Justia Drugs & Biotech Opinion Summaries

Hill filed a successful drug application with the FDA for a corticosteroid called "Derma-Smoothe." The FDA later approved three abbreviated new drug applications submitted by Identi for generic versions of Hill's products. Hill sued the FDA arguing that the FDA's approval of Identi's products was arbitrary and capricious under the Administrative Procedures Act (APA), 5 U.S.C. 500 et seq. The district court granted summary judgment to the FDA and Hill appealed. The court held that the district court did not abuse its discretion in refusing to consider 21 extra-record declarations; Hill's arguments challenging the FDA's decision to grant bioequivalence waivers to Identi have no merit; and the court rejected Hill's argument that the FDA should not have approved Identi's drugs because Identi did not use the same labeling as Hill. Accordingly, the court held that the FDA's actions were not arbitrary and capricious, and affirmed the district court's grant of summary judgment. View "Hill Dermaceuticals, Inc. v. FDA, et al" on Justia Law

The patent examiner rejected all of the inventors’ pending claims in an application entitled “Enzyme-Mediated Modification of Fibrin for Tissue Engineering,” filed in 2003, relating generally to the field of tissue repair and regeneration, and more specifically to matrices containing bidomain peptides or proteins. The examiner found obviousness-type double patenting over several patents. The Board of Patent Appeals and Interferences affirmed. The Federal Circuit affirmed; tO'Mahe Board did not err in concluding that the pending claims were barred under the doctrine of obviousness-type double patenting. View "In re Hubbell" on Justia Law

DHS sued VHS for misappropriation of trade secrets, breach of contract, and trademark violations. DHS engaged VHS to market and sell the drug Provasca. After that relationship ended, VHS began to manufacture, market, and sell Arterosil, a product similar in many respects to Provasca. The court held that the district court granted DHS's request for a preliminary injunction after making sufficient findings of fact to support each element of the analysis and applying the correct legal standard to those facts. Therefore, the court affirmed the district court's grant of the preliminary injunction in full and lifted the stay of the injunction. The court remanded and directed the district court to expedite the trial on the permanent injunction and to attempt to narrow the breadth of its preliminary injunction. View "Daniels Health Sciences, L.L.C v. Vascular Health Sciences, L.L.C." on Justia Law

The patents relate to a method of drug delivery via the mucous membrane lining or mucosa in the oral cavity. The oral mucosal route provides direct access to the bloodstream without having to travel through the gastrointestinal tract, which allows the drug to avoid the “first pass effect,” the percentage of drug lost to metabolization in the liver. Drug delivery across the oral mucosa potentially provides patients with rapid onset of action at a lower dosage. The patents disclose use of effervescent agents used as penetration enhancers, which influence drug absorption across the buccal, sublingual and gingival mucosae and use of an additional pH adjusting substance in combination with an effervescent agent for promoting the absorption. Watson filed an Abbreviated New Drug Application for a generic version of FENTORA®. In response, Cephalon instituted a patent infringement suit. The district court found that Watson’s ANDA products did not infringe and held the asserted patents invalid for lack of enablement. The Federal Circuit reversed on the issue of enablement, holding that Watson failed as a matter of law to show with clear and convincing evidence that Cephalon’s patents require undue experimentation to practice the invention. The court upheld the noninfringement finding. View "Cephalon, Inc. v. Watson Pharm., Inc. " on Justia Law

Plaintiff brought a putative class action against defendants, alleging that defendants violated Section 10(b) and Section 20(a) of the Securities and Exchange Act of 1934, 15 U.S.C. 78u-4(b)(2)(A), by issuing a misleading press release concerning the results of a clinical trial for a drug called bapineuzumab. Plaintiff appealed from the district court's dismissal of his amended complaint with prejudice for failure to state a cause of action under Rule 12(b)(6) and denying leave to amend. The court concluded that, in the context of the full presentation of the details surrounding the study of the drug, nothing omitted from the press release rendered it false or misleading to a reasonable investor. Moreover, the court held that plaintiff offered insufficient additional allegations to cure this deficiency. Accordingly, the court affirmed the judgment of the district court. View "Kleinman v. Elan Corp., PLC" on Justia Law

Plaintiff appealed from the district court's grant of summary judgment in favor of Merck and the dismissal of her products liability claim for failure to provide an adequate warning regarding the risks associated with Fosamax. Fosamax has allegedly been linked to osteonecrosis of the jaw and plaintiff claimed that Merck should have known of a possible link between the drug and the condition. At issue was whether the district court erred in granting Merck's summary judgment motion after discrediting expert testimony from plaintiff's treating physician. Because the physician's expert testimony contained contradictions that were unequivocal and inescapable, unexplained, arose after the motion for summary judgment was filed, and were central to plaintiff's failure-to-warn claim, the court held that the district court did not err in determining that there was no genuine dispute of material fact raised by the later testimony. View "In Re: Fosamax Products Liability Litigation" on Justia Law

