Word comes to us from attorneys at the CCPIT Patent and Trademark Law Office that the Patent Affairs Administration Department of the State Intellectual Property Office of the PRC (SIPO) "clarified" examination procedures for pharmaceutical patent applications with respect to sufficiency of disclosure and supplemental evidence. A copy of their report can be found at the AIPLA web site this link. Clarification was apparently necessary because examiners were deviating from SIPO standards. The effective date for application of the "clarified" standards was October 17, 2013, and apply only to Office Actions issued after that date and not retroactively.
Those who practice in Asian countries, including, most notably, China and Japan, know that the support requirements ("sufficiency of disclosure") for claims to products intended for pharmaceutical use are quite stringent. And although some leeway is given with respect to generalizing specific examples, claims are much more strictly limited in China (and Japan) than, for example, the U.S. and Europe. For chemical compounds, Chinese examiners generally require claim scope to closely conform to embodiments actually reduced to practice. And the standard for data to support claims to pharmaceutical compositions comprising the compounds is quite high.
Perhaps because sufficiency of disclosure must be considered at the time of application filing, as a practical matter Chinese examiners have generally refused to consider supplemental post-filing data. But now it appears that such blanket refusal is considered inconsistent with SIPO examination standards, and examiners have been instructed that supplemental data should be considered under appropriate circumstances. But as a practical matter, exactly what those circumstances are and for what purpose post-filing data can be considered remains somewhat unclear.
As noted, the sufficiency requirement must be met at the date of filing. So supplemental, post-filing data cannot be used to rectify a deficient disclosure by establishing the technical solution of the claims. Rather, post-filing experimental data can be used to confirm that the technical solution has the use or effect alleged by the applicant and to confirm statements and facts presented in the specification.
This is all very well and good. But it's an abstraction. It remains unclear and yet to be seen as to how Chinese patent examiners will implement the standard. How will they differentiate between (a) post-filing data that merely confirms a technical solution, statement, or fact in a patent application from (b) post-filing data that itself is considered as the technical solution?
The CCPIT report gives the example of a new use of a known compound that is contrary to prior art teachings. Under such circumstances experimental evidence in the application would be necessary to establish the use (or technical solution). So, post-filing data would not be accepted to demonstrate the use if the application itself was devoid of data. This is not unlike the case in the U.S., as manifest in In re '318 Patent Infringement Litigation, where the court held a claimed method of treating Alzheimer's Disease invalid as lacking an enabling disclosure because the application contained no experimental data, even though post-filing experimental evidence supported the claim.
So it would seem that not all statements in a patent application would be amenable to proof with post-filing data. Statements of therapeutic activity may need to be supported by data present in the application as filed. But one wonders whether it could be otherwise.
What if the application provides some data? Under traditional practice pharmaceutical composition and use claims would have to conform to the scope of the compounds tested for therapeutic activity. Could post-filing data for additional compounds be used to affirm their utility and permit a broader scope of claims more commensurate in scope with the post-filing data? The answer may have to be determined on a case-by-case basis and turn on a number of factors, such as how much data is presented in the application as filed compared to the scope of claims sought, the extent to which a structure-activity relationship is provided, and the structural similarity of the claims.
It will be interesting to see how this plays out and whether appeal of examiners' decisions with respect to post-filing data will be necessary to further elucidate the practice.
