Posts Tagged ‘fda’

Pharmaceutical Trademark Law: Some Tips & Considerations To Keep In Mind

Thursday, July 8th, 2010

Clearing and obtaining rights to pharmaceutical trademarks presents unique challenges unlike those associated with trademarks used in other fields. In addition to navigating the U.S. Patent & Trademark Office, the pharmaceutical trademark lawyer must counsel his or her client regarding the FDA regulatory hurdles that go along with securing a chosen product name.  After all, it does the client no good to successfully secure a Notice of Allowance if the FDA ultimately rejects the trademark during its drug name review process.  And the FDA gives no deference to U.S. Patent & Trademark Office decisions on registrability of trademarks. This is why it is critical to be mindful of both the U.S. Patent & Trademark Office’s approach and the FDA’s approach to approving chosen pharmaceutical trademarks.

Here are some quick points and tips (not by any means an exhaustive list) to keep in mind as you navigate the pharmaceutical trademark minefield:

  • You may submit up to two trademark names at a time to the FDA for approval, a process which takes approximately 3 years
  • Be careful about names that imply efficacy, risk, indication, superiority, or that are overly fanciful
  • Handwriting Analysis: Be mindful of potential confusing similarity between trademarks when they are handwritten, even if they are otherwise visually different when typewritten, or phonetically different; we all know that doctors are not known for having the best penmanship!
  • Verbal pronunciation analysis: even if 2 respective trademarks are visually distinguishable, if they sound the same when spoken verbally, this will weigh against ultimate approval
  • You may very well need to consider the trademark registration process and drug approval process in a foreign country if the product will be marketed and sold internationally; for example, the regulatory agency for the evaluation of medicinal products  in the European Union is EMEA (European Medicines Agency).  EMEA has its own process and rejects approximately 50% of proposed trademark names

Our team here at Lombard & Geliebter LLP has extensive experience representing pharmaceutical companies in connection with their trademark matters. If you have any questions relating to the pharmaceutical trademark law, please call Mathew Lombard or Darren Geliebter at 212-551-1755 or reach us by email: mail@lgtrademark.com.

Sanofi Facility Approved in U.S.

Thursday, May 7th, 2009

Earlier today it was announced that the FDA has approved a new production facility for the manufacture of flu vaccines.   The facility, based in the U.S. is owned by sanofi pasteur, (a division of our client sanofi-aventis) which manufactures Fluzone Influenza Virus Vaccine. This new facility will greatly increase sanofi pasteur’s production capability.

Congratulations to them.  (Send some Fluzone our way!)

FDA Playing Catch-Up Again

Thursday, May 7th, 2009

FDAlogo The FDA is playing catch up, again.  On the heels of requiring the dreaded black box warning for Botox and similar products, the FDA today announced it would also require black box warnings for two testosterone replacement productsAndroGel 1% and Testim 1%.

After having been on the market for some time, the FDA has decided that the products could have negative effects if children are exposed to the products.

Mary Roberts, an FDA medical officer, said in some instances people were applying the product to their chest and then holding their children without wearing shirts.

You may view the FDA’s press release here.

FDA Nominee Faces Senate

Thursday, May 7th, 2009

fdalogoMargaret Hamburg, President Obama’s selection to head the U.S. Food & Drug Administration (“FDA”) is scheduled to face senators today as they consider her nomination.

Hamburg is a physician and a bioterrorism expert who has served as Commissioner for Health of New York City. 

The Senate is expected to grill Hamburg in light of some notable FDA failures such as salmonella outbreak in peanut products early this year, tomatoes and peppers in 2008 and spinach in 2006.