This is Personal: A Legislative Attack on Personalized Medicine

11/19/07

It has long been known that different individuals react to the same drug differently. Matching the right therapy with the right individual, commonly know as “personalized medicine,” could improve treatment, reduce side effects, and ultimately save healthcare dollars.

This idea has captured the attention of not only research scientists, but also healthcare providers, the pharmaceutical industry, pharmacy benefits managers, venture capitalists, and the FDA. Progress is being made in this area, and a number of personalized medicine products are already on the market. Though sales numbers are still quite small, diagnostic tests and targeted treatments aimed at enabling personalized medicine are expected to become part of mainstream medical practice within 10 years. Yet, passage of pending legislation that is purported to promote medical advances will likely have the opposite effect, hindering much-needed venture capital investment in this emerging field.

At the heart of personalized medicine are diagnostics tests that reveal, for example, a patient’s risk of a particular disease or likelihood of responding well or poorly to a particular drug—often based on gene expression or gene mutations. But there are many hurdles that a diagnostic company must overcome before bringing a diagnostic to market. It is estimated, for instance, that it could cost as much as $100 million to bring a broad-based screening test successfully to market. Who will fund such work remains uncertain.

There are other uncertainties. Costs and volatility could increase even more if proposed FDA regulations are enacted. Questions still remain as to who will pay for this technology when it reaches the clinic. Will it be the patient? Will it be insurance companies? Will such technology even be accepted by healthcare professionals?

As with any emerging technology, if risk and uncertainly are outweighed by the potential for profits, investment and development will continue. And as with any emerging technology, the potential for profit in the diagnostics and personalized medicine space is protected by strong patents. However, recent congressional action would prevent patent protection on inventions critical to personalized medicine.

On February 9, 2007, Representative Xavier Becerra introduced the Genomic Research and Accessibility Act, a bill that, once enacted, is purported to put an immediate end to the practice of patenting any and all portions of the human genome. The legislation proposes to amend chapter 10 of title 35, United States code, by adding the following new section:

“Notwithstanding any other provision of law, no patent may be obtained from nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies.”

According to a press release from Congressman Becerra’s office, “The practice of gene patenting is preventing critical research from advancing because scientists are wary of trespassing patent laws.” Congressman Becerra adds that “enacting the Genomic Research and Accessibility act does not hamper innovation, indeed, it encourages it. The proliferation of scientific prowess, medical innovation, and economic advancement will all occur if the study of genes is allowed to happen unabated. Incredible manifestations of intellectual property will result: medicines, machines, processes—most deserving of recognition, some potentially life-saving, and all worthy of a patent.”

While Representative Becerra’s statements promise innovation, enactment of his simple bill into law will have the opposite effect with respect to personalized medicine. Enactment of the bill would not just prevent patenting DNA, which itself is harmful to the biotechnology industry. It would also prevent patents on gene correlations, e.g., the association of gene mutations with risk of disease or response to treatment—associations that form the basis for personalized medicine’s diagnostic tests.

While Congressman Becerra and others argue with few facts that gene patents stifle scientific research, the inability to obtain intellectual property protection in the field of diagnostics and personalized medicine will stifle a nascent industry.

Becerra’s bill, a political move in response to popular press attacks on gene patenting, appeared likely to fail, but like other aspects of patent reform, the subject is still alive in Congress.

On October 30, 2007, the House Judiciary Committee held a hearing on “Stifling or Stimulating—The Role of Gene Patents in Research and Genetic Testing.” It was no surprise that not all witnesses spoke in favor of patenting DNA-based inventions. What was surprising and encouraging was that representatives of the Biotechnology Industry Organization (BIO) and the Association of University Technology Managers (AUTM) testified that the Becerra bill or similar legislation altering patent rights in nucleic acid inventions would harm commercialization of genetic medicine.

As discussed at the October 11th conference “Personalized Medicine: Breaking Down the Barriers and Achieving Results” that my firm, Nixon Peabody, cosponsored, companies looking to invest in nucleic acid inventions and personalized medicine need to realize that the public relations battle may affect future legislation. And as such, all stakeholders in the personalized medicine industry should be planning and implementing their public outreach now to decrease the risk of legislation that may threaten the future of personalized medicine. Failure to act may result in erosion of IP protection and a commensurate decline in investment in biotechnology and diagnostics.

