Justia Drugs & Biotech Opinion Summaries

Mallinckrodt’s 112 patent is directed to methods of distributing nitric oxide gas cylinders for pharmaceutical applications. Inhaled nitric oxide is approved by the FDA for treating neonates with hypoxic respiratory failure, a condition where oxygen levels in the blood are too low. Nitric oxide functions to dilate blood vessels in the lungs and can thereby improve blood oxygenation. Mallinckrodt exclusively supplies inhaled nitric oxide in the United States for pharmaceutical use under the brand name INOmax®. On inter partes review, the Patent and Trademark Office Patent Trial and Appeal Board found claim 9 not unpatentable as obvious under 35 U.S.C. 103 but found claims1-8 and 10-11 unpatentable as obvious. The Federal Circuit reversed as to claim 9 but otherwise affirmed. The Board did not err in applying the printed matter doctrine to claims 1–8 and 10, but its findings regarding the differences between the prior art and claim 9 and its findings on secondary considerations depended on an incorrect interpretation of that claim, and are not supported by substantial evidence. The Board’s uncontested findings regarding prior art render claim 9 obvious under the proper reading of the claim. View "Praxair Distribution Inc. v. Mallinckrodt Hospital Products IP, Ltd." on Justia Law

The Supreme Court affirmed the order of the Mass Litigation Panel through which summary judgment was granted in favor of Defendants, Pfizer, Inc., Roerig, a division of Pfizer, Inc., and Greenstone, LLC (collectively, Pfizer) on Plaintiffs’ claims that Pfizer negligently failed adequately to warn them of the risk of birth defects through the ingestion of Zoloft, a prescription medication, during pregnancy.The Court held (1) this was a case where expert testimony was necessary, and therefore, the Panel did not erroneously based its decision on the absence of expert testimony to support Plaintiffs’ claims that Pfizer failed adequately to warn women of childbearing age of the risks of Zoloft; (2) Petitioners could not sustain their evidentiary burden with Pfizer’s witnesses; and (3) there was no unfairness in requiring Plaintiffs to meet their burden of proof with expert testimony under the circumstances of this case. View "J.C. v. Pfizer, Inc." on Justia Law

Anacor’s patent, entitled “Boron-containing Small Molecules,” is directed to the use of 1,3-dihydro-5- fluoro-1-hydroxy-2, 1-benzoxaborole, also known as tavaborole, to topically treat fungal infections that develop under fingernails and toenails. The patent teaches that tavaborole can be used to treat onychomycosis, a fungal infection that is responsible for approximately half of all nail disorders in humans. On inter partes review, the Patent Board found all of the claims of the patent unpatentable for obviousness. The Federal Circuit affirmed. Anacor was not denied its procedural rights with respect to the theory of obviousness the Board adopted or any evidence it relied on. The Board understood that the petitioner’s theory was “not based on structural similarities alone,” but was “based on the combination of structural similarity and functional similarity” and agreed with the petitioner that “a person of ordinary skill in the art would have expected that tavaborole, which shares functional activity with the compounds of Brehove, would have shared other activities as well, such as the inhibition of additional fungi responsible for onychomycosis.” View "Anacor Pharmaceuticals, Inc. v. Iancu" on Justia Law

There is no cause of action in West Virginia for failure to warn and negligent misrepresentation against a branded drug manufacturer when the drug ingested was produced by a generic manufacturer.Petitioners, Kimmy and Larry McNair, filed an action against Respondent, Janssen Pharmaceuticals, alleging that Kimmy developed acute respiratory distress after ingestion the generic drug levofloxacin that was manufactured by Dr. Reddy’s Laboraties Limited. Janssen originally trademarked and sold levofloxacin under the brand Levaquin and produced the warnings on the label that accompanied the distribution of the drug, which were subsequently used by generic manufacturers of levofloxacin. The McNairs alleged that Janssen had exclusive control of the content of the warning for both the brand-name and generic forms of the drug and was therefore liable for their alleged injuries. The federal district court granted summary judgment to Janssen, finding that because Janssen did not manufacture the product ingested by Kimmy, there was no basis on which to hold Janssen liable. On appeal, the Fourth Circuit Court of Appeals certified to the Supreme Court a question of law. In answering as set forth above, the Supreme Court declined to expand its products liability law. View "McNair v. Johnson & Johnson" on Justia Law

