Justia Drugs & Biotech Opinion Summaries

A case involving Lebanon County Employees' Retirement Fund and Teamsters Local 443 Health Services & Insurance Plan, as plaintiffs-appellants, and Steven H. Collis, Richard W. Gochnauer, Lon R. Greenberg, Jane E. Henney, M.D., Kathleen W. Hyle, Michael J. Long, Henry W. McGee, Ornella Barra, D. Mark Durcan, and Chris Zimmerman, as defendants-appellees, was heard by the Supreme Court of the State of Delaware. The plaintiffs, shareholders in AmerisourceBergen Corporation, brought a derivative complaint against the directors and officers of the Corporation alleging that they failed to adopt, implement, or oversee reasonable policies and practices to prevent the unlawful distribution of opioids. The plaintiffs claimed that this led to AmerisourceBergen incurring liability exceeding $6 billion in a 2021 global settlement related to the Company's role in the opioid epidemic. The Court of Chancery of the State of Delaware initially dismissed the complaint, basing its decision on a separate federal court finding that AmerisourceBergen had complied with its anti-diversion obligations under the Controlled Substances Act. However, the Supreme Court of the State of Delaware reversed the Court of Chancery's dismissal of the complaint, ruling that the lower court had erred in considering the federal court's findings as it changed the date at which demand futility should be considered and violated the principles of judicial notice. The case was remanded for further proceedings. View "Lebanon County Employees' Retirement Fund v. Collis" on Justia Law

Former executives of medical device manufacturer Acclarent, Inc., William Facteau and Patrick Fabian, were found guilty of multiple misdemeanor violations of the Federal Food, Drug, and Cosmetic Act (FDCA) for commercially distributing an adulterated and misbranded medical device. They appealed their convictions, claiming First Amendment violations, due process violations, and insufficiency of evidence. The United States Court of Appeals for the First Circuit rejected all of these claims and affirmed the convictions. The court held that the use of promotional speech as evidence of a device's intended use did not implicate the First Amendment. The court also found that the term "intended use" was not unconstitutionally vague and that Facteau and Fabian had fair warning of the conduct prohibited under the FDCA. Finally, the court found that the evidence was sufficient to support the convictions and that Fabian's fine did not violate the Eighth Amendment. View "United States v. Facteau" on Justia Law

In this case before the United States Court of Appeals for the Eighth Circuit, the defendant, Bradley Ready, appealed his sentence following his guilty plea for possession with intent to distribute methamphetamine and possession of a firearm as an unlawful user of a controlled substance. The court affirmed the district court's decision.During a search of Ready's residence, law enforcement officers found drug paraphernalia, scales, a loaded hunting rifle, and three bags of methamphetamine. Ready was subsequently charged and pleaded guilty to both counts. At sentencing, the U.S. Probation Office recommended grouping the drug and gun counts together and applying a two-level enhancement due to the possession of a dangerous weapon. Ready objected to this enhancement, but the district court overruled this objection.On appeal, Ready argued that the district court erred in applying the enhancement for possession of a dangerous weapon and applied the wrong standard in determining his eligibility for safety valve relief. The appellate court found no error in the district court's conclusions.The appellate court held that the district court did not err in applying the enhancement for possession of a dangerous weapon, as it was not "clearly improbable" that the rifle found in Ready's bedroom was connected to the distribution of methamphetamine from his home. The court also held that the district court did not err in its application of the standard for determining Ready's eligibility for safety valve relief. Therefore, the district court's judgment was affirmed. View "United States v. Ready" on Justia Law

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

Cloudbreak’s patent discloses compositions and methods for treating pterygium, an eye condition in which a tumor-like growth extends from the nasal or temporal side of the eye to the cornea, by administering multikinase inhibitors to the eye to inhibit specific growth factors that contribute to tumor growth and hyperemia (i.e., eye redness). The patent discloses that nintedanib in particular “may be one of the most powerful multikinase inhibitors for reducing corneal neovascularization.”In inter partes review, the Patent Trial and Appeal Board held that the petitioner, Allgenesis, failed to prove two claims of the patent are unpatentable. The Federal Circuit dismissed an appeal. Allgenesis failed to establish an injury in fact sufficient to confer standing to appeal. Allgenesis identified no concrete plans to develop and bring to market a nintedanib treatment for pterygium and has not shown its activities will create a substantial risk of infringement or will likely cause Cloudbreak to assert a claim of infringement. The court rejected an argument that Allgenesis suffered an injury in fact based on the Board’s priority determination that will have a preclusive effect on the scope of its pending patent application. Allgenesis has not established that the Board’s decision will have preclusive effect. View "Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC" on Justia Law

Epoprostenol, a naturally occurring substance, useful for treating cardiovascular diseases, was discovered in the early 1980s and was first brought to market under the brand name Flolan® in 1995. Epoprostenol is unstable in water, it was prepared as a freeze-dried, or lyophilized, powder for use in the Flolan composition. Actelion owns two patents directed to improved epoprostenol formulations that can be reconstituted with commercially available IV fluids and do not require refrigeration after reconstitution until use.” The inventor “unexpectedly found that epoprostenol solution in the presence of an alkalinizing agent, and high pH (>11) is very stable compared to Flolan.” Mylan sought approval to manufacture and sell a generic epoprostenol sodium for injection by filing an Abbreviated New Drug Application (ANDA) with the FDA, containing a certification that the Actelion patents’ claims were invalid or would not be infringed by the ANDA product.The Federal Circuit vacated the district court’s claim construction order with respect to the term “a pH of 13 or higher” and its judgment of infringement. The issue involves understanding what the significant digits are for “a pH of 13.” The district court must address extrinsic evidence explaining how a person of ordinary skill in the art would view the significant digits for a pH value. View "Actelion Pharmaceuticals LTD v. Mylan Pharmaceuticals Inc.," on Justia Law

