Supplemental Examination Requests: Benefits and Limitations, Strategic Use

Description

Supplemental examination permits patent owners to submit prior art and explanatory statements to the USPTO after patent issuance. Ushered in by the America Invents Act, under 35 U.S.C. §257 patent owners may file a request for supplemental examination and have a determination within three months as to whether the information presented raises a substantial new question of patentability and warrants re-examination. By statute, anything considered by the USPTO in the supplemental examination is barred as the basis for a later finding of inequitable conduct.

There are limitations and potential downsides. A supplemental examination request is not available if the basis was already raised as an inequitable conduct allegation in a patent litigation or in a paragraph IV notice letter. Moreover, any cleansing effect of a supplemental examination occurs only once the supplemental examination proceeding and any ex parte re-examination ordered therefrom has drawn to a close. There also is a steep fee for the procedure, and the USPTO requires patent owners to make, on the record, what may turn out to be fairly substantial admissions regarding putative errors made during prosecution.

Counsel to pharmaceutical inventors may be able to reasonably predict when they will receive patent validity challenges, leveraging the interplay between the patent system and regulatory approval of new pharmaceutical products. As a result, pharma patent owners may benefit by submitting a supplemental examination request well before their patents become the subject of litigation.

If used strategically, supplemental examination may provide a powerful tool for patent owners. Counsel should evaluate the enforceability of valuable patent portfolios to determine whether such a request for supplemental examination is an appropriate strategy.

Listen as our authoritative panel of patent attorneys examines supplemental examination requests filed to date, both generally and with a focus on chemical patent supplemental examination requests. The panel will discuss the limitations of supplemental examinations and the outcomes of completed requests. The panel will also provide guidance on the strategic use of supplemental examinations.