Defendants produce or sell patented drug products containing the antiviral agent tenofovir alafenamide fumarate (TAF), which is used in the treatment of AIDS. Healthcare provides medical care to persons afflicted with AIDS, including providing antiviral drugs, including the TAF products that Healthcare buys from Defendants. Healthcare sought declarations of invalidity for patents purportedly covering TAF and various combination products so that it could partner with generic makers and purchase generic TAF on the expiration of the five-year New Chemical Entity exclusivity s(21 U.S.C. 355(j)(5)(F)(ii)). Healthcare filed suit two months after the FDA approved Genvoya®—the first TAF-containing product to receive FDA approval; other TAF products were still undergoing clinical trials. No unlicensed source was offering a TAF product or preparing to do so. Healthcare told the court that “none of the generic makers wanted to enter the market because there was the fear of liability.” The court ruled that Healthcare’s actions in encouraging others to produce generic TAF products and interest in purchasing such products did not create an actual controversy under the Declaratory Judgment Act. The Federal Circuit affirmed. The declaratory requirement of immediacy and reality is not met by litigation delay. Healthcare has not otherwise shown that there is a controversy of sufficient immediacy and reality to create declaratory judgment jurisdiction. Liability for inducing infringement requires that there be direct infringement. An interest in buying infringing product is not an adverse legal interest for declaratory jurisdiction. View "AIDS Healthcare Foundation, Inc. v. Gilead Sciences, Inc." on Justia Law

Defendants produce or sell patented drug products containing the antiviral agent tenofovir alafenamide fumarate (TAF), which is used in the treatment of AIDS. Healthcare provides medical care to persons afflicted with AIDS, including providing antiviral drugs, including the TAF products that Healthcare buys from Defendants. Healthcare sought declarations of invalidity for patents purportedly covering TAF and various combination products so that it could partner with generic makers and purchase generic TAF on the expiration of the five-year New Chemical Entity exclusivity s(21 U.S.C. 355(j)(5)(F)(ii)). Healthcare filed suit two months after the FDA approved Genvoya®—the first TAF-containing product to receive FDA approval; other TAF products were still undergoing clinical trials. No unlicensed source was offering a TAF product or preparing to do so. Healthcare told the court that “none of the generic makers wanted to enter the market because there was the fear of liability.” The court ruled that Healthcare’s actions in encouraging others to produce generic TAF products and interest in purchasing such products did not create an actual controversy under the Declaratory Judgment Act. The Federal Circuit affirmed. The declaratory requirement of immediacy and reality is not met by litigation delay. Healthcare has not otherwise shown that there is a controversy of sufficient immediacy and reality to create declaratory judgment jurisdiction. Liability for inducing infringement requires that there be direct infringement. An interest in buying infringing product is not an adverse legal interest for declaratory jurisdiction. View "AIDS Healthcare Foundation, Inc. v. Gilead Sciences, Inc." on Justia Law

By 2000, Altaire was manufacturing R-phenylephrine hydrochloride products, used to dilate patients’ pupils. In 2011, Altaire and Paragon agreed to pursue FDA approval. Paragon submitted a new drug application (NDA). The FDA recommended that Paragon consider adding a chiral purity test. Altaire measured the optical rotation of Lots 11578 and 11582, 2.5% and 10% phenylephrine hydrochloride ophthalmic solution products. Paragon submitted a supplementary NDA, which was FDA-approved. Altaire also conducted high-performance liquid chromatography testing on the two lots (TMQC-247). Paragon proposed an amendment to the Agreement to address filing a patent application. Altaire responded that: “the formulation, processes[,] and controls ... were developed solely by [Altaire’s Chief Executive] … and are . . . the proprietary and confidential information of Altaire”; the Agreement “does not contemplate ... a patent application.” Paragon did not respond but filed a patent application, entitled “Methods and Compositions of Stable Phenylephrine Formulations.” While the application was being prosecuted, Paragon requested “all the work [Altaire] ha[s] on chiral purity” for its annual FDA report. Altaire provided a report. Altaire later sued, alleging that Paragon breached a nondisclosure agreement; Paragon counterclaimed. Altaire sought a declaratory judgment of invalidity of the patent and sought post-grant review, arguing that the Asserted Claims would have been obvious over Lots #11578 and #11581. The Patent Board rejected the argument. The Federal Circuit reversed. The Board erred in refusing to consider a declaration by Altaire’s Chief Executive concerning the TMQC-247 and optical rotation test data. View "Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc." on Justia Law

