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.
Do You Want a .health Domain Name?
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!
Times You May Not Need a US Affiliate
Ten days ago I was in Belfast, speaking on a joint Invest Northern Ireland- Catalyst program about doing business in the US. Much virtual ink has been spilled on this blog about when an Irish or Northern Irish company should form an affiliate in the US, and the reasons why. At the Belfast program, a participant asked me when an Irish or Northern Irish company might not need to form an affiliate in the US. Specifically, I was asked whether having/using a ‘hot desk’ in the US would require the Irish or Northern Irish company to form a US affiliate. The short answer is ‘no.’
Of course, there is a bit more explanation needed (I’m a lawyer after all…). First, the answer to the question of whether one needs to form an affiliate in the US depends in part on whether the parent company can be deemed or determined to be doing business in one of the US states. That analysis can vary from state to state, and each US state has its own rules. But, in general, the use of a ‘hot desk’ on a periodic basis should not cause an Irish or NI company to be deemed to be doing business in most states. The second point is that the ‘doing business’ determination can and will change the more things an Irish or Northern Irish company does with that ‘hot desk.’ The more activity–making sales, servicing customers, executing contracts, hiring employees or contractors–and the greater the likelihood that the parent company would be deemed to be doing business in that state, and that’s when I recommend the formation of a US affiliate. In other words, the more you do with a ‘hot desk’ and the more commercial contacts you have, the greater the likelihood that you’d be deemed to be doing business in a US state (or more than one) and should consider forming an affiliate.
Irish Export Insights 