Justia Drugs & Biotech Opinion Summaries

A biotechnology company developed a gene therapy for two hereditary blood disorders, which may negatively affect patients’ fertility. To address potential deterrence due to fertility concerns, the company created a program offering up to $70,000 for fertility services to patients receiving the therapy. The program was initially limited to privately insured patients, as the company was concerned it might violate federal healthcare statutes if extended to federally insured patients. To clarify the legality, the company requested an advisory opinion from the Department of Health and Human Services (HHS), arguing that the program did not violate relevant statutes and, alternatively, qualified for statutory exceptions.After significant delays and exchanges, HHS issued an unfavorable advisory opinion, concluding the program violated both the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Statute (BIS), and denied immunity from enforcement. The company sued HHS and its officials in the United States District Court for the District of Columbia, challenging both the advisory opinion and the regulations governing timing for advisory opinions. The district court granted summary judgment to HHS, finding that the program violated the AKS and deferring to HHS’s reasoning regarding the BIS exception, while dismissing the challenge to the timing regulations as moot after the opinion was issued.On appeal, the United States Court of Appeals for the District of Columbia Circuit reviewed the district court’s decision de novo. The court affirmed summary judgment for HHS regarding the AKS, holding that the program constituted prohibited remuneration intended to induce patients to purchase the therapy. However, it reversed as to the BIS, finding HHS’s determination arbitrary and capricious due to its failure to explain why the statutory exception did not apply. The court also held that the company had standing to challenge HHS’s timing regulations and that those regulations unlawfully evaded the statutory deadline. The judgment was affirmed in part, reversed in part, and remanded. View "Vertex Pharmaceuticals Inc. v. HHS" on Justia Law

A woman brought her nearly two-year-old son to a hospital in Lincoln, Nebraska, where he was found with multiple injuries, including bruises, swelling, and a fractured leg. Subsequent medical examinations revealed further injuries, such as broken ribs, a lung contusion, brain swelling, and ultimately, the child died from his injuries. The mother, who had left the child in the care of her boyfriend and others, admitted to noticing symptoms and injuries over a period of weeks but did not seek medical care, citing reasons such as believing the injury was minor and fear of involvement with Child Protective Services. Evidence at trial included interviews, witness testimony, text messages, and internet searches indicating the mother was aware of the child’s worsening condition.The District Court for Lancaster County reviewed the case and presided over a jury trial. The jury found the mother guilty of intentional child abuse resulting in death, intentional child abuse resulting in serious bodily injury, and possession with intent to deliver or delivery of a controlled substance near a school. The court denied pretrial motions to exclude certain photographic evidence and sentenced her to consecutive prison terms totaling 70 years to life for the most serious charges, and additional years for the drug offense.The Nebraska Supreme Court examined claims of insufficient evidence, improper admission of photographs, ineffective assistance of counsel, and excessive sentencing. Applying the appropriate standards of review, the court held that there was sufficient evidence for the convictions, the photographs were relevant and not unduly prejudicial, and the sentences were within statutory limits and not an abuse of discretion. Claims of ineffective assistance were rejected as either unsupported or not prejudicial. The court affirmed the judgment of the district court. View "State v. Cook" on Justia Law

