Monday, June 17, 2013

Isolated DNA not patentable subject matter, says the US Supreme Court.

Keeping up with the recent trend of path breaking decisions, the Supreme Court of the United States, four days ago, in a unanimous ruling in Association for Molecular Pathology v. Myriad Genetics held that DNA is not patentable in the United States any longer. 

The issues before the Court were as follows:

1. Do DNA sequences amount to patentable subject matter?
2. If not, are cDNA (Complementary DNA) excluded too?

As regards the first question, the court unanimously held that DNA sequences, being products of nature cannot be granted patents. Myriad, in this case, did not create anything new but merely extracted existing genetic material found in human blood. The genetic information in the BRCA1 and the BRCA2 genes were neither created nor altered, the court added. 

The court also held that HAD Myriad created synthetic genetic material, it would have obtained a patent, for the simple fact that those do not exist in nature, thus answering the second question. (cDNA is nothing but synthesized DNA from a messenger RNA template). cDNA, by virtue of having a chemical composition distinct from that of naturally occurring genes, is thus entitled to patent protection. 

This decision overrules the landmark judgment in the Diamond v. Chakravarthy case which had upheld patentability of human genes. It is important to now note that the court, however clarified that the instant case does not include method claims, patents on new applications of knowledge about the genes or the patentability of DNA sequences in which the order of naturally occurring nucleotides has been altered. 

In most patent systems including the US, EPC and India, abstract ideas are not patentable as they are not regarded as being inventions in themselves. Laws of nature, comparable to abstract ideas are thus not patentable, either. What is patentable is a method of practical application of the abstract idea. 

In the Myriad judgment, the court, in my opinion has failed to differentiate between two vital things- That patenting an idea is not the same as patenting something that embodies that idea. In this case, Myriad's contribution was the knowledge of the function of the BRCA1 and BRCA2 genes and its 
claims were constructed similarly- they focussed on the genetic information contained in the said genes and not on their chemical composition. 

Therefore, Myriad's claim, in effect, related to these genes embodying this information. If seen this way, the court's only objection seems to have been with the claim- The claim to the information in the genes alone. Had Myriad constructed its claim in such a way that it clarified it sought to patent the information as embodied in the molecule, the court would have perhaps granted the patent. 

By this, the court has only erred by being ambiguous. If indeed, as the court clarifies in the end, new applications of knowledge about the genes are patentable, if it is possible to enumerate all applications of knowledge about the genes in the claim, would it effectively not be the same as seeking a patent for the genes themselves? 

1 comment:

  1. I don't think Diamond v. Chakravarthy ever said that human genes are patent eligible matter. The ruling in this case centered around human ingenuity in creating non naturally occurring microorganism. I do concur that it did upheld that the US Congress's intention of including anything under the sun that is made by man is patentable. But the Court did clarify that
    theat the microorganism in question in that case qualified as patentable subject matter. as it was related to a non-naturally occurring manufacture or composition of matter—a product of human ingenuity, which in that case was an organism capable of breaking the chemical bonds in oil and the use was also unknown to mankind, treating oil spills by the bacterium of the pseudomonas genus.

    This is what i think, i may be wrong correct me if I am