Controller General of Patents has on March 9, 2012 granted Natco Pharma Ltd. (NTCPH) a so-called compulsory license to manufacture Bayer AG (BAYN)’s Nexavar, which goes by the generic name Sorafenib.
This is the first Compulsory License granted by India and there are several such applications that are pending. This development will also open the doors for other such more applications seeking Compulsory Licenses.
This development puts additional onus on clients having un-commercialized OR under-commercialized IP in India to take steps OR risk losing enforceability.
Here are some steps that may be taken by Companies having Issued Intellectual Property Assets in India.
Please note these steps are not comprehensive and not prescriptive, each instance may require customized solutions:-
Working of Invention In India: - Patent Act creates an obligation on the Patentee to work the invention in India and also inform the Patent Office annually about the working of the Invention in India. A form 27 (statement of working) needs to be filed by March 31 every year informing the Patent Office.
Importation into India: - As the interpretation of the law stands for now, mere importation into India of the invention is NOT enough; the Invention needs to be manufactured in India.
- Applying for approvals to manufacture is a good defense as well.
- Tie up with local manufacturers is potentially a good fall back option if targeted.
Access to general public: - Product (invention) needs to be accessible to public at large and not priced unreasonably and is not available to general public.
- It is important to maintain a just and reasonable computation of how the cost was arrived at
- Clients may be well advised to have a “special needs” program for the poor so that products reach out to poor and needy on recommendations OR under special conditions
When targeted: - If targeted, patentees may be well advised to take pro-active steps to counter the compulsory license/voluntary license applicant with aggressively.
The statute provides for several checks, balances and steps that the patentee can take to ensure that the applicant is frustrated/application is delayed.
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