India: Pharmaceutical Patent Provisions In India

The Patents (Amendment) Act 2005 (herein after 'the Act') revolutionized the patent regime in India. This amendment act incorporated the provision of granting product patents in India in the area of pharmaceutical and other chemical inventions. With the commencement of the amendment act, patent protection in the fields of food, medicine and drug products was made possible.

Although the recent amendments in patents act and other IP related laws have made these laws TRIPS1 compliant, there is a need for stringent enforcement of these laws. This article analyses the provisions laid in the Indian Patents (Amendment) Act, 2005 regarding the pharmaceutical patenting in India.

INVENTIONS NOT PATENTABLE

Section 3 of the Act puts down the exceptions to patentability. Section 3(d) and Section 3(e) very specifically excludes pharmaceutical substances which are not patentable under this act.

As per Section 3(d)2 of the Act, the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant, is not an invention within the meaning of this Act. The explanation under this section is as follows:

For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

According to Section 3(e)3 an invention is not patentable if it is a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance.

As per Section 3(d) of the Act, to obtain a patent for the second and subsequent use of a medicament, the therapeutic efficacy must be enhanced or at least a new reactant must be employed in its manufacture.

GENERAL PRINCIPLES APPLICABLE TO WORKING OF PATENTED INVENTIONS

The provision of section 83 confers power on the Indian Government to make the medicines available to patients at affordable rates. The predominant rationale behind the grant of a compulsory license is to ensure:

  • availability of the patented invention in the market,
  • commercial exploitation of patented invention in India and not merely importation into India,
  • products manufactured under the patent shall be available to the public at the reasonable prices,
  • that patentees derive a reasonable advantage from their patent rights.

The provisions laid down under the said section is in line with the Directive Principles of the state policy under Article 47 of the Constitution of India, which states that it is the duty of the State to raise the level of nutrition and standard of living and to improve the public health.

COMPULSORY LICENCES

A compulsory license (CL) is a license granted by the Government to a third party to use the Patented invention so as to restrict the rights of the Patentee for the purpose of preventing the abuse/misuse of the rights by the property holder and to prevent the negative effect of such action on the public.

As per section 84 of the Act, an application for the grant of CL on patent can be made to the Controller at any time after the expiration of three years from the date of the grant, by any person interested on any of the following grounds:

(a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or

(b) that the patented invention is not available to the public at a reasonably affordable price, or

(c) that the patented invention is not worked in the territory of India.4

The controller, when satisfied by the grounds presented to him, may grant a licence. However, this option can be explored only after the expiration of three years from the date of the grant of a patent. That is to say, if the Controller is satisfied that the aforesaid grounds exists, he may grant a CL upon such terms as he may deem fit.

SPECIAL PROVISION FOR COMPULSORY LICENCES ON NOTIFICATIONS BY CENTRAL GOVERNMENT

According to Section 92 of the Act, the compulsory license on patent shall be granted by the Central Government any time after the sealing of the patent under following situations:

(a) circumstance of national emergency; or

(b) circumstance of extreme urgency; or

(c) case of public non-commercial use,

However, as per Section 92(3) public health crises relates to Acquired Immuno Deficiency Syndrome, Human Immuno Deficiency Virus, tuberculosis, malaria and other epidemics. The point is, whether the uncontrolled growth of abnormal cells in the body leading to Cancer comes under the purview of the said section.

COMPULSORY LICENSE FOR EXPORT OF PATENTED PHARMACEUTICAL PRODUCTS IN CERTAIN EXCEPTIONAL CIRCUMSTANCES

Section 92A of the Act facilitates the manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems by granting compulsory license for that patented pharmaceutical products.

The point to be noted is that the compulsory license is granted solely for manufacture and the export of the concerned pharmaceutical product to such country.

POWER OF CONTROLLER TO CALL FOR INFORMATION FROM PATENTEES.

According to the section 146 of the Act, during the continuance of the patent the Controller may give notice to the patentee or licensee to furnish the information or periodical statements to the Controller stating the extent to which the patented invention has been commercially worked in India. The information should be provided to the Controller with in two months from the date of such notice or within such further time as the Controller may allow.

As per Rule 131 of the Patents Rules, 2003, the statements stating the extent to which the patented invention has been worked in India on a commercial scale, shall be furnished by every patentee and every licensee in Form 27 in respect of every calendar year within three months of the end of each year. The statement needs to be duly verified by the patentee or the licensee or his authorized agent.

It is to be noted that not being able to file a working statement on time is a punishable offence.

CONCLUSION

The patent rights, on the one hand, provide economic incentives to innovate, but on the other hand, the exclusive rights they confer result into monopoly and unaffordable pharmaceutical products. The legislative intent of the provisions laid down in the Patents Act & Rules is to raise the threshold of obtaining pharmaceutical patents to maintain ordre public & morality.

The Act mandates that for being patentable a substance or a composition must be novel, should involve an inventive step and should be capable of industrial application. The additional filters to patentability put down in the form of section 3(d), section 3(e), Compulsory licensing provisions & annual filing of the working statements, have contributed to granting patents to the genuine inventions only. Further to this, these additional features also strive to prevent patent abuse through evergreening.

The provision of Compulsory licensing under the Act is available as a remedy against abuse of patent right, not working of patent and to address the public health concern in India.

Footnotes

1. Trade-Related Aspects of Intellectual Property Rights

2. http://ipindia.nic.in/ipr/patent/eVersion_ActRules/sections/ps3.html (retrieved on 11/04/2014)

3. http://ipindia.nic.in/ipr/patent/eVersion_ActRules/sections/ps3.html (retrieved on 11/04/2014)

4. http://ipindia.nic.in/ipr/patent/patent_2005.pdf(retrieved on 11/04/2014)

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