Over the next few months, a member of the House of Representatives will be searching for a likeminded Senator who can introduce legislation similar to a bill currently stagnating in the House aimed at banning gene patenting.
The Congressman, Rep. Xavier Becerra, a Democrat from California, introduced the “Genomic Research and Accessibility Act” in February with Rep. Dave Weldon, a Republican from Florida, to “prohibit the patenting of human genetic material” in the US.
“Notwithstanding any other provision of law, no patent may be obtained for a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies,” the House bill (H.R. 977) states.
The bill has stagnated on Capitol Hill since March 1 when the House Committee on the Judiciary referred it to the Subcommittee on Courts, the Internet, and Intellectual Property.
But at a conference on gene patenting hosted by Johns Hopkins University’s Genetics & Public Policy Center last week, opponents and supporters of the legislation voiced their opinions.
Steve Haro, senior advisor and communications director to Becerra, urged participants to contact lawmakers to support the bill, claiming that the bill is critical to spurring scientific innovation and protecting people’s ownership over their own genes.
“One-fifth of the genome is patented; 20 percent of everything that makes up you, me, my friends on this stage is owned by somebody else,” Haro said.
However, F. Scott Kieff, Washington University School of Law professor and Hoover Institute fellow, told Pharmacogenomics Reporter this week that he thinks the bill hasn’t made any movement in the House because “most people recognize that it just is not a good idea.”
Opponents of gene patenting are employing scare tactics to suggest that not passing the bill would stifle innovation and hand ownership over people’s genes to companies, said Kieff at the GPPC meeting.
Rather, passing the bill would “help one group of companies at the expense of American innovation, economic growth, and jobs,” he said. According to Kieff, the House bill, by banning “upstream patents” of genes, would provide an unfair market advantage for large pharmaceutical and diagnostics companies, since they would not have to pay for isolated versions of previously existing DNA used to develop their patented drugs and diagnostics.
However, the bill would fail to compensate small companies, universities, and non-profit research organizations that own patents for the versions of the pre-existing DNA they have isolated.
“This bill targets so-called upstream patents in the field of basic biotechnology. But terms like ‘upstream’ and ‘downstream’ are merely selfish synonyms for the things I buy and the things I sell,” Kieff said. “Of course, everyone would like the things they buy to be free and the things they sell to be expensive. But we shouldn’t write laws in this country to favor some large politically powerful players who just want to get for free the things they use in their businesses so that they can charge for the things they sell in their businesses.”
Other panelists took the view that continued gene patenting would hinder innovation. Barbara Caulfield, executive vice president and general counsel for Affymetrix, noted that US law doesn’t allow for the ownership of natural phenomena such as DNA isolates.
“How do people innovate if somebody owns the basics?” Caulfield posited, who likened gene patenting to patenting iron when it is isolated as a naturally occurring metal in the environment for use in the lab.
“If you isolate — if you develop a test that goes with a drug that treats that condition — you can own the relationship between those two and you can own those two,” she added. “But you can’t own the DNA itself.”
Caulfield argued gene patents would block innovation by allowing certain companies to monopolize ownership of all drug and diagnostic products related to a particular marker.
The fear of monopoly was the overarching reason why European competitors of diagnostic company Myriad protested the firm’s patents for BRCA1 and BRCA2 mutations linked to breast and ovarian cancer susceptibility. Myriad’s patents had sparked controversy among European research organizations that had developed their own methods of BRCA1 testing and no longer wanted to pay the $2,600 fee Myriad was charging to analyze samples for the mutation in its labs.
In 2004 the European Patent Office revoked Myriad’s patent covering methods to diagnose patients’ predisposition to breast or ovarian cancer using the BRCA1 sequence. In 2005 the EPO decided to maintain Myriad’s patent for the BRCA2 mutation in amended form.
While the original patent covered 34 mutations and the diagnostic methods for detecting these mutations, the amended patent covers “the use of a particular nucleic acid carrying a mutation of the BRCA 2-gene which is associated with a predisposition to breast cancer.”
At the GPPC conference, Caulfield noted that the BRCA patent case has “been a cause celebre” because people question the fairness of awarding gene patents. “Every discovery of natural phenomena always starts with some brilliant person isolating the natural phenomena,” she said. “Can you patent a natural relationship that occurs in human nature, that occurs in the body? And the answer to that is, no, under the patent law itself.”
It was following the landmark 1980 Supreme Court decision in Diamond v. Chakrabarty – which held “anything under the sun … made by man” is patentable – that the US biotech industry began to flourish. However, Chief Justice Warren Burger stressed in his opinion that the “relevant distinction is not between living and inanimate things," but between natural phenomena and human-made inventions.
Advocates for gene patenting often cite the biotech boom after Diamond v. Chakrabarty to suggest that IP protection is a catalyst for economic growth, innovation, and research collaboration. While the US had few biotech firms prior to 1980, by the end 2005 there were 1,415 biotechnology companies, 329 of which were publicly held. According to the latest figures from the Biotechnology Industry Association, the market capitalization of publicly traded US biotech companies in 2005 was $410 billion.
