A TRIBUTE TO P. H. KURIAN: WHEN PUBLIC WELFARE MEETS GUTS

P. H. Kurian, the first Controller General of Patents, Designs and Trademarks, appointed from the Indian Administrative Service, is no more. As the Controller General, this swashbuckler awarded the very first (and till date, the only) Compulsory License to Natco Pharma, in respect of Bayer Corporation’s patented cancer drug Nexavar [Patent Number 215758]. In this article, we look back at the Order that granted the Compulsory License.

Reasonable Requirements of the Public

While arguing that the reasonable requirements of the public had been satisfied, the patentee tried to combine its sale figures, with those of Cipla, an alleged infringer. However, this was struck down, as follows:

M/s. Cipla is an alleged infringer, as per patentee's own submissions, and accordingly cannot discharge the obligations of Patentee under the Act. The Patentee appears to have treated M/s. Cipla, in this case, as if they are their licensee. M/s. Cipla may be injuncted at any time by the Hon'ble Court. Such an uncertain supply by an alleged infringer cannot be considered while deciding this matter, as it involves the lives of cancer patients, which in my opinion cannot be left to the uncertainties of legal proceedings.

Reasonably Affordable Price

Similarly, the patentee’s arguments that that reasonably affordable price has to be construed with reference to the public as well as patentee were also struck down, as follows:

During the last four years the sales of the drug by the Patentee at a price of about Rs. 2,80,000/- (for a therapy of one month) constitute a fraction of the requirement of the public. 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.

The Order resulted in a 97% reduction in the price of the drug.

Not Worked in the Territory of India

Likewise, the patentee’s arguments that the word “worked” also includes imports were also struck down, as follows:

In the instant case, the Patent was granted in the year 2008. It is an admitted fact that the Patentee does have manufacturing facilities for manufacturing drugs in India, including oncology drugs. However, even after the lapse of four years from the date of grant of patent, the Patentee failed to do so. The Patentee has also failed to grant a voluntary license on reasonable terms to anyone including the Applicant herein to work the invention within the territory of India.

An Order that Stood the Test of Time

As expected, the patentee left no stone unturned in its attempt to regain control over its patents. However, the erstwhile Intellectual Property Appellate Board (IPAB) and the Courts, including the Supreme Court, refused to overturn the Order. The IPAB, which was then headed by the dynamic Justice Prabha Sridevan, did slightly dilute the Order of the Controller by holding that the meaning of “working” is to be determined on a case-to-case basis. Further, the royalty rate was increased from 6% of the licensee’s net sales to 7%.

Balancing Monopoly with Public Welfare and Access to Health

The Order was inline with the legislative intent of the Indian Patents Act. In fact, Section 83(d) expressly states that the Controller shall take into regard the following: patents granted do not impede protection of public health and nutrition and should act as instrument to promote public interest specially in sectors of vital importance for socio-economic and technological development of India.

Where There’s a Will, There’s a Way

Mr. Kurian’s tenure was an example of how the Indian society could benefit when public welfare meets guts. With growing inequality and increasing hypercapitalism, India would do well to use the different provisions of its patent legislation to its advantage. But the question is… will we?

Setting the Gold Standard

Leaders may come and go, but people like Mr. Kurian will forever remain etched in the sands of time.

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