Justia Drugs & Biotech Opinion Summaries

Under "loyalty contracts," Physician Buying Groups (PBGs) members are entitled to discounts if they buy a large enough percentage of their vaccines from Merck. The loyalty contracts include an arbitration provision. Membership contracts between PBGs and medical practices give medical practices discounts on Merck vaccines for enrolling in PBGs. PBGs contract with both Merck and medical practices and are middlemen but PBGs never possess the vaccines. Medical practices buy their vaccines directly from Merck, receiving discounts for belonging to a PBG. The Pediatricians, members of PBGs that contracted with Merck, never signed contracts containing an arbitration clause.The Pediatricians filed federal suits alleging Merck’s vaccine bundling program was anticompetitive. Merck moved to compel arbitration. On remand, following discovery, the district court again denied Merck’s motion and granted the Pediatricians summary judgment, reasoning that the Pediatricians were not bound under an agency theory. The Third Circuit reversed. The PBG membership contract made the PBG a “non-exclusive agent to arrange for the purchase of goods and services,” and the PBG acted on this authority by executing the loyalty contract with Merck that included the arbitration clause. The Pediatricians simultaneously demonstrated intent to create an agency relationship and exercised control over the scope of the PBG’s agency by contract. View "In re: Rotavirus Vaccines Antitrust Litigation v." on Justia Law

The Supreme Court held that the federal Defend Trade Secrets Act (DTSA) prohibits disclosure, under the Nevada Public Records Act (NPRA), of documents from pharmaceutical companies and pharmacy benefit managers collected under S.B. 539.The Nevada Independent (TNI) filed a petition with the district court seeking an order directing the Department of Health and Human Services (DHHS) to release the documents at issue. The district court concluded that the documents were not subject to disclosure under the NPRA because the information contained in them comprised trade secrets protected under the DTSA. The Supreme Court affirmed, holding (1) because the DTSA classifies the requested documents, obtained pursuant to S.B. 539, as confidential trade secrets, the documents were exempt from disclosure under the NPRA; and (2) TNI's remaining allegations of error were without merit. View "Nevada Independent v. Whitley" on Justia Law

Almirall’s patent relates to methods of treating acne or rosacea with dapsone formulations that include an acrylamide/sodium acryloyldimethyl taurate copolymer (A/SA) thickening agent and the solvent diethylene glycol monoethyl ether (DGME), which allows compositions to be prepared with increased solubilized concentrations of dapsone. A polymeric viscosity builder such as an A/SA, can minimize the yellowing of the composition and can reduce the particle size, and minimize a gritty feel upon application. The Almirral patent includes 62 generalized composition embodiments and eight specific example formulations.On inter partes review, the Patent Trial and Appeal Board agreed that claims 1–8 would have been obvious over prior art at the time the alleged invention was made. The Federal Circuit affirmed. The Board’s decision sets forth factual findings of similarity between carbomers and A/SA agents that support its conclusion that prior art discloses a range for each component of the composition that either fully encompasses or overlaps/abuts the ranges and amounts for those components recited in the challenged claims, sufficient to create a presumption of obviousness. The court upheld the Board’s analysis of whether a skilled artisan would have had a reasonable expectation of success in combining prior art teachings to achieve the claimed invention. View "Almirall, LLC v. Amneal Pharmaceuticals, LLC" on Justia Law

