Posts by: Jeanette Jakobsson | (3) posts

India’s Supreme Court rejects patent plea by Novartis for the cancer drug Glivec

For years, India did not offer any patent protection for chemical compounds, but was obliged to do this after joining the World Trade Organization. In 2005, the patent protection act therefore was amended to also include such compounds, but only if they proved significant clinical efficacy enhancements over already patented compounds, Section 3(d) of the Indian patent law.

The battle for the cancer medicine Glivec in India has been going on since 2006, when Novartis’s patent application for Glivec was rejected. The application then was rejected based on the law aimed at preventing companies from getting new patents by making only minor changes to existing drugs, a practice known as “evergreening”.

In 2009 Novartis filed a Special Leave Petition with the Indian Supreme Court, challenging the decision to reject a patent for Glivec and also challenging aspects of the Indian patent law,  since Novartis considered the concept of innovation was too narrowly defined. Specifically at issue was Section 3(d), since Glivec is a salt formulation of the already known molecule Imatinib.

In the beginning of April 2013, the Supreme Court rejected the arguments from Novartis and came to the conclusion that Glivec is not novel, not inventive and does not satisfy Section 3(d). In this contect, it should be noted that Glivec has been patented in nearly 40 countries including US, Russia, China and Taiwan.

Ranjit Shahani, Vice Chairman and Managing director, Novartis India Limited, commented the outcome, saying “We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options”.

“The Supreme Court’s decision now makes patents on the medicines that we desperately need less likely. This marks the strongest possible signal to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law.” said Dr Unni Karunakara, MSF International President, one of many organisations celebrating the decision.

In view of the decision of the Supreme Court, viewed alongside other recent patent setbacks for Bayer (see previous blog) and Roche (see previous blog), Novartis, as well as other multinational drug companies, are concerned about the deteriorating innovation environment in India, and will probably carefully evaluate whether to launch new drugs in India in the future.

Jeanette Jakobsson, European Patent Attorney

Poverty versus patenting in India – round two

Earlier this year the first compulsory license, regarding the anti-cancer drug Sorafenib, was granted in India. (See previous blog post.) The compulsory license was granted inter alia on the ground that the patented invention was not available to the public at a reasonable affordable price.

The battle towards affordable medicaments in India continues. In a decision issued 2 November 2012, the Intellectual Property Appellate Board (IPAB) of India came to a decision in favour of the patients in India by the revocation of Patent No. 198952 (Roche). The patent concerns PEG derivatives of IFN?. Roche’s product was sold under the name Pegasys® and used for the treatment of Hepatitis C.

The process began when two post-grant oppositions were filed against the grant of the patent, one by M/s. Wockhardt Ltd. and the other by an NGO (non-governmental organization) named Sankalp Rehabilitation Trust. Both oppositions were disallowed, resulting in an appeal filed by the NGO.

During the appeal, Roche challenged the right of an NGO to oppose a patent in a post-grant proceeding, since, acording to S.25 (2) of the Patents Act, 1970, only “any person interested” may challenge a patent after grant. Roche meant that Sankalp was neither a competitor nor a researcher in the sector, and that a non-profitable organization working for the benefit of drug users cannot be said to have any interest of the nature as required by the act.

The IPAB stated: “We must take a common sense approach to construe the interest that the opponent has in opposing the grant of the patent. In the present case, the appellant claims that it is a society which works for the community of HCV and HIV sufferers. This is not challenged. The invention is admittedly for the use in the case of hepatitis-C. The continuance or removal of the patent will definitely affect the interest of the community for whom the appellant claims to work………We therefore hold that the appellant who works for a community which needs the medicine is definitely a “person interested” The locus standi objection is rejected”.

The IPAB held that the invention was obvious in view of prior art. The appeal was allowed and the grant of Patent No. 198952 was set aside.

This case is of great importance since NGOs are given the status of “interested person” under the Patents Act, giving them the possibility to challenge granted patents in India.

The decision in this case is seen as a victory for public health and for affordable drugs in India. The immediate effect of a revocation like this is the availability of cheaper generic products for the people in India.

The drug companies, however, consider that intellectual property is not being valued in India. This might result in them changing their plans regarding development of drugs well needed in for instance India. Thus, the long-term effects of this decision are still to be seen.

Jeanette Jakobsson, European Patent Attorney

India Grants the First Compulsory License

The Compulsory License Application No. 1 of 2011, the first of its kind in the history of the Indian Patents Act 1970, concerns the anti-cancer drug Sorafenib, where the patentee is Bayer Corporation and the applicant for a compulsory license is Natco Pharma Limited.

The anti-cancer drug Sorafenib, sold under the brand name NEXAVAR, is used for treatment at advanced stages of kidney and liver cancer. The drug is not a life-saving drug, but a life extending drug. The cost of the drug is very high – around Rs. 280,000 per month, a sum that is unaffordable to many of the patients in India. Natco wanted to sell the drug for around Rs. 8880 per month.

According to the Indian patents act, a compulsory license is to be granted at any time after the expiration of three years after the grant of the patent, on any one of three grounds:

(a)    that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or

(b)   that the patented invention is not available to the public at a reasonable affordable price, or

(c)    that the patented invention is not worked in the territory of India.

According to the decision, the requirements for each of the three grounds were separately met and a compulsory license was granted. In view of the fact that India has such a huge population and also a huge pharmaceutical industry, the decision to grant a compulsory license is of great importance.

The Controller General of Patents was in the decision influenced by the high price and low sales by Bayer, and concluded: “It stands to common logic that a patented article like the drug in this case was not bought by the public due to only one reason, i.e. its price was not reasonably affordable to them”.

Regarding item (c) above, this, according to the decision, is to be construed in that the drug must be manufactured in India, i.e. not imported to India, since it was concluded by the Controller General of Patents that ‘worked in the territory of India’ means ‘manufactured to a reasonable extent in India’.

The conditions of the license were many, including for instance that the price of the drug covered by the patent, sold by the licensee shall not exceed Rs. 8880 for a pack of 120 tablets, required for one month’s treatment, and that a royalty at the rate of 6% of the net sales of the drug is to be paid by the licensee.

The decision can, and will be most probably, appealed by Bayer. I look forward to the outcome of a future appeal!

Jeanette Jakobsson, European Patent Attorney