INTRODUCTION

Drug patent laws in the United States, the United Kingdom, and India are perhaps exemplary examples of vastly different approaches to the dialectic between pharmaceutical innovation, IP protection, and accessing medicines at an affordable price.

In the United States, the Hatch-Waxman Act of 1984 plays a pivotal role in shaping drug patent regulations. Under this legislation, drugs can be patented, which provides exclusive rights for a standard period of 20 years. That exclusivity provides pharmaceutical companies with a defined window to market and sell the drug free from competition. That, of course, assists in recovering significant investment in research. Besides, patent term extensions have also been provided for by the Act, particularly where delays due to regulations impeded the process of approval. Importantly, the US system seeks a fine balance between encouraging innovation through strong patent rights and ensuring accessiveness by enabling expedient entry of generic drugs after the expiry of patents.

The European Union, at least until the full implementation of Brexit, has EU pharmaceutical patent law under Regulation 469/2009. Drugs in the UK, similar to drugs in the US, typically receive 20 years of exclusivity from the date of patent filing. The system further contains provisions for patent term adjustments aimed at making up for drug approval delays through regulations, thereby leaving sufficient time for innovation to commercialize inventions. There is a pre-resolution mechanism aimed at potential patent disputes arising when reaching regulatory approval between brand-name manufacturers and generic drug producers in the UK. This overall structure supports robust intellectual property rights, but at the same time, it allows generic alternatives to become available.

India, from its very inception, has followed a unique drug patent regime. Till the amendments of 2005, India had prohibited product patents for drugs. This unique approach had opened up scopes for the country to gain a strong pharmaceutical generic industry supplying cheap essential medicines both within and outside the country. However, amendments in 2005, which were TRIPS-compliant brought 20-year product patents on drugs to India. Importantly, such amendments also contained provisions on compulsory licensing under certain conditions of public health, and thereby conveyed an added dimension of assurance and commitment from the country towards safeguarding competition based on generics and allowing greater access to such medicines. India offers far fewer protections on clinical trial data, and is said to have a different regulatory landscape than the US and the UK.

Put simply, whereas the US and the UK prefer innovation of drugs through the granting of patent exclusivity rights, India balances its emphasis on IP protections with the imperative of ensuring affordable access to medicines. The Indian regulatory framework has unique public health safeguards and flexibilities that distinguish it from the regimes of the US, the UK, and other developed countries. Differential approaches reflect diverse policy priorities regarding domestic healthcare systems, economic development strategies, and trade positions.

International trade negotiations continue to pressure countries to harmonize and adopt more stringent IP standards worldwide. As countries negotiate, they will probably be forced to reassess and adapt their drug patent laws in the context of the delicate interplay between encouraging innovation, protecting IP, and meeting the imperative of ensuring that life-saving medicines are generally available.

PUBLIC HEALTH AND WHO ESSENTIAL DRUG POLICY

Arguments against the Indian patent regime are that it runs against the World Health Organization’s essential drug policy whereby governments of the world are mandated to reduce prices of drugs. The critics argue that any policy that hampers the availability of essential medicines at affordable prices in developing and least-developed countries cannot be helped. Besides, opposition to the product patent regime in India finds greater sustenance due to apprehensions of ‘evergreening’. It implies new patents obtained in the US concerning aspects such as processes, dosage forms, or administration procedures but not related to the actual active ingredient. Such practices, it is contended, can delay further even after the expiration of the patent protection period the entry of patented drugs into the public domain. Such a delay in generic production would limit the availability of such drugs at cheaper rates and, thus, defeat the objective of their cost-effective availability to the majority.

Despite much opposition from most of the Indian pharmaceutical companies and not-so-cautious remarks made by the Indian Drug Manufacturer’s Association (IDMA) in regard to adverse repercussions, this amending act that gave sanction to more stringently implemented patent regimes ran into opposition. The sector has indeed thrived on the principle of ‘reverse engineering’ since 1970, and apprehensions have naturally gone on to emerge over the likely adverse fallout on both the drug industry and the consumers at large in India.

However, with a gestation period of 35 years having been built on reverse engineering, the Indian pharmaceutical sector has acquired adequate stability to invest in R&D. India also boasts the most comprehensive compulsory licensing regime globally. Although there existed loopholes in compulsory licensing provisions, there was a known necessity to alter attention from reverse engineering toward encouraging innovation. Therefore, a more stringent patent regime was required in the context to force innovative pharmaceutical manufacturing activities in the country, gradually away from manufacturing copy versions of drugs.

In practice, it has achieved a good mix of positive results. It can be seen that increased investments in R&D along with collaborations, mutual licensing, and a spurt in mergers and acquisitions-this all points to the direction. The Amendment thus seems to have improved access to medicine by providing for the sharing of foreign medicinal research in India while at the same time opening avenues for the sharing of indigenous Indian research on a global scale.

CONCLUSION

The landmark amendment to the Patents Act in 2005, which has brought India in line with the provisions of the TRIPS Agreement, requires India to move away from the process patent regime for pharmaceuticals to a product patent regime. Given the huge impact drugs can have on other people’s lives especially in the face of an increasingly disturbing AIDS crisis and growing demand for life-saving drugs in developing countries, the challenge is that providing effective patent protection raises the challenge between long-term investments by industry and promoting affordable access to indispensable medicines.

This fragile equilibrium has been admirably well-balanced by the 2005 Act by introducing a product patent regime to strengthen the ambit of pharmaceutical patent protection in India, simultaneously unlocking to the maximum the flexibilities available under the TRIPS Agreement. The amended Patents Act has brought into place an effective opposition system to curb improper grants of patents, spelled out limited exceptions to patentability, and implemented elaborate provisions related to compulsory license and parallel importation facilities.

Hence, since 2005 “there has been improved investment in research and development by pharmaceutical companies within and outside of India. The industry has changed from having a generic drug-based approach to an originator drug approach. This means that the revised patent law in India has more intense potential to take the fragile balance between patent intensity and public health to unprecedented heights. However, such potential will depend on the proper implementation of the provisions of the new law. What extent this will be actualized remains yet to be observed.”

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

REFERENCES

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9. Id.