Lifecycle Management at risk? Will Asian countries follow India's 3(d) lead?

The Indian Economic Times newspaper has reported that at least 10 Asian countries may add a provision along the lines of India’s section 3(d).

The article quotes an official in the Indian ministry of commerce & industries as saying -“We get a lot of enquiries from a host of countries
about the provision. The Philippines has already amended its law on similar

Chapter II of Part II of the Philippines Intellectual Property Code deals with Patentability. I haven’t seen an amendment to this Chapter which resembles section 3(d), but would be delighted to be pointed in the right direction.

Other countries named in the article included: the Maldives, Pakistan, Sri Lanka, Vietnam, Indonesia,
Malaysia and Bangladesh.

See my earlier posts, discussion and article on section 3(d) which conclude that it won’t be surprising if the PhRMA or a similar group gets involved in the near future…


  1. Indian Economic Times article
  2. SpicyIP post

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6 Comments on “Lifecycle Management at risk? Will Asian countries follow India's 3(d) lead?

  1. Interesting title! Depends on where you draw that line between true ‘Lifecycle Management’ and ‘Evergreening’ (if there is a line).
    I’d personally like to see these clauses/amendments be a huge success in India and other adoptee countries, in that they hopefully keep the patent courts clear for more important questions to be tried and make an easier path for affordable generics, rather than posing such questions as whether or not an expert deems the selection of a salt or polymorph to be an inventive step at the date of the patent. True lifecycle management resulting directly in benefit to the patient is not hindered by such legislation.
    Perhaps then, the US and European patent offices may then follow suit…but I doubt this will be in my working life…

  2. Thanks LeightonThe line between innovation and patentable invention is also indistinct and this debate obviously goes to the core of this question.One of the arguments used to support s 3(d) is that it complies with TRIPS as it is merely an obviousness standard which allows greater latitude in implementation.If it is indeed an obviousness standard, then why is it needed?  Shouldn’t obviousness just be determined according to usual principles and before the courts?

  3. I believe the value in the clause is that it can be interpreted at the patent office level in an unambiguous fashion, thus avoiding the need for each and every patent to go to the courts to determine what the obviouslness standard is in every case, as determined by paid experts.
    The EPO and US patent grants that we have seen recently are perhaps a reason not to let the ‘usual principles’ be interpreted at the patent office level.
    Do you agree?

  4. Thanks LeightonA problem with this is that it casts a net which is too broad. As in many other areas of the law, obviousness is a factual question (except, of course, in the US where it is a question of law determined by reference to the facts… go figure…), and such questions really should be left to be determined by the facts in each case – not by a blanket prohibition.So, the standard has to change with the circumstances – that’s why we have skilled addressees.  (And that’s why patent offices are supposed to hire people with technical backgrounds to examine patents.)I really think that poor quality issued patents are more a product of overworked patent examiners than the standards that they are to apply.(PS – s 3(d) is itself quite ambiguous, but I get your point – that something (drafted more clearly) which is like it could have some benefit.)

  5. Thanks Duncan, the points you raise make perfect sense from the legal perspective and I guess this is the difficulty with legislation – making it have only the desired effect on the ground.
    Using an analogy once described at a legal conference with regard to infringement (which I acknowledge is different from validity issues being discussed here)  in regards to a goat (bear with me!!): the obviousness criteria seems to be the stake in the ground (being the facts) to which the goat is tied via a leash. Whereas section 3d appears to introduce a secondary mechanism of restraint (if, as you say,it is better worded) in the form of a fence. Although these serve the same purpose (to stop the goat from eating your wife’s garden flowers) they offer different levels of security and, most importantly, different ways of determining the boundaries.
    This is a kind of approach , also referred to as ‘belt and braces’, provides one that can easily be interpreted at the patent office level (point taken about examination quality but it seems to be uncontrollable to the required level), and one in the courts if necessary.
    I’m not sure whether your point is that this is a ‘belt and belt’ approach so is pointless, or whether it is a ‘belt and braces’ but results in possible conflicting legislation?
    Have I made any sense here – lots of analogies I know??

  6. Nice analogy, LeightonI guess what I’m saying is that it depends on whether you own the goat or the flowers.

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