INTRODUCTION

Among the industries, the Indian pharmaceutical industry has been considered a great success story for long as the “pharmacy of the developing world” mainly on account of its ability to manufacture generic drugs at price-sensitive values to meet the health requirements of millions. The Amandment to the Indian Patents (Amendment) Act, 2005 ushered in a new era by introducing several statutory provisions. To understand the significance of this amendment, it will be pertinent to embark on the historical context provided by the Ayyangar Committee.

The Ayyangar Committee, while making its recommendations, had therein proposed exclusion of products from the purview of patent as envisaged by the Indian Patents Act of 1970. The primary reason behind this was the fact that MNCs had saturated the scene of patent applications with a countless number of applications pending their approval. More significantly, a large number of patents had already been granted in India. The recommendation of the committee was made mainly to safeguard the Indian industry. The MNCs were getting patents mainly for the purpose of their imports in the country.

So, till the enactment of the 2005 Amendment, product patents were not granted. It was in accordance with the recommendation made by the Ayyangar Committee. Such a measure helped strengthen the domestic industry against the probable adverse effects that foreign patents in plenty could pose.

The Indian Patents Act was subsequently amended due to India’s obligations as a signatory to the Trade-Related Aspects of Intellectual Property Rights, or TRIPS. In order to fulfill TRIPS commitments, the Indian government took a graduated approach; the 2005 Amendment was its culmination.

[Image Sources: Shutterstock]

Not to be reproduced for commercial use The three precedents which led up to the 2005 Amendment established that India was committed to aligning its intellectual property framework with international best practice. Considering the extensiveness of TRIPS, it committed the signatory countries to respect minimum standards relating to the protection of intellectual property. In its capacity as a responsible member of the global trading community, India had made steady moves to change its patent laws and procedures to meet those standards.

The Indian Patents (Amendment) Act of 2005 was, in effect, a watershed moment in the development of the country’s intellectual property scenario. While the amendment covered recommendations of the Ayyangar Committee, it was, at the same time, a reflection of India’s commitment to international agreements such as TRIPS. By establishing crucial statutory provisions, the amendment was to keep balance between the development of inventions and the protection of the domestic industry’s interests in the increasingly interconnected globalized economy.

THE CHANGES BROUGHT IN BY THE AMENDMENT AND THEIR SIGNIFICANCE

The Amendment has brought in an array of changes to the Act. These changes were apparently in compliance with TRIPS and were in furtherance of raising the patentability threshold.

The incorporation of the definition of a “new invention” in the Amendment has sparked debate within the Act for two main reasons. First, there already exists a definition of “invention” in the Act, clearly defining what it is to have a valid patent; apart from that, the term includes the word “new.” The prior term was, therefore considered enough and sufficient both in terms of statutory and interpretative purposes. There had a given degree of uncertainty created by the Amendment in legislative intent by the introduction of the term “new invention,” that has made interpretation complicated.

The vagueness of legislative intent suggests that the Amendment was meant to extend coverage over ideas like “state of the art” and “technology.” This might mean a more burdensome process of granting patents, which may be intended to sufficiently apply the criteria of novelty and inventiveness. There was an apparent deliberate intent to include the term “new invention” since it was intended to adjust and delineate improvements in the standards for patent approval, perhaps as a characteristic of changes in a new picture of the understanding and assessment of innovation in relation to state-of-the-art technologies.

Moreover, in the Amendment to the Act, one of the controversial areas about the definition in terms of specificity and clarity can be seen regarding the newly defined terms like “state of the art,” “technology,” and the previously ambiguous term “new.” If the purpose of the amendment was to remove ambiguity, it would have been more prudent to have provided clear definitions to the terms. This “new invention” definition, however, appears to be circular and redundant, which leaves room for interpretation and really creates a legal void without any clear indication of the true intent of the Legislature.

Another more apparent anomaly is inconsistency in the novelty standard applied across the board under the Act. Objections to patents are provided under S. 25 of the Act, showing inconsistency in that a competitor cannot effectively object to a patent if the invention is known or used worldwide, except in India. Such an inconsistency implies that applicability of the Act can vary on the grounds of the geographical origin of the invention.

