This article appeared in Pharmaceutical Compliance Monitor, December 20, 2013, and is reproduced with permission.
Every day counts when it comes to patent protection for blockbuster pharmaceuticals. A recent decision from a U.S. District Court in Virginia affirming the Patent and Trademark Office’s 57-day reduction in Patent Term Adjustment has the potential to ensnare unwary patent applicants and their attorneys, which could result in significant financial ramifications for the holder of the patent that eventually issues. Gilead Sciences, Inc. v. Rea, 1:12cv1090 (E.D. Va.). The term of a United States patent is measured as 20 years from its earliest claimed U.S. non-provisional priority date. Because the clock measuring the patent term begins at application filing, rather than at patent issuance, the length of time in which a patent is in force depends upon the PTO’s diligence in examining the application. Because PTO examination delay has the potential to shorten the effective life of a patent, applicants are compensated for such delay by adding extra days of term to the end of a patent that has undergone delayed issuance. This is determined by calculating the period of PTO delay (if any) and subtracting from it the period of applicant delay (if any). Applicant delay is defined in the statute as "the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application."
A patent applicant has a duty to disclose to the PTO all material information that is known to the applicant. Therasense, Inc. v. Becton Dickinson and Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc). An applicant’s failure to disclose such material information can lead to a finding that the patent is unenforceable due to inequitable conduct. Id. The PTO regulations encourage submission of information before commencement of examination on the merits, so that all information can be considered when the examiner mails the first office action on the merits. This is usually done in an Information Disclosure Statement, or IDS.
At the same time, if the PTO determines that two or more independent and distinct inventions are claimed in one application, it may require the application to be restricted to one of the inventions. When that happens, the Examiner requires the patent applicant to elect an invention to which the claims will be restricted. This official action, or restriction requirement, will normally be made before any action on the merits.
The Gilead Case
In Gilead Sciences, Inc. v. Rea, an IDS was submitted before the PTO mailed a first office action on the merits, but Gilead was assessed applicant delay because the IDS was submitted after Gilead had filed a response to a restriction requirement. In explaining why it believed that this IDS constituted applicant delay, the PTO said that under the PTA regulation 37 C.F.R. § 1.704(c)(8), the submission of a supplemental reply or other paper after a reply has been filed is "a failure to engage in reasonable efforts to conclude prosecution." As a result, Gilead’s PTA was reduced by the 57-day period between the response to the restriction requirement and the submission of the IDS.