Two complicated areas of law and science are involved in this- Patent Law and Molecular Science. Resolution of the discussion by the Court concerns medical professionals, researchers, advocacy groups, gene patent holders and those seeking to advance public health.
An isolated DNA, is a free-standing portion of a native DNA molecule, frequently a single gene. Genes are basic units of heredity found in all living organisms and are responsible for the inheritance of a discrete trait. When the issue of patentability is addressed in respect of this, the assertion of those favouring the same is that an isolated DNA, which has been taken out from the human body and gone through purification techniques, be considered no differently than any other chemical compound. It is advocated that the character of the DNA is changed as a result of the purification techniques.
Those who dissent from the above view, argue that isolated DNA can never not be a ‘product of nature’ and that it is only a trick to do circumvent the prohibitions on direct patentability. They say that DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical compound found in nature. It is argued further that DNA’s existence in an ‘isolated’ form alters neither the fundamental quality of DNA as it exists in the body not the information it encodes. It also feared that such patents will lead to monopolization of nature, thus leading to high costs of diagnostic testing and other processes.
In the case before the US Court of Appeals, Isolated DNA had been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule.
The Court opined that human intervention in cleaving or synthesizing a portion of a native chromosomal DNA imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA. As the above description indicates, isolated DNA is not purified DNA. Purification makes pure what was the same material, but was previously impure. Although isolated DNA must be removed from its native cellular and chromosomal environment, it has also been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body. It has not been purified by being isolated.
The Court rejected the proposed “magic microscope” test of the side opposing patentability, saying that it misunderstands the difference between science and invention and fails to take into account the existence of molecules as separate chemical entities. The ability to visualize a DNA molecule through a microscope, or by any other means, when it is bonded to other genetic material, is worlds apart from possessing an isolated DNA molecule that is in hand and usable.
An appeal to the Supreme Court looks inevitable in this isolated DNA matter. Does this represent adamancy to patent every thing under the sun that is made by man or a struggle to keep ‘nature’ pure and let it’s use be free?