Exelixis, Inc. developed Cabometyx®, a cancer treatment containing cabozantinib (L)-malate. After identifying and characterizing crystalline and amorphous forms of this compound, Exelixis obtained several related patents. MSN Laboratories Private Limited and MSN Pharmaceuticals, Inc. sought FDA approval for a generic version using a specific polymorph of cabozantinib (L)-malate and received their own patent for that form. Exelixis sued MSN in the United States District Court for the District of Delaware, alleging infringement of patents covering crystalline cabozantinib (L)-malate salts (the “Malate Salt Patents”) and a patent directed to pharmaceutical compositions with low levels of a genotoxic impurity (the ’349 patent).The District Court held a bench trial. MSN conceded infringement of the Malate Salt Patents but argued they were invalid for lack of written description under 35 U.S.C. § 112(a). For the ’349 patent, MSN contested both infringement and validity. The District Court found the Malate Salt Patents were not invalid, holding the written description requirement was met because the patents disclosed the chemical structure, formula, and crystalline nature of the claimed salts. The court analogized its analysis to GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. For the ’349 patent, the court found no infringement and no invalidity, concluding that the evidence failed to show the prior art inherently disclosed the “essentially free” impurity limitation.The United States Court of Appeals for the Federal Circuit reviewed the case. It affirmed the District Court’s finding that the asserted claims of the ’439, ’440, and ’015 patents had adequate written description support. Regarding claim 3 of the ’349 patent, the Federal Circuit dismissed MSN’s appeal as moot after Exelixis dropped its cross-appeal and vacated the District Court’s judgment of nonobviousness of that claim. The main holdings were affirmance of written description support for the asserted Malate Salt Patents and dismissal and vacatur regarding claim 3 of the ’349 patent. View "EXELIXIS, INC. v. MSN LABORATORIES PRIVATE LTD. " on Justia Law

A company sought to introduce a generic version of a prescription drug by filing an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA). The first applicant for the generic version had previously entered into a settlement with the brand-name drug manufacturer following patent litigation, obtaining a license to market the drug at a future date but still needed FDA approval. While the first applicant’s ANDA remained pending, another company (the appellant) submitted its own ANDA for the same drug, including certifications that its product would not infringe certain patents or would not be marketed for patented uses. The FDA determined that the first applicant was eligible for a 180-day period of marketing exclusivity, which prevented final approval of the subsequent applicant’s ANDA.The United States District Court for the District of Columbia denied the subsequent applicant’s request for an injunction and granted summary judgment in favor of the FDA and parties supporting the FDA’s position. The court found that the first applicant’s exclusivity remained intact, as not all statutory forfeiture conditions had been met. Specifically, it concluded that the first applicant had not forfeited exclusivity by failing to market or by failing to obtain tentative approval, interpreting the relevant statutory provisions in the FDA’s favor.On appeal, the United States Court of Appeals for the District of Columbia Circuit reviewed the statutory interpretation de novo. The court held that the FDA correctly determined the first applicant had not forfeited exclusivity under the “failure to market” provision, as forfeiture requires triggering events for each qualifying patent certification in the first applicant’s ANDA. However, the appellate court found the FDA applied an incorrect causation standard in assessing whether the first applicant forfeited exclusivity for failure to obtain tentative approval. The court ruled that a but-for causation standard applies and remanded the case for the FDA to apply this correct standard. The judgment was affirmed in part, reversed in part, and remanded. View "Norwich Pharmaceuticals, Inc. v. Kennedy" on Justia Law

A pharmaceutical company that manufactures both branded and generic drugs challenged the federal agency rules implementing the Medicare Drug Price Negotiation Program created under the Inflation Reduction Act of 2022. Specifically, the company objected to two rules: first, the agency’s grouping of two drugs with the same active ingredient and manufacturer, but approved under separate applications, as one “qualifying single source drug” for price negotiation; and second, the agency’s requirement that a generic drug must be engaged in “bona fide marketing” to be considered as marketed, which affects when a branded drug exits the negotiation program. The company argued that these rules exceeded the agency’s statutory authority and that the program deprived it of protected property interests without due process.The United States District Court for the District of Columbia reviewed the case. It found that the statutory bar on judicial review did not prevent the company’s challenges to generally applicable agency guidance. On the merits, the district court upheld the agency’s definition of a qualifying single source drug, ruled that the challenge to the “bona fide marketing” standard was not yet ripe, and rejected the due process claim due to lack of a protected property interest. The company appealed.The United States Court of Appeals for the District of Columbia Circuit reviewed the case de novo. The appellate court held that the statutory review bar precludes review only of drug-specific determinations, not generally applicable legal standards. On the merits, it concluded that the statute permits the agency to treat drugs with the same active ingredient and manufacturer as one statutory drug. The court found that the due process challenge failed because the company lacked a protected property interest. However, it determined that the challenge to the “bona fide marketing” requirement was ripe and remanded that issue to the district court for further proceedings. The court thus affirmed in part, reversed in part, and remanded. View "Teva Pharmaceuticals USA, Inc. v. Kennedy" on Justia Law

