U.S. Supreme Court Mulls Whether to Speed Up Biosimilars

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.

No Termination Payment for You!

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.

 

Please Don’t Do This With Your US NDAs

Over the past two weeks, I’ve reviewed two non-disclosure agreements (NDAs) for Northern Irish companies that are expanding to the US. I’ve written about NDAs in the past: NDAs and You: Perfect Together. The NDAs were well-drafted, but each contained the same mistake–something I’ve seen more than once: each selected the law of Northern Ireland to govern the NDA. Each company ‘was told’ (I’m not sure by whom) that selecting NI law was appropriate–and to be sure, I’ve seen the same mistake made by Irish companies. On the one hand, there is nothing wrong with selecting NI (or Irish) law to govern a NDA…if you don’t need to enforce that NDA in the US.

Most NDAs will include language that allows the disclosing party to obtain injunctive relief in the event the party receiving the confidential information threatens to disclose/breach the NDA or actually does so. Injunctive relief in the US allows a party to obtain an order requiring the other party to stop doing something or face court sanction; it is, in the most basic sense, a fast (but temporary) resolution to a legal issue that doesn’t require the time or incur the cost of full-blown litigation. But selecting a non-US law to govern an NDA can make enforcing that NDA more difficult than it should be.

Let’s take one of our NI companies–under the NDA, they would be disclosing their confidential information to a potential distributor in Virginia (for example). Therefore, if there is an actual or threatened breach of the NDA, that breach would most likely occur in Virginia. Meaning that the court with appropriate jurisdiction over a potential injunctive relief request also is in Virginia. If the NI company goes to court in Virginia to seek injunctive relief based on the NDA, and the NDA has NI (or Irish) law as the governing law, there is a very real/significant risk that the Virginia court would decline to take action, based on the idea that the Virginia court is not the appropriate venue for matters of NI law. The court could tell the NI party to have the dispute resolved in NI and then take the NI judgment back to the Virginia court to be perfected/enforced.

That’s a lot of time and expense–so much so it destroys the value of the injunctive relief option in the first instance, at least in my view.  So, here’s my recommendation- select relevant U.S. law to govern your U.S.-focused NDA. It will make enforcement easier and more predictable.

What Irish and Northern Irish Companies Need to Know Now: Doing Business in the U.S.–Free Webinar

Irish Export Insights

Thursday, June 30, 2016 at 3:00 pm Dublin/Belfast.

The attorneys of Arnall Golden Gregory’s International Business Practice invite you to attend a complimentary, 60-minute webinar “What Irish and Northern Irish Companies Need to Know Now: Doing Business in the U.S.” The webinar will be held Thursday, June 30, 2016 at 10:00 am EDT (3:00 pm Dublin/Belfast). The United States is an attractive, and expanding, market for Irish and Northern Irish goods and services. Despite suggestions to the contrary, the U.S. can be an easy market for business expansion—with a little bit of planning. This webinar will examine key legal issues for doing business in the U.S., including:

  • Protecting the Irish and Northern Irish parent company, its investors, and capital from U.S. legal risk;
  • Avoiding branch profits tax issues;
  • Reducing payment risk by ensuring prompt payment from customers, and other U.S. contract essentials;
  • The product liability risks that may attach…

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What Irish and Northern Irish Companies Need to Know Now: Doing Business in the U.S.–Free Webinar

Thursday, June 30, 2016 at 3:00 pm Dublin/Belfast.

The attorneys of Arnall Golden Gregory’s International Business Practice invite you to attend a complimentary, 60-minute webinar “What Irish and Northern Irish Companies Need to Know Now: Doing Business in the U.S.” The webinar will be held Thursday, June 30, 2016 at 10:00 am EDT (3:00 pm Dublin/Belfast). The United States is an attractive, and expanding, market for Irish and Northern Irish goods and services. Despite suggestions to the contrary, the U.S. can be an easy market for business expansion—with a little bit of planning. This webinar will examine key legal issues for doing business in the U.S., including:

  • Protecting the Irish and Northern Irish parent company, its investors, and capital from U.S. legal risk;
  • Avoiding branch profits tax issues;
  • Reducing payment risk by ensuring prompt payment from customers, and other U.S. contract essentials;
  • The product liability risks that may attach to selling in the U.S. market;
  • Navigating which jurisdiction’s laws govern the sale of Irish and Northern Irish-origin products in the U.S. market; and
  • Intellectual property protections.

Register now to hear AGG Partner Michael E. Burke discuss a business sensible, proactive approach to doing business in the U.S. while minimizing risk to the Irish and Northern Irish parent company and its investors.

Mike has an AV Preeminent™ Rating from Martindale-Hubbell, and has been named a Washington, DC Super Lawyer by Thomson Reuters since 21015. He also is a former chair of the American Bar Association Section of International Law, was named in 2014 by Business & Finance Magazine/IrelandInc.as one of the 100 Global Irish Business Leaders, and has been named three times to the Irish Legal 100.