|Image from here|
The Business Standard recently carried apiece on the Avesthagen patent controversy where the Central Government (the DIPP) revoked a patent granted to Avesthagen, using a rather rare provision of the Patent Act, on the grounds that the patent was granted for ‘traditional knowledge’. The reason for invoking the rare provision was because the Traditional Knowledge Digital Library, set up by CSIR and the Govt. had filed an opposition to the corresponding EPO patent filed by Avesthagen. You can read the previous posts over here, here and here.
I disagree with most of the analysis in the Business Standard piece. For example at one instance it states:
"India has argued that traditional knowledge cannot be patented because that will interfere with the lives of ordinary people. Those who use traditional medicine are often farmers and workers in villages, tribes or forest dwellers — poor people who cannot pay for patented cure. It is also a politically sensitive matter. Any government that allows such patents will in no time be accused of selling out to unscrupulous drug makers."
In my opinion, the reason that traditional knowledge patents are not allowed in India is because such patents fall foul of conventional patent law concepts like novelty & obviousness. I don’t think the bar on such patents has anything to do with the fact that it will interfere with the lives of ordinary people.
But what I find more objectionable in the article is this quote by an activist, where he states “The Indian patent law does not allow patents on traditional and combination medicines but the patent examiners are influenced by jurisprudence of other countries and do not interpret the law in Indian public interest in the Indian context,” .
Again, in my opinion, this is an absolutely flawed analysis and is not based on the facts. If you go to the TKDL website, over here, you will get a huge list of cases where the TKDL has outlined multiple instances where the USPTO, EPO etc. have used the TKDL to strike down patent applications pending before them. Clearly foreign ‘jurisprudence’ has nothing to do with the fact that bad patents such as the one in question are slipping through the Indian system. In fact if you have a glance at the Examination Report of this particular patent, the patent office did in fact raise an objection to the patent on the basis of Section 3(p) of the Patent Act, which bars the patenting of traditional knowledge. The problem in this case was that TKDL was not giving the Indian Patent Office the same kind of support it was giving to the foreign patent offices.
Yet another part of the article which I find flawed is the following quote:
“Section 3 (j) of the Indian Patent Act which says that a plant or animal, in whole or any part of it including seeds, other than micro-organisms, is not patentable. Even though there is no explicit exclusion of genes or DNAs under this section, it is clear that this exclusion includes gene, cell lines, DNA et cetera,” he says. However, gene patents continue to exist in India, mainly because the patent examiners are of the view that a genetically modified gene sequence or amino acid sequence is novel when it involves an inventive step and has industrial application. This anomaly, or leniency, could be the source of the government’s current embarrassment.”
The issue at hand in the Avesthagen case was not Section 3(j). Avesthagen was not trying to patent a plant, gene or DNA. You can read the claims of the Avesthagen patent applications over here. The first claim of the patent reads as follows:
“1. A synergistic ayurvedic/functional food bioactive composition for managing diabetes and related disorders, said composition comprising extracts of atleast two plants from a group comprising Eugenia at concentration ranging from about 10% to about 50%, Cinnamomum at concentration ranging from about 15% to about 50% and Salacia at concentration ranging from about 10% to 35%; optionally alongwith pharmaceutically acceptable excipients.”
The Patent Office in its First Examination Report raised several objections to the patent application before grant. Not a single one of the objections was based on Section 3(j). I reproduce the pertinent objections raised in the Examination Report below:
“Claims lack inventive step as under section 2(1) (j a) of patent act 1970,in the light of the documents given below
3.KIM S.H. ET AL.: "Anti-Diabetic effect of cinnamon extract on blood glucose in db/db mice" JOURNAL OF ETHANOPHARMACOLOGY vol. 104, 2006, pages 119 - 123, XP0022306868
5. RAVI K. ET AL.: "Protective effect of Eugenia Jambolana Seed Kernel on Tissue Antioxidants in Streptozotocin-Induced Diabetic Rats" BIOL. PHARM. BULL. vol. 27, no. 8, 2004, pages 1212 - 1217, XP008123656
1.Claim(s) 1-9 fall(s) within the scope of such clause(e) of section 3.
2.Claim(s) 1-29 fall(s) within the scope of such clause (p) of section 3.
3.Claim(s) fall(s) within the scope of such clause (i) of section 3.”
As you can see from above, the initial objections were Section 3(e) (bar against patenting mere ad-mixture), Section 3(p) (bar against patenting of traditional knowledge) and Section 3(i) (bar against patenting certain diagnostic methods. Section 3(j) was never in contention.
Unfortunately, we don’t yet have access to the Government of India’s report which revoked the Avesthagen patent. I’ve been emailing the DIPP, to no avail.
Having said all of the above I must point out that the article did also raise some pertinent issues, namely the fact that the Patent Office does not have the suo moto power to revoke bad patents. Why are Section 66 powers with the Central Govt? These powers should be with the Controller General of Patents.
As for the conclusion of the article that ‘It could get worse’. I disagree……its only going to get better.
Have faith :-)