BIOTECH JOINS OPPOSITION AGAINST PROPOSED CHANGES TO CONTINUATION PRACTICE: At the beginning of the year, the USPTO announced that significant changes were being proposed to US patent practice, where one of the proposed changes was aimed at curtailing the number of continuations that could be filed from a disclosure.

The response from the patent community was befuddled outrage. The USPTO has no overt authority to limit continuations, yet it is requiring applicants to explain why amendments, arguments, or evidence could not have been previously submitted? Aside from the fact that such a requirement injects subjective elements to an apparently objective process, this heavy-handed approach unduly restricts a valuable procedure for practitioners.

For electronics and software companies, the use of continuations is practically a necessity - the pace of development in the industry, coupled with the fact that most applications will wait 2-3 years before receiving a first office action from the USPTO, forces applicants to supplement original filings to fully cover the intended scope. Contrary to the USPTO's position, there is often no "fault" to be attributed to applicants for not contemplating every anticipated technological variation and changes in market conditions. Of course, most applications will have broad ranges of disclosure to handle the technical side of things, but even this is not perfect in every case. And applications that are originally filed on "secondary" technologies can quickly transform into "blockbuster" status (and vice-versa). The patent process should remain flexible enough to accomodate such developments without any undue hardships upon the applicant.

For biotech companies, the same concerns apply, albeit with a twist. In any case, biotech companies are also complaining that the proposed continuation rules are the wrong approach. In this industry, product development timelines can reach 10 to 15 years and can cost upwards of $500 million. Accordingly, continuing applications are needed to protect technologies that can take more than a decade to bring to market. The biotech patent process not only covers product itself but also the process to make the product. As the 12- to 15- year cycle continues, different matters about the product, process and its ultimate application are learned. All of this would require applicants to revisit applications and provide updates on any new developments. According to Todd Gillenwater, vice president of public policy at the California Healthcare Institute, a life sciences trade group in La Jolla,"If you restrict continuing applications, it will force the industry to file overly broad patents to catch everything."