Friday, November 5, 2010

Who Owns Your Genes? You Do.

I've written two previous blog articles on this subject: ACLU Challenges Patents on Human Genes and A Thank You to the Plaintiffs, the ACLU and Judge Sweet. And, as the debate ensued over health care reform, I wrote to Sen. Reid, Sen. Ensign, and Rep. Heller on more than one occasion regarding the Patent Office's practice of allowing human genes to be patented. I argued that if they were going to make a dent in reducing health care costs, they would also need to look at systemic problems created by the Government itself that contribute to driving up health costs. This particular case is a glaring example of one of those systemic problems.

For the past 20 years, the U.S. Patent and Trademark Office has been issuing patents on human genes -- the segments of DNA that we all have in our cells -- giving private corporations, individuals, and universities the exclusive rights to those genetic sequences, their usage, and their chemical composition. There is something fundamentally wrong with companies being able to own the rights to pieces of our human genome.

This raises serious civil liberties concerns in that the Patent Office has essentially been giving patent holders a monopoly over these genes and all the information contained within them. You see, patent holders then have the right to prevent anyone else from testing, studying, or even looking at the genes. Like the ACLU, I believe this is a gross violation of our First Amendment rights: our individual right to know about our own genetic makeup, a doctor's rights to provide a patient with crucial medical information, and scientists’ rights to study the human genome and develop new treatments and genetic tests.

The case at hand involves the BRCA genes that are associated with hereditary breast and ovarian cancer. As a result of the U.S. Patent Office granting patents on the BRCA genes to Myriad Genetics, Myriad's lab is the only place in the country where diagnostic testing/treatment can be performed. And, because only Myriad can test/treat for BRCA gene mutations, others are prevented from testing these genes or developing alternative tests. Accordingly, Myriad can charge anything they want for this testing/treatment, driving up the costs of both testing and treatment.

The case went to court and on March 30, 2010, Federal District Court Judge Robert Sweet issued his ruling that human genes cannot be patented, invalidating all 15 patent claims held by Myriad on the BRCA genes. Myriad is appealing that ruling in the U.S. Court of Appeals for the Federal Circuit. This week, the U.S. Government filed a 'friend-of-the-court' brief agreeing with the stance that 'isolated DNA is not patentable.'

The U.S. government filed a friend-of-the-court brief last week in a lawsuit brought by the ACLU and the Public Patent Foundation (PUBPAT) challenging patents on human genes. The government agreed with our stance that isolated DNA is not patentable.

According to the government's brief, "The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is 'isolated' from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth."
"We are extremely gratified that the government has agreed with us that genes are products of nature and therefore not patentable," said Sandra Park, staff attorney with the ACLU Women's Rights Project and a lawyer on the case. "Gene patents restrict patients' access to their own genetic information and chill important research. The lower court correctly found that no one should be able to patent human genes, and we are confident the appeals court will uphold that decision."

Representative Xavier Becerra (D-CA) introduced H.R. 977, the "Genomic Research and Accessibility Act" during the 110th Congress to bar the issuance of gene patents. He would like to reintroduce a new version of the bill this year, but needs your help. Representative Becerra needs support from colleagues on both sides of the aisle if his bill has any chance of being enacted.

Please take the time to ask your Congressional Members to contact Representative Becerra and sign on as a cosponsor of this important piece of legislation.

Take action: Tell Congress your genes aren't for sale!
(This link will take you to an ACLU page where you can fill out their form to send a letter, or where you can copy/paste/modify a form letter into an email to your Congressional Representative/Senators.)

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