Glivec, Gleevec (Imatinib) Novartis' crystalline form strategy

I posted a couple of notes (here and here) yesterday at SpicyIP about Novartis’ alpha crystalline Glivec
(imatinib) patent which has recently come to light. This application
was filed back in 2004, before the changes to Indian patent law, and
the subsequent (and ongoing) fight with the IPAB, etc. I have reposted some of that material here, to expand the discussion.

For those who aren’t aware, Novartis has other patents covering imatinib in similar ways. Take for example, WO 2007023182 for Delta and Epsilon Crystal Forms of Imatinib Mesylate.

From
a strictly Indian perspective this might seem to border on the futile
(in light of the restrictions imposed by section 3(d)). In fact, this
looks set to be the case in some other countries as well (Philippines, Maldives, Pakistan, Sri Lanka, Vietnam, Indonesia, Malaysia and Bangladesh).

However,
Novartis really has no other choice but to do this – the potential
‘upside’ is too high in all of those countries which will grant the
patent applications. In many countries, the fact that a patent has been granted (irrespective of the validity status) can be used to strategic advantage. Take, for example China and Germany where infringement and invalidity are determined in separate courts, or the situation in many European countries where a preliminary injunction application will only assess infringement and give scant regard to validity.

Don’t forget the potential enormous ‘downside’ to Novartis of allowing a
competitor to obtain such patents first. Companies other than the innovator commence patenting various aspects of a molecule long before market authorisation is obtained. So they will certainly be looking into new crystalline forms which give the chance of the benefits a new Composition of Matter patent. (See my recent article: Pharmaceutical & Biotech Lifecycle Management (II); How does timing of 1st non-innovator patent affect the period of monopoly for a new drug?

Also –
who knows? Even in those countries, these patents may get through – perhaps these crystalline forms will meet the ‘enhancement
of the known efficacy’ test. If I was Novartis, I’d be learning from
the current litigation over the beta form in preparation for my efforts
on these other forms.

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