Altogether, there is an impression of responding to the pressure of meeting the deadline of January 1, 2005, gleaned from the hasty and inconsistent way of promulgation of the Ordinance and drafting of the Amendment. The hurried legal developments have thrown this shadow over the legislative process to say the least and raised issues regarding the input lack of clarity and coherence in the provisions amended.

The inventive step, prior to the amendment, only imposed non-obviousness to a person skilled in the art. The amendment has introduced much more conditions in the form of technical advance and economic significance overlaying upon the criterion of non-obviousness for an expert. Technical progress at a very high level has been the prime intention of the inventive step along with corresponding monopolistic rights. However, the test of non-obviousness is also heavily criticized due to its complexity.

The amendment brings together the notion of technical advancement and economic significance as essentially restating the requirements of non-obviousness and industrial application, respectively. A closer view of the amended section reveals that a patent may well satisfy the inventive step criteria based on the grounds of economic significance. It would mean that a patent may not have an adequate level of advancement but will satisfy the inventive step test. Technical advance over existing knowledge” might further degrade the novelty requirement itself, and so add some degree of indeterminacy to the new terms.

, this amendment gives discretionary powers to the patent officer on interpreting obscure terms, and thus, brings about an increased chance of redundant judicial debates. As such, the much-coveted higher order of patentability does not seem to be adequately satisfied with ascribed conditions as it only adds vagueness along with the possibility of varied interpretations, which makes the system of patents questionable.

CONCLUSION

The much-vilified Section 3(d) of the Amendment is a victim of two flavors of obscurity. First, in the vague and ambiguous phrasing of the Section itself which courts down to unnecessary litigation, and second, in the confused interpretation of the courts in clearing up the inadequacies inbuilt in the law. Apparently, the intention of Section 3(d) is the prevention of the phenomenon of ‘ever-greening’, that is the practice of stockpiling patent protection by obtaining separate 20-year patents on multiple attributes to a single product. This unique section seemed to do this by excluding the patenting of new forms of existing drugs which do not show significantly increased efficacy. As an internationally accepted principle, the Bolar Exception allows research and development work to be carried on during the lifetime of a patent for the purpose of obtaining information to be submitted to a regulatory authority without inflicting any infringement of the patent.

This exception is recognized by the 2005 Act in Section 107A and also brings the act of importing within the ambit of the exception. This, therefore, will no doubt aid the generic industry to oppose those patents which have been frivolously granted.

Author : Kaustubh Kumar, in case of any query, contact us at Global Patent Filing or write back us via email at support@globalpatentfiling.com.

REFERENCES

1. The Patents (Amendment) Act, 2005, No.15, Acts of Parliament, 2005.

2. Sheja Ehtesham and Niranjan Mansingh, Conflicting Interests in Drug Pricing: Innovation v. Social Needs, 94 J. CURRENT SCIENCE, 168, 172, (2008), https://www.currentscience.ac.in/Volumes/94/02/0168.pdf.

3. Trade-Related Aspects of Intellectual Property Rights art. 27, Apr. 15, 1994.

4. Novartis AG v Natco Pharma and Others(2007) 4 MLJ 1153

5. Manoj Pillai , The Patents (Amendment)Act, 2005 and TRIPS Compliance- A critique, INDIANJOURNAL OF INTELLECTUAL PROPERTY RIGHTS 236, 239, (2005), https://www.semanticscholar.org/paper/The-Patents-(Amendment)-Act%2C-2005-and-TRIPS-Pillai/ef2074a8d64e15c50d22a4c37db567a37a5b47e1.

6. The Patents Act, 1970, § 2(1)(l), Acts of Parliament, 1970.

7. Tire and Rubber Co. v. Firestone Tyre and Rubber Co., [1972] RPC 457

8. Shamnad Basheer and Prashant T. Reddy, The Efficacy of Indian Patent Law: Ironing Out the creases in Section 3(d), Scripted, 232, 238, (2008), https://script-ed.org/wp-content/uploads/2016/07/5-2-BasheerReddy.pdf.

9. Id.

10. Supra Note 8.