India’s section 3(d) poses some interesting problems for innovator companies seeking to get the best return on investment in India (read ‘longest period of monopoly’). Is that the end of the story for Lifecycle Management in India, though?
First up – for those who think that “Lifecycle Management” is a dirty word (phrase), consider (a) the number of ‘innovators’ with generic subsidiaries, or who have entered authorised generic deals, and (b) the enormous and successful new chemical entity programs by India’s leading pharmaceutical companies, and realise that the days of pure ‘generics’ and pure ‘innovators’ are gone. I know from personal conversations that these companies are thinking long and hard about “Lifecycle Management”.
There’s been a great deal said already about India’s section 3(d). Shamnad Basheer of this blog is and, has for a long time been one of the leading commentators on 3(d) and the consequent legal and policy ramifications. (See for example, here, here and here, amongst many more.)
[For those who don’t know what I’m talking about, 3(d) seriously limits the follow – on patents which can be obtained by pharmaceutical companies in India and thus substantially affects traditional methods of extending the monopoly period. 3(d) basically raises the bar on what is patentable in India as an invention. Note, however, that the US Supreme Court seemed to make similar points about mere ‘innovations’ in their recent KSR v Teleflex decision – see my recent blog post about this.]
Setting aside for a minute whether monopoly periods should be extended (in my view it really depends on the circumstances) – does 3(d) end the Lifecycle Management game in India altogether?
No – clearly not.
There are many tools and techniques which can be brought to bear to optimise the return on investment for a particular drug.
Ok, amongst the many, what are some of things you can do that are 3(d) proof?
The most attractive, of course, is to keep on inventing (not innovating) and filing patents. Yes, as patents expire, the generic companies will be free to copy the earlier, (no longer patented) versions of the drug. But, if you really have come up with something new and useful – then people will be happy to pay a premium – right?
Another is to keep quiet.
That’s right – file patents according to the normal principles, but wait as long as you can before telling the world. The idea here is to delay for as long as you can the time at which other people start working on your drug and filing their own patents.
Have a look at the results of a recent pilot study I undertook briefly described in my recent article about the effect of early-filed non-innovator patents on monopoly periods. (There’s data in some slides which accompanies the article, and as always, there are some disclaimers that go along with the data. However, I think you can see the point I’m making.)
What do you think? Should Lifecycle Management be ‘allowed’? What other 3(d) proof techniques have you noticed?