Pharmaceutical inventions and patenting methods in India


We all are well aware of the fact that intense lobbying is happening on both to protect improvement inventions by innovator pharmaceutical companies and strategies to tackle these attempts by generic pharmaceutical companies.

Pharmaceutical innovations are always treated special in India and most of developments in patenting are happening because of pharmaceutical opposition/litigation. There are many  precedential patent case laws are related to pharmaceutical patents such as novartis case on 3(d), prodrug of ganciclovir on efficacy, appealing pre-grant opposition decisions, date of grant etc. Although, no patent linking with regulatory drug approvals, Indian patent office publishes product patent granted in India.

According to Indian Patents Act 1970, certain inventions are not patentable like polymorphs, mere development of composition for known drugs, methods of treating human/animals etc which are covered under sub-sections of section 3. In spite of section 3(d), 3(e) and 3(i) in Patents Act 1970 which prevents patenting of incremental invention thereby prevents ever-greening, many companies successfully tackle these statutory provisions and patent them by drafting them into pharmaceutical composition claims and like.

Indian patent office increasingly alert on such practices and tries overcome them, not only on non-patentable inventions, but also other statutory requirements such as unity of inventions and sufficiency of disclosure. In continuation to that, IPO conducted a session on inclusion of international non-proprietary name (INN) of chemical substance into patent specification at the time of filing or later stages, further to this IPO issued a notice and draft guidelines on examination of pharmaceutical innovations and invite comments/suggestions before March 21, 2014.

Update: IPO extended the date to April 04, 2014.

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About Guna

Interested to learn things around me
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