At a time when Indian pharmaceutical industry is doing well, the pharma manufacturers engaged in exporting of formulations and APIs must try to achieve a thorough knowledge about Intellectual Property Rights (IPR) and its applications because new inventions are protected under such laws, said G Selvaraj, director of drugs control department, Tamil Nadu.

Speaking in a seminar organised by Pharmexcil in Chennai on ‘Intellectual Property Rights’, he said the applications of IPR allow companies to charge higher than the marginal cost of production in order to recoup the costs of research and development. In Tamil Nadu, more than 100 pharmaceutical units are holding WHO GMP and engaged in exporting of formulations and APIs to various countries. Such manufacturers of international business should be aware of IPR and its applications, Selvaraj said.

He said under intellectual property law, owners are granted certain exclusive rights including manufacture and distribution of inventions, sue in case of unlawful or deceptive copying of their innovations, etc. Pharmaceutical companies engaged in manufacture can apply intellectual property rights in order to prevent other companies from manufacturing their products without any additional cost of research and development. Common types of intellectual property rights include copyrights, trademarks, patents, industrial design rights, and trade secrets, Selvaraj said.

The state drug controller informed the manufacturers that different types of protection can be obtained under IPR for products such as product composition, methods of manufacturing, utility of the compound, formulation of the product (whether cosmetic or pharma) etc.

“A novel compound is patentable if its use is novel and inventive. A novel compound fulfilling all the requirements may be protected by a ‘product patent’/‘basic (compound) patent’. Secondary or second generation patents are patents directed to new developments or improvements of the subject-matter of the basic patent. The basic requirement for patentability under the Patents law is that the invention should be new and useful, that is, it must have novelty and utility,” he maintained.

According to him, the main objective of most intellectual property law is to promote progress which literally means that it is for the exclusive rights for disclosure of inventions and creative works, society and the patentee/copyright owner mutually benefit, and an incentive is created for inventors and authors to create and disclose their work. Creators will not have sufficient incentive to invent unless they are legally entitled to capture the full social value of their inventions.

Pharmexcil has organised the seminar as part of a string of awareness programmes being conducted by the Council across the country to encourage the manufacturers for new innovations by using modern technology, said Dr Appaji, director general of Pharmexcil.