Justia Drugs & Biotech Opinion Summaries

In this case, the United States Court of Appeals for the Federal Circuit considered whether the defendants' Abbreviated New Drug Applications (ANDAs) infringed two patents owned by the plaintiffs. The patents pertained to the use of the drug vortioxetine in the treatment of patients who had previously taken certain other antidepressant medications and had to cease or reduce use due to sexually related adverse events, and for the treatment of cognitive impairment. The defendants were seeking approval to market vortioxetine for the treatment of Major Depressive Disorder (MDD) in adults, a use not covered by the patents. The plaintiffs sought to block the defendants from marketing a generic version of the drug until after the expiration of the patents.The court held that the defendants' ANDA filings did not infringe the plaintiffs' patents. The court found that the defendants' intended use of the drug, for the treatment of MDD in adults, did not infringe the patents which pertained to other specific uses of the drug.Moreover, the court found no induced or contributory infringement. Regarding induced infringement, the court held that the defendants' proposed labels for the drug did not encourage, recommend, or promote an infringing use. Regarding contributory infringement, the court held that the defendants' sale of the drug would have substantial noninfringing uses, thus there would be no contributory infringement.Additionally, the court rejected Lupin's cross-appeal, which challenged the district court's determination that Lupin infringed a patent concerning a process for manufacturing vortioxetine. The court affirmed the district court's construction of the term "reacting" in the patent and its determination of infringement. View "H. LUNDBECK A/S v. LUPIN LTD. " on Justia Law

The United States District Court for the Northern District of Ohio certified two questions to the Georgia Supreme Court regarding whether a state entity could continue asserting claims against opioid manufacturers and distributors after the State of Georgia entered into a settlement with the pharmaceutical companies, and as part of the settlement, the General Assembly enacted OCGA § 10-13B-1, et seq. (the “Settlement Act”) in 2022, which included a litigation preemption provision that “bar[s] any and all past, present or future claims on behalf of any governmental entity seeking to recover against any business or person that is a released entity under the terms of the relevant settlement.” OCGA § 10-13B-3 (a) (the “preemption provision”). In April 2019, before Georgia entered into the state-wide settlement with the pharmaceutical companies, the Hospital Authority of Wayne County, Georgia (“HAWC”) filed suit against a number of such entities, seeking to recover unreimbursed amounts it claims to have expended in treating opioid-dependent patients. HAWC subsequently chose not to participate in the state-wide settlement and did not individually release any of its claims. At some point, HAWC’s litigation was consolidated, along with over 3,000 other cases, into a federal multidistrict litigation in the District Court. See In re Natl. Prescription Opiate Litigation, (MDL No. 2804). Seven defendants named in HAWC’s complaint filed a motion to dismiss HAWC’s claims against them (the “Motion”), contending that the suit was barred by the preemption provision. The Georgia Supreme Court concluded that the Georgia General Assembly's passage of the preemption provision took away any power HAWC otherwise might have had under OCGA § 31-7-75 to pursue claims that the preemption provision and the Settlement Act were unconstitutional, and the answer to the first question certified by the District Court was no. In light of this answer, the Supreme Court did not need to answer the second certified question. View "Hospital Authority of Wayne County v. AmeriSourceBergen Drug Corp, et al." on Justia Law

Genentech manufactures and sells Rituxan, a drug used to treat leukemia and lymphoma. Rituxan is sold in single-use vials. Williamson was diagnosed with follicular lymphoma and was treated with Rituxan. Williamson later sued Genentech, on behalf of himself and a putative class of similarly situated individuals. He claims that Genentech violates the unfair competition law by selling Rituxan (and three other medications) in excessively large single-use vials; because the appropriate dosage varies based on a patient’s body size, Genentech’s vial sizes are too large for most patients. He argues Genentech should be required to offer smaller vials to reduce the waste of expensive medicine. In addition to injunctive relief, Williamson seeks to recover the amount the class spent on wasted Rituxan (and three other medications). Williamson took only Rituxan, not the other three medications, and paid a $231.15 deductible– the rest of the payments were made by his health insurer.The court of appeal affirmed the dismissal of the case for lack of standing under California’s unfair competition law (Bus. & Prof. Code 17200). Williamson suffered no economic injury caused by the alleged unfair practices and cannot establish standing by borrowing an economic injury from his insurer. The collateral source rule, under which a tortfeasor must fully compensate a victim and cannot subtract compensation the victim may have received from their insurer or another collateral source, does not apply. View "Williamson v. Genentech, Inc." on Justia Law

