New patent rules hurt biotech?

Changes to streamline patenting process could add to cost, time, experts say

By | August 21, 2007

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 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
T. Agres, "USPTO proposes controversial patent filing changes"
Ronald Eisenstein
Jon Soderstrom
Carl E. Gulbrandsen
E. Silverman, "The trouble with tech transfer," The Scientist, January 1, 2006.
USPTO announcement


August 23, 2007

The comment of Carl E. Gulbrandsen may correctly identify the prime motivation for the rules change (reduce backlog) but may be overly optimistic in the belief that backlog will be significantly improved because of the rules change.\n\nData of the USPTO for FY 2005 showed that there were 63,000 continuing applications, which included 44,500 cons/cips and 18,500 divisionals. Of these, 11,800 were second, or subsequent, applications. Separately, there were 52,000 RCEs, of which 10,000 were second, or subsequent. Thus, 21,800 applications of 384,228, were second or subsequent, which is 5.7%. As for FY2004, RCEs were the single most abundant ?continuing? form, 52,000 of 384,228 [13.5%]. All ?continuing? forms combined constituted 115,000 of 384,228 [30%].\n\nOne notes that the "target" of the initial rules change (second or more filings of continuing applications) comprised only 5.7% of all filings. The modified rules will impact still fewer filings. Separately, the major continuing application form is the RCE. RCE's are filed when the examiner and applicant can't reach agreement over the claims as presented. That is where the major problem is.\n\nThere has been a lot of misinformation about the underlying reasons for the rule changes (see 88 JPTOS 743 for discussion of faulty reporting by Science). Separately, it is quite possible that there will be a legal challenge to the new rules.\n(for example,
Avatar of: Dr.Raam, Shanthi

Dr.Raam, Shanthi

Posts: 43

August 24, 2007

I agree with Dr.Ebert. Restricting the number of claims and continuation in part applications will not solve the problem of back log that USPTO is experiencing.As a matter of fact, such a rule creates an uncomfortable bottleneck by restricting number of claims on one hand and the times you can apply for continuation applications on the other. It is similar to a traffic cop carrying two stop signs and stopping the traffic from both his right and left side. However, this rule will make the applicant wait till all data are collected to be included in the first application instead of hurrying to apply for the concept with minimal data on hand.\nThe only way the issue of back log can be addressed successfully is to announce a moratorium on new applications for a period of six months to a year- new applications could be registered but will not be responded to by USPTO for a period announced in the moratorium. This will give sufficient room to deal with the back log and start with implementation of new rules created to prevent such a back-log in the future. \n

August 27, 2007

Of the text --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,-- divisional applications are NOT re-submissions of previous applications. Divisionals arise from a restriction requirement issued by the USPTO requiring the patent applicant to split up his invention. To the extent they represent added work, they are added work created by the USPTO. It is the claims of the patent application which define the invention, and with divisionals the USPTO forces the applicant to create applications with the same specification but with different claim sets. With continuations, the applicant creates different claims, which must be supported by the initial parent specification. No new detail can be introduced. See 88 JPTOS 743. Only with continuations-in-part can the applicant introduce new detail. With RCEs, the applicant is most limited. RCEs only continue previous discussion between applicant and examiner. The applicant cannot introduce claims to different embodiments in an RCE. That RCEs are the most abundant continuing form points directly to "where" the problem at the USPTO resides. \n

September 3, 2007

Of the Gulbrandsen text --"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"--, note that Professor Mark Lemley of the Stanford Law School was quoted by Stuart Weinberg of Dow Jones Newswire on August 23, 2007 as saying the new rules "will affect 10 applications a year, maybe 50, out of 450,000 [applications]." If Lemley's guess on the impact is accurate, then Gulbrandsen's belief that this will significantly impact the backlog problem is purely whimsical. \n\nOf "getting more patents," note text appearing in the San Diego Business Journal on 3 September 2007: \n\n--Currently, the number of patent applications pending has reached 750,000, according to Rankin Byrne [USPTO spokesperson]. She says the agency has had to limit the number of patents it allows each year. --\n\nIn passing, note Gulbrandsen currently sits on an advisory committee to the federal Patent and Trademark Office [USPTO]. See for example\n\n\n[see also various posts on IPBiz.blogspot about the continuing application issue.]

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