Important Features Of Indian Patents

 

Section 3(d)

This section has been the bone of contention for the pharmaceutical sector as it prevents “evergreening” of drug patents. Under this section, the following inventions are not patentable:

• a mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance;
• the mere discovery of any new property of a known substance;
• the mere discovery of a new use for a known substance;
• the mere use of a known process unless such known process results in a new product or employs at least one new reactant;
• the mere use of a known machine or apparatus.

The explanation to section 3(d) further clarifies that the salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance may be considered to be the same substance. It however states that such salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of such known substance may be considered as patentable only if they differ significantly in properties with regard to efficacy.

In a recent case, in relation to a pharmaceutical substance, the courts held that efficacy means ‘therapeutic efficacy’. For proving increased therapeutic efficacy, strict standard of proof is required. In other words, in order to overcome the hurdle posed by Section 3(d), data based on research and experimental data showing enhanced therapeutic efficacy must be submitted.

Compulsory licenses

This provision strikes a balance between public interest (access to existing drugs at reasonable prices) and private interest (monopoly rights under patents). A compulsory license merely serves to limit the exclusive monopoly rights of a patent holder. In order to prevent abuse of patent rights, the government may authorize the grant of a compulsory license without the permission of the patent holder.

After three years from the date of grant of a patent, an interested party may apply to the Controller for the grant of a compulsory license alleging that:

• the reasonable requirements of the public with respect to the invention have not been satisfied or
• that the invention is not available at a reasonable price or
• that the patented invention has not been worked in the territory of India.

If the Controller is satisfied that a prima facie case for an applicant for compulsory license has been made, he shall serve a notice on the patentees who, if they so desire, may oppose the application for compulsory license.

Patents and Computer Software

It is possible to patent programs for computers which when run on a computer produce a "technical effect or includes hardware". However, if a program does not produce a technical effect when run on a computer, it is unlikely to be patentable. A technical effect is generally an improvement in technology and needs to be in an area of technology that is patentable. For instance, an improved program for translating between Japanese and English is not patentable because linguistics is a mental process, not a technical field. On the other hand, a program which speeds up image enhancement may be patentable because it produces a technical improvement in a technical area.

Some countries, such as the USA, with a large potential market for your software, have a more liberal approach to software patenting and often grant patents for software, which would be excluded in India and other countries. Deciding whether or not a particular computer program is patentable is a complex issue and advice from a Patent Attorney/Agent may help to determine the most effective form of protection available.