The 2005 Medicare amendment, launching prescription drug coverage, raised concerns that patient assistance plans could violate the Anti-Kickback Statute, 42 U.S.C. 1320a-7b, and the False Claims Act, 31 U.S.C. 3729, by effectively rewarding doctors and patients for choosing particular drugs. Astellas subsequently launched Xtandi, used to treat metastatic prostate cancer. Priced at $7,800 per month, Xtandi prescriptions were covered by Medicare up to about $6,000 per month. Astellas made contributions to two patient assistance plans. An Astellas marketing executive encouraged both plans to create special funds to provide co-pay assistance for only androgen receptor inhibitors like Xtandi and a few other medications. Astellas donated to the new funds but stopped after contributing about $27 million. Astellas continued contributing to broader prostate cancer funds.The Department of Justice began investigating; the Astellas marketing executive acknowledged that he had “hoped” and “expected” that the contributions would produce financial benefits for Astellas but that Astellas had made no efforts to calculate “a return on investment.” Astellas settled with the government for $100 million--$50 million for “restitution” to the government. Astellas sought indemnification from liability insurers, including Federal, which denied coverage.The Seventh Circuit affirmed summary judgment for Astellas. Under Illinois law, a party may not obtain liability insurance for genuine restitution it owes the victim of its intentional wrongdoing, but a party may obtain insurance for compensatory damages. In cases of ambiguity, Illinois favors settlements and freedom of contract. Federal wrote its insurance policy to try to extend coverage to the limit of what Illinois law would allow. Federal did not carry its burden of showing that the portion of the settlement payment for which Astellas seeks coverage is uninsurable restitution. View "Astellas US Holding, Inc. v. Federal Insurance Co." on Justia Law

Bridges and Cunningham filed a putative class action, alleging that Blackstone (the owner of Ancestry.com) violated Section 30 of Illinois’s 1998 Genetic Information Privacy Act, which provides that no person or company “may disclose or be compelled to disclose the identity of any person upon whom a genetic test is performed or the results of a genetic test in a manner that permits identification of the subject of the test,” 410 ILCS 513/30(a). Both plaintiffs had purchased DNA testing products from Ancestry and submitted saliva samples for genetic sequencing years earlier. Blackstone subsequently purchased Ancestry in a “control acquisition”— an all-stock transaction. Because Ancestry had allegedly paired the plaintiffs’ genetic tests with personally identifiable information—including names, emails, and home addresses—Bridges and Cunningham maintained that Blackstone, as part of acquiring Ancestry, had compelled the disclosure of their genetic identities in violation of Section 30.The Seventh Circuit affirmed the dismissal of the suit for failure to state a claim. The complaint focusing exclusively on Blackstone’s acquisition of Ancestry did not adequately allege any compulsory disclosure. View "Bridges v. Blackstone, 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

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

Amiodarone was developed in the 1960s for the treatment of angina and was released in other countries. Amiodarone is associated with side effects, including pulmonary fibrosis, blindness, thyroid cancer, and death. In the 1970s, U.S. physicians began obtaining amiodarone from other countries for use in patients with life-threatening ventricular fibrillation or ventricular tachycardia who did not respond to other drugs. In 1985, the FDA approved Wyeth’s formulation of amiodarone, Cordarone, as a drug of last resort for patients suffering from recurring life-threatening ventricular fibrillation and ventricular tachycardia. The FDA’s “special needs” approval issued without randomized clinical trials. In 1989, the FDA described Wyeth’s promotional activities as promoting an unapproved use of the drug. In 1992, the FDA objected to promotional labeling pieces for Cordarone. Other manufacturers developed generic amiodarone, which has been available since 1998.Consolidated lawsuits alleged that plaintiffs suffered unnecessary, serious side effects when they took amiodarone, as prescribed by their doctors, for off-label use to treat atrial fibrillation, a more common, less serious, condition than ventricular fibrillation. The FDA never approved amiodarone for the treatment of atrial fibrillation, even on a special-needs basis. The court of appeal affirmed the dismissal of the lawsuits. The claims are preempted as attempts to privately enforce the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301, regulations governing medication guides and labeling and have no independent basis in state law. The court also rejected fraud claims under California’s unfair competition law and Consumers Legal Remedy Act. View "Amiodarone Cases" on Justia Law