Justia Drugs & Biotech Opinion Summaries

The buyers of a pharmaceutical business appealed the Superior Court’s dismissal of their fraudulent-inducement and indemnification claims against the sellers. The trial court determined that the buyers had waived their fraudulent-inducement claims and that the indemnification claim was time-barred. The court’s waiver determination was based on its interpretation of a letter agreement between the parties, executed after the buyers’ acquisition of the business and following governmental proceedings involving FDA and Department of Justice investigations. The sellers argued that the letter agreement precluded further litigation, including the buyers’ claims. The buyers contended that the letter agreement only limited the size and scope of claims for losses attributable to the governmental proceedings. The Superior Court agreed with the sellers and dismissed the buyers’ fraudulent-inducement claims.The Superior Court found that the buyers’ indemnification claim was untimely because it was filed more than 60 months after the acquisition closed, as required by the Purchase Agreement. The court rejected the buyers’ argument that the survival period was tolled due to the sellers’ fraudulent concealment, reasoning that the buyers were on inquiry notice of the alleged breaches well within the limitations period.The Supreme Court of Delaware reviewed the case and held that the buyers’ interpretation of the letter agreement was reasonable, as was the sellers’ and the trial court’s. The court found the relevant provision of the letter agreement to be ambiguous, making it inappropriate to dismiss the buyers’ fraudulent-inducement claim. The court also concluded that the buyers adequately pleaded that the sellers had fraudulently concealed the facts giving rise to the indemnification claim, potentially tolling the survival period. Consequently, the court reversed the Superior Court’s judgment and remanded the case for further proceedings. View "LGM Holdings, LLC v. Gideon Schurder" on Justia Law

The case involves Early Willard Woodmore, III, who was convicted for his role in a methamphetamine distribution enterprise in eastern Oklahoma. The Drug Enforcement Administration (DEA) began investigating the Woodmore organization in 2018 after receiving a tip about methamphetamine shipments. Early Woodmore, along with his siblings Calvin and Amber, led the organization. They received methamphetamine from Kimberly Noel in California, who shipped the drugs concealed in everyday objects. The organization distributed the drugs in smaller quantities throughout eastern Oklahoma. Early Woodmore was arrested in April 2019 and continued to communicate with his sister Amber, who took over operations. The DEA intercepted a significant methamphetamine shipment in August 2019, leading to further charges.The United States District Court for the Eastern District of Oklahoma indicted Early Woodmore on five counts, including conspiracy to distribute methamphetamine and money laundering. He proceeded to a joint trial with his brother Calvin in April 2022. The jury convicted Early Woodmore on all counts, and he was sentenced to life imprisonment for the drug charges and 240 months for the money laundering charges, to run concurrently.The United States Court of Appeals for the Tenth Circuit reviewed the case. Early Woodmore raised three main challenges: judicial bias due to the district court's handling of a custody dispute during the trial, an erroneous jury instruction regarding the right of attorneys to interview witnesses, and the lack of a definitional instruction for "methamphetamine (actual)." The Tenth Circuit rejected all three challenges. The court found no judicial bias, upheld the jury instruction on attorney interviews, and determined that the term "methamphetamine (actual)" was sufficiently clear based on the evidence presented at trial. Consequently, the Tenth Circuit affirmed the district court's judgment of conviction. View "United States v. Woodmore" on Justia Law

