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Court Rules Patents on Genes Are Illegal: Products of Nature, Not Invention

by Heidi Stevenson

31 March 2010

DNA Helix

Reversing a frightening trend granting patents on living creatures and their genes, US Federal Judge Sweet has issued a ruling that may overturn patents on life forms. Myriad Genetics' claim that isolating DNA from the body transforms and makes it patentable was turned down with the statement that it's only been a "lawyer's trick" that's allowed it to happen before.

In the case brought by the American Civil Liberties Union (ACLU) and the Public Patent Foundation, Judge Sweet stated that the patents on two genes linked to breast and ovarian cancer were granted improperly. He stated that it's,

a 'lawyer’s trick' that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.

The ACLU's argument is that such patents prevent the free exchange of information, and are therefore a violation of the First Amendment right to free speech.

Judge Sweet cited a 1948 US Supreme Court ruling, Funk Brothers Seed Co, where it was found that, though their idea of using a combination of bacteria to fix nitrogen in farm soil was ingenious, it couldn't be patented because they hadn't invented the bacteria. Products of nature cannot be patented.

Myriad had erroneously cited the Funk case in its brief to the court, falsely saying that it only illustrates that "obvious" inventions can't be patented. However, in his decision, the judge stated:

Myriad suggests that the Supreme Court’s holding in Funk Brothers was premised on an obviousness determination, rather than patentable subject matter. Subsequent Supreme Court opinions, however, have treated the holding in Funk Brothers as a statement of patentable subject matter.

Implications

The judge's ruling, if upheld on appeal, has enormous implications. Currently, there are hundreds of patents on living matter.

As it stands now, pharmaceutical companies have no motivation to share information. When they hold exclusive rights to information about, and use of, natural substances and life forms, they are the only ones who may make products related to them. The public loses the benefit of this knowledge. Only products developed by the company with the patent may be produced, and if they aren't profitable, then even those may not be made available.

Claims are made that there will be no incentive to produce products—usually meaning drugs or genetic testing materials—if life forms and genes are not patentable. That implies that the results of such products are beneficial. Yet, overall, one must question just how beneficial most pharmaceutical products are. For every benefit, there are many harms. On balance, the pluses seem to be outweighed by the negatives.

Lack of patenting of life forms has never prevented innovation in the past, so why would it now? Why assume that there would be no profit in producing a product to test for the presence of a gene? Or to develop a drug? After all, millions and billions of dollars-pounds-euros are made every year on drugs to treat body parts that haven't been patented. Frankly, I think that the only thing limited by the judge's ruling is the amount of profit that can be made.

There is also the moral implication of someone—corporation, government, or university—literally owning a part of a human being. The case in point, a gene linked to breast and ovarian cancer, resulted because women were not allowed to get testing for their own genes unless they paid exhorbitant sums to Myriad for the privilege. They were the plaintiffs in the case.

While it's certainly reasonable and fair for the company to make a profit for producing a kit to test for a gene, their claim of ownership has resulted in extreme profiteering at the potential cost of women's lives. It has also prevented any other company or university from producing a different test kit, which might be better or less costly. Clearly, the notion that a part of a person can be claimed in a patent is seriously misbegotten.

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