A pharmaceutical company acquired the rights to a cancer drug called Tibsovo from another manufacturer in April 2021, including the drug’s existing stock and its New Drug Application (NDA). After the acquisition, the company sold the previously manufactured Tibsovo tablets to Medicare Part D patients for the remainder of 2021. While the company began producing its own Tibsovo tablets that year, those were not dispensed to any Part D patient until February 2022. The company had no other Part D drug sales in 2021.When the company sought to participate in the Medicare Manufacturer Discount Program, which requires manufacturers to offer discounts on certain drugs but allows “specified manufacturers” and “specified small manufacturers” a more gradual phase-in, the Centers for Medicare & Medicaid Services (CMS) determined that the company qualified only as a specified manufacturer. CMS found that, although the company owned Tibsovo’s NDA and had manufactured new tablets in 2021, none of those were dispensed to Part D patients during the relevant period; all Tibsovo dispensed in 2021 was manufactured by the prior owner. As a result, the company had zero qualifying sales for 2021 and could not meet the additional requirement for specified small manufacturers.The United States District Court for the District of Columbia granted summary judgment for the government, holding that CMS’s decision was lawful and rejecting the company’s statutory and administrative challenges.On appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed. The court held that to qualify as a specified small manufacturer, a company must have actually produced, prepared, propagated, compounded, converted, or processed the units of the drug dispensed to Part D patients in 2021. Mere ownership or responsibility for the drug was not enough. The court also rejected challenges to CMS’s use of labeler codes as a means of identifying manufacturers. The district court’s judgment was affirmed. View "Servier Pharmaceuticals LLC v. Kennedy" on Justia Law

A pharmaceutical company developed a medication for a sleep disorder that primarily affects blind individuals. The company’s drug label included the brand name and dosage in both regular print and braille, along with instructions for pharmacists not to cover the braille and to dispense the drug in its original container. When a competing manufacturer sought approval from the Food and Drug Administration (FDA) to market a generic version, its proposed label omitted the braille and related instructions. The FDA approved the generic’s label without these features. The original manufacturer objected, arguing that omitting the braille and instructions violated statutory requirements for generic drugs to have labeling “the same as” the brand-name product, except for changes required due to a different manufacturer.The United States District Court for the District of Columbia granted summary judgment in favor of the FDA and the generic manufacturer, holding that the omission of braille and the accompanying instructions fell within the statutory exception for changes required due to a different manufacturer. The court also rejected arguments that the FDA acted arbitrarily or capriciously.The United States Court of Appeals for the District of Columbia Circuit reviewed the case and held that the statutory exception for changes “required” by a different manufacturer applies only to changes that are mandatory, not merely optional or safe. The court concluded that omitting the brand name in braille was required, but omitting the dosage in braille and the related pharmacist instructions was not shown to be necessary due to the manufacturer change. The court vacated the grant of summary judgment on this issue and remanded the case for the agency to determine whether the generic label, without braille dosage or instructions, still meets the requirement of being “the same as” the brand-name label. The court otherwise affirmed the district court’s judgment. View "Vanda Pharmaceuticals, Inc. v. FDA" on Justia Law

An executive at a group of medical device companies that sell products to the federal government raised internal concerns in early 2024 that the company was violating Food and Drug Administration (FDA) regulations related to product design, quality management, and testing. He believed that selling a particular product without addressing these regulatory deficiencies could result in misrepresenting data to the FDA to obtain approval. Over a two-week period, he communicated these concerns to multiple executives and suggested implementing changes to improve compliance. Shortly after these communications, his position was eliminated.Following his termination, the executive filed suit in the United States District Court for the Eastern District of Pennsylvania, alleging, among other claims, that his employer retaliated against him in violation of the False Claims Act (FCA)’s anti-retaliation provision. The District Court dismissed the FCA retaliation claim, holding that the complaint failed to allege a sufficient connection between the plaintiff’s concerns about FDA violations and the submission of false claims for payment to the federal government, and thus did not constitute protected conduct under the FCA.On appeal, the United States Court of Appeals for the Third Circuit reviewed two questions: whether FCA retaliation claims are subject to Rule 9(b)’s heightened pleading standard, and what constitutes protected conduct under the “other efforts” prong of the FCA’s anti-retaliation provision. The court held that FCA retaliation claims are not subject to Rule 9(b), but instead require only notice pleading under Rule 8(a). It further held that, to constitute protected conduct, a plaintiff’s actions must be motivated by an objectively reasonable belief that the employer is submitting or will submit false or fraudulent claims for payment to the government. Finding no such allegation in the complaint, the Third Circuit affirmed the District Court’s dismissal of the FCA retaliation claim. View "Lisenby v. Olympus Corporation of the Americas" on Justia Law