The case involves the Food and Drug Administration (FDA) denying authorization for respondents to market certain flavored e-cigarette products. The FDA's decision was based on the lack of sufficient scientific evidence demonstrating that these products would be appropriate for the protection of public health. The FDA emphasized the need for evidence from randomized controlled trials or longitudinal cohort studies, which the respondents did not provide. Instead, respondents submitted literature reviews and cross-sectional surveys, which the FDA found inadequate.The United States Court of Appeals for the Fifth Circuit, sitting en banc, reviewed the FDA's denial orders. The court found that the FDA acted arbitrarily and capriciously by applying different standards than those articulated in its predecisional guidance. The court was particularly concerned with the FDA's failure to review marketing plans, which it had previously deemed critical. The Fifth Circuit rejected the FDA's argument that any errors were harmless and remanded the case to the FDA.The Supreme Court of the United States reviewed the case and vacated the Fifth Circuit's decision. The Court held that the FDA's denial orders were consistent with its predecisional guidance regarding scientific evidence, comparative efficacy, and device type, and thus did not violate the change-in-position doctrine. However, the Court agreed with the FDA that the Fifth Circuit's interpretation of harmless error was overly broad. The Supreme Court remanded the case to the Fifth Circuit to reconsider the harmless-error question without relying on its expansive reading of Calcutt v. FDIC. View "FDA v. Wages and White Lion Investments, LLC" on Justia Law

A father, Scott Williams, and his son, Taeyan Williams, were convicted by a federal jury of various drug-related offenses, including conspiracy to distribute and possess with intent to distribute marijuana and cocaine. The case stemmed from an investigation into the disappearance of a drug dealer, Noah Smothers, who supplied drugs to Scott and Taeyan. A search of Scott's home revealed large quantities of drugs, firearms, and cash. Both Scott and Taeyan were found guilty of conspiracy and possession with intent to distribute, while Scott was also convicted of additional charges related to methamphetamine and evidence destruction.The United States District Court for the District of Maryland denied Scott's motion to suppress evidence obtained from the search, despite his claim that law enforcement failed to knock and announce before entering. The court held that suppression was not the appropriate remedy. Scott and Taeyan were sentenced to 276 months and 150 months in prison, respectively, followed by five years of supervised release. Both appealed their convictions and sentences.The United States Court of Appeals for the Fourth Circuit reviewed the case. The court affirmed Taeyan's conviction, finding sufficient evidence to support his possession with intent to distribute charges, based on his connection to the drugs found in Scott's home. The court also upheld the district court's denial of Scott's motion to suppress, citing exigent circumstances that justified the no-knock entry. Additionally, the court rejected Scott's request for a sentence reduction under the newly promulgated U.S.S.G. § 4C1.1, advising him to seek relief through a motion under 18 U.S.C. § 3582. Finally, the court found no improper delegation of judicial authority in the conditions of Scott's supervised release, affirming the district court's judgments in their entirety. View "United States v. Williams" on Justia Law

Regeneron Pharmaceuticals, Inc. holds a Biologics License Application (BLA) for EYLEA®, a therapeutic product containing aflibercept, a VEGF antagonist used to treat angiogenic eye diseases. Regeneron also owns U.S. Patent No. 11,084,865, which covers VEGF-trap formulations suitable for intravitreal injection. Several companies, including Samsung Bioepis Co., Ltd. (SB), filed abbreviated Biologics License Applications (aBLAs) seeking approval to market EYLEA® biosimilars. Regeneron sued these companies, including SB, for patent infringement in the Northern District of West Virginia.The district court consolidated the cases and granted Regeneron’s motion for a preliminary injunction against SB, enjoining it from marketing its biosimilar product in the U.S. without a license from Regeneron. The court found it had personal jurisdiction over SB based on SB’s aBLA filing and its distribution agreement with Biogen, which indicated plans for nationwide marketing, including West Virginia. The court also found that Regeneron was likely to succeed on the merits, as SB had not raised a substantial question of invalidity of the ’865 patent for obviousness-type double patenting or lack of written description.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the district court’s decision. The appellate court agreed that the district court had personal jurisdiction over SB, as SB’s actions indicated plans to market its biosimilar nationwide. The court also upheld the district court’s findings that SB had not raised a substantial question of invalidity for the ’865 patent. The court found that the patent’s specific stability and glycosylation requirements were patentably distinct from the reference patent and adequately supported by the specification. The court also agreed that Regeneron had established a causal nexus between SB’s infringement and the irreparable harm it would suffer without an injunction. View "REGENERON PHARMACEUTICALS, INC. v. MYLAN PHARMACEUTICALS INC. " on Justia Law

