Patients in the advanced stage of kidney cancer can take some solace from the fact that a key drug in their treatment will now be available at a much lower price.

The drug is Bayer's advanced kidney cancer drug Nexavar, and a generic copy of this medicine will now be available in the market place from Hyderabad-based company Natco, at 97 per cent less than the price on the original drug.

The development follows a recent judgment by the Indian Patent Office – that granted a compulsory licence to Natco to make a generic copy of Bayer's Nexavar, on the payment of a six per cent royalty on net sales.

While this opens up the opportunity for more generic companies to take the CL pathway – there is a need to temper the enthusiasm over the grant of the CL with a reality check.

How many domestic companies will in fact bite the bullet, and seek voluntary licences or compulsory licences on critical drugs not accessible to a larger public in the country? And even if they do, how much can the Patent office take on, burdened as it is with a long pending list.

The CL judgment has opened an opportunity to look at the option, provided companies are able to meet the different criteria, observes intellectual property expert Mr Gopakumar Nair. How many companies can handle the logistics of filing for a CL, pursuing it till it is got and sustaining it thereafter, he points out.

There are few local companies that are inclined, and have the competence and capability of handling the legal requirements for the entire process, he says.

Patent office capacity

The CL judgment catapulted the Patent office into prominence, as it signalled the Government's intention to keep medicines affordable for its public. What is also true, though, is that they are burdened with a long to-do list.

“The pendency is still high ….due to lack of manpower. By electronic process though I have improved the efficiency of the work, due to paucity of manpower, pendency is still high,” says Mr P.H. Kurian, former patent controller general who scripted the path-breaking CL judgment.

Speaking to Business Line on the day the CL judgment came into public domain, which coincided with the day he handed over charge to the new Patent Controller Mr Chaitanya Prasad – Mr Kurain said, more than one lakh patent applications are pending, besides another three lakh-plus trademark applications that are at various stages of processing.

Over the last three years that Mr Kurian was at the helm, about 30,000 patents were granted and a good number have been rejected, he said.

Besides the first lot of about 150 examiners, the Patent office further recruited another 250 examiners who were being put through a structured training programme at Nagpur, he said. Further, he points out, of the 122 posts available, only 66 have been filled.

Indian participation

Even as the Patent office braces for more applications, Mr Kurian observes that Indian applications are growing at a slightly higher percentage than those filed by foreign persons or entities. However, there still is a lack of awareness among domestic players on filing patent or trademark applications, he said. Of the patent applications filed, the scale continues to be tipped in the direction of foreign filings, accounting for a lion's share of 80 per cent. But over 10 years, Mr Kurian expects filings from domestic entities to go up to 30 per cent.

No ambiguity

The recent CL judgment is expected to go into a process of legal review. And another watershed intellectual property related case on Novartis's cancer drug Glivec is coming up for its final hearing. But Mr Kurian says there is no ambiguity in the Patents law.

The Supreme Court verdict will settle the Glivec case and the issue of Section 3d (of the Indian Patents Act, 2005) – that ensures a compound does not get a fresh life of patent exclusivity for another 20 years on the basis of an incremental development on an exiting compound.

“So many foreign companies that prima facie involve a 3d scenario, where they were able to prove an enhancement of efficiency we have granted patent,” says Mr Kurian.

Pointing out that his officers have been able to work clearly because the law was unambiguous, he explains: “Prima facie 3d appearing cases were granted and that number is much more than refusal of patent on 3d ….so 3d is a test where the apparent appearance of same compound …if applicant is able to prove better efficacy, we have followed the law and given large number of patents.”

So as the amended Patents Act gets tested from different quarters and the Patent office grapples with its load of applications, patent experts point out, the stage is now set for domestic companies to scale the next frontier and seek a CL to be able to supply critical patented drugs overseas.

jyothi@thehindu.co.in

Snapshot Bayer sells Nexavar at Rs 2.8 lakh per month for 120 tables Natco now allowed to sell its version of the same medicine at Rs 8,800 in India Over three years, 30,000 patents granted by Patent office One lakh pending patent applications, and over three lakh trademark applications in different stages of processing

Published on March 26, 2012