Several plaintiffs alleged that they suffered injuries, such as renal, bone, or tooth damage, from taking a drug manufactured by Gilead Sciences, Inc. known as tenofovir disoproxil fumarate (TDF). Plaintiffs conceded that TDF was not defective but claimed that Gilead had developed an alternative drug, tenofovir alafenamide fumarate (TAF), which was equally effective and less toxic. Plaintiffs argued that Gilead unreasonably delayed bringing TAF to market, allegedly to maximize profits, and that this delay deprived them of a safer drug option, causing their injuries.In the San Francisco City and County Superior Court, Gilead moved for summary judgment, asserting that negligence liability could not attach for injuries caused by a nondefective product. The trial court denied Gilead’s motion. Gilead then petitioned the Court of Appeal, First Appellate District, Division Four, which partially granted the petition. The Court of Appeal directed summary adjudication on the fraudulent concealment claim but allowed the negligence claim to proceed. It held that drug manufacturers may owe a duty of reasonable care to users of a nondefective drug in deciding whether and when to commercialize a safer alternative.The Supreme Court of California reviewed the case and reversed the Court of Appeal’s judgment. The court held that, even assuming drug manufacturers might owe a broader duty of care beyond marketing nondefective drugs, the factors set forth in Rowland v. Christian justify an exception in this context. Specifically, the court determined that a manufacturer’s decision to delay commercialization of a safer drug during early development stages is too remote and unforeseeable to establish a duty of care, and imposing such liability would unduly burden innovation and public health. The Supreme Court directed the trial court to grant summary judgment for Gilead on all claims. View "Tenofovir Cases" on Justia Law

The dispute centers on allegations by a Minnesota-based health insurer that several related pharmaceutical companies carried out an unlawful scheme involving the distribution and sale of repackaged and adulterated oncology drugs. The scheme allegedly involved breaking sterile seals on medication vials, pooling overfill amounts—which were not intended for patient use—and creating pre-filled syringes that were then sold to healthcare providers. These syringes were ultimately administered to cancer patients, including many insured under programs operated by the plaintiff. The defendants did not themselves submit claims for reimbursement, but the plaintiff asserts it paid for treatments using these adulterated drugs, unaware of their compromised quality.Prior to this lawsuit, the scheme was the subject of other civil actions and federal investigations, including qui tam actions and a federal criminal prosecution. The defendants disclosed these investigations in annual reports filed with the Securities and Exchange Commission and the events received media attention beginning in 2012. In 2017, a related company pleaded guilty to federal charges, admitting to the repackaging scheme, and paid significant fines and settlements. The plaintiff filed suit in 2023, asserting claims for common-law fraud, unjust enrichment, and violations of several Minnesota consumer protection statutes. The United States District Court for the District of Minnesota dismissed the complaint, finding the claims were barred by the applicable six-year statute of limitations, and that the plaintiff had failed to sufficiently plead fraudulent concealment to toll the limitations period.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s dismissal de novo. It concluded that publicly available disclosures and the plaintiff’s own allegations established that the plaintiff should have discovered its causes of action no later than 2016. Because the plaintiff did not file suit until 2023, its claims were untimely. The court affirmed the district court’s judgment, holding that all claims were barred by the statute of limitations. View "United HealthCare Services, Inc. v. AmerisourceBergen Corporation" on Justia Law