This Month’s Patent Prosecution Tip, Beware of Section 3(e) of the Indian Patent Act

Patent Prosecution Process in India:
The overall process of patent prosecution in India is a bit complicated due to multiple compliances and deadlines to follow by the patent applicants. Understanding why a research needs patent protection in a particular country, what all processes and drug products can be patented or how to build a strong portfolio of patents is very vital for success of any biotech ventures.

Relevance of Section 3(e) of the Indian Patent Act for Multinational Pharmaceutical Companies
As per Section 3(e) of the Indian Patent Act “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.”
The above mentioned section is a major obstacle for new forms (salts, polymorphs, solvates, etc) of pharmaceutical drugs substances, unless until the patentee illustrates improved effectiveness over existing product. For e.g., a composition of two drugs, i.e. Paracetamol and Ibuprofen for curing fever and pain or process of preparation thereof is not patentable for the reason that the composition is a mere admixture of two drug components resulting into aggregation of properties thereof; since Paracetamol is well known for treatment of fever and Ibuprofen for treatment of pain.
However, if the mixture of drugs exhibits some unexpected results or synergistic properties in their action, then such composition is considered as patentable subject matter. Moreover, the patent description should be supported with adequate test results to confirm the synergistic properties of the pharmaceutical drug or molecule.

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