Likelihood of Issuance of New Compulsory Licenses under the Indian Patent Act

There have been news reports here and here of the likelihood that a compulsory license may be issued by the Government of India for three cancer drugs – Trastuzumab, Dasatinib and Ixabepilone. Out of the three cancer drugs in question, Dasatinib and Ixabepilone are small molecule drugs whereas trastuzumab is a biologic.

Provisions for issuance of Compulsory License under the Patent Act:

Under the Patent Act, a compulsory License can be issued either under section 84 or 92 of the Patent Act. Section 84 requires applicant to establish that, reasonable requirements of the public with respect to the patented invention have not been satisfied or the patented invention is not being made available at an affordable price to public in India. This is what happened in Bayer and Natco’s case. Under section 92, Government can notify a patent for issuance of compulsory license if any of the following 3 conditions are met: 1) National Emergency; 2) Cases of extreme urgency; or 3) In the case of public non-commercial use. Once the central government has issued a notification under section 92, any person interested may approach the controller for a compulsory license. The process becomes much simpler as the applicant does not have to establish that reasonable requirement of the public are not met.

Additionally, the under section 100, the Central Government can authorized any person in writing to use an invention for the purposes of the government. The right to use an invention under this section includes right to sell, on a non-commercial basis, the goods which have been made in exercise of that right. Section 99 defines used by the government to mean if it is made, used, exercised or vended for the purposes of the Central Government, a State Government or a Government undertaking.

Can Pharma Companies Oppose this Compulsory License?

Decisions, orders and directions issued by the Controller or the Central Government under section 92 of the Patent Act can be appealed before the Intellectual Property Appellate Board, whereas decision/direction under section 100 is not.

Issues:

Incase of Trastuzumab generic version are already available and marketed by Roche as well Emcure, at reduced price points in the Indian market. Grant of compulsory license on grounds of public non-commercial use, atleast on this drug will be fraught with many issues in view of the lower priced generic versions. Further, Traztuzumab being a biologic and being structurally more complex in comparison to the small drug molecules, is difficult, though not impossible to reproduce as it is extracted from cell culture using modern biotech techniques. Growing conditions of the cell culture can have major impact on the function and quality of the final biologic product.

No further details regarding the terms of the compulsory license or even a gazette notification by the Government of India on the three cancer drugs is available at this stage. However, the news has generated considerable buzz and apprehensions in the pharma industry and is bound to make a few companies rethink their business strategy in India.

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8 thoughts on “Likelihood of Issuance of New Compulsory Licenses under the Indian Patent Act

  1. I was searching for the definition of generics under the Drugs and Cosmetics Act. Sadly, I could not find a clear cut definition. If the product marketed by Emcure is not a generic…what would it be termed as then?

  2. As I stated earlier, I could not find a clear cut definition of generics under the Drugs and Cosmetics Act. Thus, the drug marketed by Emcure may be regarded as a generic product, unless you can provide further information as to why it cannot. However, the point of the post is not as to what can be regarded as a generic product, but the fact that there are lower priced versions of trastuzumab already available in the market and this could affect the grant of CL.

  3. Dear Ali:

    The Emcure product is not made by Emcure – its merely repacked by them and the product comes from Roche. Roche was supposed to do some tech transfer, but we do not think that this was for full product manufacture. As of today, Roche makes the product and Emcure ‘also’ sells it, in addition to Roche itself. As for the lower pricing by Emcure – which seems to be the key for you, I am not sure of the exact prices of the 2 versions – but the closest I can corelate this situation is to US – authorized generic where the Innovator’s product is sold by generic, through the generics’ distribution chain – and the 2 products are exactly same and while made by 1 Innovator, the pricing is different. But then the AG does not become a plain vanilla ‘generic’.

  4. Point noted and I said earlier, the point of the post was not to determine what can be considered as a generic. As for the pricing, it will certainly play a big role since the intent of the Government (as evident from the news reports) seems to be reduction in the price of these drugs more than anything else.

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