India’s patent law safeguards under fire

India’s patent law safeguards under fire

Subject :Science and Technology

Section: Intellectual property

Context: PMEAC has recommended to reduce  the period within which patent applications can be challenged to six months.

What is a Patent?

A Patent is a statutory right for an invention granted for a limited period of time to the patentee by the Government, in exchange of full disclosure of his invention for excluding others, from making, using, selling, importing the patented product or process for producing that product for those purposes without his consent

What is the term of a patent in the Indian system?

The term of every patent granted is 20 years from the date of filing of application

Which Act governs the patent system in India?

The patent system in India is governed by the Patents Act, 1970 as amended by the Patents (Amendment) Act, 2005 and the Patents Rules, 2003. The Patent Rules are regularly amended in consonance with the changing environment, most recent being in 2016

Does Indian Patent give protection worldwide?

 Patent protection is a territorial right and therefore it is effective only within the territory of India. There is no concept of global patent.

An invention is patentable subject matter if it meets the following criteria:

• It should be novel.
• It should have inventive step or it must be non-obvious
• It should be capable of Industrial application.
• It should not attract the provisions of section 3 and 4 of the Patents Act 1970.

What Does Patent Evergreening Mean?

• It refers to the continuing extension of patent rights. It also refers to the process of obtaining many patents for the same item.
• Patents that are evergreened are typical in pharmaceutical patents.

What is Sec 3(d)

• Section 3(d) was inserted in Indian law in 1970, but in its present form, it was introduced only in the year 2005.
• Section 3(d), as introduced in April 2005 into the Indian patent law, represents a unique requirement to be fulfilled for patentability of certain types of pharmaceutical inventions. According to Section 3(d), in order for a new form of a known substance to be patentable, it must show an enhanced efficacy with respect to the known efficacy of the substance concerned.

How does Sec 3(d) prevent evergreening of patents

Section 3(d) says that certain subject matters are not considered inventions and that the mere discovery of a new form of a known substance can only be regarded as an invention if the new form results in an enhancement in the known efficacy of that substance.

Novartis’s Glivec patent Case :

• The Supreme Court provided a clarification on certain aspects of Section 3(d) of the Indian Patent Act, 1970; in effect, it further raises the bar on the test of inventiveness and criteria for patentability.
• It found that Novartis’ patent application for the beta-crystalline form of Imatinib Mesylate (polymorph B) did not pass the test of Section 3(d) as it did not show any enhanced ‘therapeutic efficacy’.
• It held that in the case of a medicine that claims to cure a disease, the test of efficacy can only be ‘therapeutic efficacy’, and that the physico-chemical properties, namely, more beneficial flow properties, better thermodynamic stability, and lower hygroscopicity, which may otherwise be beneficial, do not render the product therapeutically more efficacious.
• As a result, the Supreme Court interpreted ‘enhanced efficacy’ in the explanation to Section 3(d) to mean therapeutic efficacy alon
• The Supreme Court provides a clarification on certain aspects of Section 3(d) of the Indian Patent Act, 1970; in effect, it further raises the bar on the test of inventiveness and criteria for patentability.
• It found that Novartis’ patent application for the beta-crystalline form of Imatinib Mesylate (polymorph B) did not pass the test of Section 3(d) as it did not show any enhanced ‘therapeutic efficacy’.
• It held that in the case of a medicine that claims to cure a disease, the test of efficacy can only be ‘therapeutic efficacy’, and that the physico-chemical properties, namely, more beneficial flow properties, better thermodynamic stability, and lower hygroscopicity, which may otherwise be beneficial, do not render the product therapeutically more efficacious.
• As a result, the Supreme Court interpreted ‘enhanced efficacy’ in the explanation to Section 3(d) to mean therapeutic efficacy alone.

Is Sec 3(d) compliant with TRIPS?

• TRIPS Article 27.1 requires that “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.”
• The patentability criteria of Section 3(d) are in addition to the internationally accepted criteria of novelty, inventive step and utility.
• The Supreme Court in the Novartis case concludes that the Act does set the invention threshold higher for medicines, drugs and other chemical substances. However, the Madras High Court had in 2007 held that the appropriate route to challenge non-compliance with TRIPS is the WTO Dispute Settlement Body and not the Indian courts.

What is an opposition proceeding?

• It refers to the administrative procedure available in most jurisdictions that enable third parties to formally challenge the granted patent or the pending application for a patent.
• An opponent must allege at least one of the grounds for opposition among those that are prescribed in the applicable law
• The Indian Patent Act, 1970 provides a mechanism that allows the public to raise objections against the grant of a patent by filing an opposition with the Patent office
• Pre-grant opposition: Where the opponent can challenge a pending application prior to the grant of a patent.
• Post-grant opposition: Where the opponent challenges the validity of a patent that has already been granted.
• Before 2005, only the ‘pre’ grant opposition system prevailed and there was no way of challenging a patent once it had been granted.
• However, the Indian patent system underwent a significant transformation on 1st January 2005 in pursuance of the TRIPS agreement (Trade-Related Aspects of Intellectual Property Rights)
• In order to comply with the International agreement, India amended its Patent Act and a post-grant opposition system was introduced in Section 25 of the Act.
• Recently, the new recommendation reduces the period within which patent applications can be challenged to six months.
• Decisions made by Indian patent offices can negatively impact generic competition and supply worldwide

Indian Patent Office

• It is an agency under the Department for Promotion of Industry and Internal Trade which administers the Indian law of Patents, Designs and Trade Marks.

Trade-Related Aspects of Intellectual Property Rights (TRIPS)

• The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is the most comprehensive multilateral agreement on intellectual property (IP)
• It plays a central role in facilitating trade in knowledge and creativity, in resolving trade disputes over IP, and in assuring WTO members the latitude to achieve their domestic policy objectives.
• It frames the IP system in terms of innovation, technology transfer and public welfare.