Justia Drugs & Biotech Opinion Summaries
United States v. Clough
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
Chavez v. Occidental Chemical Corp
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
St. Jude Medical, LLC v. Snyders Heart Valve LLC
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 Corp v. Sanofi-Aventis U.S. LLC
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
Kroessler v. CVS Health Corp.
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
GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.
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
Akebia Therapeutics, Inc. v. Azar
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
Federal Trade Commission v. AbbVie Inc
AndroGel is a testosterone replacement therapy that generated billions of dollars in sales. The Federal Trade Commission sued under Section 13(b) of the Federal Trade Commission Act, alleging that AndroGel’s patent owners filed sham patent infringement suits against Teva and Perrigo and entered into an anticompetitive reverse-payment agreement with Teva. The FTC accused the patent owners of trying to monopolize and restrain trade over AndroGel. The District Court dismissed the FTC’s claims to the extent they relied on a reverse-payment theory but found the owners liable for monopolization on a sham-litigation theory and ordered disgorgement of $448 million in ill-gotten profits. The court denied the FTC’s request for an injunction.The Third Circuit reversed in part, holding that the district court erred by rejecting the reverse-payment theory and in concluding the owners’ litigation against Teva was a sham. The court erred by ordering disgorgement because that remedy is unavailable under Section 13(b) of the FTC Act. The court affirmed in part. The district court correctly concluded that the Perrigo litigation was a sham and that the owners had monopoly power in the relevant market but did not show the monopolization entitles the FTC to any remedy. The court did not abuse its discretion in denying injunctive relief. View "Federal Trade Commission v. AbbVie Inc" on Justia Law
Biogen MA Inc. v. EMD Serono, Inc.
Biogen’s patent is directed to a method of treating a viral condition, a viral disease, cancers, or tumors, by the administration of a pharmaceutically effective amount of a recombinant polypeptide related to human interferon-β (IFN-β). Biogen sued Serono, alleging contributory and induced infringement of the patent by the sale and marketing in the U.S. of Rebif, a recombinant IFN-β product used for the treatment of Multiple Sclerosis. A jury found that the patent claims were anticipated by two references teaching the use of native IFN-β to treat viral diseases; that the asserted claims not invalid for lack of enablement or written description, or for obviousness; that patients and prescribers directly infringed the asserted claims; and that Serono contributorily infringed the claims but did not induce infringement thereof. The district court granted judgment as a matter of law of no anticipation in favor of Biogen and conditionally granted a new trial on anticipation; sustained the jury’s verdict of no invalidity based on written description or enablement; overturned the verdict of no induced infringement; sustained the verdict of contributory infringement; and held that the claims were not patent ineligible.The Federal Circuit reversed with respect to anticipation and the conditional grant of a new trial. A reasonable jury could find the claims of the patent anticipated on the record presented. The court remanded with instructions to reinstate the verdict of anticipation. View "Biogen MA Inc. v. EMD Serono, Inc." on Justia Law
Dolt, Thompson, Shepherd & Conway, P.S.C.
In this case related to the disbursement of Purdue Pharma funds, the Supreme Court reversed the court of appeals' grant of summary judgment for the Office of the Attorney General (OAG) and Dolt Thompson declaring that a contract was enforceable and a payment to Dolt, Thompson, Shepherd & Kinney, P.S.C. (Dolt Thompson) was proper, holding that the circuit court did not err.The then-attorney general filed a lawsuit against Purdue Pharma regarding the OxyContin epidemic. The OAG selected Dolt Thompson to assist in the Commonwealth's litigation against Purdue Pharma. After the OAG settled with Purdue Pharma it paid Dolt Thompson in part. The Legislature then passed a 2016 budget bill directing payment of attorney's fees and expenses in the Purdue Pharma case. The OAG filed a complaint seeking a declaration that the payment to Dolt Thompson was proper. The Finance Cabinet filed an action against Dolt Thompson. The circuit court consolidated the cases and entered summary judgment for the OAG and Dolt Thompson. The court of appeals reversed and ordered the circuit court to allow the Cabinet to conduct discovery. The Supreme Court reversed, holding that the Legislature acted within its authority in stating that the attorney's fees should be paid prior to any other disbursement of the Purdue Pharma funds. View "Dolt, Thompson, Shepherd & Conway, P.S.C." on Justia Law