The Second Thing You Should Do…

After taking the survey at http://agglaw.polldaddy.com/s/irelandnisurvey and subscribing to this blog (see left column)…

Register the IP you’ll use in the US, most likely your trademarks. Many Irish and Northern Irish companies mistakenly believe that their home jurisdiction trademark registrations will be effective in the US. Nope. Also, some will think that the Madrid Protocol causes their home jurisdiction approvals to be effective in the US.  Nope. The Madrid Protocol is useful in determining applicant priority, but doesn’t operate to extend a home jurisdiction registration.

I always encourage Irish and Northern Irish companies to inventory their IP that they intend to use in the US before they expand to the US. Part of that effort is to ensure that we’ve properly protected what needs to be protected, and part of it is to ensure that, to the extent needed, any intercompany agreements have the proper scope.

Logos, trade names, product names, etc., can be trademarked here. The US is not a first-to-file trademark registration jurisdiction (where the first to file may prevail even if they are not the first to use–China is, for example, a first-to-file jurisdiction). And, yes, the US does allow for common law trademarks that arise from usage. But the most effective way to protect the value of those marks–the value built in Ireland and Northern Ireland and leveraged in the US–is to register. A basic trademark registration can cost less than $2,500 (with no opposition or other weird developments), and that’s a small price to pay.

The reason I suggest that this is the second thing to do is timing–the USPTO takes a little while to review applications, and may have questions. This isn’t to suggest that you wait on US expansion until after you obtain appropriate registration–you shouldn’t–but you should have your registrations in motion (submitted) when you hit the US market.

The First Thing You Should Do…

Well, after taking the survey at http://agglaw.polldaddy.com/s/irelandnisurvey that is…

The first thing you should do when considering whether to export your product to the United States is determine whether the product can be marketed or sold in the United States, or if there are license or registration requirements in connection with marketing or selling your product here.  From time to time, I have seen companies go through the time and expense of setting up operations here or take other significant steps, only to discover that their product either needs prior approval/registration to be marketed or sold in the US or can’t be imported here at all.

There is an obvious reason to think of this issue first–you don’t want to waste time, effort or money if they US market is closed to your product, or if your product needs a license/registration to be sold here.  You should take into account the time and cost of a license/registration process when building and analyzing the economic/business case for expansion to the US market. Another, perhaps less obvious, reason is timing–you want to build enough lead time for your product launch in the US to account for any licensing/registration issues. You don’t want to leap into the US market without having a properly registered/licensed product.

Many products don’t need a license or registration to be marketed and sold here. But several products do, including products in areas where Irish and Northern Irish companies do well:

  • Pharmaceuticals and medical devices require authorization from the FDA to be imported, marketed, and sold here.
  • Certain ingredients in cosmetics are not allowed in the US (some ingredients may be banned on a state-by-state basis).
  • Food and drink imports may need prior approval from the US Department of Agriculture.
  • Medicinal foods require prior approval from the FDA.
  • Certain consumer products–especially those that are used by children–may need to be reviewed by the US Consumer Products Safety Commission.

There are other products that require license/registration to be marketed and sold here.

The primary observation of this post is that you should be sure whether, and on what terms, your product may be imported, marketed, and sold in the US before you set up a affiliate, create a distribution network or take any other substantive step to expand here. It’s a small up-front expense compared to the expense of finding out later and having to correct a mistake.

 

 

The Survey Says?

The good news is that we’re going to re-start our webinar series on US legal topics for Irish and Northern Irish businesses expanding to/operating in the US. But we need your help: we’re looking for feedback on the topics that might be of interest to an audience of Irish/Northern Irish businesses, their advisors, and other interested parties. The survey is at http://agglaw.polldaddy.com/s/irelandnisurvey

Please take a moment to give us some feedback, and please feel free to forward along to your colleagues and contacts. Thank you in advance for your help.

 

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.

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.