The upcoming changes to the U.S. patent law, and particularly the transition from a first-to-invent to a first-to-file system on March 16, 2013, brings with it some changes that bioscience companies should be aware of and which could adversely impact pending patent rights.

Bioscience patent applications are frequently filed as provisional applications, applications which are not examined and do not need to have claims. The provisional application must be converted to a regular “utility” application within one year of the filing of the provisional application. The lack of formalities required for provisional applications has made them particularly popular with universities and bioscience companies, where pending publication and presentation deadlines sometimes require immediate filings and the desire to stay ahead of one's competitors urges immediate, if incomplete, provisional filings. Indeed, a “cover sheet” provisional can be filed and is so named because the inventor's manuscript or data are filed without substantial change. The practice has always been fraught with danger; however, the coming changes to U.S. patent law render the practice even more dangerous and may suggest a more immediate conversion to a complete utility application and a review of pending provisional applications prior to the first-to-file transition. 

A provisional application may provide an effective priority date for all claims in a utility application (U.S. or Patent Cooperation Treaty) filed on or after March 16, 2013, only if the provisional application provides support for all claims of the utility application under 35 U.S.C. 112 (112 support). This section of the law requires that patent applicants fully disclose and support their claims to an invention. Although the requirements are relatively unchanged from the previous law, other proposed changes in the rules of practice before the U.S. Patent Office appear to indicate that a more careful examination of this priority claim will now be required and that the ability to rely on the priority of some types of provisional applications will be narrowed. Further, depending on such priority, the examination rules for an application may vary. In particular, an application may be examined under the potentially stricter first-to-file rules instead of the older first-to-invent rules.

The practical effect of the proposed rule changes is that the filing of a “cover sheet” provisional application consisting of a publication, presentation or the like may no longer provide an enforceable priority date for claims in an application filed on or after March 16, 2013, if Section 112 support is absent from the provisional application. In the case of a currently pending provisional application, a lack of 112 support may prevent a subsequent application from taking advantage of rules allowing examination under the old first-to-invent rules. As a result of such changes, applicants should consider:

1. Whether the filing and preparation of a utility, or at least a well-developed provisional, to preserve the earliest priority date possible is advisable
2. Whether such a filing should be completed prior to March 16, 2013.

Provisional applications and even “cover sheet” provisional applications will continue to be useful in the future to provide some protection for imminent disclosures or subsequent developments, as these applications protect such disclosures from being cited as prior art in subsequent applications. However, it is worth considering following up the filing of such a “cover sheet” application with another application with 112 support for all potential embodiments as soon as possible to eliminate the potential of third-party prior art and/or to allow examination under the old first-to-invent rules. The bioscience applicant must, as always, remain abreast of legal changes in a rapidly changing legal landscape.