Update on the Novartis case - Hearings on Novartis' appeals to commence in November 2008

[Guest guest]

Dear friends and colleagues,

Greetings from Lawyers Collective HIV/AIDS Unit!

We write to bring you an update on the Novartis case.

As many of you may recall, patients' groups won an important battle in the

struggle for affordable medicines in August 2007, when the Madras High Court

upheld the validity of a key public health safeguard-section 3(d) of India's

Patents Act, 1970. Section 3(d) prohibits patenting of new forms of known drugs

unless there is a significant increase in efficacy.

The challenge to section 3(d) was brought by Novartis AG, a multinational

pharmaceutical company, after the Patent Office at Chennai rejected its patent

application for the beta-crystalline form of imatinib mesylate (also known as

Gleevec), a crucial anticancer drug. In January 2006, after hearing pre-grant

oppositions filed by Cancer Patients Aid Association and several Indian generic

pharmaceutical companies, the Patent Office rejected the

patent application on several grounds including section 3(d).

Applying section 3(d), the Patent Office held that the beta-crystalline form of

imatinib mesylate for which Novartis sought a patent was a new form of

imatinib-which was an already known substance-and that Novartis had not

satisfied the Patent Office on the increase in efficacy.

In response to the rejection, Novartis filed several cases against the

Government of India, Cancer Patients Aid Association and the Indian generic

pharmaceutical companies.

The first set of cases challenged section 3(d). Novartis lost those cases in

August 2007.

The second set of cases challenged the Patent Office's rejection of

Novartis' patent application for the beta-crystalline form of imatinib

mesylate. These cases will now come up for hearing before the Intellectual

Property Appellate Board (IPAB).

The IPAB is to comprise of two members: a judicial member and a technical

member.

Novartis' appeals were held up due to procedural reasons since April 2007.

Though Novartis had filed the appeals before the Madras High Court, the cases

were transferred to the IPAB in April 2007 when the Government notified that the

IPAB would hear appeals relating to patents.

When the Government issued the notification in April 2007, it appointed Mr.

Chandrashekar as the technical member to hear appeals relating to patents.

However, when the hearings commenced before the IPAB in June 2007, Novartis

objected to this appointment. Novartis' objection was on the ground that as Mr.

Chandrashekar had filed an affidavit on behalf of the Government in the appeals

supporting the Patent Controller's rejection of Novartis' patent application, he

had already formed a view on the merits of the case and therefore would be

biased.

The IPAB rejected Novartis' plea on the ground that Mr. Chandrashekar was the

only technical member who was competent to hear appeals relating to patents.

Novartis then approached the Madras seeking the removal of Mr. Chandrasekhar

from IPAB. The Madras High Court, pursuant to the suggestion of the Government,

decided that a two-member bench consisting of the Chairman (Judicial Member) and

Vice-Chairman could hear the appeals without a Technical Member.

Natco Pharma Ltd, one of the generic companies involved in the litigation,

approached the Supreme Court challenging the order of the Madras High Court.

It contented that it would be difficult for the IPAB to arrive at a proper

decision without a Technical Member because the matter was too technical and

involved chemistry of complex compounds.

At the commencement of proceedings before the Supreme Court of India, the court

stayed the proceedings before IPAB until the matter was finally disposed of by

it. This stay order brought the proceedings before the IPAB to a halt.

After hearing both sides, the Supreme Court of India directed the Government to

submit a list of qualified persons who could be appointed as a Technical Member

for the purposes of hearing the appeals filed by Novartis.

On 1 October 2008, the Supreme Court of India appointed Dr. P. C.

Chakraborti, Deputy Controller of Patents and Designs, as an ad-hoc

technical member on the IPAB, to hear Novartis' appeals against the

rejection of its patent application.

The Supreme Court has directed the specially constituted IPAB to list the

appeals on 3 November 2008. The order further directs hearing on a

day-to-day basis, preferably in November 2008.

The order of the Supreme Court in this case (Natco Pharma Limited v. Union of

India and Others) is available at www.lawyerscollective.org

<http://www.lawyerscollective.org/>

All other documents relating to the case will be made available shortly on our

website.

In the coming weeks, we will update you further on the developments in this

case.

In solidarity,

Lawyers Collective HIV/AIDS Unit

e-mail: <aidslaw1@...>