Chennai High Court order for Gleevec

Friends,

Here is the Chennai High Court order rejecting Novartis' challenge to S.3d of the Indian patent act as well as stating that section 3(d) is not unconstitutional. It also ruled that it is not competent to adjudicate upon whether or not section 3(d) is TRIPS compliant.

Shamnad Basheer had written interesting analysis on this decision here and here and hence I am not analysing the order further.

Chennai Patent Office for Gleevec

The Novartis/ Imatinib/ Gleevec pre-grant opposition saga started at the Chennai patent office.

Natco had filed a pre-grant opposition for this patent application.
The Examiner had issued an order against Novartis.

Here is a copy of that order.

Salient points:
Application in question: 1602/MAS/1998
This application claims: a beta crystal form of methanesulphonic acid salt of 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-[4-pyridin-3-yl]pyrimidin-2-ylamino]phenyl]-benzamide commercially called as imatinib mesylate.
The base salt – Imatinib was known / disclosed earlier in EP-A-056409, published on October 6, 1993, and its equivalent US5521184.

Main grounds:
a) Anticipation:
The Controller held that the earlier base compound covered the salt form and that the salt form normally exists in the beta crystalline form which is the most thermodynamically stable product.

b) Obviousness:
On the basis of the reports of the Indian Institute of Technology, and Indian Institute of Chemical Technology, the Controller held that the salt prepared using instructions of the 1993 Patent inherently exists in beta crystalline form. Hence the product claims were held to be obvious over the aforesaid technical reports.

c) S. 3(d):
The Controller held that the present claimed product was a only a new form of a known substance without having any significant improvement in efficacy, hence not patentable under section 3(d) of the Patents Act, 1970.

d) Claiming priority from Swiss document:
Switzerland became a Convention Country in September, 1998. Hence no priority can be claimed from a Swiss application prior to this date.

In view of the above, the application was rejected and the Opposition was upheld.

First post

Friends,

This blog is for all Indian patent system users who want to keep a track of Patent office/ Court decisions regarding patents.

This is a collaborative venture between me [Sandeep K. Rathod] and my dear Advocate friend Feroz [Feroz Ali].

I have a separate blog focusing on the generic pharmaceutical business with a focus on IP issues and Feroz has his blog that focuses on the legal aspects of pharmaceutical and biotechnology patents in India.

Why this blog?
This blog is a forum to share, contribute and disseminate information relating to any contentious patent decision rendered by any judicial or quasi judicial body in India. Though we have named this blog as 'indianpatentoppositions' for reasons of easy web search and familiarity, we do not intend to confine the reporting of decisions of patent oppositions alone.

We both will try and host as many patent decisions from the Patent office as well as the Courts, as we can lay our hands on, but both of us would appreciate if you readers would share the patent office decisions that you have.

You are free to contribute or bring to our attention any contentious decision relating to patents. As the fundamentals of patent law are the same for all inventions, including pharmaceutical inventions, we would be glad to know about any decision on patent law and would be happy to post the same (if a scanned copy is send to us) and review the decision (if the details of its reporting, say in PTC or IPLR or other journal is brought to our notice). You may also bring to our attention any decision reported in any journal by sharing with us its citation. We shall review the decision on this blog.

Why should you contribute?
As you would be aware, the Indian Patent Office, unlike certain other patent offices does not host the opposition decisions rendered by it. Being in a legal system which works on a system of following precedents, the reporting of patent decisions will go a long way in the development of the Indian patent law, regardless the binding effect of these decisions. We know very well that the Patent Controller is not bound by his own decisions. But a like decision following established principles of patent law will be hard to ignore, when brought to notice, and will compel the deciding authority to give reasons, if it is to differ with its own earlier decision. All this would certainly be beneficial for any one who is interested in the Indian patent system in general and in pharmaceutical patents in particular.

We understand that knowledge of a patent decision can sometimes come in different circumstances. If you (or your company) have been successful in any contentious proceeding relating to patents, we will be glad to inform the world on your behalf by posting the decision on this blog. If you (or your company) are not entirely satisfied with a decision, this forum will be a fit place to disclose to the world and bring public attention to the relevant decision. Our work model is solely based on quid pro quo.

What can be contributed?
Being public documents, irrespective of the fact whether they are reported or not, we would be delighted to post any contentious patent decision on this blog. We would appreciate if you could send scanned copies or re-typed copies of the decisions with you. Should you only have hard copies, you may send legible photocopies of the same by post to us. We shall do our best to post them on this blog.

Please note: Patent Office decisions are public domain documents and their sharing would not be a problem from your employers' legal dept. as well.

Please let us know if you would like us to disclose your identity. We will be glad to acknowledge each one of you (and the organisation you represent). If you choose anonymity, we will respect that too. The only thing that drives us is our strong conviction that these decisions are public documents and everyone has a right to know.

Sincerely,
Sandeep and Feroz