IP Coach Marcel Mongeon shares his opinions on the landmark ruling that invalidated several of Myriad's BRAC patents.
As everyone waits for the Supreme Court of the United States' decision in Bilski – which may change the fundamental nature of what constitutes a patentable invention – a trial level judge of the US Federal Court has invalidated gene patents. I note that although the ruling was close to, it was not on the first of April, so it's no joke!
In a 152 page ruling issued on Monday (March 29, 2010), the Court in the Southern District of New York made a far-reaching decision against Myriad Genetics relating to its BRCA gene patents. The American Civil Liberties Union had brought suit seeking the invalidity of the patents. The judge agreed with this position and has invalidated the patents. No doubt, the decision will be appealed.
The BRCA-1 and BRCA-2 gene patents are well-known.
Based on work originally done at the University of Utah, the patents claim the identification of certain alleles of genes which indicate a higher propensity to breast cancers. Myriad Genetics has built a large testing business on the basis of these patents.
Specifically, Myriad charges over $3,000 per test. Not all health insurers provide coverage. Myriad provides some tests at little or no charge recognizing that it is effectively the sole provider in those jurisdictions which honor the patents. As you will see in the next paragraph, I come from a jurisdiction that does not.
The decision notes that in the Canadian province of Ontario, where the public healthcare plan is purposely ignoring Myriad's patent, the testing is done by the system at a third of Myriad's cost. Many genetics labs elsewhere could do the tests for similar amounts but are blocked from doing so due to Myriad's enforcement of its patents (especially within the United States.)
This lawsuit was brought by the ACLU alleging that the enforcement of the patents has hindered patients from receiving the highest-quality breast cancer genetic testing and has impeded improvements in the testing. The court also noted the challenges of the effects of gene patents on the progression of scientific knowledge. A large number of scholarly articles on the subject are cited.
In his reasoning, the judge notes that it is clear that a product of nature without modification cannot be patented. He further reasons that the purification of a product of nature, without some additional improvement, cannot yield a patentable product. Applying this test, the judge decides that as the BRCA-1 and -2 genes that are isolated for identification are not 'markedly' different than the native DNA as it exists in nature and, therefore, to the extent that the patents claim the isolated genes they are invalid.
The patents also claim methods relating to the isolated genes. The methods claims fail on the "machine or transformation" test in that the method does not comprise either a machine or effect a transformation.
Conclusions and Implications
Obviously, this decision will be hailed as a victory for those who see evil in gene patents and bring out the sackcloth and ashes for those who make a living from biotechnology. The reality is that the impact will be somewhere in the middle. Although there is no question that the biotechnology industry will be affected as investors try to determine what the "new normal" is for such tests, the reality is that many academic research institutions have found little market for the last decade in genetic tests per se.
Ultimately, the phrase in the Diamond v. Chakrabarty case about "anything under the sun made by man" being patentable holds. The court, in this case, points out that there really is no invention; only the detection of a product of nature.
Read the Myriad Case History
Read the complete Myriad decision.
See other opinions of the Myriad ruling.