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How to have a robust product patent enforcement mechanism, without getting involved into expensive litigations, frequently?

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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.

Patent Linkage: an important step yet to be taken by the Government of India for proper enforcement of product patents granted in the country

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The process of Patent Linkage establishes a desirable communication process between the Health Ministry and the Patent Offices to prevent marketing approval of generic drugs before expiration of patents granted in India. It also ensures that one Government Department / Ministry does not impair the efforts of another Government Department / Ministry to provide effective intellectual property protection as required by Article 28 of the WTO TRIPS Agreement.
The system of Patent Linkage exists around the world:Following are some examples:

Australia – Health Authorities do not provide marketing approval for a generic copy which would infringe an existing patent.

Brazil – As of 2006, no copies of products still under patent have been launched in the market place. However, the Brazilian Health Agency (ANVISA), grants registration to copy products, based only on the merits of the case from the regulatory point of view, whether or not a patent has been granted for the same.

Canada – Health Regulatory Authorities do not provide marketing approval for pharmaceutical products protected by patents listed in the equivalent of the US FDA Orange Book.

China – The State Food & Drugs Administration (SFDA) must be satisfied that no patent is being infringed before it will issue marketing approval. If there has been litigation over a patent, SFDA will wait until the appeals process has been exhausted before acting.

Jordan – Marketing approval for a pharmaceutical product is not permitted during the period of patent protection.

Mexico – Applicants seeking marketing approval for generic pharmaceutical products in Mexico must certify that their patent rights are not infringed. The Health Regulatory Authorities then check with the Patent Office, which must respond within ten days to confirm whether a patent is involved. While Health Authorities will accept an application of marketing approval during the patent period, grant of marketing approval will be delayed until the patent expires.

Singapore – Applicants seeking marketing approval for generic pharmaceutical products in Singapore must declare that the application does not infringe any patent.

U.A.E – The Health Regulatory Authorities do not provide marketing approval for pharmaceutical products that remain under patent protection in the country.

U.S.A – U.S. FDA maintains a listing of pharmaceutical products known as the Orange Book. The Electronic Orange Book is also available via the internet at: http://ww.fda.gov/cder/ob The U.S. FDA does not authorize the marketing approval for a generic copy of a pharmaceutical product protected by a patent listed in the Orange Book.

Europe – Instead of Patent Linkage, the period of data exclusivity is for 10/11 years.

The Patent Linkage System is in progress in countries like Bahrain, Chile, Dominican Republic – Central America FTA (DR-CAFTA), Morocco and Oman.

Some people question why should India follow Patent Linkage system in the regulatory approval process?

In India ground realities in the patent enforcement process are quite unique. Thus there is an urgent need for having a Patent Linkage system in place for the following reasons:

1. The Government is granting product patent to encourage, protect and reward innovation in India, it will not be in the best interest of the innovators if the same Government grants marketing approval for a generic equivalent of the patented molecule during the patent life of the product.

2. Unlike many other countries, the Indian Patent Law has provision for both pre-grant and post-grant oppositions. Therefore, if anyone wants to challenge the patent, enough time will be available for the same.

3. After patent is granted for a product in India, if marketing approval is given to a generic equivalent of the same molecule, a dispute or patent infringement may arise. As per the Patents Act 2005, such disputes regarding patent infringement have to be challenged in a High Court. The judicial process is a long drawn one and it is quite possible that the patent life of the concerned molecule would expire during the dispute settlement period, which in turn, would raise doubts about the sanctity of granting a product patent to an innovator in our country.

Conclusions:

I therefore submit the following recommendations to ensure proper enforcement of products patent in India:

 The status of the grant of patent should be reviewed, through appropriate drug regulatory mechanism, before granting marketing permission to generic formulations and if the concerned innovative product is already patented in India, marketing permission for the generic formulation should be withheld.

 Appropriate mechanism/system should soon be worked out in co-ordination with other Ministries to avoid cases of infringement of product patents in India.

 The procedure (Patent Linkage) of checking the patent status of a product before granting marketing approval already exists in the Form 44. This procedure needs to be implemented.

India has instances where marketing permission has been granted by the DCGI for a generic product even when a product patent already exists for the same molecule in India. Such instances put the patent holder in a hardship and avoidable litigation involving huge resources both in terms of time and money. Situation like this can be effectively avoided by ascertaining the patent status before granting marketing permission to a generic manufacturer through an appropriate drug regulatory system, as indicated above.

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.