WASHINGTON A House Democrat introduced legislation that would allow scientists to conduct research using patented genetic sequence information without obtaining permission from the patent’s owner.
Furthermore, another section of the proposed bill (HR3967), introduced by Rep. Lynn Rivers (D-Mich.), allows “medical practitioners” to freely use patented genetic diagnostic tests without fear of lawsuits.
When she introduced HR3967 about two weeks ago, Rivers told reporters that much of her concern stems from the fact that the U.S. Patent Trademark Office has issued about 8,000 patents on genes or genetic material. “There is little doubt that most of the significant claims on our genetic code will be tied up as private property within a very few years,” she said.
So Rivers, along with co-sponsor Rep. Dave Weldon (R-Fla.), introduced legislation that has intellectual property attorneys and lobbyists cringing. Weldon is known in science circles for his bill (HR2505) that would ban all forms of cloning, including therapeutic cloning.
Lila Feisee, director, federal government relations and intellectual property, for the Washington-based Biotechnology Industry Organization, characterized the Rivers legislation as an unnecessary measure.
“We think the bill is sort of a solution [to] a problem that doesn’t exist,” Feisee told BioWorld Today. “This bill would allow a university to take my patent sequence and essentially develop their own test using my sequence without getting my permission, and without fear of infringement.”
Indeed, Bob Palmer, democratic staff director for the House Committee on Science, told BioWorld Today that the bill, known as the “Genomic Research and Diagnostic Accessibility Act of 2002,” simply codifies what BIO says is going on in the real world today allowing a scientist to use a patented sequence for research purposes only.
“Now if they come up with something like a commercial product, they still have to go back to the patent holder and negotiate the rights to the licensure in order to develop [the product],” Palmer said. “BIO says we don’t need a research exemption because nobody prosecutes anybody anyway. My response to that is: If it’s not threatening, then let’s make it statutory and put into law what current practice already is.”
But Feisee countered with: “It’s a slippery slope. How are you going to write a bill that’s not as broad as the sun? We don’t see any need for it; they haven’t made a case that there’s a problem.”
Opponents, though, would say that advancements in science are being slowed by requiring researchers to jump through hoops simply for permission to do their jobs.
In fact, Palmer said, under current law, researchers are left with three choices.
“They either stay away from the research, or they just do the research and don’t tell anyone, or they go to the patent holders,” he said.
BIO said patents often are the only assets biotechnology companies have to attract the capital needed to develop life-saving products. In a letter to Rivers, BIO’s president, Carl Feldbaum, said, “Any attempt to undermine patent protection on genetic materials will be detrimental to our companies’ survival. HR3967 would diminish the incentives patent laws provide to conduct genomics research and develop genetic tests.”
The other section of the bill, which involves diagnostic testing, is an extension of a 1996 law passed by Congress that permits patents on surgical procedures, but prohibits lawsuits for infringement on those patents. Before that law was passed, Palmer said, “You would be faced with a situation where a doctor said Gee, I would love to do this new procedure to save your life, but I can’t because someone else owns the patent.’”
Rivers’ proposal to allow “medical practitioners” to use diagnostic test without permission begs the question of just how to define a medical practitioner.
Palmer said there are a growing number of angered clinicians, pathologists, medical groups and doctors because companies are controlling genes used for diagnostic purposes. And remember, he said, the human genome project essentially was completed with taxpayer money (with the exception of Rockville, Md.-based Celera Genomics Group’s role in sequencing the human genome).
“We have no intention of stopping someone from developing a drug or developing a kit or a device based on a gene sequence this bill would not affect that in any way, shape or form,” Palmer said.
Craig Kaufman, an intellectual property partner with the law firm Orrick, Herrington & Sutcliffe in Menlo Park, Calif., told BioWorld Today that the Rivers bill would have a profound effect on the development of genetic diagnostic tests.
“The difference in this legislation and current law is that this would remove a whole class of diagnostic tests developed using DNA technology from either human DNA or DNA of human pathogens from any meaningful patent protection,” he said. “You could still obtain a patent, but it would be, in effect, unenforceable in the market because you couldn’t exclude anybody from selling repeated diagnostic kits.”
The legislation is written prospectively, and does not include current patents, Palmer said.
And while he concedes that private money does move research along more quickly, Palmer said if the legislation passes and causes biotechnology companies to back away from such research, there are plenty of hospitals, laboratories and clinics that would be willing to take up the slack.
Echoing points made by BIO, Kaufman also said the legislation is unnecessary. “I think a better balance is struck by the Hatch-Waxman bill back in 1984. It provides companies incentive to challenge patents and it clears the good patents from the bad.”
Given the current climate in Washington, Feisee said it’s unlikely that the Rivers legislation will make it far this year.
“My sense is that there’s not much traction on this,” she said. “The problem is that any perception of a problem could cause devastating blows to our industry, so even though nothing may come of it, just the talk of things like this causes huge problems for us.”