5 December 2013Americas

C5 Congress: Patenting natural products after Myriad

Speaking at Wednesday's C5 Congress on Biotech and Pharma Patenting in London, Michael McGraw, a partner from Fitzpatrick, Cella, Harper and Scinto in New York, considered the line that separates natural and man-made products.

What differences or changes to a natural product will make it “man-made?” he asked. How different from the original product is “different enough”?

Ever since Diamond v Chakrabarty in 1980, where the US Supreme Court decided that a genetically modified organism can be patented, it has been well-established that products of nature are not patentable.

You cannot claim nature-purification or isolation are irrelevant, McGraw said. But it is possible to claim purified compounds if they have a new use. There must be a sufficiently transformative stage in the process of isolation.

However, as the Supreme Court's decision in the Association of Molecular Pathology v Myriad Genetics case this year demonstrated, when it comes to patenting genes, there are still some grey areas.

Of the nine claims at issue in the Myriad case, none of which were method claims, four were held invalid.

The BRCA1 and BRCA2 patents, which were the focus of the case, were filed in 1994 and 1995.

McGraw asked why, given the established rules on patenting natural products, the patents were allowed at the time, flagging it up as a “sign of the times”.

At the time of filing, the technology for isolating genes was cutting-edge, he said. Today we better understand the technology and have greater access to information about the technology, so a contemporary decision on whether the human gene is patentable may be different.

Does this mean that patenting trends change according to technological advancement?

In the Myriad case, in a mixed ruling, it was decided that cDNA (synthesised from a messenger RNA) is patent-eligible as it does not exist in nature. However, McGraw mused that in 20 years time, we may decide that the process of isolating cDNA is not transformative enough, rendering the cDNA patents invalid.

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