On April 26, the U.S. Supreme Court heard arguments over whether to speed up the time it takes to bring to the market biosimilars. The case involved a section of the 2010 Affordable Care Act that created an expedited path for regulatory approval of biosimilar drugs. The Court heard arguments in an appeal by Novartis AG of a lower court decision that prevented the Swiss pharmaceutical company from selling its biosimilar version of California-based Amgen Inc’s Neupogen until six months after the Food and Drug Administration approved it. Federal regulators have not given clear guidance on the issue of whether brand-name manufacturer have an extra six months of exclusivity on top of the 12 years already provided under federal law, or whether biosimilars may be launched immediately upon the conclusion of that 12-year exclusivity period. The ruling in the case, due by the end of June, could determine how quickly patients have access to biosimilars at potentially lower prices.
When Irish and Northern Irish companies ask if there is *one* thing they can or should do to minimize the risk of operating in the US, I channel my inner Mr. McGuire (from the movie The Graduate) and say ‘process.’ It’s not quite as pithy as ‘plastics,’ but it works. What I mean by that remark is this: adopting and consistently using a process for developing and executing US contracts will go a long way in terms of risk mitigation. Comprehensive, American-style contracts, and the process by which they are built, are the most powerful defenses in an Irish or Northern Irish company’s risk-avoidance arsenal. Continue reading