Justia Patents Opinion Summaries

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

Indivior’s patent, which generally describes orally dissolvable films containing therapeutic agents, was issued as the fifth continuation of the 571 application, which was filed in 2009. DRL petitioned for inter partes review of claims 1–5 and 7–14. alleging that the polymer weight percentage limitations, added to the claims by amendment, do not have written description support in the 571 application as filed and thus are not entitled to the benefit of its filing date.The Patent Trial and Appeal Board held that several challenged claims are unpatentable as anticipated, but that DRL failed to demonstrate that claim 8 is anticipated. The Federal Circuit affirmed, upholding the Board’s finding as to claim 8. The Board properly determined that claims 1, 7, and 12 do not have written description support in the 571 application; the remaining challenged claims were anticipated by prior art published in 2011. View "Indivior UK Ltd. v. Dr. Reddy's Laboratories S.A." on Justia Law

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

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

Qualcomm accused Apple of infringing various patents. Apple petitioned the Patent Trial and Appeal Board for inter partes review (IPR) of those patents. In 2019, the parties settled all their patent-infringement litigation worldwide and entered a six-year global patent license agreement with a two-year extension option, resulting in the dismissal of the infringement case with prejudice. The Board determined that Apple failed to prove various claims unpatentable. The Federal Circuit dismissed Apple’s appeal for lack of standing.Subsequently, Qualcomm again accused Apple of infringement and Apple again sought IPR. Then came the settlement and license agreement, resulting in the dismissal of the district court action with prejudice. The Board then issued final written decisions concluding that Apple had not proven various claims unpatentable. The Federal Circuit again dismissed an appeal for lack of Article III standing and rejected Apple’s request that, if it lacked jurisdiction, it should vacate the Board’s decisions “to eliminate any doubt about the applicability of estoppel.” View "Apple Inc. v. Qualcomm Inc." on Justia Law

Ravgen filed suit in the federal district court in Waco, Texas, accusing Quest’s QNatal Advanced test of infringing patents relating to non-invasive tests for prenatal genetic disorders. Quest moved to transfer the case (28 U.S.C. 1404(a)), arguing that the Central District of California was a more convenient forum; its knowledgeable employees work in that district and third-party witnesses reside in the district. Although Quest maintains patient service centers across the country—including in the Western District of Texas—Quest designed, developed, and continues to perform QNatal Advanced testing only in the Central District of California. Quest argued that Ravgen, headquartered in Maryland, has no meaningful connections to the Western District of Texas. Ravgen noted that it had filed three related complaints in the Western District of Texas, alleging infringement of the same patents. After analyzing the public and private interest factors that govern transfer determinations, the district court denied Quest’s motion.The Federal Circuit directed the district court to transfer the case. When there are numerous witnesses in the transferee venue and the only other witnesses are far outside the plaintiff’s chosen forum, the witness-convenience factor favors transfer. The court erroneously discounted documents located in California that relate to the development, validation, testing, and performance of the accused product and in weighing court congestion as strongly against transfer. View "In Re Quest Diagnostics, Inc." on Justia Law