Justia Drugs & Biotech Opinion Summaries

Articles Posted in Intellectual Property
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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

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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

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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

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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

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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

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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

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Methicillin-resistant Staphylococcus aureus (MRSA), and other Gram-positive bacteria that have developed resistance to antibiotics cause health problems, particularly in the hospital environment. TheUniversity of Strathclyde’s 706 patent addresses problems resulting from the “availability of few effective sterili[z]ation methods for environmental decontamination” of air and surfaces and discloses photoinactivation as a method that has emerged for killing harmful bacteria like MRSA and describes a method for photo-inactivating antibiotic-resistant bacteria like MRSA without using a photosensitizing agent.In inter partes review, the Patent Trial and Appeal Board found claims 1–4 of the 706 patent unpatentable as obvious, 35 U.S.C. 103. The Federal Circuit reversed. Neither the Board’s finding that the prior art disclosed all claim limitations nor its finding of a reasonable expectation of success is supported by substantial evidence. No reasonable factfinder could have found that the combination of the prior art discloses inactivating one or more Gram-positive bacteria without using a photosensitizer. In this case, where the prior art establishes only failures to achieve that at which the inventors succeeded, no reasonable factfinder could find an expectation of success based on the teachings of that same prior art. View "University of Strathclyde v. Clear-Vu Lighting, LLC" on Justia Law

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Celgene markets pomalidomide as a multiple-myeloma drug under the brand name Pomalyst. Many drug companies questioned the validity or applicability of Celgene's patents and sought to bring generic pomalidomide to market. The defendants submitted an abbreviated new drug application (ANDA) to the FDA. Celgene filed suit in New Jersey. Celgene is headquartered there, but no defendant is. MPI is based in West Virginia, Mylan Inc. in Pennsylvania, and Mylan N.V. in Pennsylvania and the Netherlands. The district court dismissed the case for improper venue (MPI; Mylan Inc.) and for failure to state a claim (as to Mylan N.V.).The Federal Circuit affirmed. Under the Hatch-Waxman Act, 21 U.S.C. 355(j)(5)(B)(iii), venue was improper in New Jersey for the domestic corporation defendants, MPI and Mylan Inc. Celgene did not show that those defendants committed acts of infringement in New Jersey and have a regular and established place of business there. The court rejected Celgene’s argument that receipt of the ANDA notice letter is an infringing act in New Jersey. Under section 271(e)(2), submitting an ANDA is the act of infringement; although the ANDA applicant must later send a notice letter that happens after the infringing submission. As to the foreign-corporation defendant, Mylan N.V., Celgene’s pleadings failed to state a claim upon which relief could be granted. View "Celgene Corp. v. Mylan Pharmaceuticals Inc." on Justia Law

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OptiNose AS and OptiNose, Inc. (collectively, OptiNose) agreed to license its Exhalation Delivery Systems (“EDS”) technology to Currax Pharmaceuticals, LLC. The parties limited the License Agreement to a product which used a powder EDS device to deliver the migraine treatment drug sumatriptan into the nasal cavity. The product covered by the license, a powder EDS device and sumatriptan together, was trade-named ONZETRA(R) XSAIL(R). Currax had a limited right to sell the sumatriptan powder EDS device (the “Product”) in Canada, the United States, and Mexico. OptiNose retained the right to sell EDS devices: (1) with powders and liquids other than sumatriptan around the world; and (2) EDS devices with sumatriptan in every area other than those three countries. OptiNose also gave Currax the “first right” to “prosecute and maintain” certain patents related to the Product, listed in the License Agreement as the Product Patents. During Currax’s prosecution of the ’009 Patent Application, the U.S. Patent and Trademark Office (“USPTO”) rejected claims because they were not “patentably distinct” from the claims in another Product Patent. To overcome the patent office rejection, Currax needed to file a terminal disclaimer over the issued Product Patent. Currax needed a power of attorney from OptiNose to file a terminal disclaimer. OptiNose refused to provide it. Currax filed suit against OptiNose in the Court of Chancery, seeking an order of specific performance requiring OptiNose to grant it a power of attorney. OptiNose counterclaimed for a declaration that the License Agreement did not require it to provide a power of attorney. According to OptiNose, Currax’s right to prosecute Product Patents did not include a power of attorney, and, in any event, Currax could not file a terminal disclaimer without OptiNose’s advance approval, which it had not given. The Court of Chancery granted Currax’s motion for judgment on the pleadings, finding the License Agreement OptiNose to provide a power of attorney to prosecute the ’009 Application. On appeal, the parties focused primarily on OptiNose’s advance approval right, and whether a terminal disclaimer “relate[s] to or characterize[s] the Device component of the Patent or other OptiNose intellectual property.” The Delaware Supreme Court affirmed the Court of Chancery’s judgment that filing a terminal disclaimer in the ’009 Application prosecution was included in the rights OptiNose gave to Currax under the License Agreement. View "Optinose AS v. Currax Pharmaceuticals, LLC" on Justia Law

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Epinephrine (adrenaline), a hormone that has been on the market since approximately 1938, is used for various medical purposes. It degrades by racemization and oxidation. A 1986 publication taught that “there is an optimum pH at which racemization and oxidation can be balanced to minimize loss of intact drug by these two routes.” In 2012, Belcher submitted New Drug Application (NDA) for a 1 mg/mL injectable l-epinephrine formulation. The NDA was literature-based; Belcher did not perform any studies on its epinephrine formulation. Belcher responded to FDA inquiries concerning pH levels and racemization. In 2014, Belcher filed an application entitled “More Potent and Less Toxic Formulations of Epinephrine and Methods of Medical Use,” resulting in the 197. Hospira then submitted an NDA seeking approval of a 0.1 mg/mL injectable l-epinephrine formulation, including a Paragraph IV certification (21 U.S.C. 355(b)(2)(A)(iv)) alleging that the patent’s claims are invalid, unenforceable, and/or not infringed. Belcher sued Hospira for infringement.The Federal Circuit affirmed a finding that the patent was unenforceable for inequitable conduct. Belcher’s Chief Science Officer withheld material information about the pH range and the impurity levels from the Patent and Trademark Office. Belcher’s alleged critical improvement over the prior art was already within the public domain, just not before the examiner. Belcher’s officer acted with intent to deceive. View "Belcher Pharmaceuticals, LLC v. Hospira, Inc." on Justia Law