Indian Pharmaceutical Lifecycle Management – an oxymoron?


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.

Sounds bizarre?

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?

2 comments.

  1. Duncan Bucknell

    A friend sent in the below:

    Great post and very valid points. A few doubts:

    “In other words, mere innovations are not capable of patent protection.”

    Why do you say that “innovations” are not capable of patent protection? Or, what is you’re definition of an “innovation”. Why do you think that section 3(d) supports innovations (the ones that demonstrate increased efficacy?)

    2. “Except in Australia, which has Innovation Patents designed specifically to have an extremely low threshold of ‘inventiveness’ – much easier to meet than obviousness”

    Are you saying that “inventiveness” is a lower standard than “non obviousness” (TRIPS uses them interchangeably). Also, do you mean that Australia has a utility model kind of system.

    3. how does it matter whether the statute drafts them as patentable subject matter issues or as an obviousness question (apart from the fact that there wil be an issue of “timing”–at what point in time will the controller examine the application to see whether it complies with a sectin 3(d) type section?

    Reply
  2. Duncan Bucknell

    Dear anonymous
    Thanks very much for the great questions. Here are some brief responses.
    Let me know what you think – and please join in everyone – we can all explore this together.
    1 – I was (perhaps inelegantly) observing that India’s 3(d) puts a lower threshold on what would be considered patentable which basically relies on the law of inventive step. Many people use the term ‘innovation’ to describe something that is new but not quite up to that standard. To reinforce the point that this is not an India-only issue, I referred to the US Supreme Court decision in KSR v Teleflex.
    Does that help?

    2 – Inventiveness and Obviousness. I agree that in many contexts they can be used interchangeably. Note, however, to be pedantic, one should probably use ‘inventive step’ and ‘obviousness’, not interchangeably, but as the opposite descriptions of this ground of invalidity. In some countries, ‘inventiveness’ is used to describe the quality of ‘being an invention’ – which is basically broadly the same as patentability.

    Yes – Australia has a Utility model system – the 8 year right is called an ‘Innovation Patent’. There is no obviousness test for the Australian Innovation Patent – instead, the test is one of ‘innovative step’. To pass the test and maintain validity, one must simply show that the difference between the claimed innovation and the prior art makes a substantial contribution to the working of the thing (be it a product or process). There’s some obvious strategic implications of this for Australian patentees which I will pick up in a future article back at duncanbucknell.com

    3 – Words, the labels we give things and the way they are used are incredibly important. If we start using them in other contexts, we can have some unintended results. We usually don’t find these out until much later.
    I also believe that harmonisation of IP law across the globe is a very good thing for the commercial users of the system – saving time and money if nothing else. Consequently, while countries are free to make these amendments, they should ideally be placed in the correct context in the relevant legislation.

    I look forward to the continuing discussion.
    (Please post comments directly on the blog, if you can – as that helps everyone.)

    Reply

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