Patent Baristas: USPTO Biotech Backlog: Bad, Getting Worse, No End in Sight:


The San Francisco Business Times ran an article reiterating what patent practitioners already know. That is, the increasing backlog at the U.S. Patent & Trademark Office is bad, it's getting worse and the new set of proposals meant to reduce the waiting time will not provide relief.

The backlogs are an increasingly serious issue for biotechs. It can take patent examiners up to 15 months to begin reviewing an organic chemistry patent application. It can take more than three years to get a drug application to a patent examiner. Once a review has begun, the USPTO can take several more years to grant a patent.

As we've discussed, the new rules under consideration would allow just one follow-on to a pending application. A subsequent application would have to include an explanation as why it was not submitted previously. A second, related proposal would limit an application to 10 claims, which are statements describing the heart of the invention. The USPTO is currently reviewing comment on the proposed rules and will issue final regulations in the fall or winter.

Admittedly, almost one-third of new applications in 2004 were for follow-on applications but that's not necessarily a bad thing. Part of the reason for continuations is to allow an applicant the opportunity to carve our the proper claim scope. That is, coverage that would not be too overbroad or too narrow but just right.

Many industries besides biotech rely on obtaining adequate patent protection in a timely fashion. However, biotech companies are particularly affected by both the backlog and the proposed rule changes. And, perhaps no other industry is as dependent upon patents as is the biotechnology industry. A biotechnology company can spend hundreds of millions of dollars over more than a decade before seeing any revenue. The long development time and intensive capital needs make the early stages of development critical in terms of patent protection in order to entice investors to get involved in what is already an incredibly risky venture. Thus, a flexible patenting system that allows companies to protect the full scope of their inventions through the filing of continuations is critical.