By Donald Zuhn --
It took a bit longer than many members of the patent bar expected, but the new continuation and claims rules, which were preliminarily enjoined on October 31st by Judge James Cacheris of the U.S. District Court for the Eastern District of Virginia, and the patent reform bills passed by the House and before the Senate, are finally starting to draw wider attention from those in the biotech and pharma community. One example of the industry's increased focus on the new rules is a report by Amy Coombs in this month's issue of the journal Nature Biotechnology.
Although the article does a good job of introducing the new rules and patent reform issues to a non-legal audience, perhaps not surprisingly, it takes a few missteps along the way. For example, in discussing the limit on continuations resulting from the benefit claims limits of new Rule 1.78(d) (see Patent Docs report), the article states that "[t]he main concern for drug developers is that limiting continuations will make it more difficult for them to establish utility," explaining that applicants may require more than two continuations in order to buy more time to, among other things, "collect additional clinical data." However, as any biotech prosecutor who has had to overcome a utility rejection knows, if an application does not contain an assertion of a specific, substantial, and credible utility (or readily apparent well-established utility), post-filed data establishing patentable utility will be of very little use in overcoming the utility rejection.
In addition, by contending that the new rules, if implemented, will limit total claims to 25, independent claims to five, and the total number of continuations per application family to two, the article glosses over the U.S. Patent and Trademark's strongest argument against a permanent injunction: namely, that there are no hard and fast limits on claims or continuations. By so describing the impact of the new rules, the article may provide those in the biotech and pharma industry with too rosy a picture of the final outcome in the consolidated cases of SmithKline Beecham Corp. v. Dudas and Tafas v. Dudas. (While experienced patent prosecutors understand that the mechanisms provided by the new rules for securing additional claims and continuations - ESDs and petitions with a showing - are illusory, these mechanisms nevertheless allow the Patent Office to argue with a straight face that the new rules do not limit the number of claims an applicant can present or the number of continuations that an applicant can file.)
Notwithstanding the missteps described above, the article provides some useful and interesting information. With respect to the value of continuation applications in the biotech and pharma industry, the article notes that 41% of drug patents that issued between 1995 and 1999 were based on continuations, whereas only 22% of patents that issued in the mechanical engineering arts in this same time period were similarly based on continuations. In addition, the article states that about 30% of the 467,000 applications filed in 2007 were continuations.
The article also poses a question that has likely been on the tongues of all biotech and pharma prosecutors since the new rules were published on August 21, 2007: what took the industry so long to realize that the new rules would create serious problems? Outside of crediting the information technology industry's lobbying efforts, however, the article does not offer any new insights into the biotech and pharma industry's reluctance - until GSK entered the fray in October - to mount a strong attack on the new rules or, thus far, the patent reform bills passed by the House and before the Senate.
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