Justia Drugs & Biotech Opinion Summaries

In 2014, Merck and Bayer entered a Stock and Asset Purchase Agreement (SAPA) whereby Merck sold, and Bayer purchased, Merck’s consumer care business and consumer care product lines, including the Claritin, Coppertone, Dr. Scholl’s, and Lotrimin foot powder product lines. The transaction closed in October 2014. Bayer paid Merck more than $14 billion. After the transaction closed, both companies were the subject of lawsuits alleging injuries arising from consumers’ use of talc-based products that Merck used in foot powder product lines sold to Bayer; asbestos allegedly contained in talcum powder has caused fatal cancers.The Delaware Court of Chancery dismissed Merck’s suit in which it argued that Bayer breached the SAPA by refusing to assume liability for the claims. Both companies, as sophisticated participants in the pharmaceutical industry, understood that consumer products businesses face potential liability for torts associated with the sale of such consumer products. The SAPA clearly and unambiguously provides that Merck indefinitely retained substantive liability for the product liability claims related to products sold before the transaction closed. Merck attempted to argue that its liability for the product liability claims ceased in 2021; the court found that interpretation contrary to the SAPA's clear and unambiguous terms. Bayer’s interpretation of the SAPA is the only reasonable one. View "Merck & Co., Inc. v. Bayer AG" on Justia Law

Liposomal bupivacaine is a nonopioid pain medication that Pacira manufactures under the name EXPAREL; it is a local anesthetic administered at the time of surgery to control post-surgical pain. As of 2020, EXPAREL sales represented nearly all of Pacira’s total revenue. Pacira complains that the defendants, the American Society of Anesthesiologists, its journal, its editor, and authors published statements in a variety of forms, conveying their view that EXPAREL is “not superior” to standard analgesics or provides “inferior” pain relief.The Third Circuit affirmed the dismissal of Pacira’s suit for trade libel. Opinion statements are generally nonactionable. A “fair and natural” reading of the statements at issue shows that these are nonactionable subjective expressions. Pacira’s allegations boil down to disagreements about the reliability of the methodology and data underlying the statements; “a scientific conclusion based on nonfraudulent data in an academic publication is not a ‘fact’ that can be proven false through litigation.” Pacira failed to identify any aspect of the Articles, a Continuing Medical Education program, or a Podcast that “bring their conclusions outside the protected realm of scientific opinion.” View "Pacira Biosciences Inc v. American Society of Anesthesiologists Inc" on Justia Law

The Supreme Court affirmed the order of the circuit court dismissing Appellants' complaint alleging that the Arkansas Medical Marijuana Commission had granted a marijuana cultivation license to a corporate entity that had been dissolved, holding that the circuit court correctly dismissed this appeal on the merits.Appellants, existing cultivation license holders, challenged the Commission's decision to allegedly grant a license to a dissolved corporate entity, arguing that the circuit court erred by holding that it lacked subject-matter jurisdiction and wrongly held that Appellants lacked standing. The Supreme Court reversed, holding that the circuit court (1) erred by not finding that it lacked subject-matter jurisdiction and that Appellants lacked standing; but (2) properly dismissed the complaint because it failed to allege facts sufficient to mount the State's sovereign immunity defense. View "Osage Creek Cultivation, LLC v. Ark. Dep't of Finance & Administration" on Justia Law

The Supreme Court affirmed in part, reversed in part and vacated in part the judgment of the circuit court holding that Bristol-Myers Squibb and Sanofi had violated Hawai'i's Unfair or Deceptive Acts or Practices law (UDAP) by misleading the public about the safety and efficacy of their anitplatelet drug, Plavix, holding that remand was required.The circuit court concluded that Defendants misled Hawai'i consumers by failing to warn them that Plavix was less effective for poor responders, granted the State's motion for partial summary judgment, and imposed an $834 million penalty. The Supreme Court (1) reversed the circuit court's deceptive acts or practices holding, holding that the summary judgment ruling circumscribed Defendants' ability to present a full defense and affected the penalty award, requiring a new trial; (2) affirmed the holding that Defendants committed unfair acts under UDAP; and (3) held that Defendants' procedural arguments failed. View "State v. Bristol-Myers Squibb Co." on Justia Law

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