According to Kieff, the $5 trillion US patent system facilitates that inventions are used after they are made. “Getting inventions put to use requires … complex coordination among a lot of different folks — inventors, venture capitalists, managers, laborers, factory workers, skilled laborers, other technologists — and getting all of those people to dance with each other is what” patents are all about, Kieff said at the meeting.
IP ownership battles can often make or break companies’ mergers and acquisitions strategies. Roche’s unsolicited — and unwelcome — bid to purchase 50.1 percent of Ventana is meant to enable Roche to control the Tucson, Ariz.-based company’s IP, which would make it easier for Roche to offer a more complete suite of services and fuel Rx-Dx collaborations with other pharmaceutical companies [see PGx Reporter 06-27-2007].
However, gene-patenting opponents take the view that allowing a company to monopolize product development related to a particular genetic target will restrict US companies from engaging in international research collaborations, limit patient choice for drug and diagnostic products in certain disease markets, and slow advances in gene-based research.
“Let’s remember that the software industry in the United States had no patents in the 1970s and 1980s, and ended up with, what: Microsoft, a single large player.”
“The BRCA1 patent, if nobody can write a test … for the relationship between that particular piece of DNA and breast cancer … then how do you get a second opinion on whether that test really covers the right thing?” Caulfield said “If we have all of this rubric around DNA patents in the US, then the really good research is going to be done in places where they have more open ability to innovate at the test level” allowing doctors to buy different kinds of tests.
Specifically, Caulfield pointed out that gene patenting may become a barrier for test makers when developing different types of genetic tests, such as multi-gene tests or diagnostics based on gene copy number.
“If somebody has one copy of a particular set of five genes and somebody else has two, it may make the difference between propensity or susceptibility,” Caulfield said. “If you leave the ownership at the test level, then somebody who’s testing for copy number is different from somebody who’s just testing for BRCA1.”
In Kieff’s view, however, it is the lack of patent protection that leads to monopolies. Without patent protection, the biotech industry may create its own Microsoft, he warned.
“Let’s remember that the software industry in the United States had no patents in the 1970s and 1980s, and ended up with, what? Microsoft, a single large player,” Kieff said. “So … the absence of patents in software was correlated with a single large player, and the presence of patents in biotechnology was correlated with a massive increase in competition and a massive increase of access.”
In an effort to maintain open access to the genetic information needed to develop their own proprietary tests and drugs, large pharma and biotech companies are employing scare tactics so the public and Congress will oppose genetic patenting, according to Kieff.
The semantics surrounding gene patenting change depending on which side of the issue one is on. Pro-patent advocates say that companies are trying to own the claims associated with a particular DNA sequence, while anti-patenting groups say that since the DNA is naturally occurring, holding a patent for an isolated form of a preexisting DNA is just like owning a piece of an individual’s genes.
The US Patent and Trademark Office has issued 44,000 DNA patents, of which approximately 15,000 are sequence-based patents and 3,000 are gene patents, estimated Robert Cook-Deegan, director for Duke University’s Center for Genome Ethics, Law & Policy. Cook-Deegan also spoke at the GPPC meeting.
Advocates of gene patenting, at the meeting, emphasized that companies trying to patent genes are not trying to grab control over people’s DNA. Rather, they are trying to have ownership over the claims associated with the genes that they have discovered. The USPTO issues gene patents based on the claims associated with the DNA or RNA.
“[T]he touchstone of patentability is that the claim, as a whole, must be new; and human genes have been around for millions of years,” Kieff said. “So, when folks … said that a gene patent covers your genes or mine they were simply not correct.
“They later backed away from this and said, ‘Well, it’s almost like they do.’ [People] should be aware [that such] wiggle words are just like what street magicians use to distract you from the trick they are pulling,” he continued. “The trick that is being pulled here is to get everyone afraid that gene patents mean that companies own our DNA.”
It is in the best interest of companies like Affymetrix to push for the ban of genetic patents because it gives them more control over drug and diagnostic development, according to Kieff.
“They make this argument because their own business models will be a little bit easier for them to run if they don’t have to negotiate with the many small innovative companies and small patentees out there at universities and other non profits who actually are the ones likely to be owning the DNA patents that companies like Affymetrix might infringe,” Kieff said. “We should respect Affymetrix’s patents on the basic technologies for gene chips just like we should respect the patents other people hold on the versions of the DNAs that are not in our bodies and are perhaps of interest to Affymetrix.”
While opposing upstream patents, Affy holds more than 375 downstream patents in its portfolio and is not hesitant about aggressively defending the IP covering its technologies. The US District Court of Delaware in March issued a verdict in favor of Affy that competitor Illumina's arrays, scanners, software, and related products “infringed on one or more claims of five of Affymetrix’s patents-in-suit.” The IP win netted Affy more than $16 million and a 15-percent royalty payment on the sale of the infringed products between 2002 and 2005.
“The best way to keep patents from blocking innovation and competition is to keep the patent system from being held up for change every time a large company decides that its business model would be helped if we made just one special change for them,” Kieff said.
In contrast, Becerra’s advisor Haro equated gene patenting to patenting air, water, birds, diamonds, and the alphabet. He maintained that that the House bill does not hamper innovation but encourages it. “Medical innovation and economic advancement will occur if the study of genes is allowed to happen unabated,” he said.