Thursday, May 14, 2009

Legal challenge to patent on breast cancer genes

The Chronicle is reporting that:
"The American Civil Liberties Union and the Public Patent Foundation filed suit on Tuesday to challenge the constitutionality and validity of patents on two human genes linked to breast and ovarian cancer.

The patents on the BRCA1 and BRCA2 genes belong to the University of Utah and a company called Myriad Genetics, in Salt Lake City, which pays the university for the right to use them commercially in a test it sells to patients who want to know if they have hereditary risks of developing those cancers.

The lawsuit, filed in the U.S. District Court in New York on behalf of thousands of breast-cancer and women’s health groups and a number of medical societies and academic researchers, accuses the University of Utah Research Foundation, which owns the patents, Myriad, and the U.S. Patent and Trademark Office of stifling scientific research."

The formal announcement of the lawsuit is available at the Public Patent Foundation website. This one has been building for some time and given the number of prestigious plaintiffs involved, organising the lawsuit will have been non-trivial exercise. It's also potentially something of a blockbuster since not only are they challenging the BRCA1 and BRCA2 patents but the whole practice of patenting human genes:
"1. Every person's body contains human genes, passed down to each individual by his or her parents. These genes determine, in part, the structure and function of every human body. This case challenges the legality and constitutionality of granting patents over this most basic element of every person's individuality."
So opens a lawsuit that has the potential to completely alter the landscape of medical science and the genetics and pharmaceutical industries. The specific patent claims challenged are outlined in paragraph 32:
"Plaintiffs challenge the legality and constitutionality of four categories of claims in these patents:

a. Patent Claims Over Natural Human Genes: Claims 1,2,5, and 6 of patent 5,747,282 ('282) and claim 1 of patent 5,837,492 ('492)

b. Patent Claims Over Natural Human Genes With Natural Mutations: Claim 1 of patent 5,693,473 ('473), claim 7 of patent '282, and claims 6 and 7 of patent '492.

c. Patent Claims Over Any Method, Including Non-Patented Methods, Of Looking For Mutations in Natural Human Genes: Claim 1 of patent 5,709,999 ('999).

d. Patent Claims Over the Thought That Two Genes Are Different or Have Different Effects, Including But Not Limited To The Thought That The Differences Correlate With An Increased Risk Of Breast And/Or Ovarian Cancer: Claim 1 of patent 5,710,001 ('001), claim 1 of patent 5,753,441 ('441), claims 1 and 2 of patent 6,033,857 ('857) and claim 20 of patent '282."
Paragraph's 102 and 103 sum up the causes of action stating that the patent claims identified are invalid under Article 1, section 8, clause 8 of the US Consitution, and 35 U.S.C. 101. In addition the plaintiffs submit that all the claims challenged are unconstitutional under the 1st and 14th amendments to the US Constitution. They are asking the court to declare the claims invalid and/or unenforceable, to issue an injunction against pursuing legal action to enforce the patent claims and for costs to be awarded against the respondents. Certainly one to follow closely.

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