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Two New Bills Present Challenges to DNA Patentability

NEW YORK - Patents directed at isolated DNA molecules or other isolated nucleic acids are under threat once again.


This time the challenge to the patents, commonly called gene patents, comes from the US House of Representatives in the form of two bills introduced on March 15 by Rep. Lynn Rivers (D-Mich.). If enacted, each of these would threaten future biotech innovation in the US.


One bill, HR 3966, mandates that the White House Office of Science and Technology Policy conduct a study "that assesses the impact of Federal policies, including intellectual property policies, on the innovation process for genomic technologies."


Called the Genomic Science and Technology Innovation Act of 2002, the bill calls for a thorough examination of the effects of the current IP system, alternative IP systems, and alternative incentive systems on the rate and quality of innovation, costs of new products, and availability of capital and funding relating to gene patents.


The second bill, HR 3967, would provide an exemption from patent infringement for use of patented genetic sequence information in non-commercial research or for genetic diagnostic testing. If enacted, this bill, called the Genomic Research and Diagnostic Accessibility Act of 2002, would mandate that all federal agencies and most recipients of federal research funding be required to disclose all sequence information filed in a patent application within 30 days of such filing.


A law of this kind, which would not apply to patents issued from an application filed before it was enacted, would effectively deprive these entities various rights to secrecy they might otherwise have (at least until the patent application is published). 


Both bills are detrimental to future biotech innovation in the US. While HR 3966 appears relatively innocuous on its face, certain aspects of the mandated study of gene patents are actually quite biased. The legislation mentions studying the rate and quality of innovation in several places and draws attention to some factors that influence innovation, such as the availability of capital. Given that the patent system is designed to encourage innovation, that portion of the inquiry is valid.

However, the detailed list of topics to study goes on to mention other factors that are simply inherent in our patent system. These include inquiries into the costs of downstream products, and choice of research area.  But the lack of study standards and protocols in the bill could readily lead to a biased assessment against gene patents.


A significant purpose of a patent is to reward innovators by allowing them to recoup the costs of their research. Moreover, certain economic studies have shown that in certain disciplines, especially biotechnology and pharmaceuticals, most innovation and products development are driven by the ability to obtain patent protection. Such developments are extremely costly and most likely would not occur if patent protection were not available. In such cases, the potential economic "harm" in granting a patent is offset by the benefit to consumers.


An objective, non-biased study should consider whether intended and perceived-unintended effects of the current patent system in the US discourage innovation in genomics more than in any other field. If that is not the case then the government should provide some additional reasons why patents for DNA molecules should be treated differently from patents for any other technology. 


For instance, the study might consider whether the cost of a diagnostic kit that uses a patented DNA molecule is offset by the savings in health-care costs that the diagnostic kit provides. Moreover, Congress has never imposed such cost analysis as a reason for denying patent protection for inventions in other technologies.


HR 3967, meanwhile, seeks to limit the rights available to a gene-patent holder.  (Recall that a patent provides a patentee to preclude others from practicing his or her invention.) The bill provides a broad exception to patent infringement for non-commercial research, presumably to overcome the "problem" of prohibiting research using a patented technology, particularly by those in academia. 


But it's not clear how such a research exception would foster innovation in the field. A great deal of genomics research is undertaken, even in academia, with the idea of eventual commercialization. This is true even if the institution is not primarily interested in licensing revenues because commercialization is currently a primary vehicle of making any useful invention accessible to the public. Thus, there are many reasons why even a nonprofit may not embark on a path of research if commercialization of the results is not possible. Certainly, university tech-transfer departments are well aware of this. In addition, the patent law currently recognizes a limited "research exemption" for intellectual curiosity.


The second major provision of HR 3967 is also misguided. The provision attempts to piggyback on an existing law that exempts from liability for potential patent infringement physicians who perform certain medical and surgical procedures that rely on patented techniques or technologies. The law was implemented because of very compelling concerns over whether patients would be harmed if physicians and hospitals were overly worried about being sued for infringing a patent while conducting a medical procedure. (In fact the law was enacted in response to an infringement lawsuit in which one physician sued another for infringing a surgical procedure patent.) 


Of special concern are inhibitions that might arise during emergency situations when there is no time to consult a patent database. Furthermore, the suppliers of instruments and compositions that are specifically used in such patented medical or surgical procedures, however, are not exempt from infringement.


Such a compelling concern is not presented by genetic diagnostic testing. Unlike medical techniques, a physician is not likely to develop a new genetic test on the spot in his office or operating room. Most of these tests are conducted using a test the physician or his diagnostic lab purchase that is generally licensed to carry out the tests by the patent holder. This is unlikely to change in the near future. Thus the basic need that resulted in a medical method exception to patent infringement is not present in the context of genetic testing. Moreover, the costs of such tests are usually reasonable, especially when bundled with other diagnostic tests that physicians carry out on their patients.


A fair reading of HR 3966 and 3967 indicates that they are facially unfair to gene patents. HR 3966 study could produce useful and informative results if it were formulated in a more objective manner.


The proposed provisions in HR 3967, however, presuppose the results of a biased study, which is inappropriate. Furthermore, even assuming the presumptions of HR 3967 are true, the bill would fail to correct the perceived problems. Strong patent protection is necessary for the biotechnology industry. These bills provide a threat to patent protection at the end of the pipeline that can lead to reduced investment in bringing new drugs, therapies and diagnostics to market.


Rochelle K. Seide is a partner at the law firm of Baker Botts. She is experienced in biotechnology, intellectual property, and patent issues, and also has a Ph.D. in human genetics. Michelle LeCointe is an associate at Baker Botts and a registered patent agent. They can be reached at [email protected] and [email protected]

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