Justia Drugs & Biotech Opinion Summaries

Articles Posted in Intellectual Property
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Pirfenidone is a drug used to treat idiopathic pulmonary fibrosis (IPF), a chronic, irreversible lung disease. There is no cure for IPF. Patients living with the disease face an average survival of two-five years. The FDA has approved two drugs for the treatment of IPF, pirfenidone, and nintedanib; differences center on side effects and metabolism. Pirfenidone was first studied as an investigational new drug in 1973. In 2004, the FDA granted pirfenidone orphan drug status for treatment of IPF. In 2014, pirfenidone was approved to treat IPF in the U.S. as Esbriet®, sold by Genentech. Sandoz submitted two Abbreviated New Drug Applications, seeking FDA approval to market a generic version of pirfenidone. Genentech then brought this Hatch-Waxman suit, asserting that Sandoz’s generic product would induce the infringement of its patents. The asserted patents do not claim pirfenidone itself, or the use of pirfenidone to treat IPF but claim methods for managing side effects when using pirfenidone to treat IPF.The Federal Circuit affirmed district court holdings that the claims of Genentech’s Liver Function Test patents are unpatentable as obvious, sales of Sandoz’s generic product would not induce infringement of the LFT patents, and sale of Sandoz’s generic product would not directly infringe Genentech’s Drug-Drug Interaction patents. View "Genentech, Inc. v. Sandoz Inc." on Justia Law

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Merck’s 708 patent describes sitagliptin dihydrogen phosphate (sitagliptin DHP), which belongs to the class of dipeptidyl peptidase-IV (DP-IV) inhibitors that can be used for treating non-insulin-dependent (Type 2) diabetes. Mylan petitioned for inter partes review, arguing that claims 1–3, 17, 19, and 21–23 were anticipated by the Merck-owned 489 publication, and the equivalent 871 patent (collectively, Edmondson) Edmondson is directed to compounds that are DP-IV inhibitors, useful in the treatment or prevention of diseases in which the dipeptidyl peptidase-IV enzyme is involved, such as diabetes and particularly type 2 diabetes. Mylan also argued that claims 1–4, 17, 19, and 21–23 would have been obvious over Edmondson and two additional publications.The Federal Circuit affirmed the Patent and Trademark Office Patent Trial and Appeal Board holding that Mylan failed to show that claims 1–4, 17, 19, and 21–23 were anticipated or would have been obvious over the cited prior art at the time the alleged invention was made. Merck reduced to practice more than what is shown in Edmondson for the claimed subject matter. View "Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.," on Justia Law

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The First Circuit affirmed the judgment of the district court dismissing Amyndas Pharmaceuticals, S.A.'s claims against Zealand Pharma A/S and vacated the dismissal of Amyndas's claims against Zealand Pharma U.S., Inc., holding that the district court erred in dismissing Amyndas's claims against Zealand Pharma U.S.When Amyndas was considering separate joint ventures with Zealand Pharma and Alexion Pharmaceuticals, Inc. it shared trade secrets before understanding that neither of the joint ventures would materialize. Zealand Pharma and Zealand US, its newly established affiliate, subsequently announced a partnership with Alexion Pharmaceuticals, Inc. Amyndas sued for misappropriation of trade secrets and other confidential information. The district court (1) dismissed Amyndas's claims against Zealand Pharma on the ground that Amyndas was required to litigate those claims in Denmark; and (2) dismissed Amyndas's claims against Zealand US for failure to state a claim. The First Circuit vacated in part and remanded the case for further proceedings, holding that the district court (1) correctly dismissed Amyndas's claims against Zealand Pharma; and (2) erred in concluding that Amyndas's claims against Zealand US were futile. View "Amyndas Pharmaceuticals, S.A. v. Zealand Pharma A/S" on Justia Law

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Since 2014 Par has manufactured and sold Vasostrict®, an FDA-approved vasopressin injection product used to treat patients with critically low blood pressure. The Orange Book identifies Par’s 785 and 209 patents as encompassing Vasostrict®. Both patents require the vasopressin composition to have a rounded pH between 3.7–3.9. In 2018, Eagle filed an abbreviated new drug application (ANDA) to manufacture and sell a generic version of Vasostrict® before those patents expired. Eagle represented in its release specification that the pH range would be between 3.4–3.6. Eagle’s ANDA also contained 35 U.S.C. 355(j)(2)(A)(vii)(IV) certification that Par’s patents are invalid or will not be infringed by Eagle’s proposed product.Par sued for infringement under 35 U.S.C. 271(e)(2). Eagle stipulated that its proposed product would meet all asserted claim limitations except the claimed pH range. Par argued that “real-world” evidence shows the pH of Eagle’s product drifts up over time and that Eagle sought authority to release products into the marketplace with a pH of 3.64, just 0.01 beneath the infringing range. The Federal Circuit affirmed the rejection of those arguments. Minor fluctuations in pH value identified by Par did not reveal any discernible trend and the stability specification imposed an additional constraint that Eagle’s proposed product maintain a pH between 3.4–3.6 from the time of its distribution through its entire shelf life. View "Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc." on Justia Law

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After the district court granted summary judgment in favor of two government agencies and a pharmaceutical company in this Freedom of Information Act ("FOIA") case. Plaintiff, a science writer and journalism professor, sought records from the government agencies relating to the pharmaceutical company's successful application for accelerated approval of a drug for the treatment of a neuromuscular disease. The agencies produced over 45,000 pages of documents, some of which were redacted under Exemption 4 of FOIA. The district court granted summary judgment for the agencies and the pharmaceutical company on the basis that the redacted information fell within Exemption 4 and publication would either cause foreseeable harm to the interests protected by Exemption 4 or was prohibited by law.Plaintiff appealed and the Second Circuit affirmed the district court’s ruling. The court held that the interests protected by Exemption 4 are the submitter's commercial or financial interests in the information that is of a type held in confidence and not disclosed to any member of the public by the person to whom it belongs. Defendants' declarations show that the release of the information Plaintiff seeks would foreseeably harm the pharmaceutical company’s interests and Plaintiff does not raise a genuine dispute as to that showing. View "Seife v. FDA, et al." on Justia Law

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The patents share the same specification and are entitled “Non-Invasive Diagnosis of Graft Rejection in Organ Transplant Patients.” They discuss diagnosing or predicting organ transplant status by using methods to detect a donor’s cell-free DNA (cfDNA). When an organ transplant is rejected, the recipient’s body, through its natural immune response, destroys the donor cells, releasing cfDNA from the donated organ’s dying cells into the blood. These increased levels of donor cfDNA—which occur naturally as the organ’s condition deteriorates—can be detected and then used to diagnose the likelihood of an organ transplant rejection.In an infringement action, the district court found the patents ineligible under 35 U.S.C. 101. The Federal Circuit affirmed. The court applied the Supreme Court’s two-part “Alice” test to determine whether the claims were patent-eligible applications of laws of nature and natural phenomena or claims that impermissibly tie up such laws and phenomena. The claims boil down to collecting a bodily sample, analyzing the cfDNA using conventional techniques, including PCR, identifying naturally occurring DNA from the donor organ, and then using the natural correlation between heightened cfDNA levels and transplant health to identify a potential rejection, none of which was inventive. This is not a case involving a method of preparation or a new measurement technique. View "CareDx, Inc. v. Natera, Inc" on Justia Law

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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

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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

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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

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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