New patent rules hurt biotech?

The US Patent and Trademark Office (USPTO) will today (Aug. 21) issue new rules intended to streamline the patenting process. But the change will also make it more costly and time consuming for universities and biotech companies to secure rights to their life sciences discoveries, patent experts say.

The new rules, to be published in today's Federal Register, will restrict the number of times patent applications can be re-evaluated and will also limit the number of claims contained in any one application. Inventors will be limited to two new continuing applications, through which they can add additional claims to the same patent, and only one request for a continued examination, which an inventor can file after the patent office has rejected his or her patent application. The rules, which will take effect Nov. 1, 2007, also restrict to 25 the number of claims in any single patent submission.

In its original proposal, published Jan. 3, 2006, the USPTO sought one continuing examination application and 10 representative claims, but modified these in response to "extensive" public comments, the agency noted yesterday.

Currently, applicants can file an unlimited number of continuation requests accompanied by new arguments and evidence to support their claims. That strategy is frequently employed by universities and biotech companies when the full scope of their discoveries cannot be immediately established or when researchers seek to extend patent coverage from one or two new molecules to an entire class of compounds.

Under the new rules, applicants must demonstrate why an additional continuation is necessary and provide supplementary information to support additional claims.

"It's going to have a big effect on biotechs, universities, and nonprofits because it limits their ability to fight with the PTO," said Ronald Eisenstein, a partner in the biotech and intellectual property group at the law firm Nixon Peabody in Boston. "If all that the patent examiner has to say is no, it's going to get much harder to negotiate, and will lead to applicants having to file costly appeals," he told The Scientist.

Still unknown are USPTO's criteria for approving requests for continuations and additional claims. "There will be some cases, probably ones with significant claims, that we would like to continue to pursue that may end up being impacted," said Jon Soderstrom, managing director of the Office of Cooperative Research at Yale University. "The question is, what are the grounds of actually receiving an extension? That's the critical issue - the criteria that they will enforce," he told The Scientist.

For several years the patent office has been struggling to reduce its backlog of cases - currently around 750,000. Nearly one-third of the 355,000 new patent applications received in fiscal 2004 involved resubmissions of previous applications - a situation patent officials say impedes productivity and delays the issuing of new, well-qualified patents.

"Some accommodation has to be made for the bad situation due to the backlog," said Carl E. Gulbrandsen, managing director of the Wisconsin Alumni Research Foundation, the tech transfer office of the University of Wisconsin-Madison. "I would rather give a little bit on the front end [in terms of restricting the number of continuations and claims] and hope that we get more patents on the back end," he told The Scientist.

"These rules better focus examination and will bring closure to the examination process more quickly, while ensuring quality and maintaining the right balance between flexibility for applicants and the rights of the public," USPTO Director Jon Dudas said in a statement yesterday.

Ted Agres
mail@the-scientist.com

Links within this article

"Changes To Practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent Applications; Final Rule," Federal Register, Aug. 21, 2007
http://a257.g.akamaitech.net/7/257/2422

T. Agres, "USPTO proposes controversial patent filing changes"
http://www.thescientist.com/article/display/23177

Ronald Eisenstein
http://www.nixonpeabody.com/attorneys_detail1.asp?ID=58

Jon Soderstrom
http://www.yale.edu/ocr/about/who/soderstrom.html

Carl E. Gulbrandsen
http://www.warf.org/contact/staff.jsp?staff_id=52

E. Silverman, "The trouble with tech transfer," The Scientist, January 1, 2006.
http://www.the-scientist.com/article/display/39379

USPTO announcement
http://www.uspto.gov/main/homepagenews/bak2007aug20.htm