Elekta’s 648 patent, titled “Method and apparatus for treatment by ionizing radiation,” discloses a device for treating a patient with ionizing radiation for certain types of radiosurgery and radiation therapy. The invention uses a radiation source, e.g., a linear accelerator (linac), mounted on a pair of concentric rings to deliver a beam of ionizing radiation to the targeted area of the patient. ZAP Surgical Systems sought inter partes review (IPR). The Patent Trial and Appeal Board addressed Elekta’s arguments that a skilled artisan would not have been motivated to combine, and would not have had a reasonable expectation of success in combining, one prior art device (Grady) with the linac described in the prior art, Ruchala, and whether a skilled artisan would have been dissuaded from combining the devices because one device was an imaging device, rather than a radiation device, and because the linac’s weight would render the Grady device inoperable, imprecise, and unsuitable for treatment.The Board concluded that a skilled artisan would have been motivated to combine Grady and Ruchala. The Federal Circuit affirmed, finding substantial support for the finding that a person of ordinary skill in the art would have been motivated to make the proposed combination. View "Elekta Ltd. v. ZAP Surgical Systems, Inc." on Justia Law

In a “key step” of the "coagulation cascade" that forms blood clots, an enzyme (Factor VIIIa) complexes with another enzyme (Factor IXa) to activate Factor X. Hemophilia A is a disorder where the activity of Factor VIII is functionally absent, impeding the body’s ability to effectively form blood clots. Historically, Hemophilia A has been treated by intravenously administering Factor VIII. Approximately 20–30% of Hemophilia A patients cannot benefit from that treatment because they develop Factor VIII inhibitors. Baxalta’s patent provides alternative means to treat Hemophilia A.Baxalta sued, alleging Genentech’s Hemlibra® (emicizumab) product infringes the patent. Emicizumab is a humanized bispecific antibody that binds to Factor IXa with one arm and Factor X with the other arm, mimicking the function of Factor VIIIa. Following the district court’s construction of the claim terms “antibody” and “antibody fragment” to exclude bispecific antibodies, the Federal Circuit held the proper construction of “antibody” was “an immunoglobulin molecule having a specific amino acid sequence comprising two heavy chains (H chains) and two light chains (L chains),” and the proper construction of “antibody fragment” was “a portion of an antibody” and remanded. On remand, Genentech successfully moved for summary judgment of invalidity of multiple claims for lack of enablement. The Federal Circuit affirmed. The patent fails to teach skilled artisans how to make and use the full scope of claimed antibodies without unreasonable experimentation. View "Baxalta Inc. v. Genentech, Inc." on Justia Law

The First Circuit affirmed the judgment of the district court dismissing Plaintiff's putative class action against McNeil Nutritionals, LLC and Johnson & Johnson Consumer, Inc. challenging certain statements on the packaging of Lactaid products, holding that the district court correctly dismissed the complaint.Plaintiff brought this action claiming that Lactaid's labels violated federal labeling requirements, leading Plaintiff to have been mislead into purchasing Lactaid products, which she claimed were more expensive than other lactase supplements. The district court granted Defendants' second motion to dismiss. The First Circuit affirmed, holding that Plaintiff's claims were impliedly preempted by the statutory enforcement authority of the Food and Drug Administration. View "DiCroce v. McNeil Nutritionals, LLC" on Justia Law

Titus’s solo medical practice, in its last 13 months, earned $1.1 million by distributing more than 20,000 prescriptions for Schedule II drugs. Titus often did only cursory physical examinations before prescribing opioids. He kept prescribing drugs despite signs that his patients were diverting or abusing them. At least two of Titus’s patients overdosed. Other doctors filed professional complaints. Titus closed his practice. Federal agents raided the homes of Titus and two of his employees and found thousands of patient files. Titus was indicted on 14 counts of unlawfully dispensing and distributing controlled substances (based on 14 prescriptions) and maintaining drug-involved premises, 21 U.S.C. 841(a)(1), (b)(1)(C), 856(a)(1).The government's statistician, using the Prescription Monitoring Program, identified 1,142 patients for whom Titus had prescribed controlled drugs, drew a random sample of 300 patients, and extrapolated to conclude that Titus had provided 29,323 controlled substance prescriptions to 948 patients with at least one inconsistent drug test and 1,552 such prescriptions to 352 patients he had already discharged from his practice. The government’s medical expert reviewed 24 of those files and determined that Titus had written illegal prescriptions for 18 of the patients.The district court held Titus responsible for at least 30,000 kilos, citing “general trial evidence” and extrapolating from the 24-file sample. The Third Circuit affirmed Titus’s convictions but vacated his 240-month sentence. The government failed to prove that extrapolating from a small sample satisfied its burden to prove the drug quantity by a preponderance of the evidence. View "United States v. Titus" on Justia Law