Friday, September 7, 2007

New USPTO Continuation rules and the implications for Ag Biotech research

The U.S. Patent and Trademark Office (USPTO) released new rules regarding continuations this past August 21, 2007. The new rules, in general, limit an applicant’s opportunities to gain patent protection for any given invention. The number of patent applications that can be filed on one invention are restricted to one parent application followed by two continuations or continuations-in-part (CIP). Also, only one request for continued examination (RCE) in a patent family is allowed, and the number of claims in any patent application is restricted to 25.

There is still some debate, as to how many patents a year will be affected by the new rules. Biotechnology industry representatives are protesting, feeling that a more liberal view of continuations is required for the biotechnology industry. In general, continuations are most popular in the chemical, pharmaceutical and biotechnology fields. Continuations accounted for 70-80% of patents awarded to the top biotechnology companies, in the period from 1995 - 1999. With these new rules restricting applicant’s to filing two continuations, it may be that the biotechnology industry will be severely impacted.

Some industries have a large expenditure of both time and money when obtaining experimental data, especially when human or animal experiments are involved. Continuations help applicants in these situations by allowing an applicant to file one original application, and then subsequent applications for any further claims supported by new experiments. Without an opportunity for the applicant to file a continuation, the ability of an applicant to satisfy all statutory requirements to obtain a patent may be severely restricted.

Some feel the new restriction on continuations will particularly affect small biotechnology companies. Dr. Tom Herlache from the Office of Intellectual Property at Michigan State University (a PIPRA member), believes that the new rules will essentially force applicants to bundle inventions together “so that they do not become prior art against each other”. He feels that the new rules regarding RCE’s “would likely greatly extend patent pendancy and patenting costs”, which would in turn “decrease licensing opportunities somewhat”.

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