By Lisa Seachrist
WASHINGTON - In the wake of the human genome announcements last month, the House Subcommittee on Courts and Intellectual Property of the Judiciary Committee explored Thursday the Patent and Trademark Office's standards for patenting genomic discoveries.
Subcommittee chair Howard Coble (R-N.C.), however, took the opportunity to send a pointed message to fellow legislators on the practice of skimming fees collected by PTO for other uses.
"I, perhaps indelicately, admonish the administration and appropriators to keep their grubby paws out of the PTO's coffers," Coble said. "The diversion of fees is unfortunate to say the least and will result in a negative effect for the biotechnology industry due to increased patent application pendency, lessened overall patent quality, and the deprivation of resources."
Coble went on to say the quality of genome patents will play a critical role in the success of moving the discoveries coming out of the map of the human genome to new medicines and therapies. Coble invited PTO Commissioner Todd Dickinson to address the new guidelines for granting gene-based patents.
While many people who are opposed to patents for DNA argue that you can't patent nature, the Supreme Court has ruled otherwise in a couple of different instances. As the patent office sees it, the determination of whether a genomic invention is patentable is the question of the utility of the invention. Raw DNA sequence such as that generated by the Human Genome Project is not patentable because the raw sequence alone has no utility.
When PTO first began considering DNA-based patents, the utility requirement could be as mundane as coding for a protein or peptide for use as an animal feed supplement or as ethereal as describing a theoretical use. However, PTO recently has published a number of new guidelines that raise the utility standard significantly and demand patent applicants demonstrate a credible real-world utility. The standards will require a utility be both specific and substantial. As a result, a number of patent applications disclosing only theoretical utilities may be rejected.
"The new guidelines were published last December in the Federal Register," Dickinson said. "They will likely be finalized sometime this fall."
"There are some of us who are asking whether the goals of the patent system and the goals of science and medicine are properly balanced," said Rep. Howard Berman (D-Calif.). "Some are concerned the patent office will not raise the bar high enough. There clearly are policy questions to be answered."
One of those concerned with the utility standards is former NIH Director Harold Varmus, who praised the efforts of PTO, but questioned the need to seek intellectual property protections so early in the discovery process.
"Recently, to the relief of many of us, the PTO has considered raising the bar to gene patenting, especially for the utility standard," Varmus said. "Although the new proposal is an improvement and the final position of the PTO has not been announced, I believe that the bar may still not be raised high enough. Under the new proposal, a patent could be issued for a gene or a portion of a gene based on still quite superficial and potentially misleading information about the gene or about how it may be used to diagnose, prevent or treat disease. Establishing the legitimacy of such claims, even if the predictions were confirmed experimentally, would doubtless require legal proceedings, such as those that follow accusations of infringement."
Varmus suggested public disclosure of an invention could prevent others from seeking patent protection for the same thing. He noted the SNP Consortium - a group of pharmaceutical companies and a private philanthropy - pooled resources to identify and disseminate markers of human genetic variation. Varmus said any remedies to the situation would need to be undertaken with great care, however, in order to avoid jeopardizing the scientific discoveries made both in academia and industry.
Industry representatives, while agreeing gene patents should have high utility standards, took opposite views on whether patent applications should be granted when the biological function of a gene is unknown.
"We believe the utility cannot be described without knowing the specific function of the gene," said Dennis Henner, senior vice president of research at South San Francisco-based Genentech Inc. "At Genentech, we believe just using computer modeling is not enough to know the function of a gene."
Randy Scott, president and chief scientific officer for Incyte Genomics Inc., of Palo Alto, Calif., took a different view, noting people didn't know what prostate specific protein did, but researchers were able to patent a test measuring the protein in the bloodstream as a marker for prostate cancer.
"We don't believe the homology issue is an all-or-nothing thing," Scott said. "The structure-function relationship is the basis of biochemistry. A patent should be rewarded for commercial utility, not biological function."
Returning to the funding issue a number of times throughout the hearing, Coble asked Dickinson to describe how the appropriations shenanigans were affecting PTO.
"We were not able to hire 100 new examiners this year, [and] because of the vagaries of the 2001 budget, we can't pay them next year," Dickinson said. "As a result patent reviews will be delayed, and I don't want to see a de facto submarine patent situation develop."
By delaying the time to patent issuance, the PTO would have to return time lost during review to the patent applicants. As a result, a patent could be issued well after a process becomes state of the art. The skimming of funds also is happening at a time when PTO's workload has increased dramatically.
"The complexity of some of these applications is almost unimaginable," Dickinson said. "We received a DNA sequence listing as part of a patent application that, had it been submitted on paper, would have totaled over 400,000 pages. The challenges of searching and examining applications of this complexity are enormous."
In addition, Coble admonished PTO stakeholders to step up their efforts to rectify the situation, noting the subcommittee members couldn't tackle the problem on their own.
"Many people think you can take care of a problem with a half-page add in Roll Call," Coble said. "I'm here to tell you folks you are going to have to knock on some doors to get this point across. Well, in the interest of political correctness I should mention there are two Hill newspapers so for some of you it may be a half-page ad in The Hill."