The Gene Returns to its Body
This post was first published on April 1, 2010.
I’m still in denial of the summary judgment ruling provided by Judge Robert W. Sweet of United States District Court for the Southern District of New York in Association for Molecular Pathology v. USPTO on March 29th 2010. Looks like all that I read, understood and was convinced that gene patents demands a revisit. The 156 pages summary judgment that was issued on this Monday has for sure taken me by surprise. To give you the context, Myriad Genetics is a gene diagnostic company which in together with University of Utah Research foundation had seven controversial patents in its basket relating to BRCA1 and BRCA2 genes (susceptibility genes) bearing over 15 objectionable claims. Some were directed to the isolated DNA containing all or portions of the BRCA1/2 gene sequence and some others claimed the method for comparing or analyzing the gene sequences to identify the presence of mutation correlating with a predisposition to breast and ovarian cancer.
The question addressed by the court was: Are isolated human genes and the comparison of their sequence patentable?
To refresh your memory, in Amgen v.Chugai, the landmark decision with respect to gene based patent, the court taught and convinced us that gene sequence inside the body is very different than its isolated form. The non coding region or the introns present in the DNA sequence of the body is not present in an isolated form as the isolated sequence has only the coding region of the DNA. Moreover, DNA being chemical compound should not be treated different than other patentable chemical compounds. The convincing power of this decision was such that the entire world followed the suit.
The district court on 29th March revisited this concept. And guess what they found? The court stated that DNA’s existence in an isolated form alters neither the fundamental quality of DNA as it existed in the body, nor the information it encodes. Hence the court stated that claims directed to the isolated DNA sequences found in nature are unsustainable as a matter of law and are deemed unpatentable. In other words, isolated gene sequences are products of nature which is non patentable subject matter as per US patent Law.
Furthermore, since the act of comparing the DNA sequences are considered to be abstract mental processes, they are also considered as non-patentable subject matter.
Thus the 15 claims were invalidated by the court on the grounds that the patent claims cover product of nature, laws of nature and/or natural phenomena and abstract idea or basic human knowledge or thought.
The US district courts decision seems to be not in consonance with the philosophy that has been followed by the Courts in the US till now. And this surely is not very good news for the Molecular biologists and patent assignees of gene patents. When the rest of the world is expanding the gamut of patentable inventions to include gene based inventions (following the foot steps of US) US seems to be taking a U turn. Let’s wait and watch the fate of this decision with crossed fingers.