Justia Drugs & Biotech Opinion SummariesArticles Posted in International Law
Boehringer Ingelheim Pharm. v. Herndon
A number of suits have challenged the accuracy of the warning label on Pradaxa, a prescription blood-thinning drug manufactured by Boehringer. The litigation is in the discovery stage. The district judge presiding over the litigation imposed sanctions on Boehringer for discovery abuse. Boehringer sought a writ of mandamus quashing the sanctions, which included fines, totaling almost $1 million and also ordered that plaintiffs’ depositions of 13 Boehringer employees, all of whom work in Germany be conducted at “a place convenient to the [plaintiffs] and [to] the defendants’ [Boehringer’s] United States counsel,” presumably in the United States. The parties had previously agreed to Amsterdam as the location. The Seventh Circuit rescinded the order with respect to the depositions but otherwise denied mandamus. View "Boehringer Ingelheim Pharm. v. Herndon" on Justia Law
Sanofi-Aventis Deutschland, GMBH v. Genentech, Inc.
In 1985, Behringwerke filed a U.S. patent application directed to the use of DNA sequences (enhancers) identified in human cytomegalovirus. An enhancer, when introduced into a cell that produces a drug, can enable the cell to produce the drug at a much higher rate. In 1992, Behringwerke and Genentech entered into a licensing agreement related to enhancers that matured into the patents-in-suit; for fixed annual payments, Genentech could practice the patents for research purposes. Genentech was to pay a royalty on sales of commercially marketable goods incorporating a “Licensed Product.” The Agreement, governed by German law, required that disputes be settled by arbitration. Behringwerke sold its pharmaceutical business to Sanofi, but the Agreement and patent rights stayed with Hoechst; both are German entities. In 2008, Sanofi sued Genentech for infringement based on sales of the allegedly infringing drugs Rituxan and Avastin, which Genentech had not identified as licensed products. Hoechst demanded arbitration before a European arbitrator. The district court found no infringement. The Federal Circuit affirmed. Arbitration continued. On remand, Genentech sought to enjoin Sanofi from continuing the foreign arbitration. The district court denied the motion, finding that Hoechst is a party to the arbitration, but not a party to the litigation and that an injunction would frustrate policies favoring enforcement of forum selection clauses, and would not be in the interest of international comity. The arbitrator determined that German substantive law, not U.S. patent law, would be used, that a drug could be a licensed article even though it did not contain the patented enhancers, if those enhancers were used in its manufacture, and that Genentech was liable for damages. The Federal Circuit affirmed that Genentech was not entitled to an injunction. View "Sanofi-Aventis Deutschland, GMBH v. Genentech, Inc." on Justia Law
Aziz, et al. v. Alcolac, Inc., et al.
Appellants filed a class action, alleging that defendant, a chemical manufacturer, sold thiodiglycol (TDG) to Saddam Hussein's Iraqi regime, which then used it to manufacture mustard gas to kill Kurdish enclaves in northern Iraq during the late 1980's. At issue was whether appellants have alleged viable claims under the Torture Victim Protection Act (TVPA), 28 U.S.C. 1350, or the Alien Tort Statute (ATS), 28 U.S.C. 1350. The court held that the TVPA excluded corporations from liability. The court also held that the ATS imposed liability for aiding and abetting violations of international law, but only if the attendant conduct was purposeful. Appellants, however, have failed to plead facts sufficient to support the intent element of their ATS claims. Accordingly, the court affirmed the district court's grant of defendant's motion to dismiss under Rule 12(b)(6). View "Aziz, et al. v. Alcolac, Inc., et al." on Justia Law