Life Sciences

IP Update: Irish and Northern Irish Businesses Now Must Be Represented by a U.S.-Licensed Attorney on USPTO Matters

Mike Burke Intellectual Property, Life Sciences

As of early August, all Irish and Northern Irish persons and entities (whose permanent legal residence or principal place of business is outside the U.S.) are required to be represented by a licensed U.S. attorney in good standing in all matters before the U.S. Patent and Trademark Office and the Trademark Trial and Appeal Board. This is a significant change for Irish and Northern Irish companies with IP registrations in the US, especially those protecting their brands.

This new rule applies to (i) new application filings and subsequent filings in pending applications; (ii) maintenance filings in connection with existing registrations; and (iii) ex parte appeals and contested proceedings before the TTAB, including, opposition and cancellation actions.

Irish and Northern Irish applicants, registrants and parties now need to engage a licensed U.S. attorney to file submissions on their behalf.

If you have any questions about the impact of this changed rule, contact me –AGG has a great IP practice that represents a number of Irish and Northern Irish businesses on US IP matters.

@agglaw

The First Thing You Should Do…

Mike Burke Distribution Agreements, Economics, Life Sciences, Smart Exporting , , , , , , , , ,

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?

Mike Burke About, Choice of Entity, Distribution Agreements, Formation Issues, Life Sciences, Smart Exporting , , , , , , , , ,

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.