Natural or Man Made
Under the US Patent Law, anything that exists in nature is not patentable subject matter. This is also referred to as ‘Product of Nature Doctrine’. The test for determining whether something exists in nature or not as laid down in Chakrabarty’s case is whether a hand of man is involved in creating the invention. If there is a hand of man, the invention is said to be not naturally existing and therefore, patentable subject matter. Gene sequences were considered to be patentable subject matter because a hand of man is required to isolate and purify them; synthesize them outside the body; and because the cDNA sequence that is generally the subject of a patent application is different from the gene sequence that naturally exists.
Many scholars argued that the identification of a gene sequence is nothing but discovering what exists naturally in the body and does not merit patent protection as it is a prodduct of nature. Moral and Ethical arguments were made against patentability of gene sequences, which primarily emphasized on the fact that patenting gene sequences would proscribe research and access to treatment and diagnosis. The negative effects of patenting gene sequences was brought to light through the BRCA gene patent controversy, where the patent holder prevented access to breast cancer diagnosis by imposing high license fee for using the gene sequences or in other words by charging a very high fee for diagnosis of breast cancer.
As per the standards laid down under the law and practice followed by the USPTO, isolated gene sequences are patentable subject matter and rejection of patentability by the District Court goes against the gene patent jurisprudence. Having said that, the logic adopted by the courts while accepting patentability of gene sequences was always against common sense. Though a gene sequence that is isolated would always be same as that exists in nature, Courts and Patent Offices found a way to differentiate it from a naturally existing one by stating that such a sequence does not have introns and is therefore different from a naturally existing one. This reasoning is not in consonance with the product of nature doctrine because the coding region is same as that exists in nature.
Though human effort is involved in identifying the gene sequence, it amounts to discovering something that exists in nature.Therefore, as rightly pointed out by the US District Court, a gene sequence is a product of nature and is not susceptible to patent protection. Despite the fact that the possibilities of this decision being overturned by the CAFC on appeal are very high, the decision is right and has been successful in invoking the much needed gene patentability debate. It would be best for research and development and for access to treatment, if gene patents are limited to specific application of a sequence for a practical purpose.