Nashaun Drake pleaded guilty to several drug offenses after police found significant quantities of fentanyl, cocaine, methamphetamine, and drug trafficking tools in his apartment. He was charged with five counts of possessing illegal drugs with intent to distribute. At sentencing, the district court classified Drake as a "career offender" based on a prior marijuana conviction, resulting in a 200-month prison sentence.The United States District Court for the Northern District of Ohio determined that Drake's prior marijuana conviction qualified as a predicate offense for the career-offender enhancement under the Sentencing Guidelines. This classification led to a sentencing range of 188 to 235 months, and the court imposed a 200-month sentence.The United States Court of Appeals for the Sixth Circuit reviewed the case. Drake argued that his prior marijuana conviction should not have triggered the career-offender enhancement and that his sentence was unreasonable. The court held that binding precedent required the use of a time-of-conviction approach to determine whether a prior offense qualifies as a "controlled substance offense" under the Sentencing Guidelines. Since hemp was included in the drug schedules at the time of Drake's 2016 conviction, his marijuana offense qualified as a controlled substance offense. The court also found that the district court did not abuse its discretion in imposing a 200-month sentence, considering Drake's extensive criminal history and the need for deterrence and public protection.The Sixth Circuit affirmed the district court's decision, upholding both the career-offender enhancement and the 200-month sentence. View "United States v. Drake" on Justia Law

Galderma Laboratories, L.P. and TCD Royalty Sub LP (collectively, Galderma) own and market Oracea®, a doxycycline-based treatment for rosacea. They hold U.S. Patent Nos. 7,749,532 and 8,206,740 (the Asserted Patents), which cover a specific formulation of doxycycline. Lupin Inc. and Lupin Ltd. (collectively, Lupin) filed an abbreviated new drug application (ANDA) to market a generic version of Oracea®, claiming bioequivalence. Galderma sued Lupin for patent infringement under the Hatch-Waxman Act, asserting that Lupin’s product infringed the Asserted Patents.The United States District Court for the District of Delaware held a three-day bench trial and found that Lupin’s ANDA product did not infringe the Asserted Patents. The court concluded that Galderma failed to prove that Lupin’s product met the specific formulation requirements of the Asserted Patents, particularly the immediate release (IR) and delayed release (DR) portions of doxycycline. The court also found that Galderma did not demonstrate infringement under the doctrine of equivalents.The United States Court of Appeals for the Federal Circuit reviewed the case. Galderma argued that the district court erred in disregarding dissolution test data from Lupin’s ANDA, admitting evidence from a rebuttal batch, imposing additional claim limitations, and not finding infringement under the doctrine of equivalents. The Federal Circuit found no clear error in the district court’s findings. It held that the district court correctly determined that the two-stage dissolution test did not represent in vivo behavior and that Galderma did not prove its theory of infringement. The court also found no abuse of discretion in admitting the rebuttal batch evidence and no imposition of additional claim limitations. Finally, the court upheld the district court’s finding that Galderma did not prove infringement under the doctrine of equivalents.The Federal Circuit affirmed the district court’s decision, concluding that Lupin’s ANDA product did not infringe the Asserted Patents. View "Galderma Laboratories, L.P. v. Lupin, Inc." on Justia Law