David Resnick is a partner and the co-team leader of the Biotechnology/Chemistry team at Nixon Peabody. David assists clients in obtaining and defending intellectual property protection in the life sciences, including stem cells, RNAi and personalized medicine. The views expressed in this column represent only those of the author and not of Nixon Peabody or its clients. Follow @

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  • http://www.diaceutics.com Mollie Roth

    I wonder if you would comment on how to prevent people from being squeezed out of using patented gene sequences for research based on exorbitant licensing fees if we continue to allow gene sequences to be patented. How do you prevent that from happening while still allowing for patent protection (or some other vehicle) to encourage this sort of research?

    Further, patents are for inventions, not finds. No one is inventing these sequences they are simply finding that they are important and doing the research to understand and characterize what they do. They should get something for being the first to characterize the find but should they really get to put a lock on the use of it through a patent? Newton discovered gravity and characterized it, he did not invent it so a patent would not have been appropriate right? What’s the difference here that justifies patents other than the potentially enormous profits to be made? Isn’t this the worst example of the use of the patenting system? Restricting access to naturally occurring phenomenon simply because it costs a lot to undertake the research?

  • Hannah Koyfman

    I agree 100% that laws of nature should not be patentable – and they’re not patentable. A gene, however, is something else entirely. A gene is a physical object that can be made by humans. And an isolated gene in a test tube is something novel, and patentable. A gene in its natural habitat (that is, a normal cell) has clearly been around for years or millennia, and is not patentable.
    I spent the better part of a decade doing academic research in molecular biology. In that time I never had to forgo an experiment because of patent issues. I’m curious whether there are any readers out there who had to. I would guess that this happens in more often in companies than in universities.
    (My opinions are my own; I don’t speak for my current or past employers.)

  • http://www.xconomy.com/author/dresnick/ David Resnick

    There is little evidence that “gene” patents have an affect on scientific research. In close to 20 years of practice I have never seen research stop as a result of a DNA patent or a patent directed to a biomarker/disease correlation. However, a problem could arise if one wishes to commercialize a product that results from such research. This is a problem for any technology and is not unique to diagnostics. Some suggest that the roadblock to commercialization is exclusive patent licensing of such innovations by institution that make these discoveries, mainly universities and research hospitals. At the conference noted above, Lita Nelsen, director of technology transfer at MIT, gave an excellent overview of the issue and provided some potential solutions. If you are interested, her slides can be found at the conference web page.
    http://www.nixonpeabody.com/events/personalizedMedicine/presentations.asp

    (The views expressed in this column represent only those of the author and not of Nixon Peabody or its clients.)

  • http://www.diaceutics.com Mollie Roth

    Thanks for your thoughts on this issue. While direct research has perhaps not been impeded, I would agree with you that commercialization of innovative products, which is to some extent the beneficial outcome we are looking for from such research, has been impeded.

    I looked at Lita’s presentation, which was quite good, but I still question whether a patent is appropriate for something not invented. A direct link between a gene polymorphism and a disease state is not “invented” by the researcher, it is discovered. Discovering the means to replicate a gene snp in the lab, invention. Inventing the means to discover the correlation, invention. The person who discovered the correlation between a tendon contricting and the corresponding movement of the muscle to which it attached did not invent that. Unless I am very mistaken, (which is posisble) the patent system was created for invention, not discovery.

  • http://www.xconomy.com/author/dresnick/ David Resnick

    You stated that “[a] direct link between a gene polymorphism and a disease state is not “invented” by the researcher, it is discovered.” However, you have an invention if that discovery is applied to a method to diagnose a disease or to predict a patient’s response to a drug and that method meets the requirements of the law, e.g., it’s non-obvious, novel and useful. There are some, including a few members of the US Supreme Court, that believe that a correlation between a biomarker and disease state is not patentable subject matter because it’s a “natural phenomenon.” Take a look at the decision this year in LabCorp v. Metabolite. In that case the Supreme Court looked at the issue but dismissed the case as not having a proper record. Given the current anti-patent enviroment, this issue will be back.

  • Cheuk Tam

    Thanks for clarifying your position, but I still question the nature of the patent. If the patent is for the application of the discovery, why does the discovery itself hold patent status? Claiming the possible application of the association between a gene and a disease would be like patenting E=MC2 as a method of producing (nuclear)energy. Shouldn’t the inventor of the application of the discovery be granted a patent, and not the discoverer of the association?

  • http://www.xconomy.com/author/dresnick/ David Resnick

    I’m not sure I get your point. There are thousands of patents that claim methods to produce nuclear energy that directly result from Einstein’s theory. A theory can’t be patented. As Chief Justice Burger stated in his majority opinion to Diamond v Chakrabarty: “The laws of nature, physical phenomena, and abstract ideas have been held not patentable. [cites omitted] Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2.; nor could Newton have patented the law of gravity. Such discoveries are “manifestations of . . . nature, free to all men and reserved exclusively to none.”