Justia Patents Opinion SummariesArticles Posted in US Court of Appeals for the Federal Circuit
ModernaTx, Inc. v. Arbutus Biopharma Corp.
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
ModernaTx, Inc. v. Arbutus Biopharma Corp.
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 International GmbH v. Mylan Pharmaceuticals, Inc.
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 UK Ltd. v. Dr. Reddy’s Laboratories S.A.
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
University of Strathclyde v. Clear-Vu Lighting, LLC
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
Celgene Corp. v. Mylan Pharmaceuticals Inc.
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
Apple Inc. v. Qualcomm Inc.
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
In Re Quest Diagnostics, Inc.
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
ROHM Semiconductor USA, LLC v. MaxPower Semiconductor, Inc.
In 2007, ROHM Japan and MaxPower entered into a technology license agreement (TLA). ROHM Japan was permitted “to use certain power [metal oxide semiconductor field-effect transistors (MOSFET)]-related technologies of” MaxPower (Licensor) developed under a Development and Stock Purchase Agreement in exchange for royalties paid to MaxPower. The TLA, as amended in 2011, includes an agreement to arbitrate “[a]ny dispute, controversy, or claim arising out of or in relation to this Agreement or at law, or the breach, termination, or validity thereof.” Arbitration is to be conducted “in accordance with the provisions of the California Code of Civil Procedure.”In 2019, a dispute arose between ROHM Japan and MaxPower concerning whether the TLA covers ROHM’s silicon carbide MOSFET products. MaxPower notified ROHM Japan of its intent to initiate arbitration. Shortly thereafter, ROHM's subsidiary, ROHM USA, sought a declaratory judgment of noninfringement of four MaxPower patents in the Northern District of California and four inter partes review petitions. The district court granted MaxPower’s motion to compel arbitration and dismissed the case without prejudice, reasoning that the TLA “unmistakably delegate[s] the question of arbitrability to the arbitrator.” The Federal Circuit affirmed. In contracts between sophisticated parties, incorporation of rules with a provision on the subject is normally sufficient “clear and unmistakable” evidence of the parties’ intent to delegate arbitrability to an arbitrator. View "ROHM Semiconductor USA, LLC v. MaxPower Semiconductor, Inc." on Justia Law
Energy Heating, LLC v. Heat On-The-Fly, LLC
The district court found HOTF’s patent, which relates to a “method and apparatus for the continuous preparation of heated water flow for use in hydraulic fracturing” (fracking), unenforceable due to inequitable conduct. The court found by clear and convincing evidence that the patent would not have been issued but for HOTF’s deliberate decision to withhold information from the Patent Office information about substantial on-sale and public uses of the claimed invention before the patent’s critical date, and that it withheld with an intent to deceive. The jury found that HOTF tortiously interfered with Energy’s business when it represented in bad faith that it held a valid patent. The court denied attorneys’ fees under 35 U.S.C. 285. The Federal Circuit remanded on that issue alone.On remand, the district court found the case to be exceptional and awarded attorneys’ fees. The Federal Circuit affirmed, citing findings that “HOTF litigated the case in an unreasonable manner by persisting in its positions,” that “[t]he number of undisclosed prior sales and the amounts HOTF received from those prior sales constitute affirmative egregious conduct” and that HOTF “pursued claims of infringement without any apparent attempt to minimize litigation costs” “despite [its] knowledge that its patent was invalid.” View "Energy Heating, LLC v. Heat On-The-Fly, LLC" on Justia Law