WASHINGTON - Representatives of the biotech industry want a U.S. Patent and Trademark Office that's predictable, able to enforce patents and staffed with enough knowledgeable employees to swiftly move applications through the process.
And the patent office probably wants the same thing. But for the biotechnology and pharmaceutical industries, those strengths are particularly important given that millions of dollars and decades of research and development are invested in products that may never make it market.
"The process has to be predictable because it does us no good in a 10-year cycle to find that there are sudden rule changes that we can't adapt to," James Davis, senior vice president, general counsel and secretary of Rockville, Md.-based Human Genome Sciences Inc., said.
Davis was a speaker Friday at a Biotechnology Industry Organization briefing on the role of gene patents in health care product development.
Davis said Human Genome Sciences was founded a decade ago to treat and cure diseases by bringing new gene-based products to market. To date, the company has 1,000 employees, eight products in the clinic and has raised about $2 billion in funding.
"How did we raise this money? Of course it's our research, but there also has to be tangible proof that you are going to be able to get to the market and make money. What has allowed us to do that is the patent system," he said. "We need the patents to convince investors that they will get their money back."
Indeed, Jeff Kushan, an attorney representing South San Francisco-based Genentech Inc., characterized it like this: "If I spend the money today, am I going to have rights down the road. If there's a change that looks at removing eligibility - that's an earthquake and it would have a dramatic impact on the industry."
The PTO certainly isn't in the business of creating earthquakes. In fact Jasemine Chambers, a director at the patent office, said the office's purpose is to encourage invention.
Generally, she said, the term of a patent is 20 years from the date the application is filed (it takes about two years get approval). But under certain circumstances, the patent term can be extended or other adjustments can be made.
Kushan said there's some confusion and concern about gene patenting, though. "When you find a gene, you have to find a way to use it in a nonhuman environment."
Chambers said a gene patent "contains claims drawn to nucleic acids that have been isolated and are distinguishable from those found in nature. Patents to nucleic acids do not cover the nucleic acids as they exist in nature. Instead, they are drawn to molecules that have been manipulated by the hand of man."
She said there are 6,000 issued gene patents, and thousands more pending.
Regarding all pending patents, it has long been known that the office has a hefty backlog. James Rogan, PTO director, told a House subcommittee recently that the backlog could reach in excess of 1 million by 2008 (double today's amount), if he can't get access to PTO money raised in user fees.
Under current law, some PTO revenues are diverted to pay for unrelated federal programs. Rogan wants the money to pay for an additional 3,000 patent examiners and to accelerate the processing time from paper to e-government processing, among other things.
If patent applications continue to pile up without new examiners to review them, processing time could reach three to four years, Rogan told the subcommittee.