Justia Drugs & Biotech Opinion Summaries

The Valeant plaintiffs reside in Japan, Ireland, and Delaware. The defendants are incorporated and have principal places of business in West Virginia, Pennsylvania, and India. The brand-name FDA-approved drug Jublia® has nine patents listed in the Orange Book. Defendant, a generic drug company, executed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Jublia®, sending the ANDA from its West Virginia office to the FDA in Maryland. Valeant sued for infringement in the District of New Jersey, alleging that the district is a likely destination for the generic solution; each defendant does business in New Jersey and is registered to do so; each defendant has previously submitted to the court's jurisdiction and has a place of business in New Jersey; the generic drug will be “purposefully directed at … New Jersey. The district court dismissed for improper venue, finding that the ANDA was submitted from West Virginia, rendering venue proper there, while acknowledging that MLL, a foreign entity, was subject to venue in every judicial district.The Federal Circuit affirmed in part, citing the 2017 Supreme Court “TC Heartland” holding: the general venue provision in 28 U.S.C. 1391, which provides that a corporation is deemed to “reside” in any judicial district in which it is subject to personal jurisdiction, does not modify the term “resides” in 28 U.S.C. 1400, the specific patent venue statute; “resides” refers only to a corporation’s state of incorporation. A corporation may be sued for patent infringement in districts in the state of its incorporation and those in which it has a regular and established place of business and an act of infringement has occurred. In Hatch-Waxman Act, 35 U.S.C. 271(e)(2)(A) infringement cases, section 1400 “acts of infringement” occur only in districts where actions related to the ANDA submission occur, not in all locations where future distributions of the products specified in the ANDA is contemplated. The court remanded the dismissal of the foreign defendant. View "Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc." on Justia Law

In this lawsuit brought against Johnson & Johnson, Inc. and other entities (collectively, Defendants) alleging state tort claims due to injuries caused by a Class III medical device the Supreme Court reversed the judgment of the trial court granting Defendants' motion for judgment on the pleadings based on federal preemption of all claims, holding that, under Kentucky's notice pleading standards, the motion for judgment on the pleadings should have been denied.In their complaint, Plaintiffs asserted claims for, inter alia, strict liability negligence, and lack of informed consent. Defendants moved for judgment on the pleadings based on federal preemption of all claims. The trial court granted the motion and dismissed all of Plaintiffs' claims. The court of appeals affirmed. The Supreme Court reversed, holding that, under Kentucky's notice pleading standard, Plaintiffs' complaint sufficiently put Defendants on notice of parallel claims under Kentucky law that may not be preempted. View "Russell v. Johnson & Johnson Inc." on Justia Law

After the State of Hawaii filed suit against several pharmaceutical companies in state court for allegedly deceptive drug marketing related to the medication Plavix, the companies turned to federal court, seeking an injunction against the state court litigation based on a violation of their First Amendment rights.The Ninth Circuit agreed with the district court that the state court litigation is a quasi-criminal enforcement proceeding and that Younger v. Harris, 401 U.S. 37 (1971), bars a federal court from interfering with such a proceeding. The panel explained that, even though the state proceeding is being litigated by private counsel, it is still an action brought by the State of Hawaii. The panel stated that what matters for Younger abstention is whether the state proceeding falls within the general class of quasi-criminal enforcement actions—not whether the proceeding satisfies specific factual criteria. Looking to the general class of cases of which this state proceeding is a member, the panel concluded that Younger abstention is appropriate here. In this case, the State's action has been brought under a statute that punishes those who engage in deceptive acts in commerce, and the State seeks civil penalties and punitive damages to sanction the companies for their allegedly deceptive labeling practices. Because the companies' First Amendment concerns do not bring this case within the scope of Younger's extraordinary circumstances exception, they have no bearing on the application of Younger. Accordingly, the panel affirmed the district court's dismissal of the action. View "Bristol-Myers Squibb Co. v. Connors" on Justia Law

The First Circuit affirmed Defendant's conviction of violating federal laws by conspiring to receive, and of receiving, kickbacks from the pharmaceutical company Insys in exchange for prescribing its synthetic opioid, Subsys, holding that there was no merit to Defendant's arguments on appeal.Specifically, the First Circuit held (1) the government introduced sufficient evidence to prove that Defendant participated in a conspiracy to receive kickbacks or to prove that he accepted those kickbacks in exchange for prescribing Subsys; (2) Defendant's conduct fell outside the Anti-Kickback Statute's safe harbor provision; and (3) the district court did not err in failing to instruct the jury about that same safe harbor provision. View "United States v. Clough" on Justia Law

The Court of Appeals answered questions certified to it by the United States Court of Appeals for the Second Circuit regarding whether New York recognizes so-called American Pipe tolling of the statute of limitations for absent class members of a putative class action filed in another jurisdiction.In 2012, Plaintiffs filed individual lawsuits alleging injuries based upon the manufacturing of a nematicide by Occidental Chemical Corporation. The cases were consolidated, and the action was transferred to the United States District Court for the Southern District of New York. Occidental moved for judgment on the pleadings, arguing that Plaintiffs' claims were time-barred under New York law. Plaintiffs argued in response that a putative class action originally filed in Texas state court in 1993 had tolled the applicable three-year statute of limitations. The New York District Court Judge denied the motion and certified an interlocutory appeal to the Second Circuit, which, in turn, certified questions to the Court of Appeals. The Court of Appeals answered (1) New York recognizes American Pipe & Construction Co. v. Utah, 414 US 538 (1974), tolling for absent class members of putative class actions filed in other state and federal courts; and (2) a non-merits dismissal of class certification, as occurred here in 1995, extinguishes tolling. View "Chavez v. Occidental Chemical Corp" on Justia Law

