Washington Editor

WASHINGTON - Some scientists and intellectual property attorneys worry that existing laws associated with gene patenting may actually stifle research rather than serve the intended purpose of encouraging it.

That's on this side of the pond. On the other side of the pond, Tim Powell, a partner with Bristows law firm in London, told an audience at BIO 2003, the Biotechnology Industry Organization's annual conference, that in certain cases the British have characterized genome patenting as revolting, an invasion of privacy or a method that allows many large companies to control important patents.

If you're big pharma or big biotech you may see it differently, depending on the number of patents your company holds.

For anyone who doesn't know, the life of a patent is 20 years from the date the application is filed (it takes about two years to get approval). Under certain circumstances the patent term can be extended, according to the U.S. Patent and Trademark Office, located in Arlington, Va. The USPTO has issued 6,000 gene patents, and thousands are pending.

A four-member panel at the conference asked to discuss "Owning the Genome" essentially had the same attitude about patents and the process governing their issuance as speakers at a recent BIO briefing on the subject. What everyone seems to want is predictability at the patent office. Basically, scientists, researchers, business people and lawyers want to know 10 years in advance what is patentable - and what isn't.

As research and the art of practicing medicine advance, Reid Adler, a panel member and general counsel for the Rockville, Md.-based J. Craig Venter Science Foundation, said there will come a time when everyone will have a copy of his or her personal genome on a CD. "With respect to ownership of a genome, people own their own genomes like they own other parts of their body," Adler said.

But, what people don't own is the function of the gene or the way it is used in a nonhuman environment.

One of the larger issues here is a company's ability to attract enough research funding to actually get a patent, according to Barbara Caulfield, a panel member and executive vice president and general counsel at Affymetrix Inc., of Santa Clara, Calif. As many have stated before, if a company can't guarantee investors certain protections such as the security provided through patents, research dollars could dry up quickly.

Caulfield said the World Health Organization has questioned whether gene patents are necessary for successful innovation in health care, and whether the government actually should mediate between commercial interests.

"Do we see people deferred from research because of patents? The answer is yes," Caulfield said. "If you want to research four gene patents and the fourth patent owner sends you a nasty letter, then you research the first three and not the fourth."

Carefully crafted gene patents would remedy the obstacles to accessing certain science, Caulfield said.

But Robert Blackburn, also a panel member and vice president and chief patent counsel at Chiron Corp., of Emeryville, Calif., said many people in the field don't actually understand what it means to have a patent because they are not involved in its enforcement. "What is a patent - it's a cause of action, you can sue, you can get an injunction. When we look at gene patents, I think they are litigated at the cost of hundreds of thousands of dollars to recover a few thousand dollars."

He said the Hatch-Waxman Act of 1984 is the best example of compromising on patents. The legislation, which does not include biologics, is credited with creating the generic drug industry. Hatch-Waxman allows a brand-name company (or holder of the original patent) to file an automatic 30-month patent stay upon expiration if a generic company is seeking to produce a functionally equivalent product. In exchange, generic companies are allowed to conduct clinical trials over the 30-month extension period.

As the law stands today, brand-name companies are allowed to stack 30-month stays by filing extension requests on multiple drug patents.

The Bush administration wrote an FDA rule last fall that limits the brand-name or pioneer company to one 30-month stay. It goes into effect Aug. 18. Similar legislation is making its way through the Senate. (See BioWorld Today, June 16, 2003.)