Between 1994 and 1997 Wyeth’s predecessor sold fenfluramine and dexfenfluramine, prescription weight loss drugs. After the drugs were linked to valvular heart disease and an FDA public health advisory, Wyeth withdrew the drugs from the market in 1997. Thousands of individuals filed suit; the cases were consolidated. In 1999, Wyeth entered into a Settlement Agreement; in 2000, the court certified the class, approved the Agreement, and retained jurisdiction. The Agreement enjoins class members from suing Wyeth for diet drug-related injuries, but allows class members to sue Wyeth if they can demonstrate that they developed PPH (a condition that deprives the lungs of oxygen) at a specified level through the use of the diet drugs. In 2011, Cauthen sued, alleging that she developed PPH. She produced a pulmonary consultation prepared by Fortin, a cardiologist. Because Cauthen’s report showed that lung capacity of less than 60 percent of predicted at rest, Wyeth sought to enjoin the state court lawsuit for failing to satisfy the precondition provided by the Agreement. Dr. Fortin asserted that comparing individual lung capacity with average capacity of persons having a similar demographic profile is not determinative in diagnosing PPH. The district court enjoined the suit. The Third Circuit affirmed. View "In Re: Diet Drugs Prod. Liab. Litig." on Justia Law

Ethypharm, a French corporation, contracted with Reliant, an American company. Ethypharm would manufacture and provide its drug (Antara®); Reliant would obtain approval and market the drug. Reliant sought FDA approval under 21 U.S.C. 505(b)(2), using data from an approved, fenofibrate drug, TriCor®, developed by Fournier and distributed in the U.S. by Abbott. Antara received approval. Reliant began marketing and sought a declaration of non-infringement or unenforceability of Abbott’s patents. Abbott counterclaimed. In 2006, the companies settled: Abbott and Fournier would license the patents to Reliant and Reliant would pay royaltys. The agreement prohibited Reliant from assigning its rights to or partnering with specific companies. Reliant sold its rights to Oscient, which was not a prohibited purchaser. Losing market share to generic fenofibrate, Oscient discontinued promotion of Antara and filed for bankruptcy. Ethypharm sued Abbott, alleging antitrust and sham litigation under 15 U.S.C. 1, asserting that the settlement agreement was designed to ensure that Antara would be marketed by a company with “limited resources and a relatively small sales force,” so that it could not effectively compete with TriCor and that the royalty payment weakened Antara’s profitability. The district court granted Abbott summary judgment. The Third Circuit vacated, holding that Ethypharm lacked standing under the Sherman Act. View "Ethypharm SA France v. Abbott Labs" on Justia Law

The DEA, under the authority of the Controlled Substances Act of 1970, 21 U.S.C. 812(b)(1)(B), classified marijuana as a Schedule I drug, the most restricted drug classification under the Act. Petitioners challenged the DEA's denial of its petition to initiate proceedings to reschedule marijuana as a Schedule III, IV, or V drug. The principal issue on appeal was whether the DEA's decision was arbitrary and capricious. First, the court denied the Government's jurisdictional challenge because the court found that at least one of the named petitioners had standing to challenge the agency's action. On the merits, the court held that the DEA's denial of the rescheduling petition survived review under the deferential arbitrary and capricious standard where the petition asked the DEA to reclassify marijuana, which, under the terms of the Act, required a "currently accepted medical use." A "currently accepted medical use" required, inter alia, "adequate and well-controlled studies proving efficacy." The court deferred to the agency's interpretation of these regulations and found that substantial evidence supported the agency's determination that such studies did not exist. Accordingly, the court denied the petition for review. View "Americans for Safe Access, et al v. DEA" on Justia Law

Kentucky commenced this action in Kentucky state court against Purdue, alleging that Purdue violated Kentucky law by misleading health care providers, consumers, and government officials regarding the risks of addiction associated with the prescription drug OxyContin, which Purdue manufactures, markets, and sells. Following transfer from the Eastern District of Kentucky to the Southern District of New York, the district court granted Kentucky's motion to remand, concluding that it lacked subject-matter jurisdiction because the suit did not meet the Class Action Fairness Act of 2005's (CAFA), Pub. L. No. 109-2, 119 Stat. 4, requirements. Purdue appealed the remand order under 28 U.S.C. 1453(c)(1). The court held that the district court correctly determined that Kentucky's action was not a class action as defined in CAFA, and therefore the case was properly remanded. Accordingly, the petition for leave to appeal was denied. View "Purdue Pharma, L. P. v. Commonwealth of Kentucky" on Justia Law