By: Richard Park

 

The American Civil Liberties Union (ACLU; New York City) and the Public Patent Foundation (New York City) filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer not only stifle research that could lead to cures but also limit women's options regarding their medical care.

ACLU filed the lawsuit in the U.S. District Court for the Southern District of New York on behalf of breast cancer and women's health groups, individual women, and scientific associations representing approximately 150,000 researchers, pathologists, and laboratory professionals. ACLU is suing the U.S. Patent and Trademark Office as well as Myriad Genetics (Salt Lake City) and the University of Utah Research Foundation (Salt Lake City), which hold the patents on the BRCA1 and BRCA2 genes.

Under the patents, Myriad has the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes, and prevent any researcher from even looking at the genes without first getting the company's permission. Myriad also has the right to enforce its patents against other entities and the rights to future mutations discovered on the BRCA2 gene. According to the lawsuit, such control over these genes hampers clinical diagnosis and serves as a disincentive for further research.

One of ACLU's arguments is that Myriad's gene patents are illegal and invalid under patent law because genes are products of nature. ACLU attorneys believe that current legal precedents support its case.

“A 1980 case, Diamond v. Chakrabarty, involved patents on bacteria that had been genetically engineered to eat oil for use in oil spill cleanups,” says Sandra Park, JD, a staff attorney at the ACLU's Women's Rights Project. “We think the Diamond case is very favorable to us. While it involved genetically engineered bacteria, our case doesn't involve anything that's been engineered or changed. Moreover, in that case, the Supreme Court said that products and laws of nature are not patentable. If that precedent is applied in our case, we think that Myriad's gene patents should be invalidated as products and laws of nature.”

ACLU is also arguing that Myriad's gene patents are unconstitutional under the First Amendment. This case is the first one to apply the First Amendment to a gene patent challenge.

“If you look at the particular claims we're challenging, some of them represent patents on thoughts or ideas rather than things,” says Park. “For example, one of the claims is a patent on the knowledge that a specific mutation in a gene correlates with an increased risk of breast and ovarian cancer. It's a correlation found in nature which we argue is a piece of knowledge and not something that anybody invented or created. But by getting a patent on it, Myriad has patented an idea that scientists and doctors should be able to freely think about and analyze. The First Amendment prohibits granting ownership of particular ideas or thoughts. What the patent office has allowed is the patenting of pure knowledge. With these gene patents, it's a thought that's been patented, the correlation between a mutation and disease.”

Some industry analysts disagree with ACLU's First Amendment arguments that the patenting of genes is a prohibition of freedom of speech.

“The idea behind the patent laws and the issuance of patents is that an inventor and those to whom the rights to an invention are assigned should be rewarded for the investment of time and money in pursuing the discovery with a time-limited monopoly,” says Timothy B. McBride, JD, an attorney at Senniger Powers LLP (St. Louis). “This allows the inventor to recoup the costs and to benefit from the endeavors in exchange for the full disclosure of the invention to advance the useful arts. This disclosure of the invention does not limit free speech in a traditional sense.”

Park counters that what ACLU believes is encapsulated in the First Amendment are a scientific freedom and a freedom of inquiry.

“What we're saying is that what Myriad has patented here is this relationship between a mutation and disease. It's an idea, and we don't think exclusive rights over an idea should ever be given by the government to any particular entity.”

Additional information about this lawsuit can be accessed via ACLU's Web site at www.aclu.org/freespeech/gen/brca.html.