Intellectual Property - AIA Series

New with the America Invents Act ("Act") is a procedure, available only to a patent owner, for supplemental examination of an issued patent. This is the first and only procedure by which inequitable conduct that occurred during the procurement of a patent may be remedied.

Supplemental examination of a patent is invoked by a patentee filing a request to consider, reconsider, or correct information believed relevant to the patent. Such information is not limited to prior art patents and printed publications, as it was in reexamination proceedings before the Act - it may include any information. For example, a request for supplemental examination may now include any ground of unpatentability, such as statements asserting that the specification fails to contain sufficient written description or enabling description of the claims. That is not the case with ex parte reexamination.

If the U.S. Patent and Trademark Office determines that the information raises a substantial new question of patentability, then the Office must order supplemental examination. That is the same threshold showing required for ex parte reexamination.

Supplemental examination proceeds as an ex parte reexamination with one major difference. The patent holder may not file a statement in response to the Office's order for reexamination and may not submit claim amendments or new claims for consideration in response to the order.

The main advantage of supplemental examination, over ex parte reexamination, is its estoppel effect against future charges that the patent was procured through inequitable conduct and, therefore, is unenforceable. Inequitable conduct is alleged in approximately 80% of infringement cases, is expensive to litigate, and usually fails. The Act is intended to benefit patentees and aims to limit the overuse of the inequitable conduct defense.

Specifically, the Act provides that a "patent shall not be held unenforceable on the basis of conduct relating to information that had not been considered, was inadequately considered, or was incorrect in a prior examination of the patent if the information was considered, reconsidered, or corrected during a supplemental examination of the patent." That provision acts to prevent parties from asserting inequitable conduct against a patent holder for innocent failure to cite a prior-art reference to the Office during prosecution if it is later cited during supplemental examination. But, even more interestingly, it also provides a way for a patent holder to erase prior inequitable conduct, for example, due to non-disclosure of a prior-art reference during prosecution. Past case law held that inequitable conduct could not be cured. Now it can be.

The ameliorative effects of supplemental examination, however, have limits. If an allegation of inequitable conduct has been pled with particularity in a civil action or if the patentee received a Paragraph IV Notice of Factual and Legal Basis in connection with an Abbreviated New Drug Application (ANDA) before supplemental examination is requested, the usual ameliorative effects of the supplemental examination do not apply to the allegations in the pleadings or Paragraph IV Notice. (Oddly, the allegations in an earlier received Paragraph IV Notice in connection with a §505(b)(2) new drug application are not explicitly within this exception.)

Supplemental examination is also not without risk. If, during the course of supplemental examination, the Office becomes aware that a material fraud on the Office may have been committed in connection with the patent, the Office must refer the matter to the Attorney General, who may bring criminal charges.

The major effects of supplemental examination are threefold. First, it provides a way for a patent holder to cite information to the Office and foreclose any later, possibly frivolous, attempt by another to use that information as a basis for a charge of inequitable conduct. Second, it allows patent holders to cure prior inequitable conduct. Third, it provides a mechanism other than reissue to have the Office consider patentability issues, such as written description and enablement issues. But, unlike in reissue, there is no requirement in supplemental examination to admit that there is an error in the patent.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.