Gene patents

I wonder how surfing internet sometimes become like falling down a rabbit hole. I was once looking up something for a friend during when I came across the 'standard essential patents'. This somehow lead me to gene patents. This term revived a distant memory. When I was in B.Sc., one of my friend told me that  the biotech industry stocks suffered a huge loss in single day when president Bill Clinton declared human genome sequences should be available freely ( see Clinton - Blair Statement). Of course, this was quite far from the day when their supreme court declared genes are not patent-able after long legal tussle (this I learned now, not then). So I have decided to simply collect the status of gene patents in India and abroad. I present a summary of what I learned and thoughts over here.

 A little bit of history for the most famous gene patent litigation. BRCA1 and 2 are quite infamous genes. These genes are involved in DNA double strand breaks repair. They are known as breast cancer susceptibility genes i.e. a mutation in one of these genes can vastly increase your chances of having breast cancer. So, the scientists who discovered their function realized their commercial value and created a test panel to check for mutations  (having herself tested positive for these mutations, lead to mastectomy as preventive measure for Angelina Jolie). BUT, what they actually patented was the whole gene (natural or mutant otherwise). So, If you want even to check for wild type (naturally occurring ) gene in your own body, you have to pay THEM. If you want to visualize those genes. pay them. check their interaction with other genes, pay them. A simple PCR in your lab for this, for whatever purpose that maybe, pay them. basically, if you event want to touch any functionality of those gene and gene products, you will have to pay them.
In 2013, after several round of litigation back and forth, the US Supreme Court ruled that "A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated", invalidating Myriad's patents on the BRCA1 and BRCA2 genes. 

Now, lets talk about the current scenario.

China and Brazil do not consider life forms ( in whole or parts) patent-able but patenting genes is permissible. currently Shanghai Joint Gene Technology Co. Ltd, has applied for more than 37,000 genes patents which cover many health related genes (see WHO: Human genomics in global health ).

Indian patent law, did not permit gene patents ( according to Section 3(C) - Discoveries of living things or non-living substances occurring in nature are not patent-able subject matter ). Thus, DNA, RNA or proteins isolated from living organisms are unpatentable but this provides for the patent-ability of genetically modified versions. Therefore, use of recombinant DNA technology to produce products, and product patents for DNA and RNA are now allowed. but the monopolization resulting from this, if it leads to jacking up price of products, it could be in violation of section 3(B) - an invention the primary or intended use or commercial exploitation of which could be contrary public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment. 

probably, the exclusion of gene patents till 2005, was what led to a gene patent filing in US patent office by Prof. Asis Dutta in 1995 ( never saw him ,but obviously he was quite a influence in SLS, JNU long before I came into that picture). He isolated  AmA1 gene from ramdana plant. Its gene product contains reasonably high quantity of essential amino acids. He claimed that apart from covering creation of transgenics (e.g. creating common crops containing this beneficial genes to increase their nutritive values) by constructing the artificial sequence, his patent also covers isolation of the gene in this interview. But he refused to comment on the conflicts arising from his patent like the demand from other countries that India allows patents on life forms, making access to germplasm more difficult even for Indian scientists and rights of Indian farmers who have actually developed and conserved that specific variety by natural breeding over the resulting royalties.

As stated by USA supreme court, genes are preexisting. It was their discovery. not innovation. mere discovery of something does not qualify for patent. It should be an innovation. Its application should be non obvious ( one of the key point in ongoing CRISPR patent war is whether application of CRISPR-Cas9 system from prokaryotes to eukaryotes for gene editing was an obvious one ). Patenting a gene restricts further research over its functions and interactions in the limited hands. It should not be patented because they did not build it up from the scratch. But the area is grey in many countries. 

Agreed that the expected monetary benefits drive the investment from private sector and funds the new research. therefore, they need to have the assurance that their interests will be protected. When the human genome sequence was made public, imagine what would have happened if the Celera Genomics (the private entity which was also sequencing the human genome along with public consortium) would have gone ahead and patented the human genome ? I don't like even the idea of research landscape resulting from this.