Justia Arbitration & Mediation Opinion SummariesArticles Posted in Drugs & Biotech
In re: Rotavirus Vaccines Antitrust Litigation v.
Under "loyalty contracts," Physician Buying Groups (PBGs) members are entitled to discounts if they buy a large enough percentage of their vaccines from Merck. The loyalty contracts include an arbitration provision. Membership contracts between PBGs and medical practices give medical practices discounts on Merck vaccines for enrolling in PBGs. PBGs contract with both Merck and medical practices and are middlemen but PBGs never possess the vaccines. Medical practices buy their vaccines directly from Merck, receiving discounts for belonging to a PBG. The Pediatricians, members of PBGs that contracted with Merck, never signed contracts containing an arbitration clause.The Pediatricians filed federal suits alleging Merck’s vaccine bundling program was anticompetitive. Merck moved to compel arbitration. On remand, following discovery, the district court again denied Merck’s motion and granted the Pediatricians summary judgment, reasoning that the Pediatricians were not bound under an agency theory. The Third Circuit reversed. The PBG membership contract made the PBG a “non-exclusive agent to arrange for the purchase of goods and services,” and the PBG acted on this authority by executing the loyalty contract with Merck that included the arbitration clause. The Pediatricians simultaneously demonstrated intent to create an agency relationship and exercised control over the scope of the PBG’s agency by contract. View "In re: Rotavirus Vaccines Antitrust Litigation v." on Justia Law
In re: Remicade (Direct Purchaser) Antitrust Litigation
RDC is a direct purchaser and wholesaler of Remicade, the brand name of infliximab, a “biologic infusion drug” manufactured by J&J and used to treat inflammatory conditions such as rheumatoid arthritis and Crohn’s disease. For many years, Remicade was the only infliximab drug available. That position was threatened when the FDA began approving “biosimilars,” produced by other companies and deemed by the FDA to have no clinically meaningful differences from Remicade. RDC alleged that J&J sought to maintain Remicade’s monopoly by engaging in an anticompetitive “Biosimilar Readiness Plan,” which consisted of imposing biosimilar-exclusion contracts on insurers that either require insurers to deny coverage for biosimilars altogether or impose unreasonable preconditions governing coverage; multi-product bundling of J&J’s Remicade with other J&J drugs, biologics, and medical devices; and exclusionary agreements and bundling arrangements with healthcare providers. RDC’s own contractual relationship with J&J is limited to a 2015 Distribution Agreement, which is not alleged to be part of J&J’s Plan. The Agreement contains an arbitration clause, applicable to any claim “arising out of or relating to the Agreement. Reversing the district court, the Third Circuit held that RDC’s antitrust claims do “arise out of or relate to” the Agreement and must be referred to arbitration. View "In re: Remicade (Direct Purchaser) Antitrust Litigation" 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
In Re: Pharmacy Benefit Mgrs. Antitrust Litig.
AdvancePCS is a prescription benefits manager for plans sponsored by employers, unions, and others and is retained to achieve savings by negotiating discounts from drug manufacturers, providing mail order service, contracting with retail pharmacies, and electronic processing and paying of claims. Plaintiffs are retail pharmacies that entered into agreements with AdvancePCS that include an agreed reimbursement rate and an arbitration clause. In 2003, plaintiffs filed suit, asserting that AdvancePCS engaged in an unlawful conspiracy with plan sponsors to restrain competition in violation of the Sherman Act, 15 U.S.C. 1; that AdvancePCS used the economic power of its sponsors to reduce the contractual amount it pays below levels prevailing in a competitive marketplace; and that the agreements impose other limitations. For almost a year, AdvancePCS litigated without mentioning arbitration. After denial of a motion to dismiss and reconsideration, AdvancePCS filed an answer with affirmative defenses, then sought to compel arbitration. The court granted the motion. Plaintiffs did not initiate arbitration, but sought dismiss pending appeal. A different judge vacated the order compelling arbitration. The Third Circuit remanded with directions to reinstate the order compelling arbitration. On remand, a third judge granted dismissal. The Third Circuit ruled in favor of plaintiffs, holding that AdvancePCS waived its right to arbitrate. View "In Re: Pharmacy Benefit Mgrs. Antitrust Litig." on Justia Law
Promega Corp. v. Life Tech. Corp.
In 1996, RG, exclusive licensee of a German patent and corresponding patents in the U.S., Europe, and Japan relating to genetic identification, entered into a license agreement with Promega, granting Promega certain licenses. The agreement included a clause, providing that “all controversies or disputes arising out of or relating to this Agreement, or relating to the breach thereof, shall be resolved by arbitration” and prohibited assignment without consent. Assignments were approved in 2001 and 2003; a subsequent assignment from IP to LT was not approved. In 2008 LT believed that Promega was paying less than required royalties. Negotiations failed and LT demanded arbitration. Promega sought a declaratory judgment of non-arbitrability, alleging infringement of five patents and contenting that rights under the 1996 agreement had never been assigned to LT. IP then moved to compel arbitration. The district court ordered arbitration, finding that IP was the assignee, remained in existence, and that it was irrelevant that Promega alleged that IP was merely a puppet of LT. The Federal Circuit affirmed.View "Promega Corp. v. Life Tech. Corp." on Justia Law
Affymax, Inc. v. Ortho-McNeil-Janssen Pharmaceuticals, Inc.
In 1992 two companies began a joint venture to develop peptide compounds. The agreement provides that inventions created by joint efforts are jointly owned, but inventions attributable to a single party are owned by that party and that disputes will be arbitrated. In court-ordered arbitration, a panel decided that a certain group of patents are jointly owned, but that another group is owned by defendant. The district court confirmed those rulings, but vacated a ruling in defendant's favor on foreign patents. Holding that appeal is authorized by 9 U.S.C. 16(a)(1)(E), and that the dispute does not concern patent law, but is a contract issue, the Seventh Circuit reversed. The Federal Arbitration Act authorizes a court to vacate an award for any of four reasons, 9 U.S.C. 10(a); a conclusion that the arbitrators disregarded the law by failing to discuss the foreign patents separately from the domestic patents did not justify vacating the award. The judge mistakenly inferred from silence that the arbitrators must have had an extra-contractual ground; the arbitrators had no reason to discuss the foreign patents separately from the domestic patents. View "Affymax, Inc. v. Ortho-McNeil-Janssen Pharmaceuticals, Inc." on Justia Law