On August 28, 2009, the Supreme Court of India dismissed the special leave petition filed by Roche challenging the order of the division bench of the Delhi High Court. Earlier the division bench had refused to grant an interim relief on Roche’s allegation that Cipla’s generic version of the anti-cancer therapy ‘erlotinib’ has infringed upon the patent granted to ‘Tarceva’. The Supreme Court, at the same time, issued an order to the Delhi High Court to hasten the trial of Tarceva patent infringement case, which is pending with the honourable court for some time.One of the main grounds for not granting an interim relief in favour of Roche by the Delhi High Court was of ‘public interest’, as the generic version of the Tarceva equivalent being sold by Cipla costs almost a third of that of the originator.Thereafter, when the case came before the Division Bench of the Delhi High Court, the appellate bench upheld the earlier judgement of the court on the subject, with some other additional observations. One of which was on the challenge by Cipla regarding the validity of Tarceva patent.

After the August 28 order of the Supreme Court, it is expected that the patent infringement dispute of the case will be now be expeditiously resolved.

However, despite the above developments, the answer to the key question, ‘how to effectively enforce product patents in India, without getting involved into expensive and protracted litigation’, still remains as illusive.

How to find an answer to the root question?

Although astute legal experts will keep expressing their legal interpretations on such cases for all time to come and similar disputes will not cease to come up even after the pending cases are resolved, the key question about the effective enforcement mechanism of product patents in India, still keeps haunting. The moot question is:

‘How to effectively protect the product patents in India avoiding time consuming and expensive litigations by all concerned’?

Possible scenario:

It is quite likely that soon, we may witness the following scenario, as a routine:

1. Product patent is granted to the innovator, in India.

2. The product is marketed in India.

3. Marketing approval is granted to generic equivalents of the patented molecule, soon after the launch of the patented product.

4. Generic company launches the product with significant price differential.

5. The originator files a suit for patent infringement and seeks an interim relief from the court.

6. The generic company files a countersuit on the product patent.

7. The honorable court decides not to grant an interim relief against marketing of the cheaper generic equivalent, on the ground of ‘Public Interest’ among other key reasons.

8. The generic Company continues to sell the product.

9. Patent infringement case continues in the court of law.

10. The originator Company has no other option available, but to operate without a robust patent protection mechanism in the country and keep incurring expensive litigation related expenses, for years.

11. The next step, which may follow, we have not witnessed, as yet, in India.

12. However, if more number of generic equivalents is launched by more number of generic players, the litigation costs of the originator to protect the product patent will indeed be very exhorbitant.

What then could be the role of the government in such a scenario?

It is indeed a robust argument that all patent related disputes after the grant of a product patent (beyond post grant opposition) and product launch should be resolved by a court of law. But, will it encourage an innovator to grow its business in India with the patented products, meeting the unmet needs of many patients and contributing to the growth of the industry?

Why then should the country have a product patent law?

Generic equivalent of a patented product will always cost significantly less than an innovator’s patented product for which there will perpetually be an important issue of ‘Public Interest’. This issue will not be very easy to ignore either. However, if the government also feels that way, it will be interesting to fathom, why then did the country opt for a product patent regime, enacting product patent laws in 2005 with a promise for effective enforcement of product patents in the country?

Conclusion:

In my view, as I expressed in my previous articles as well, if the government wants to enforce the product patents granted in India, without burdening the companies with expensive litigation costs, the only way will be to work out a robust system of ‘Patent Linkage’ within the country.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.