Nov. 13, 2007
| Last August, the United States Patent and Trademark Office (USPTO) published controversial rule changes to come into force November 1. On Oct. 31, GlaxoSmithKline (GSK) was awarded a preliminary injunction by the U.S. District Court for the Eastern District of Virgina to delay the new rules from taking effect. (At press time, the hearing date had not been set.)
As set by the USPTO, the new rules would place an additional burden on patent holders and those seeking new patents by limiting the number of continuation patent applications that may be filed and the number of claims that will be examined per application as a matter of right. GSK argued that the rule changes were “not within the legal purview” of the USPTO, and would impede innovation in the pharmaceutical industry.
Rules state that patent seekers may no longer file an unlimited number of multiple continuations to describe and claim ultimate products developed from a basic pioneering patent and may no longer expect to easily obtain multiple patents to different claim sets covering different aspects of their products, a common practice in the long drug discovery process.
If the USPTO rules are upheld in the courts, there will be new issues and strategies to consider when preparing and managing an IP portfolio in order to maximize the now more limited patent rights available. Under the rules in question, applicants may only file two continuation applications and one Request for Continued Examination (RCE). Additional patent applications must be accompanied by a petition showing that the new amendment or evidence could not have been submitted during the prosecution of the earlier application. When filing a continuation-in-part (CIP) patent application, applicants must now identify all claims supported by the parent application’s disclosure. Divisional applications may only be filed if the claims were the subject of a USPTO restriction requirement that is not traversed by the applicant or based on a Suggested Restriction Requirement (SRR) filed with the USPTO. (In each divisional application, two continuation applications/CIPs and one RCE can be filed.)
In addition, no more than 25 total claims will be examined in any single application, unless a complicated examination support document is filed. The USPTO rules presume that multiple applications having the same priority or filing date count as a single application for claim number purposes if the applications include substantially overlapping disclosures, a common inventor, and a common owner.
Strategies for Managing Portfolios
For applications that have not been examined or are not subject to a restriction requirement, applicants should make sure that all disclosed inventive subject matter is claimed, adding additional claims if necessary. Then consider whether to file an SRR, await a restriction requirement, or call the Examiner to discuss appropriate restriction to the claims. The more restriction groups, the more divisionals that may be filed. Once the SRR is accepted or the restriction requirement arrives, an applicant should cancel non-elected claims and request a refund of the excess claims fees.
Applicants should organize any potentially material prior art and if they are planning to perform a prior art search, do so earlier in prosecution and submit it (ideally) before a first office action. Further, applicants should realistically consider their chances of winning an argument versus amending the claims, and consider more aggressively amending in non-final office actions in order to preserve the option to file an RCE without a petition and showing. Applicants should also consider more frequently holding interviews with examiners, so that arguments and amendments can be discussed before potentially wasting an office action response. Finally, applicants should consider making more use of the appeals process in cases where the examiner is clearly misinterpreting and misapplying the law, rather than engaging in rounds of fruitless argument trying to readjust the examiner’s view.
The new rules would also require rethinking how and when to file new applications, and what to include. Applicants should assume a CIP is not available. They should consider if it is “too early” to file on a discovery, and if it is possible to develop the invention further without triggering any bars to patentability, such as publication. Rather than file utility applications, applicants should consider relying on provisional applications to obtain filing dates and an extra year to develop the invention. For example, applicants may consider filing multiple provisionals around an invention as it evolves, wherein the provisionals are cumulative of the original filing.
Applicants should consider pursuing first those claim sets that are best enabled and appear to be the easiest to argue before the USPTO, the “low-hanging fruit,” in a serial prosecution strategy. This will buy time to conduct research for the claims that will need to have data “sworn in” and preserve the continuations needed to pursue such claims when they will be more easily prosecuted. Applicants may be able to make this easier by combining all possible inventions surrounding a discovery into a single application, and writing the initial claim set to support the most complex restriction requirement possible.
In response to the GSK objection, the USPTO issued a statement supporting the rules, to the dismay of the biotech, pharma, and university communities. The practical consequences for drug discovery will be decided in the hearing.
Jen Zarutskie is an associate at Foley Hoag. Email her at: email@example.com.
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