Indian Patent Office (IPO) Issues New Guidelines for Pharmaceutical Patents

The Indian Patent Office (IPO) has issued new draft guidelines for pharmaceutical patents.

 “Enhanced Therapeutic Efficacy” Replaces The Earlier Phrase “Enhanced Efficacy”: Becomes The Only Criteria For Grant Of A New Patent For Drug Substances

These guidelines have clearly defined the scope of “enhanced efficacy” by replacing this phrase with “enhanced therapeutic efficacy”. Thus, it has become the only criteria for grant of new pharmaceutical patents for drug substances,  which are the modified forms of a known drug. And other criteria’s such as enhanced bioavailability (the availability of drug ingredient in a patient’s body) has clearly been denied as an assessment criterion of the patentability of a known drug.

The draft norms are in line with rulings by both Madras high court in 2006 and the apex court in April 2013.

Objective of Issuance of New Guidelines

              –  Will help standardize the patent examination method and improve the quality of examination of pharmaceutical patents across all the four regional offices of India

            –  Further, it will also help patent officials to enforce uniform standards of patent examination and grant and avoid confused views on patent claims of pharmaceutical patents, as was the case earlier

            –  Take a strong stance against the criticism by foreign companies and their trade bodies that India’s patent system lacks consistent adherence to patent rules and procedures between regional patent offices

              –  Minimize the risk of patent litigations such as the one initiated by Swiss drug-maker Novartis AG

# Note that Novartis AG v Union of India  was one of the most controversial and lengthy patent cases in India, running for seven years from 2006 to 2013 wherein Novartis AG, a swiss pharmaceutical drug manufacturer, challenged the IPO’s rejection of its patent application for the blood cancer drug “Glivec” and a crystal form of a previously known drug called Imatinib Mesylate.

IPO Amends Norms: Reasons

       #    Of all the reasons, the most critical reason why an amendment was required in the norms for granting pharmaceutical patents in India was the “Criticism of Section 3(d) of Indian Patent Act 1970”.

       #  Allegations against Indian Patent Office and Its Procedures

        Among other reasons for introducing these reforms was that several trade bodies, for instance, BIO (a trade body of US biotech firms) had alleged, about the lack of consistent adherence to patent rules and procedures between the regional patent offices and the need for increased training on patentability criteria in India.

Conclusion

There have been constant allegations against the Section 3(d) of Indian Patent Act 1970 because is not very encouraging from business perspective. This is so because it keeps a check on patenting of trivial modifications of current patented inventions besides preventing ever-greening by disallowing the patenting of a known substance unless it results in an ‘enhancement of the efficacy of that substance’.

But there was no clarity as to what exactly is the scope of the term “enhanced efficacy”.

But with the introduction of the phrase “enhanced therapeutic efficacy” in the new revised guidelines, it has become very easy for the Indian patent officials to make patentability assessment of previously known drug substances and either grant (or deny) a patent for them.

Besides, this has also given much needed clarity to patent applicants with respect to patentability criteria for grant of a new patent for drug substances so that they may make informed decisions while applying for or contending against the grant (or denial) of a patent for drug substances.

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