November 10, 2017

Prescriptions for Pharmaceutical Marks

Some types of applications have a more difficult time than others proceeding to registration before the United States Patent and Trademark Office (the "PTO"). Sometimes the nature of a mark (such as product packaging) requires more evidence to demonstrate eligibility for registration. But sometimes the industry or goods with which the mark is used present a special challenge for the application. For example, marks chosen for use with heavily-regulated goods or services like pharmaceutical products may face unique challenges that require extra planning and strategy. Here we will talk about just one factor that makes the road to trademark registration more difficult for pharmaceutical products than for more other products: time.

Pharmaceutical products undergo review by the Food and Drug Administration (the "FDA"). This review can take a very long time, much longer than takes to examine a trademark application. What is a trademark applicant to do if the PTO completes its examination of the application and/or requires proof of use of the mark in commerce before the FDA completes its review of the product? There are some things the trademark applicant can do to buy itself more time in the trademark application process.

At the outset, the trademark applicant could consider filing an application in a jurisdiction outside the U.S. that is party to the Paris Convention or a similar treaty. This way, the applicant can delay filing the application in the US for up to six months and still rely on the foreign application's filing date for priority in the U.S. This can potentially extend the period of time between the applicant's selection of a mark and the date it will have to prove use by up to six months.

When filing the application with the PTO, the applicant will usually file on an intent-to-use basis since it has not already used the mark in commerce. (And if it is able to file the application to register the mark on the basis of foreign registration, it should consider adding that basis as well.) Once the application has been filed with the PTO, it will usually take approximately three months for the application to be assigned to an examining attorney for review. If the examining attorney raises any substantive issues or formalities, the applicant will have up to six months to respond to the office action. Once the applicant satisfactorily addresses any substantive concerns or formalities raised by the examining attorney, the application will be published. If no third party opposes registration of the mark after publication, the PTO will issue a notice of allowance giving the applicant six months to prove use of its mark in commerce.

At this point, the applicant may be in a position to prove use even if the FDA has not approved the product for the marketplace if the applicant has already begun clinical trials (depending on whether and how the mark is used in such clinical trials). But if the applicant's product has not reached the clinical trial stage, or if the applicant cannot satisfy the criteria to prove use, the applicant may seek a six-month extension of time. The applicant may seek up to five such extensions if necessary.

If the applicant was able to file its application on both an intent-to-use basis and foreign registration basis, the applicant may have some advantages. If the application includes a foreign registration basis, and the applicant has exhausted the available extensions of time to prove use, the applicant may choose to drop the intent-to-use basis upon expiration of the last extension period. This would allow the application to proceed to registration without first having to prove use. If the application is not eligible for registration in the US on the basis of a foreign registration, then it will need to start the application process over again (and should think about the potential for this eventuality well before the application reaches this stage to decide whether to take alternative precautionary measures, including filing a new application).

If the mark proceeds to registration on the foreign registration basis, the registrant will have to prove use of the mark in commerce between the fifth and sixth anniversaries of the registration date. It is possible that third parties could challenge the registration on abandonment grounds before that deadline if the mark has not been used since registration (and such challenges would benefit from a presumption of abandonment if the mark has not been used for three or more years following registration). But if the registrant can demonstrate that its product is still progressing in the FDA review process, that it has documented plans for using the mark, and that but for the absence of FDA approval the mark would be in use, it may be able to defend against an allegation of abandonment successfully.

In short, while the length of time it takes to obtain FDA approval may pose an extra burden on applicants seeking to register marks for use with pharmaceutical products, applicants can implement strategies to overcome this obstacle, including (1) filing applications abroad first and taking advantage of the 6-month period during which the applicant may file in the US and claim priority back to the filing date of the foreign application, (2) filing on an intent-to-use basis (as well as foreign registration basis, if that is available), (3) maximizing the number of extensions available to prove use, and (5) dropping the intent-to-use basis to obtain registration based on the foreign registration alone (if that is available to applicant). Throughout the trademark application process, the applicant should regularly consult with the trademark attorney to keep her apprised of the status of the FDA's review of the product. Together, the applicant and attorney can periodically assess whether FDA approval is likely to take so long that it is worth starting over with a new application.