Kathan Daniel Wiley was convicted of conspiracy to distribute fentanyl and possession with intent to distribute fentanyl resulting in serious bodily injury. On October 30, 2021, Wiley's 18-month-old child ingested fentanyl pills, leading to severe health issues but ultimately surviving. Wiley had been distributing fentanyl pills for months, and evidence showed he obtained the pills shortly before the incident. The jury found him guilty on both counts, and the district court sentenced him to 240 months for the conspiracy charge and 324 months for possession with intent to distribute, to be served concurrently.The United States District Court for the Southern District of Iowa denied Wiley's motion for judgment of acquittal. Wiley appealed, arguing insufficient evidence for the conspiracy charge, claiming his possession was to support his addiction rather than for distribution. He also contended that the evidence did not support the conviction for possession with intent to distribute resulting in serious bodily injury, asserting the fentanyl ingested by his child was intended for personal use.The United States Court of Appeals for the Eighth Circuit reviewed the sufficiency of the evidence de novo, affirming the district court's decision. The court held that the evidence, including Facebook messages and testimony, supported the jury's finding of a conspiracy and intent to distribute. The court also upheld the district court's application of a four-level enhancement under U.S.S.G. § 2D1.1(b)(13) for misrepresenting the substance as another drug. Additionally, the court found no abuse of discretion in the district court's consideration of the § 3553(a) factors, affirming the 324-month sentence as substantively reasonable. The judgment was affirmed. View "United States v. Wiley" on Justia Law

Ethan Driskill and Marchello Oliver were charged with multiple drug-related offenses, including distribution of fentanyl and possession of firearms. Driskill was charged with distribution resulting in death, among other counts, while Oliver faced charges including possession with intent to distribute fentanyl and cocaine. Both defendants entered plea agreements; Oliver pleaded guilty to possession with intent to distribute fentanyl, and Driskill pleaded guilty to distribution resulting in death.The United States District Court for the Western District of Arkansas sentenced Oliver to 168 months, an above-guidelines sentence, and Driskill to 456 months, a within-guidelines sentence. Both defendants appealed, arguing their sentences were substantively unreasonable.The United States Court of Appeals for the Eighth Circuit reviewed the sentences for procedural errors and substantive reasonableness. For Oliver, the court found no procedural errors in the district court's application of an upward departure under USSG § 5K2.1, which was based on the finding that Oliver's distribution of fentanyl resulted in a death. The court also found the sentence substantively reasonable, noting that the district court had appropriately considered the relevant factors and the extent of the departure.For Driskill, the court noted that his within-guidelines sentence was presumed reasonable. The court found that the district court had properly considered mitigating factors and the significant differences between Driskill and Oliver, including their criminal histories and the specific charges to which they pleaded guilty. The court concluded that the district court did not abuse its discretion in sentencing Driskill.The Eighth Circuit affirmed the sentences imposed on both Oliver and Driskill. View "United States v. Driskill" on Justia Law

The case involves doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF) by removing fat tissue from patients, processing it to concentrate stem cells, and then re-administering it to the same patients. The FDA inspected the clinics and found that the doctors were manufacturing and administering unapproved drug products, leading to a lawsuit alleging violations of the Food, Drug, and Cosmetic Act (FDCA).The United States District Court for the Central District of California held a bench trial and ruled in favor of the defendants. The court concluded that the SVF was not a "drug" under the FDCA and that the same-day SVF treatment fell under the "same surgical procedure" (SSP) exception, which exempts certain procedures from FDA regulation. The district court found that the cells in the same-day SVF were not altered chemically or biologically and that the procedure did not introduce any foreign material into the body.The United States Court of Appeals for the Ninth Circuit reviewed the case and reversed the district court's judgment. The appellate court held that the SVF constitutes a "drug" under the FDCA based on the plain text of the statute, which defines drugs as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body. The court also rejected the defendants' argument that their same-day SVF treatment was exempt from FDA regulation under the SSP exception. The court concluded that the SSP exception applies only if the removed and implanted human cells, tissues, and cellular and tissue-based products (HCT/Ps) are the same, and in this case, the removed fat tissue and the implanted SVF are not the same.The Ninth Circuit reversed the district court's judgment and remanded the case for further proceedings. View "USA V. CALIFORNIA STEM CELL TREATMENT CENTER, INC." on Justia Law