Justia Drugs & Biotech Opinion Summaries

Generic versions of ranitidine-containing antacids are sold under the brand name Zantac. In 2019, after an independent laboratory found “significant quantities of NDMA,” a known carcinogen in ranitidine-containing antacids, the FDA issued a public alert. Some manufacturers voluntarily recalled their products. In 2020, the FDA “request[ed that] manufacturers withdraw all prescription and [OTC] ranitidine drugs from the market immediately.”CEH, a nonprofit corporation, sued under Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, Health and Safety Code 25249.5, alleging that the generic-drug defendants continued to expose individuals to NDMA without clear and reasonable warnings regarding the carcinogenic hazards. The trial court dismissed the generic defendants without leave to amend, citing preemption by the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301. The court determined that the generic-drug defendants cannot give a Proposition 65 warning without violating the federal requirement that the generic version of a drug have the same “labeling” as the brand-name version. The court of appeal affirmed that dismissal. Although not all methods of publicly communicating a warning about a drug necessarily qualify as “labeling,” CEH fails to identify any method by which the generic-drug defendants could provide a warning that would satisfy both Proposition 65 and the federal duty of sameness. View "Center for Environmental Health v. Perrigo Co." on Justia Law

Gilead filed an inter partes review (IPR) petition challenging claims of the University of Minnesota’s 830 patent, directed to phosphoramidate prodrugs of nucleoside derivatives that prevent viruses from reproducing or cancerous tumors from growing. The U.S. Patent and Trademark Office Patent Trial and Appeal Board found certain claims unpatentable as anticipated by the asserted prior art.The Federal Circuit affirmed. There is no “ipsis verbis” written description disclosure sufficient to support the patent’s claims, 35 U.S.C. 112. The court referred to “a compendium of common organic chemical functional groups, yielding a laundry list disclosure of different moieties for every possible side chain or functional group. Indeed, the listings of possibilities are so long, and so interwoven, that it is quite unclear how many compounds actually fall within the described genera and subgenera.” The court found no violations of the Administrative Procedures Act and rejected the University argument that sovereign immunity barred IPR proceedings against it. View "Regents of the University of Minnesota v. Gilead Sciences, Inc." on Justia Law

Jazz holds an approved New Drug Application (NDA) for the narcolepsy drug Xyrem®, with the active ingredient, GHB, which exerts a heavily sedating effect and is prone to misuse; it is known as a date rape drug. The FDA conditioned approval of Jazz’s NDA upon the development of Risk Evaluation and Mitigation Strategies (REMS). The 963 patent relates to Jazz’s distribution system, which controls access to the drug through a central pharmacy and computer database, tracking prescriptions, patients, and prescribers. Jazz listed the 963 patent in the Orange Book as covering a method of using Xyrem. The patent’s claims expired in 2022. In 2020, Avadel submitted an NDA for the GHB-based drug FT218. Unlike Xyrem, FT218 is dosed once nightly. FT218’s REMS describe multiple pharmacies and databases for ensuring proper drug handling. Although Avadel had filed an NDA, not an Abbreviated NDA, the FDA required Avadel to file a certification that to the best of its knowledge, the 963 patent’s single-pharmacy system was invalid, unenforceable, or would not be infringed by its product.Jazz sued Avadel for infringement. Avadel sued the FDA for requiring certification; the suit was dismissed because 21 U.S.C. 355(c)(3)(D)(ii)(I) provided Avadel with a separate adequate remedy. Avadel responded to Jazz’s infringement assertions, seeking de-listing of the 963 patent. The Federal Circuit affirmed the district court order that Jazz request de-listing. The 963 patent claims a system and does not claim an approved method of use. View "Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, Inc" on Justia Law

