Impact of Government Shutdown

By: Jeremy A. Cubert, Esq. Clinical Technology Transfer Group, PLLC

As many of you already have heard, the United States government partially shut down operations as of today, October 1, 2013. We are writing to alert you about certain governmental agencies that may affect your patent applications, clinical trial operations, and R&D activities. Below is a brief summary of the operating status of some relevant governmental agencies:

FDA
http://www.fda.gov/Drugs/ucm370582.htm

According to the FDA, their operations will be limited to “emergency work involving the safety of human life or the protection of property,” “criminal law enforcement work,” and “activities funded by carryover user fee balances including user fee balances under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), Medical Device User Fee Amendments (MDUFA), Animal Drug User Fee Act (ADUFA), Animal Generic Drug User Fee Act (AGDUFA), and Family Smoking Prevention and Tobacco Control Act. Carryover user fee balances will only be spent on activities for which the fees are authorized under the Federal, Food, Drug, and Cosmetic Act (FD&C Act).”

In addition, regarding medical product user fees, the “FDA will not have legal authority to accept any regulatory submissions for FY2014 that require a fee payment and that are submitted during the lapse period.”

National Institutes of Health (NIH)
http://www.usa.gov/shutdown.shtml

According to the NIH, their clinical center is not accepting new patients or initiating new clinical trials. Clinical trials that were in process prior to 10/1/2013 will continue. Information regarding other functions is not available at this time.

Office of Human Research Protection (OHRP)
http://www.hhs.gov/ohrp/index.html

Some institutions’ Federal-wide Assurances (FWA) or IRB registration may be set to expire during the shut-down. According to the OHRP website, registration renewals will not be renewed and will expire.

HHS has suggested that “research review be deferred to another IRB designated under a particular institution’s assurance that is not affected by the shutdown.” OHRP “encourages reasonable attempts to defer oversight to another, non-federal, IRB or to suspend research, if appropriate.”

United States Patent and Trade Office (USPTO)
http://www.uspto.gov/news/2013ops.jsp

According to the USPTO website, the USPTO has reserve funds to operate fully for approximately 4 weeks. Once those funds run out, and if the government is still shut down, according to the USPTO, “a very small staff would continue to accept new applications and maintain IT infrastructure.” Information regarding other functions is not available at this time. It is unclear from the above guidance whether accepting new applications will provide a filing date to the applicant.

Therefore, for those considering filing new applications, the best practice is to file within the 4 week period the USPTO expects to remain fully operational and to monitor the USPTO web site for additional guidance during the shutdown. You should expect significant delays in receipt of office actions or other decisions or documents from the USPTO during and immediately after the shutdown.

Contact: Jeremy A. Cubert, Esq. at jacubert@cttg-law.com or 703-734-0484, ext. 109

The information contained herein is for informational and educational purposes only and does not constitute legal advice, substitute for legal counsel, or establish an attorney-client relationship. You should not act or rely on any information contained in this website without first seeking the advice of an attorney.