Justia Drugs & Biotech Opinion Summaries

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

Stereochemistry is the study of a molecule’s three-dimensional structure. Stereoisomers are molecules with the same chemical formula and structure but different three-dimensional configurations. Enantiomers, non-superimposable mirror images of one another, often have identical physical properties, such as density and boiling point, but can exhibit different pharmacological properties in the human body. Sumitomo’s 372 patent relates generally to “novel imide compounds and their acid addition salts” that are useful as antipsychotic agents. The patent discloses and claims more than one billion compounds, some of which have stereo and optical isomers. Lurasidone, the (–)-enantiomer of an imide compound covered by the patent, is the active ingredient in Sunovion’s schizophrenia and bipolar depression drug LATUDA®. After Emcure filed Abbreviated New Drug Applications with the FDA, seeking approval to market generic versions of LATUDA®, Sumitomo sued for infringement. The claim construction question centered on what combination of enantiomers claim 14 encompassed. The Federal Circuit rejected Sumitomo’s attempt to “import limitations from the specification into the claim” and affirmed the district court, holding that the patent covers at least the specific orientation depicted in the claim, which is the active pharmaceutical ingredient in each party’s commercial product. View "Sumitomo Dainippon Pharma Co., Ltd. v. Emcure Pharmaceuticals Ltd." on Justia Law

In 2017, Maryland enacted “An Act concerning Public Health – Essential Off-Patent or Generic Drugs – Price Gouging – Prohibition.” The Act, Md. Code, Health–General 2-802(a), prohibits manufacturers or wholesale distributors from “engag[ing] in price gouging in the sale of an essential off-patent or generic drug,” defines “price gouging” as “an unconscionable increase in the price of a prescription drug,” and “unconscionable increase” as “excessive and not justified by the cost of producing the drug or the cost of appropriate expansion of access to the drug to promote public health” that results in consumers having no meaningful choice about whether to purchase the drug at an excessive price due to the drug’s importance to their health and insufficient competition. The “essential” medications are “made available for sale in [Maryland]” and either appear on the Model List of Essential Medicines most recently adopted by the World Health Organization or are “designated . . . as an essential medicine due to [their] efficacy in treating a life-threatening health condition or a chronic health condition that substantially impairs an individual’s ability to engage in activities of daily living.” The Fourth Circuit reversed the dismissal of a “dormant commerce clause” challenge to the Act, finding that it directly regulates the price of transactions that occur outside Maryland. View "Association for Accessible Medicine v. Frosh" on Justia Law

Vanda had an exclusive license to the now-expired 198 patent and owns the 610 patent, relating to treatment of schizophrenia with iloperidone wherein the dosage range is based on the patient’s genotype. Vanda owns the New Drug Application for Fanapt® (iloperidone), an atypical antipsychotic approved by the FDA in 2009 under 21 U.S.C. 355(b) and based on the invention disclosed in the 610 patent, which reduces the side effects, enabling safer treatment of schizophrenia. The 198 and 610 patents are listed in connection with Fanapt® in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, (Orange Book). In 2013, West-Ward filed an Abbreviated New Drug Application (ANDA) seeking approval to commercially manufacture, use, offer to sell, and sell a generic version of Fanapt® for the treatment of schizophrenia (21 U.S.C. 355(j)). At that time, the 610 patent had not yet issued and only the 198 patent was listed in the Orange Book. The ANDA contained a Paragraph IV certification that the 198 patent was invalid and/or would not be infringed by West-Ward. The proposed ANDA label is substantially identical in all material respects to the Fanapt® label. The Federal Circuit affirmed a holding that the 610 patent is infringed and not invalid. View "Vanda Pharmaceuticals, Inc. v. West-Ward Pharmaceuticals International, Ltd." on Justia Law

The district court did not err in dismissing Plaintiffs’ first amended complaint (FAC) for failure to state a claim or in denying Plaintiffs leave to file their proposed second amended complaint (PSAC) in this litigation in which Plaintiffs brought securities fraud claims against Sarepta Therapeutics, Inc. (Sarepta), Sarepta’s chief executive officer and Sarepta’s chief scientific officer (collectively, Defendants).Plaintiffs sought to represent a class of purchasers of securities that Sarepta issued between April 21, 2014 and October 27, 2014. Plaintiffs alleged that Defendants knowingly or recklessly misled investors about their target date for submitting an application to the United States Food and Drug Administration (FDA) for approval of the drug eteplirsen. The district court dismissed the FAC and denied Plaintiffs leave to file the PSAC. The First Circuit affirmed, holding (1) the district court did not err in dismissing the FAC for failure to state a claim because Plaintiffs did not adequately plead scienter in the FAC; and (2) and even assuming that the PSAC was not futile, the district court did not abuse its discretion in denying the PSAC on undue delay grounds. View "Kader v. Sarepta Therapeutics, Inc." on Justia Law

The Supreme Court affirmed in part and reversed in part the order of the circuit court requiring the Arkansas Department of Correction (ADC) to provide Plaintiff, an Arkansas resident and attorney, with the pharmaceutical package inserts and labels for its supply of potassium chloride, one of the drugs in the State’s execution protocol. In so ordering, the circuit court held that the General Assembly did not intend to protect the identity of manufacturers of drugs used in the ADC’s lethal-injection protocol. On appeal, the Supreme Court held (1) the circuit court correctly found that the identity of drug manufacturers is not protected under the confidentiality provisions of Ark. Code Ann. 5-4-617; but (2) the ADC is still required to redact certain information such as lot, batch, and/or control numbers that could lead to the identification of other sellers and suppliers in the chain of distribution. View "Arkansas Department of Correction v. Shults" on Justia Law

The Supreme Court affirmed in part and reversed in part the order of the circuit court requiring the Arkansas Department of Correction (ADC) to provide Plaintiff, an Arkansas resident and attorney, with the pharmaceutical package inserts and labels for its supply of potassium chloride, one of the drugs in the State’s execution protocol. In so ordering, the circuit court held that the General Assembly did not intend to protect the identity of manufacturers of drugs used in the ADC’s lethal-injection protocol. On appeal, the Supreme Court held (1) the circuit court correctly found that the identity of drug manufacturers is not protected under the confidentiality provisions of Ark. Code Ann. 5-4-617; but (2) the ADC is still required to redact certain information such as lot, batch, and/or control numbers that could lead to the identification of other sellers and suppliers in the chain of distribution. View "Arkansas Department of Correction v. Shults" on Justia Law

The FDA counted both the sale to a minor and the failure to verify age as two separate violations on Orton's second failed inspection and assessed the maximum penalty of $500 for three violations within a 24-month period under the civil money penalty schedule. The DC Circuit denied Orton's petition for review, finding no merit in Orton's contention that the Tobacco Control Act precludes the FDA's methodology of charging multiple violations in a single inspection, and that the FDA violates the law by failing to provide a process for retailers to challenge first violations before the issuance of a warning letter. The court held that the statute was easily understood to permit multiple violations where multiple regulations were breached, and the FDA interpreted the statute consistently. The court also held that the FDA's adjudication of the subsequent violation provided a meaningful opportunity for a retailer to be heard regarding the underlying first violation, at the time that the first violation carried legally significant effects. In this case, due process required nothing more. View "Orton Motor, Inc. v. HHS" on Justia Law