India’s Patent Law safeguards under fire

• The Economic Advisory Council (EAC) to the Prime Minister has recommended new reforms to the Indian Patent system.

What is a Patent?

• According to the World Intellectual Property Organization (WIPO), “A patent is an exclusive right granted for an invention, which in the process provides a new way of doing something, or offers a new technical solution to a problem”.
• To get patent rights, technical information about the invention must be disclosed to the public in a patent application.

Patent laws in India

• Patent laws in India are defined by the provisions in the Patents Act, 1970.
• The Office of the Controller General of Patents, Designs and Trademarks (CGPDTM) famously known as the Indian Patent Office working under the Department for Promotion of Industry and Internal Trade (DPIIT) is the agency that administers the Indian law of Patents, Designs and Trademarks.
• The Act was amended by the Patents (Amendment) Act, 2005 under which:
• Lawmakers from all political parties brought changes into the Indian patent law to ensure that the Indian patent office did not grant monopolies on old science or for common compounds already used in the public domain.
• It prevents drug manufacturing firms from indulging in “evergreening” which is a common strategy employed by the firms to obtain separate patent monopolies relating to the same medicine by extending the term of a granted patent that is about to expire
• The amended act also provided that any individual would be permitted to raise a “pre-grant opposition” anytime before the patent is granted or rejected.

Recommendations by the Economic Advisory Council (EAC)

• Hiring more Patent Officers
• Currently, the patent offices in India are understaffed.
• India has only about 850 officers but has over 1,60,000 pending patent applications.
• Use of advanced technologies like Artificial Intelligence (AI) to simplify the process at the Indian Patent Office and to become globally competitive.
• Fixing a timeline of just six months for “pre-grant opposition” proceedings from the date of its publication

The significance of “pre-grant opposition”

• As the Indian Patent Offices get over 50,000 patent applications annually, the officers miss certain critical information about the patent application a few times.
• A study on pharmaceutical patents in India showed that 7 out of 10 patents are granted in error by the Indian Patent Office.
• Hence an efficient pre-grant opposition system acts as an additional administrative layer of scrutiny that prevents errors in the grant of patents.
• A first pre-grant opposition was filed by the Cancer Patient Aid Association (CPAA) in 2005 against a patent application of Imatinib Mesylate (Gleevec) which is a life-saving anti-cancer drug.
• CPAA argued that this patent application claimed a salt form of old medicine which was a common practice within the pharmaceutical industry, and should not be considered patentable.
• Based on this, the patent office rejected the patent, and the move was upheld by the High Court and the Supreme Court.
• The rejection of the patent rights reduced the prices of this crucial drug from about ₹14 lakh/patient/year to about ₹40,000/patient/year from generic manufacturers.
• Various generic manufacturers and people infected with HIV, DR-TB, and viral hepatitis have filed pre-grant opposition to ensure that quality and affordable generic drugs can be procured through various health programmes.
• In 2006, PLHIV networks raised a pre-grant opposition against a patent application by Glaxo Group Limited (GSK) for Combivir on a fixed-dose combination of two AIDS drugs, zidovudine/lamivudine.
• The drug manufacturing firm withdrew its patent application in India and several other countries after the patent oppositions highlighted that the patent claims did not account for a new invention as it just used the combination of two existing drugs.
• The reduction in the prices on account of the rejection of patent claims has resulted in extending antiretroviral treatment to lakhs of people in low and middle-income countries.

Criticism of the recommendations of fixing a timeline for pre-grant oppositions

• Fixing a timeline and putting limits on a window period for pre-grant opposition will make it difficult to challenge fraudulent patent applications on life-saving drugs and vaccines.
• It also hinders the ability of the public to go through the information in patent applications and identify loopholes and errors in the claims.
• Further, the reduction in the timeline for the pre-grant oppositions will not translate into speedy processing of the pending patent claims or reducing pendency.
• Instead, these pre-grant oppositions help provide critical information to the officers and hence speed up the process.