The Snyders patent describes and claims an artificial heart valve and a system for inserting the valve. In 2017, St. Jude filed two petitions under 35 U.S.C. 311–19, seeking inter partes reviews (IPR) of claims 1, 2, 4–8, 10–13, 17–19, 21, 22, and 25–30. The Patent Trial and Appeal Board instituted two reviews, each addressing all the challenged claims. In IPR-105, the Board ruled that St. Jude failed to establish unpatentability of any of the challenged claims, rejecting the contention that all the challenged claims were anticipated by the Leonhardt patent and would have been obvious over Leonhardt plus either the Anderson patent or the Johnson and Imachi patents. In IPR-106, the Board found claims 1, 2, 6, and 8 anticipated by the Bessler patent, but it rejected St. Jude’s contentions as to all other claims, finding that St. Jude had not proved, as to all but claims 1, 2, 6, and 8, anticipation by Bessler or obviousness over Bessler combined with either Anderson or Johnson and Imachi. The Federal Circuit affirmed the decision in IPR-105; reversed the finding in IPR-106 that Bessler anticipated claims 1, 2, 6, and 8; did not reach the anticipation argument as to claim 28; and affirmed the obviousness rejection in IPR-106. View "St. Jude Medical, LLC v. Snyders Heart Valve LLC" on Justia Law

Immunex’s 487 patent is directed to antibodies that bind to the human interleukin-4 receptor, the resulting inhibition of which is significant for treating various inflammatory disorders, such as arthritis, dermatitis, and asthma. Amid infringement litigation, Sanofi filed three inter partes review (IPR) petitions challenging claims 1–17 of the patent. Two were instituted. In one final written decision, the Board concluded that claims 1–17 were unpatentable as obvious over two prior references. Immunex appealed, contesting the construction of the claim term “human antibodies.” In the other IPR, involving a subset of the same claims, the Board did not invalidate the patents for reasons of inventorship. Sanofi contested the Board’s inventorship determination. In consolidated appeals, the Federal Circuit upheld the Board’s claim construction, affirming the invalidity decision, leaving valid no claims at issue in the inventorship appeal. View "Immunex Corp v. Sanofi-Aventis U.S. LLC" on Justia Law

The Ninth Circuit reversed the district court's dismissal of a putative class action against CVS based on Federal Food, Drug, and Cosmetic Act (FDCA) preemption of California state law claims. Plaintiff alleged that the supplement he purchased, and five additional CVS glucosamine-based supplements, did not provide the advertised benefits. The FDCA distinguishes between "disease claims" and "structure/function claims" that manufacturers make about their products, applying different regulatory standards to each.The panel held that the district court erred in concluding that the FDCA preempts plaintiff's state law causes of action simply because CVS's glucosamine-based supplements present only structure/function claims. The panel explained that Dachauer v. NBTY, Inc., 913 F.3d 844 (9th Cir. 2019), was distinguishable from this case and the district court erred by applying it. Furthermore, the district court erred by greatly expanding the present state of federal preemption jurisprudence under the FDCA, contrary to public policy. The panel also held that the district court erred in dismissing the complaint without granting plaintiff leave to amend to add allegations regarding an implied disease claim. In this case, plaintiff may have been able to "bolster" his complaint with allegations of extra-label evidence showing that CVS's glucosamine-based supplements present implied disease claims. Accordingly, the panel remanded for further proceedings. View "Kroessler v. CVS Health Corp." on Justia Law

GSK’s 067 patent for “carvedilol” issued in 1985. The FDA initially approved carvedilol for treating hypertension; the product was marketed with the brand name Coreg®. Scientists continued to study carvedilol. In 1997, the FDA approved carvedilol for the additional treatment of congestive heart failure. GSK’s 069 patent issued in 1998, describing and claiming treatment with a combination of carvedilol and an angiotensin-converting enzyme (ACE) inhibitor, a diuretic, and digoxin. The patent was listed in the FDA’s Orange Book. In 2003, the FDA approved this Coreg® combination for use by patients suffering from left ventricular dysfunction following myocardial infarction. In 2002, Teva applied for FDA approval of generic carvedilol, certifying in the ANDA that its product would not be launched until the 067 patent expired and that the 069 patent was “invalid, unenforceable, or not infringed.” Teva received FDA tentative approval “for treatment of heart failure and hypertension,” to become effective in 2007. GSK, in 2003, sought reissue of the 069 patent, 35 U.S.C. 251. The 000 patent issued in 2008. In 2011 the FDA required Teva to amend its carvedilol label to be “identical in content to the approved [GSK Coreg®] labeling.GSK sued for infringement.A jury found the 000 patent valid and infringed, assessed damages, and found the infringement willful. The district court granted Teva judgment of non-infringement as a matter of law. The Federal Circuit reinstated the jury verdicts as supported by substantial evidence. View "GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc." on Justia Law

The First Circuit affirmed the judgment of the district court denying Akebia Pharmaceuticals, Inc.'s motion for a preliminary injunction, holding that the district court did not err or abuse its discretion in denying a preliminary injunction in this case.Akebia sued the Administrator of the Centers for Medicare & Medicaid Services (CMS), the Secretary of the Department of Health and Human Services, and other related defendants asserting that CMS acted arbitrarily, capriciously, and contrary to law regarding the reimbursement protocol for Auryxia, a drug owned by Akebia, when prescribed for treatment of iron deficiency anemia in patients with chronic kidney disease. Akebia moved for a preliminary injunction seeking to pause the coverage determination until CMS's interpretation could be entirely litigated. The district court denied the motion. The First Circuit affirmed, holding that the district court did not err in holding that Akebia failed to carry its burden of showing that it was likely to succeed on the merits of its claims. View "Akebia Therapeutics, Inc. v. Azar" on Justia Law