ChromaDex’s 807 patent is directed to dietary supplements containing isolated nicotinamide riboside (NR), a form of vitamin B3 naturally present—in non-isolated form—in cow’s milk and other products. Animal cells convert ingested NR into the coenzyme nicotinamide adenine dinucleotide, or NAD+. NAD+ deficiencies can cause diseases in both animals and humans. ChromaDex sued Elysium, a former ChromaDex customer, for patent infringement.The district court construed several claim terms, finding “isolated [NR]” to mean “[NR] that is separated or substantially free from at least some other components associated with the source of [NR].” The district court granted Elysium summary judgment, finding that the asserted claims were invalid under 35 U.S.C. 101. The Federal Circuit affirmed. The asserted claims concern a product of nature and are not patent eligible. They do not have characteristics markedly different from milk; both “increase[] NAD+ biosynthesis upon oral administration.” Recognizing the utility of NR is nothing more than recognizing a natural phenomenon, which is not inventive. The act of isolating the NR by itself, “no matter how difficult or brilliant it may have been” does not turn an otherwise patent-ineligible product of nature into a patentable invention. View "ChromaDex, Inc. v. Elysium Health, Inc." on Justia Law

Doctor Shakeel Kahn (Dr. Kahn) was convicted in federal district court in Wyoming, in part, for dispensing controlled substances not “as authorized,” in violation of the Controlled Substances Act (the CSA). Included in his appeal to the Tenth Circuit Court of Appeals was his contention that the jury instructions issued by the district court improperly advised the jury regarding the mens rea requirement of CSA § 841(a). The Tenth Circuit affirmed Dr. Kahn’s convictions, rejecting both his challenge to the instructions given, and his challenges to multiple searches and the evidence seized. In upholding the instructions, the Tenth Circuit relied on precedent, United States v. Nelson, 383 F.3d 1227 (10th Cir. 2004), and further reaffirmed its holding, which was guided by 21 C.F.R. § 1306.04(a). Dr. Kahn appealed to the U.S. Supreme Court, raising only his instructional challenge. The Supreme Court held that § 841(a)’s “knowingly or intentionally” mens rea applied to the “except as authorized” clause of the statute, vacated the Tenth Circuit's judgment, and remanded the case for further proceedings consistent with its opinion. The parties submitted supplemental briefing, and the matter went again before the Tenth Circuit. After review, the Tenth Circuit concluded the jury instructions issued in Dr. Kahn’s trial incorrectly stated the mens rea requirement of § 841(a) and the error was not harmless beyond a reasonable doubt. This prejudicial error infected all of Dr. Kahn’s convictions. Therefore, Dr. Kahn’s convictions were v View "United States v. Kahn" on Justia Law

Drug makers participating in Medicare or Medicaid must offer their drugs at a discount to certain “covered entities,” which typically provide healthcare to low-income and rural individuals, 42 U.S.C. 256b, 1396r-8(a)(1), (5) (Section 340B). Initially, few covered entities had in-house pharmacies. A 1996 HHS guidance stated that covered entities could use one outside contract pharmacy each; a 2010 HHS guidance stated that covered entities could use an unlimited number of contract pharmacies. Drug makers thought that contract pharmacies were driving up duplicate discounting and diversion and adopted policies to limit any covered entity’s use of multiple contract pharmacies. A 2020 HHS Advisory Opinion declared that Section 340B required drug makers to deliver discounted drugs to an unlimited number of contract pharmacies.In 2010, Congress told HHS to establish a process for drug makers and covered entities to resolve Section 340B–related disputes. In 2016, HHS issued a notice of proposed rulemaking and accepted comments on the proposed ADR Rule. HHS subsequently listed the proposed rule as withdrawn. In 2020, HHS stated that it had just “paus[ed] action on the proposed rule,” responded to the four-year-old comments. and issued a final ADR Rule.Drug companies sued. The Third Circuit held that Section 340B does not require drug makers to deliver discounted drugs to an unlimited number of contract pharmacies. HHS did not violate the APA by purporting to withdraw the proposed ADR Rule before later finalizing it. View "Sanofi Aventis US LLC v. United States Department of Health and Human Services" on Justia Law

Lawsuits brought by governmental bodies and health clinics alleged that Quest, a wholesale pharmaceutical distributor, engaged in misconduct that contributed to a nationwide epidemic of opioid abuse. The plaintiffs plead violations of the RICO Act and state statutes, common law public nuisance, and negligence, seeking damages for “significant expenses for police, emergency, health, prosecution, corrections, rehabilitation, and other services.” Some complaints clarify that the claims “are not based upon or derivative of the rights of others” and that the plaintiffs “do not seek damages for death, physical injury to person, emotional distress, or physical damages to property[.]”Quest's insurance policies covered "damages because of 'bodily injury' or 'property damage'" and explain that “[d]amages because of ‘bodily injury’ include damages claimed by any person or organization for care, loss of services or death resulting at any time from the ‘bodily injury.’” “Bodily injury” is defined as “bodily injury, sickness or disease sustained by a person, including death resulting from any of these at any time.”The insurers sought declaratory judgments that they had no duty to defend or indemnify Quest. The district court granted the insurers summary judgment. The Sixth Circuit affirmed. Based on the plain language of the policies and their overall context and purpose, the court concluded that the Kentucky Supreme Court would find that the insurers have no duty to defend because the lawsuits do not seek damages “because of bodily injury” and claim only economic damages. View "Westfield National Insurance Co. v. Quest Pharmaceuticals, Inc." on Justia Law

