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!
I was recently asked whether the US had any regulations similar to the EU’s Commercial Agent Regulations–pursuant to which, upon termination or expiration of certain agency contracts, the agent would be entitled to an indemnity/compensation payment. The specific question related to a sales agency agreement, but the answer for the US is valid for agency, distribution and similar agreements. The short answer is ‘no,’ the general rule in the US is that there are no termination payments due upon termination of a ‘commercial agent’ (or expiration of the term of the agency agreement). Notwithstanding that answer, I’d point out two things for an Irish/NI company potentially appointing a commercial agent in the US: (i) the underlying agency agreement should be clear on intellectual property rights in that the ownership of principal’s IP remains with the principal, the agent’s use of that IP inures to the benefit of the principal, and that the agent, even after termination/expiration, will execute whatever document are reasonably necessary to reflect the principal’s ownership of its IP; and (ii) the underlying agreement should also be clear that the agent must return all confidential materials/information to the principal upon termination/expiration of the term.
I’ve previously written in this blog about the importance of trade secrets. See: Protecting Your Trade Secrets in the US. Some recent changes in US Federal trade secrets legislation will help Irish and Northern Irish companies better protect their trade secrets in the US.
“Trade secrets” are defined in the US as (i) information, including a formula, pattern, compilation, program, device, method, technique, or process; (ii) that derives independent economic value, actual or potential, from not being generally known to or readily ascertainable through appropriate means by other persons who might obtain economic value from its disclosure or use; and (iii) is the subject of efforts that are reasonable under the circumstances to maintain its secrecy. Continue reading
Remember earlier posts about non-disclosure agreements, and the role they play in defining and protecting trade secrets? Of course you do—but in case you don’t, one of them is here. I even drafted a brief two-page outline for NDAs, here.
The macro point of those posts, at least as to protecting trade secrets, is that in the US, a trade secrets owner must take all “reasonably available steps” to protect their trade secrets. In an unpublished opinion filed on May 8, 2015, the US Court of Continue reading
Every now and then, a non-US company will contact me after they have started US operations…but have not protected their intellectual property here. In some cases, the company does not have a full picture of what they have or where they could/should protect it—they have not audited what they have. Continue reading