By 2000, Altaire was manufacturing R-phenylephrine hydrochloride products, used to dilate patients’ pupils. In 2011, Altaire and Paragon agreed to pursue FDA approval. Paragon submitted a new drug application (NDA). The FDA recommended that Paragon consider adding a chiral purity test. Altaire measured the optical rotation of Lots 11578 and 11582, 2.5% and 10% phenylephrine hydrochloride ophthalmic solution products. Paragon submitted a supplementary NDA, which was FDA-approved. Altaire also conducted high-performance liquid chromatography testing on the two lots (TMQC-247). Paragon proposed an amendment to the Agreement to address filing a patent application. Altaire responded that: “the formulation, processes[,] and controls ... were developed solely by [Altaire’s Chief Executive] … and are . . . the proprietary and confidential information of Altaire”; the Agreement “does not contemplate ... a patent application.” Paragon did not respond but filed a patent application, entitled “Methods and Compositions of Stable Phenylephrine Formulations.” While the application was being prosecuted, Paragon requested “all the work [Altaire] ha[s] on chiral purity” for its annual FDA report. Altaire provided a report. Altaire later sued, alleging that Paragon breached a nondisclosure agreement; Paragon counterclaimed. Altaire sought a declaratory judgment of invalidity of the patent and sought post-grant review, arguing that the Asserted Claims would have been obvious over Lots #11578 and #11581. The Patent Board rejected the argument. The Federal Circuit reversed. The Board erred in refusing to consider a declaration by Altaire’s Chief Executive concerning the TMQC-247 and optical rotation test data. View "Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc." on Justia Law

The Supreme Court affirmed the circuit court’s denial of Appellants’ requested writ of certiorari to challenge an Attorney General’s ballot explanation of a proposed initiated measure that would limit the price state agencies may pay for prescription drugs.Appellants alleged as grounds for the writ that the Attorney General’s explanation did not comply with the requirements of S.D. Codified Laws 12-13-25.1. The circuit court denied the writ. The Supreme Court affirmed, holding that the Attorney General did not fail to carry out his statutory duty to provide a ballot explanation meeting the requirements of section 12-13-25.1. View "Johnson v. Jackley" on Justia Law

Merck's patents claim classes of compounds, identified by structural formulas, and the administration of therapeutically effective amounts of such compounds for treating Hepatitis C. Gilead developed its own Hepatitis C treatments, marketed as Solvadi® and Harvoni®, based on the compound sofosbuvir. Gilead sought a declaratory judgment that Merck’s patents were invalid and that Gilead was not infringing. Merck counterclaimed for infringement. Gilead stipulated to infringement based on the court’s claim construction, which was not appealed. A jury trial was held on Gilead’s challenges to the patents as invalid for lack of both an adequate written description and enablement of the asserted claims, and Gilead’s defense that Merck did not actually invent the subject matter but derived it from another inventor, employed by Gilead’s predecessor. The jury ruled for Merck but the district court ruled for Gilead, finding pre-litigation business misconduct and litigation misconduct attributable to Merck, and barred Merck from asserting the patents against Gilead. The court awarded attorney’s fees, relying on the finding of unclean hands. The Federal Circuit affirmed the judgment based on unclean hands. The district court found, with adequate evidentiary support, two related forms of pre-litigation business misconduct attributable to Merck. The court noted clear violations of a “firewall” understanding between Gilead’s predecessor and Merck, with a direct connection to the ultimate patent litigation. View "Gilead Sciences, Inc. v. Merck & Co., Inc." on Justia Law