Under the Hatch-Waxman Act, a drug may receive “new chemical entity exclusivity” if no active ingredient in the drug was previously “approved.” The drug Aubagio was awarded this exclusivity because the Food & Drug Administration (“FDA”) determined that Aubagio’s only active ingredient, teriflunomide, had never previously been approved. This case concerns a challenge to Aubagio’s exclusivity period, which Sandoz Inc. raises to secure a solo period of marketing exclusivity for its generic equivalent. Sandoz maintains that teriflunomide was previously “approved” as an impurity in the drug Arava. In the alternative, Sandoz argued that teriflunomide was in fact approved as an active ingredient in Arava. The district court granted summary judgment for the FDA, agreeing with the agency that Aubagio was entitled to exclusivity because teriflunomide had never previously been approved.   The DC Circuit affirmed the district court’s judgment. The court held that while Sandoz did not exhaust its statutory argument before the FDA, in the absence of a statutory or regulatory exhaustion requirement, the court found it appropriate to decide Sandoz’s challenge. When the FDA approves a new drug, it does not also “approve” known impurities in that drug for the purpose of new chemical entity exclusivity. And the record is clear the FDA did not approve teriflunomide as an active ingredient when it approved Arava. Aubagio was therefore entitled to new chemical entity exclusivity, and Sandoz cannot benefit from a solo exclusivity period for its generic equivalent. View "Sandoz Inc. v. Xavier Becerra" on Justia Law

In this appeal arising out of a multidistrict litigation concerning the pharmaceutical drug ondansetron hydrochloride, better known as Zofran, the First Circuit affirmed the order of the district court granting summary judgment in favor of GlaxoSmithKline (GSK), holding that there was no error or abuse of discretion.Various plaintiffs filed separate lawsuits alleging that the use of Zofran during pregnancy caused birth defects and that GSK engaged in an intentionally misleading plan to market Zofran for pregnancy in violation of state law. The district court granted summary judgment in favor of GSK, holding that federal law preempted Plaintiffs' state law claims. The First Circuit affirmed, holding that federal law preempted Plaintiffs' state law claims that GSK should have warned both prescribing doctors and pregnant people that "animal studies showed harm to the fetus when Zofran was ingested during pregnancy." View "Perham v. GlaxoSmithKline, LLC" on Justia Law

Pirfenidone is a drug used to treat idiopathic pulmonary fibrosis (IPF), a chronic, irreversible lung disease. There is no cure for IPF. Patients living with the disease face an average survival of two-five years. The FDA has approved two drugs for the treatment of IPF, pirfenidone, and nintedanib; differences center on side effects and metabolism. Pirfenidone was first studied as an investigational new drug in 1973. In 2004, the FDA granted pirfenidone orphan drug status for treatment of IPF. In 2014, pirfenidone was approved to treat IPF in the U.S. as Esbriet®, sold by Genentech. Sandoz submitted two Abbreviated New Drug Applications, seeking FDA approval to market a generic version of pirfenidone. Genentech then brought this Hatch-Waxman suit, asserting that Sandoz’s generic product would induce the infringement of its patents. The asserted patents do not claim pirfenidone itself, or the use of pirfenidone to treat IPF but claim methods for managing side effects when using pirfenidone to treat IPF.The Federal Circuit affirmed district court holdings that the claims of Genentech’s Liver Function Test patents are unpatentable as obvious, sales of Sandoz’s generic product would not induce infringement of the LFT patents, and sale of Sandoz’s generic product would not directly infringe Genentech’s Drug-Drug Interaction patents. View "Genentech, Inc. v. Sandoz Inc." on Justia Law