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  • The future of preemption

    For FDA (Food and Drug Administration)-regulated companies, federal preemption can provide a potentially powerful defense to state tort claims. In recent years, the U.S. Supreme Court has decided numerous preemption cases, each emphasizing the highly context-sensitive nature of the inquiry. Determining when preemption applies and how to deploy it to...

  • The products of tomorrow

    Rapidly changing technologies and exciting new products offer seemingly limitless opportunities for growth and progress across a broad range of industries. But the same innovative qualities that make new products likely to gain widespread publicity may also attract unwanted – and unwarranted – attention from the plaintiffs’ bar and others...

  • IP: Obamacare’s constitutional impact on patents

    Enactment of the Patient Protection and Affordable Care Act (commonly known as the PPACA or Obamacare) resulted in barrage of media coverage that has endured as the law nears its 2014 implementation date.

  • IP: Bring on the biosimilars

    The Supreme Court’s approval of the Affordable Care Act means that the Biologics Price Competition and Innovation Act of 2009 (BPCIA) within the law now goes into full effect.

  • FDA releases biosimilars draft guidances

    Documents are first step in expedited pathway for generic biotech drugs

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