US Judge Rules That Gene Patents Are Invaild

BRAC1 Gene on Chromosome 17,Image via Wikipedia

In a powerful ruling a district Judge  for the Southern District of New York in the  US has ruled that patents on genes are invalid.Approximately 20 per cent of the human genome is currently subject to a patent.The judge,Robert Sweet,has overturned the patents on two genes linked to breast and ovarian cancer on the grounds that they’re not man-made, but products of nature. A company Myriad Genetics had previously patented the BRCA1 and 2 genes which were the subject of the ruling.They were charging women more than $3000 for one test for genetic mutations and banned them from getting a second opinion.

BRAC1 and BRAC2

BRAC 1 and 2 are human tumor suppressor genes that produce proteins which combine with other tumor suppressors to repair damaged DNA and destroy the cell if the DNA is unrepairable. Some inherited mutations in these genes lead to uncontrolled cell division i.e. cancer and testing for these mutations can determine the risk of contracting ovarian or breast cancer.

Court Case

The case was taken to court by the American Civil Liberties Union (ANLU) and individual breast cancer patients who argued that the patent stifled medical research.This ruling  follows much earlier rulings in Europe by the European Patent Office in 2004 which revoked Myraid genetics European patents on the BRAC1 and 2 genes ,effectively locking them out of the European market.However those patents were revoked because the charity Cancer Research UK had filed its patent on the BRAC2 gene first and the patent on the BRAC1 was deemed not ‘inventive’.

Previous Fate of Myriad Genetics Patents in Europe

The European Patent Organisation (EPO) had originally granted 3 patents on the BRCA1 gene (EP-B-699754, EP-B-705903, EP-B-705902) to Myriad Genetics. The patents, and the option by the patent holder to strictly exert its monopoly right by requesting that all diagnostic testing be done at its laboratory in the United States,evoked strong reactions throughout Europe. Several opposition procedures had been started against these patents. After oral hearings at the EPO in Munich in May 2004, the first patent was revoked due to discrepancies of about 10 DNA letters between the BRCA1 gene sequence described in Myriad’s patent, issued in 2001, and the sequence in Myriad’s original patent application on the gene in 1994.By the time that Myriad had resubmitted the correct sequence it was found that the sequence had already been openly published elsewhere-this is known as ‘prior art‘.This deemed it automatically unpatentable as inventions have to be original/ inventive to be patented.At oral proceedings in January 2005, the other two patents were also severely limited in scope.

Current Law on Gene Patents

Patents cannot be granted on things found in nature and logically you would think that genes would fall into the

nature category since they are not man-made.However, patents can be granted on gene sequences as long as these sequences are claimed in the form of ‘isolated DNA’,that is DNA which has been purified from the body.This practice is based on the view that DNA should not be treated any differently to another chemical compound and that its isolation from the body renders it patentable as it has been transformed into a different character.Supporters of gene patents look at this as getting a patent on identifying the gene and not on the actual gene.However many scientists in the genomics and molecular biology field consider this to be a ‘lawyers trick’ as it gets around the problem of patenting DNA in the body which cannot be done since it constitutes a component of ‘nature’,but which in practical terms produces the same results as if we had patented DNA in the body

Breast cancer associated protein, BRCA1.

US Court ruling

DNA is essentially the physical form of biological information,and is distinct in its essential characteristics from other chemicals found in nature. It is concluded that DNA’s existence in an “isolated” form alters neither this fundamental quality of DNA as it exists in the body i.e. in nature  nor the information it encodes. Therefore, the patents at issue which were on  “isolated DNA” containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 USC 101.

Also because the claimed comparisons of DNA sequences are abstract mental processes ,they also constitute unpatentable subject matter under Section 101

Comments

Myriad Genetics is likely to appeal this ruling so the story is far from over but its a nice step forward for research in this area.

References

Europe revokes controversial gene patent-New Scientist 2004

The European opposition against the BRCA gene patents.-Paper from Fam Cancer. 2006;5(1):95-102.

US Judge rules cancer gene patent invalid-abc.net.au

Court:Essentially All Gene Patents Are Invalid-patentlyO (patent law blog)

Human Genetics Commission

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