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.
As Irish and Northern Irish companies expand to the U.S., they need to make a decision or two about the company’s (or the US affiliate’s) domain name. Companies that provide health products, services, and/or information–life sciences companies–can register for a ‘.health’ domain name from and after December 5, 2017. But registering for a ‘.health’ domain name can also present challenges to trademark owners in protecting their intellectual property. This is a great article from my colleagues Tucker Barr and Sean Sullivan on the subject: http://www.agg.com/do-you-want-a-health-web-domain-name-do-you-want-to-prevent-others-from-using-your-trademark-in-a-health-web-domain-name-05-02-2017/. Take a look!
Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and has several updates of interest for Irish and Northern Ireland life sciences companies operating, or looking to operate, in the US: (i) additional discussion of the Amarin off-label promotion case; (ii) guidance for data-driven medical device companies on implementing effective data security and privacy measures; and (iii) potential changes that could streamline 510(k) medical device reviews at FDA. If you have questions or comments about the newsletter, please contact me or the author(s) of the articles in question.