Rep. Xavier Becerra from Southern California, and Rep. Dave Weldon of Florida have introduced the Genomic Research and Accessibility Act, a bill that would end the practice of patenting any and all portions of the human genome. They point out that the Human Genome Project has led to the discovery of approximately 35,000 genes and approximately twenty percent of those genes have already been granted patents by the United States Patent and Trademark Office (USPTO).

“The practice of gene patenting is preventing critical research from advancing because scientists are wary of trespassing patent laws,” Rep. Weldon said. “This not only violates the spirit of the Human Genome Project, it hinders the discovery of medical breakthroughs that could save lives. Our bill is a common sense measure to ensure that genes yet unpatented remain the province of science.”

The bill, H. R. 977, would amend title 35 of the U.S. Code, to prohibit the patenting of human genetic material. Chapter 10 of title 35 would be amended to at the end the following new section:

`Sec. 106. Prohibition on patent of human genetic material

`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.’.

(b) Table of Contents- The table of sections of chapter 10 of title 35, United States Code, is amended by adding at the end the following:

`106. Prohibition on patent of human genetic material.’.

(c) Applicability- The amendment made by subsection (a) shall not apply to a patent issued before the date of the enactment of this Act .

According to patent law, one who “invents or discovers any new and useful process, machine, manufacture, or any composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.” To be patentable, an invention must be useful, novel, and nonobvious and once the USPTO issues a patent, the owner gets the right to exclude others from making, using, selling, offering to sell, or importing into the United States the patented invention.

Genes are just chemical compounds and, as such, they qualify as compositions of matter with respect to patent criteria. Although products of nature (a preexisting substance that is found in the wild) may not be patented, per se, the courts have determined that such a product of nature may be patentable if significant artificial changes are made. By purifying, isolating, or otherwise altering a naturally occurring product, an inventor may obtain a patent on the product in its altered form. Thus, “one cannot patent a naturally occurring gene or protein as it exists in the body, but one can patent a gene or protein that has been isolated from the body and is useful in that form as a pharmaceutical drug, screening assay or other application.”

It is, however, important to recognize that patent protection is what secures the economic payback that allows companies to invest in the research to develop new drugs from gene sequences even when the odds are high that it will fail. Without the limited exclusive rights of patents, much research would never occur.

Author Michael Crichton, apparently now an expert on patents and genomics, followed this with a NY Times Op Ed piece about how evil gene patents are used to “halt research, prevent medical testing and keep vital information from you and your doctor. ” He also contends that they raise costs exorbitantly claiming that “a test for breast cancer that could be done for $1,000 now costs $3,000.” No word on just where he pulled those numbers from or if he will be writing on how copyrights raise costs on his books.

More reasoned views can be found here and here.

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  1. I have to say that as much as you complain that Crichton pulls numbers without reference (although, they are referenced in a former NY Times article linked on the same page) the idea that “much research would never happen” is blindly absurd. The Human Genome Project is one of the largest undertakings in scientific research to date, and it was not promised or even made known the possibility of patentability of discoveries made therin.

    It is absurd that a company can own a patent on a gene that naturally occurs in my body. It is further absurd that I cannot donate for testing my own tissue if it contains a gene that is thusly patented.

    Patents on genes are scary and nothing more than government-created monopolies on naturally occuring material. No invention or discovery of a non-obvious nature was made, and discovery of said genes all rest on the contributory work of the Human Genome Project.

    Patentability of genes must be squashed immediately, or we’ll be the only country in the world respecting such absurd patents. Europe is already overturning them, Canada and other countries are ignoring them, and we’ll find ourselves even further behind other countries in science than we already do.

  2. Dave,

    I understand your concerns. On the pricing, the original article states:

    “Myriad charges $2,975 — raised in February from $2,760 — for the complete testing of BRCA1 and BRCA2 genes. But tests looking for single suspected mutations are priced as low as $400”

    Making the leap from one specific genetic test and saying it should be equivalent to the lowest priced test found on the market feels a little like claiming that “a computer that could be sold for $1,000 now costs $3,000.” Maybe they’re not the same computer (or test).


  3. I like to think that there are “reasoned views” worth hearing on both sides of the debate, especially since the legal status quo cannot be said to be the product of any public policy debate on the social costs and benefits of gene patents. For more on this, please see my blog.