Biotech overwhelms U.S. patent office - The Business Journal of Milwaukee:

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Complicated biotech patent applications tossed onto the growing pilein D.C., are partly responsible for a backlofg of some 500,000 pateng applications at the Patent & Trademark Office. In five the backlog is projected to reach1 million, absent significantf reforms. U.S. patent pendency time frames average more than twoyeard -- twice that for some typese of filings. "I don't believe the patent office has been adequatelg staffed for morecomplex applications," said Rob Fincher, directoe of the technology commercialization office at the Universityt of Georgia Research Foundation Athens, Ga. "It has to be a frustratingh placefor them.
" Biotech applicationas are generally the most difficult to get he said. "The more complex they are, the more complex the process," Fincher said. "Sciencwe has been so explosive in the last 20 yearsx it has created possibilitieswe couldn'y have anticipated. Biotech has expanded the order of magnitude in what kindas of things might be possible to and even created disputesz over whatis patentable." Problema can arise when a patent describes one invention but also claims otherd dependent uses of the invention.
If the patenft examiner believes the filing representsw more thanone invention, the patentt office requires a completely different Besides delay, that means more applicatioj and attorney fees. Applicants don't always agree with the logicf examiners use in restricting inventions and pateny attorneys argue their addingadditional cost. Clark Sullivan, an attorne y with King & Spalding L.L.P., Washington, represents a number of clientw inpatent work.
Securingt patents in a timely fashion is especially because a meaningful patent portfolio is essentiakl toobtain funding, he "I haven't had much difficulty with narrow such as in the pharmaceutical arena, where the examininv core is sufficiently robust and there are plentyt of examiners," he said. "The examineres are very smart -- they're all Ph.D.s -- but when more biotechnologicao developments and inventionsare involved, they generall don't have that level of Sometimes the patent office gives examiners more time to Sullivan said.
A year can easily pass between filinfg a provisional patent and receiving a response on how thePaten & Trademark Office intends to divided the application into additional filing requirements. The offics has formulated a program to speed the biotechnologypatent process. A road map for digginyg out of the workloaddilemmqa -- the 21st Century Strategic Plan -- is slowl y getting off the ground, said Brigid Quinn, deputhy director for public affairs at the Patent & Trademarkj Office. Part of the however, is a proposed restructuring of patent fees that requirezcongressional approval.
"The fee proposal will give us resourced to fully enactthe plan," Quinn "We remain hopeful the bill will be enacteds by the end of the fiscapl year, in October." Some initiatives can be take with existing resources, such as more traininb of examiners and changes in the patent review procesx to make it more useful as a traininfg tool, she said. Moreover, the Patentr & Trademark Office is convertinh to automated application and processinyof applications, with a target for full electronic implementation by 2004.
Unti improvements take hold, however, biotecy firms will likely continue to have mixedr success in getting timelypatentr approvals, usually depending on the type of technology involved. For gene research is more likely to create delays because of the many variationa ofthe discoveries, said Kirby Black, senior vice president of researcg and development for CryoLife Inc., Kennesaw, Ga. "It depends on what patentz we file and which examiner we get as towhethef we're going to have a lot of he said. CryoLife has generallyh had timely reviews, he said, emphasizingv that some time can be cut from the proces s by ensuring that a patent offerssomething new.
One responsibilitt of examiners is toreview "priofr art," establishing that the patent is novel. CryoLife performs a priot art search, as does its patent attorney Black cited two drug patents filed recentlt by CryoLife subsidiary AuraZymePharmaceuticals Inc. that received a responsd from the patent office less than nine monthsd after the provisional patent wasfiled -- a time frames he considers acceptable.