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November 7, 2010

Gene Patent Debate is Alive Again

Image by Chris Madden

The amicus brief submitted by the Department of Justice (DOJ) in the Breast Cancer Gene patent appeal before the Federal Circuit has drawn great attention during the last week. A US District Court had earlier rejected isolated gene sequence claims in Myriad's patent stating that they do not satisfy the patentable subject matter requirement because they are products of nature. Aggrieved by the decision of the District Court, Myriad appealed to the Federal Circuit. The Department of Justice has filed an amicus brief before the Federal Circuit stating that the District Court's opinion was right with respect to genomic DNA sequences. As the DOJ's opinion is very persuasive, it has once again brought the gene patent debate to life.

The DOJ has clearly pointed out in its brief that cDNA sequences, vectors, recombinant plasmids and chimeric proteins are patentable but the genomic DNA sequence, which exists in human body is not patentable.As per DOJ, merely isolating the exact sequence as it exists in the body does not merit patent protection as it amounts to product of nature. The DOJ has in its brief logically pointed out that isolation of such a sequence and identifying the fact that it encodes a protein that causes breast cancer, which is a natural relationship, is not sufficient to make the sequence patentable.

The DOJ's argument is not only well founded but also very obvious. For a long time, one wondered the difference between gene sequences that exist in nature and their isolated counter-parts. Though genomic DNA claims were granted on the pretext that they were eligible subjects because of their purification, the argument never made sense. The fact that research in identifying gene sequences assumes very high importance because of its relevance to curing many diseases was also well countered by DOJ, which pointed out that such an argument does not have a basis in patent law.

It is time that the US Courts and Patent Office open their eyes to the nature and change the law and policy with respect to patentability of gDNA sequences. The same applies to the Indian Patent Office, which has been allowing patent claims with respect to gDNA sequences. One example of such a claim is provided hereunder for your reference:

Patent No. 239864
Title : AN ISOLATED OR RECOMBINANT POLYNUCLEOTIDE
Assignee: 1.MAXYGEN, INC.2. PIONEER HI-BRED INTERNATIONAL, INC.3. E. I. DU PONT DE NEMOURS AND COMPANY

Claims
1. An isolated or recombinant polynucleotide, such as herein described,comprising:
(a) a nucleotide sequence encoding an amino acid sequence that can beoptimally aligned with a sequence selected from the group consisting of SEQ ID NO:300, SEQ ID NO:445 and SEQ ID NO:457 to generate a similarity scoreof at least 720 , using the BLOSUM62 matrix, a gap existence penalty of 11, and a gap extension penalty of 1; or
(b) a complementary nucleotide sequence thereof.

The claim has been very broadly drafted and claims both cDNA and gDNA sequences. Though many scholars and patent officer officials argue that genes are not patentable, many gene sequence patents have been granted and many of them have broad claims including gDNA. As it stands today, gDNA and cDNA sequences are patentable subject matter in India.

Even after the world had witnessed two rounds of debate on the extent of patentability of genes, the Indian patent office's policy with respect to the same is not clear. The lack of court decisions on the subject is one strong argument in favour of the patent office. The 2010 patent manual, which has been released last week does not like the earlier version throw any light on the subject. The laws of nature exclusion under Section has not been expounded from the gene sequence perspective. As pointed out by the DOJ and by common sense, gDNA sequences, their functions and their relationships with proteins are products of nature and natural relationships and must be rejected based on laws of nature exclusion. Though this post, I wish to open the gene sequence patent debate in India, especially at a time when the patent office has asked for comments on its latest manual.

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