Adapt’s patents-in-suit claim methods of treating opioid overdose by intranasal administration of a naloxone formulation, and devices for intranasal administration. Naloxone—the active ingredient in Adapt’s NARCAN® Nasal Spray—is an opioid receptor antagonist that blocks opioids from reaching the opioid receptors, helping reverse the effects of opioid overdose. Before the priority date of the patents-in-suit, numerous naloxone products had been used to treat opioid overdose. The patents-in-suit are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” “Orange Book.” Teva submitted to the FDA Abbreviated New Drug Application (ANDA) seeking approval to manufacture and sell a generic version of NARCAN®., with a Paragraph IV certification asserting that the patents-in-suit are invalid, unenforceable, and/or not infringed, 21 U.S.C. 355(j)(2)(A)(vii)(IV).Adapt sued Teva for infringement under 35 U.S.C. 271(e)(2). The Federal Circuit affirmed a holding that the asserted claims of the patents-in-suit would have been obvious in view of prior art. The district court’s findings, supported by ample evidence, provide a detailed explanation as to why a skilled artisan would have been motivated to combine the prior art references to arrive at the claimed invention. Prior art, as a whole, did not teach away from the claimed invention. The court rejected Adapt’s argument that its evidence of unexpected results, copying, skepticism, long-felt need, and failure of others indicated nonobviousness. View "Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc." on Justia Law

An attorney sought guidance on how a physician could administer psilocybin to a terminally ill patient without incurring liability under the Controlled Substances Act (CSA), specifically asking the Drug Enforcement Administration (DEA) how the CSA would accommodate the Right to Try Act (amending the Food, Drug, and Cosmetic Act) to give patients the possibility of access to new investigational drugs under certain circumstances. The DEA responded by identifying the available exemptions in the CSA and indicating that the Right to Try Act did not create any additional exemptions.The Ninth Circuit dismissed a petition for review for lack of jurisdiction, reasoning that DEA’s response was not a final decision of the Attorney General under 21 U.S.C. 877. To be considered final, the agency action must mark the consummation of the agency’s decision-making process and must be one where rights or obligations have been determined, or from which legal consequences flow. The DEA’s response was the sort of advice letter that agencies prepare multiple times a year. There was no indication that the letter represented the consummation of a decision-making process. The letter did not lead to legal consequences for the prescribing physician but only provided guidance about the interaction of the Right to Try Act and the CSA. View "Advanced Integrative Medical Science Institute v. United States Drug Enforcement Administration" on Justia Law

The First Circuit affirmed the judgment of the district court ordering compliance with an administrative subpoena issued to Appellant by the United States Drug Enforcement Administration (DEA) pursuant to 21 U.S.C. 876, to produce certain prescription drug records of an individual, holding that there was no error.The instant subpoena was issued by the DEA pursuant to 21 U.S.C. 876 to produce the prescription drug records kept by New Hampshire's Prescription Drug Monitoring Program (the PDMP) of an individual. The district court ordered Appellant, who was then the PDMP program manager, to comply with the subpoena. The First Circuit affirmed, holding (1) the district court did not abuse its discretion in concluding that the subpoena was enforceable under 21 U.S.C. 876(c); and (2) the third-party doctrine applied to this case. View "U.S. Dep't of Justice v. Jonas" on Justia Law

The First Circuit affirmed the judgment of the district court dismissing a relator's qui tam action brought under the False Claims Act (FCA), 31 U.S.C. 3729 through 3733, holding that the district court did not err in dismissing the action.At issue before the First Circuit was the function of the hearing provided by statute when the government files a motion to dismiss a relator's FCA qui tam action over the relator's objections. The Court held (1) the government must provide its reasons for seeking dismissal such that the relator can attempt to convince the government to withdraw its motion at the hearing; (2) if the government does not agree to withdraw its motion, the district court should grant the motion unless the relator can show that, in seeking dismissal, the government is transgressing constitutional limitations or perpetrating a fraud on the court; and (3) the district court properly granted the government's motion to dismiss this case. View "Borzilleri v. Bayer AG" on Justia Law

