Delhi High Court turned down the request of Bayer Corporation in August 18, 2009 to link patent status of its kidney cancer drug Nexavar (sorefenib tosylate) with the marketing approval of the generic equivalent of the same patented molecule manufactured by Cipla, during the patent life of Nexavar in India.Bayer received an Indian patent for Nexavar in March 2008, which is one of the potential blockbuster drugs of Bayer Corporation and is expected to clock an annual global sales turnover of around U.S $1 billion soon.In this particular case, Bayer argued that an approval for its generic equivalent from Cipla would infringe on their patent.

The interim and the final judgment of the Delhi High Court:

Honorable Delhi High Court granted an interim injunction in response to the petition filed by Bayer Corporation and refrained the Drug Controller General of India (DCGI) from granting marketing approval of the generic version of sorefenib tosylate of Cipla, until the final order is passed by the Court.

In its final judgment, the Delhi High Court ruled that Bayer should not have brought this case to the honorable court as the drug regulation is not linked to patent rights in India.

Further, the court could not, “conclude that unpatented drugs are spurious drugs” and said, “this court is constrained to observe that the present litigation was what may be categorized as speculative foray, and attempt to ‘tweak” public policies through court mandated regimes.”

Besides, the honorable Court has asked the Bayer Corporation to pay Rs 6.75 lakh to the Government and Cipla as legal costs.

Will this High Court ruling encourage more such incidence in India?

Some experts feel that the Delhi High Court ruling may encourage generic pharmaceutical companies to launch generic versions of patented drugs in India despite the risk of paying damages, if patent infringement is proved in a court of law.

Keeping all these in view, let us now discuss the relevance of Patent Linkage in India.

What really is a patent linkage?

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.

However, the generic companies argue that the role of the DCGI is restricted to regulating safety and efficacy of the drugs, whereas ascertaining patent status of products fall within the ambit of Indian Patent Offices. Thus these two cannot be linked.

The argument in favour of a robust Patent Linkage system:

1. WTO TRIPS Article 28.1a says that the member countries agree to ensure exclusive rights to patent holder for a specific time period. In case of India, like most other countries, this time period is for 20 years.

2. During this period the member countries agree to prevent third parties from making, using, offering for sale the patented product without the owner’s consent.

3. In India there is no known strong deterrent for patent infringement. In absence of which, the opportunity to make significant commercial gain through patent infringement, on the pretext of extending benefits to patients could indeed be, many a times, difficult to resist.

4. Media reports that the National Pharmaceutical Pricing Authority (NPPA) has raised huge demand in crores of rupees for overcharging the common man, flouting the drug pricing norms, by some of these large companies involved in patent infringement litigations, vindicates the point of their basic overall intention of significant commercial gain over extending pricing benefits to the common man.

Who is responsible to ensure the sanctity of the product patent system in India?

1. The prevailing situation warrants a strong regulatory system, which could prohibit marketing approval of generic equivalents of patented molecules during their patent period.

2. The question that is often raised in this context is who exactly be held responsible for implementation of such a system in our country? While addressing this question one should realize that it is the Government in its entirety and not just the Patent offices or any particular ministry or ministries of the Governments is bound by the WTO TRIPS Agreement. Therefore, it is justifiably the responsibility of all Government departments/ministries to ensure that TRIPS obligations of the Government on proper enforcement of patent are properly met.

3. The process of granting marketing approval for patented molecules, in general, rests on the Ministry of Health (MoH) of WTO member states. Thus for WTO member states to meet TRIPS obligations effective communication between the MoH and the Patent offices of the country is absolutely essential. Such a system will help prevent approval of generic versions of patented molecules before expiration of the product patents.

4. Establishing this communication process will ensure that one department/ministry of the Government (say DCGI) does not impair the efforts of another Government department/ministry (say IPOs) to provide effective intellectual property protection as articulated in Article 28.1 of the WTO TRIPS Agreement.

5. This system will ensure that Health Regulatory Authorities do not, even unintentionally, undermine the commitment of the Government to conform to the TRIPS Agreement.

Will India be the unique country if such a system of “Patent Linkage” is put in place?

The answer is obviously ‘no’. 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.

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 effectively implemented soon to encourage innovation in India.

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.