury-in-fact requirement for appeal. Moderna lacked standing at the time the appeal was filed. Moderna conceded that the basis for its standing shifted during the pendency of this appeal, i.e., from the financial burdens of its sublicenses to a potential infringement suit for the COVID-19 vaccine. Moderna did not present evidence to demonstrate the necessary continuity of jurisdiction. View "ModernaTx, Inc. v. Arbutus Biopharma Corp." on Justia Law

Biogen’s 514 Patent claims a method of treating multiple sclerosis with a drug called dimethyl fumarate. Mylan filed an Abbreviated New Drug Application (ANDA) seeking FDA approval to manufacture, use, and market a generic dimethyl fumarate product for the treatment of multiple sclerosis before the expiration of the 514 Patent. Biogen sued Mylan alleging patent infringement. Mylan sought a declaratory judgment that the patent was invalid and not infringed. The district court determined that the asserted claims of the 514 Patent were invalid for lack of written description.The Federal Circuit affirmed. The district court did not clearly err in determining that Mylan has established its burden of showing, by clear and convincing evidence, that the asserted 514 Patent claims are invalid for lack of written description under 35 U.S.C. 112. View "Biogen International GmbH v. Mylan Pharmaceuticals, Inc." on Justia Law