Plaintiff Scott Paine appealed a superior court decision granting judgment on the pleadings for his employment discrimination claim against defendant, Ride-Away, Inc. Plaintiff suffered from Post-Traumatic Stress Disorder (PTSD) for many years, which substantially limited a major life activity. He was employed by defendant at its facility in Londonderry, New Hampshire as an automotive detailer in May 2018. In July 2018, his physician prescribed cannabis to help treat his PTSD, and plaintiff enrolled in New Hampshire’s therapeutic cannabis program. Plaintiff submitted a written request to defendant for an exception from its drug testing policy as a reasonable accommodation for his disability. Plaintiff explained that he was not requesting permission to use cannabis during work hours or to possess cannabis on defendant’s premises. Plaintiff was informed that he could no longer work for the company if he used cannabis. After plaintiff notified defendant that he was going to treat his PTSD with cannabis, his employment was terminated in September 2018. Plaintiff sued for employment discrimination, based on defendant’s failure to make reasonable accommodation for his disability. Defendant moved for judgment on the pleadings, asserting that, because marijuana use was both illegal and criminalized under federal law, the requested accommodation was facially unreasonable. After a hearing, the trial court granted defendant’s motion. The sole question before the New Hampshire Supreme Court was whether the court erred in ruling that the use of therapeutic cannabis prescribed in accordance with New Hampshire law could not, as a matter of law, be a reasonable accommodation for an employee’s disability under RSA chapter 354-A. The Supreme Court held the trial court erred in determining that the use of therapeutic cannabis prescribed in accordance with RSA chapter 126-X could not, as a matter of law, be a reasonable accommodation for an employee’s disability under RSA chapter 354-A. "[P]laintiff’s disability is PTSD, not the illegal use of or addiction to a controlled substance." Judgment was reversed and the matter remanded for further proceedings. View "Paine v. Ride-Away, Inc." on Justia Law

Appellees, Rite Aid Corporation, Rite Aid Hdqtrs. Corp., and Rite Aid of Maryland, Inc. (collectively, “Rite Aid”), held a general liability insurance policy underwritten by defendany Chubb, Limited ("Chubb"). Rite Aid and others were defendants in multi-district litigation before the United States District Court for the Northern District of Ohio (the “MDL Opioid Lawsuits”). Plaintiffs in that suit filed over a thousand suits in the MDL Opioid Lawsuits against companies in the pharmaceutical supply chain for their roles in the national opioid crisis. Certain suits were bellwether suits - including the complaints of Summit and Cuyahoga Counties in Ohio (“the Counties”) which were at issue here. The question this case presented for the Delaware Supreme Court was whether insurance policies covering lawsuits “for” or “because of” personal injury required insurers to defend their insureds when the plaintiffs in the underlying suits expressly disavowed claims for personal injury and sought only their own economic damages. The Superior Court decided that Rite Aid’s insurance carriers were required to defend it against lawsuits filed by two Ohio counties to recover opioid-epidemic-related economic damages. As the court held, the lawsuits sought damages “for” or “because of” personal injury because there was arguably a causal connection between the counties’ economic damages and the injuries to their citizens from the opioid epidemic. The Supreme Court reversed, finding the plaintiffs, governmental entities, sought to recover only their own economic damages, specifically disclaiming recovery for personal injury or any specific treatment damages. Thus, the carriers did not have a duty to defend Rite Aid under the governing insurance policy. View "ACE American Insurance Company v. Rite Aid Corporation" on Justia Law

Novartis markets a 0.5 mg daily dose of fingolimod hydrochloride under the brand name Gilenya. The medication is used to treat relapsing-remitting multiple sclerosis, a debilitating immune-mediated demyelinating disease in which the immune system attacks the myelin coating the nerves in the central nervous system. Most MS patients initially present as RRMS patients, but many eventually develop a secondary progressive form of MS, causing them to experience growing disability. There is currently no cure for MS. The disease is managed by reducing or preventing relapses and thereby slowing disability.HEC filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Gilenya. Novartis sued, alleging that HEC’s ANDA infringes all claims of the 405 patent. The Federal Circuit affirmed a holding that the patent is not invalid and that HEC’s ANDA infringes. The 405 claims do not fail the written description requirement of 35 U.S.C. 112(a). The district court did not clearly err in finding that a skilled artisan would read the 405 patent’s disclosure to describe the “absent an immediately preceding loading dose” negative limitation. View "Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc." on Justia Law