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.

 

 

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.

It’s About the Process…

When Irish and Northern Irish companies ask if there is *one* thing they can or should do to minimize the risk of operating in the US, I channel my inner Mr. McGuire (from the movie The Graduate) and say ‘process.’ It’s not quite as pithy as ‘plastics,’ but it works. What I mean by that remark is this: adopting and consistently using a process for developing and executing US contracts will go a long way in terms of risk mitigation. Comprehensive, American-style contracts, and the process by which they are built, are the most powerful defenses in an Irish or Northern Irish company’s risk-avoidance arsenal. Continue reading