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In the ultra-competitive life sciences industry, managing litigation is just a part of doing business. From complex governmental regulation to the battles between brand and generics drug companies, life sciences companies require a team with a deep understanding of all legal, regulatory, industry and scientific issues that are part of resolving litigation before or during trial.

  • Generics Pharmaceuticals Pricing Antitrust Litigation

    Buchanan currently represents a major generic pharmaceutical company in complex antitrust litigation brought by 49 states and numerous private plaintiffs alleging an industry-wide conspiracy to fix prices and allocate customers for more than 300 generic drugs. The litigation, consisting of dozens of individual cases, has been consolidated in a multidistrict litigation in the Eastern District of Pennsylvania and has been called “the largest cartel case in the history of the United States.”

  • Federal False Claims Act

    We represented a pharmaceutical company in litigation brought by a relator under the federal False Claims Act and the similar laws of more than 30 states. The relator alleged that our client published “false” prices that caused pharmacies to obtain excessive reimbursements from federal healthcare programs. We obtained a partial victory on our motion to dismiss, narrowing the claims significantly, and following limited discovery, were able to negotiate a favorable settlement that saved the client tens of millions of dollars.

  • AWP Drug Pricing Litigation

    Our team has represented various pharmaceutical companies in the AWP drug pricing litigation for more than a decade. Recently, we represented Teva Pharmaceuticals USA, Inc. and its affiliates in a complex, multi-year litigation by the State of Illinois. The State claimed that industry-standard practices including the publication of Average Wholesale Prices violated the Illinois False Claims Act and other statutes and caused the Illinois Medicaid Program to pay excessive reimbursements for prescription drugs. Following years of litigation and a bench trial in 2013, we were able to negotiate a favorable settlement that saved the client hundreds of millions of dollars in potential damages and penalties.

  • Angiotensin Receptor Blocker NDMA Contamination Products Liability Litigation

    Buchanan currently represents a national pharmacy retailer in class actions and hundreds of individual cases alleging economic losses and personal injuries related to alleged nitrosamine contamination of angiotensin receptor blockers. The cases have been consolidated for pretrial proceedings in a multidistrict litigation in the District of New Jersey. The litigation is ongoing, and with favorable decisions on motions to dismiss resulting in a narrowing of the plaintiffs’ claims.

  • Kolon TissueGene Product Liability and Government Investigations

    Our relationship with Kolon TissueGene, a biopharma company that develops advanced cell therapies, began when we helped them to successfully resolve a complex manufacturing contract dispute. As the relationship with the client grew, we helped them to weather government investigations by the South Korea Ministry of Food and Drug Safety (similar to the US FDA). The case involved alleged non-disclosure/fraudulent product claims in the company’s submission for approval to bring the product to market.

  • Inter Partes Review Success on behalf of Patent Owner FibroGen

    GlaxoSmithKline LLC (GSK) filed sixinter partesreview (IPR) petitions to challenge the patentability of U.S. Patent Nos. 8,466,172; 8,609,646; 8,614,204; 8,604,013; 8,604,012; and 8,629,131. The patents challenged in the petitions are owned by FibroGen, Inc. The ’172 patent is generally directed to methods for treating a hypoxic or ischemic disorder or condition. The ’646 patent is generally directed to methods for decreasing hepcidin expression. The ’204 patent is generally directed to methods for treating iron deficiency, functional iron deficiency, or anemia of chronic disease. The ’013 patent is generally directed to methods for treating anemia. The ’012 and ’131 patents are generally directed to methods for increasing serum iron and for increasing iron absorption, respectively.

    In its IPR petitions, GSK presented anticipation and obviousness challenges against the claims of FibroGen’s patents. Represented by members of Buchanan’s Patent Office Litigation practice group, FibroGen filed preliminary patent owner responses to each of GSK’s petitions explaining why GSK failed to demonstrate that the claims are unpatentable. On January 11, 2017, a panel of the Patent Trial and Appeal Board (PTAB) agreed with FibroGen and denied institution of all six IPR petitions.

    The decisions underscore the importance of filing patent owner preliminary responses under appropriate circumstances. In each of these proceedings, the decisions reflected the PTAB panel’s careful review of the arguments presented in the preliminary responses against the challenges presented in the petitions.

    The case numbers are IPR2016-01315, IPR2016-01318, IPR2016-01319, IPR2016-01320, IPR2016-01322, and IPR2016-01323.

  • Hatch Waxman Litigation

    Our team has extensive experience representing an array of companies in Hatch Waxman Litigation. We have represented innovator pharmaceutical manufacturers in enforcement of Orange Book Listed patents involving formulations and methods of treatment. We have also represented generic manufacturers in first to file litigation involving polymorphs, formulations, methods of use and delivery methods. These matters included development of invalidity and non-infringement strategies; coordination of Notice Letters and Detailed Statements and litigation in Federal District Courts through trial. Additionally, we have represented pharmaceutical manufacturers in targeting products for acquisition and to challenge in Hatch Waxman litigation.