From Pharmacy of The World to Patent Prison: India’s Shift Under Trips

Patented, which means giving an exclusive right to the patentee to protect their invention from a third person, who cannot use the invention or sell it without permission from the rightful patentee, with a few exceptions. Getting patients right does not mean a green light to sell. According to the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement, any invention can be protected only up to 20 years from the date of filing the application. TRIPS help in figuring out and balancing the interests between the private and public interests.

This blog highlights the pharmaceutical patent, as outlined in the Indian Patent Act of 1970 and the TRIPS agreement, where that patent on medicine affects people’s access to medicine. It covers the international implications of patent laws and their role in restricting access to essential medicines globally.

TRIPS AFFECTED INDIAN PHARMA COMPANIES

India’s adoption of the TRIPS agreement into patent law, which implemented a compliant patent regime in 2005, marked a significant shift in the pharmaceutical landscape. This shift marked India with international intellectual property standards, but this raised serious concerns about access to affordable medicine both domestically and in other developing countries that relied on India’s generics. Before adopting TRIPS, the Indian Patents Act,1970 had excluded pharmaceutical product patents, which allowed local companies to manufacture low-cost generic versions of essential medicines mainly related to HIV and AIDS. In this phase, India earned the reputation of being the pharmacy of the developing world. However, after the adoption of TRIPS, which includes patents for generic medicines, Indian companies faced restrictions on producing affordable generics of newly patented drugs.

The impact was particularly imposed on small and medium-sized pharmaceutical companies; many of these companies could not compete and were forced to shut down at the same time raised in patent protections reduced generic competition which reducing generic competition in pharmaceutical so that higher drug prices and greater market dominance among a few large firms. However, the TRIPS regime was expected to increase innovation and R&D (Research and Development), but a surge in new drug development did not materialize. According to a report, after TRIPS, some companies increased their R&D spending, their primary focus was developing generics for the regulated market, like the U.S. (United States), not innovating for diseases prevalent in developing countries.

India has been facing challenges in exporting medicines, including seizure of drug consignment in Europe and increasing pressure from developed countries to tighten IP enforcement. Although India incorporated TRIPS flexibilities such as compulsory licensing into its patent law, there is a complex procedure and a rare use of it, which limits its effectiveness. So, growing partnerships and acquisitions involving multinational corporations led to reduced competition and a shift toward profits.

INDIA’S PATENT LAW IN PHARMACEUTICALS

Indian’s patent law, particularly in the pharmaceutical sector, joined the TRIPs agreement in 1955. India amended its patent acts in 1999,2002, and 2005 to adopt TRIPS. This amendment introduced product patents for medicines, granting 20-year patent terms as rights, and the concept of mailbox applications and exclusive marketing rights (EMRs). India ensures important safeguards through section 3(d), which restricts patents on new forms or uses of known substances unless they significantly increase efficacy. This provision helps prevent “evergreening” of patents by pharmaceutical companies and supports access to affordable medicines. India has a legal mechanism for patent applications and the grant of pre-grant opposition, post-grant opposition, and revocation. The mechanism processes are crucial for preventing weak or unjustified patents.

However, many companies do not use this mechanism effectively, and the opposition system can cause delays in patent enforcement. Also, there is a concern about multinational companies; India generally resolves this issue faster than many other jurisdictions. Generally, India’s patent system seeks to maintain the balance between honouring international commitments and protecting public health by supporting generic competition and affordable drug access.

INTERNATIONAL LAWS ON PPHARMACEUTICAL PATENTS: THE U.S. AND U.K. APPROACH TO BALANCING INNOVATION AND ACCESS

Pharmaceutical patent law differs around the countries based on priorities like innovation and public interest. The U.S and the U.K. offer effective patent mechanisms that promote drug innovation while allowing generic entry, setting global benchmarks that influence developing nations like India.

The United States: Hatch-Waxman

In the United States, the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch Waxman Act, is the backbone of pharmaceutical Patent law in the U.S. According to this law, drugs are granted patent protection for 20 years from the date of filing the application. Additionally, the patent term can be extended to compensate for the delays in FDA (Food and Drug Administration) approval, as they recognize the lengthy regulatory hurdles drug manufacturers face.

There is a unique feature of Hatch- Waxman’s unique features is the Abbreviated New Drug Application (ANDA) process, which allows generic drug manufacturers to seek approval by demonstrating bioequivalence rather than repeating costly clinical trials and introduce the Paragraph IV certification, that provide right on generics to challenge existing patent even before they expire. This dual system makes an effective and clear pathway for generics, which makes a careful balance between rewarding innovation and promoting affordability.

The United Kingdom: Structured Exclusivity with Market Entry Mechanisms

The United Kingdom, previously under EU regulation 469/2009, has a similar kind of regulation system wherein pharmaceuticals enjoy 20 years of protection with supplementary protection certificates (SPCs), which grant an additional 5 years in some instances to make up for regulatory delays. The U.K. system also facilitates pre-launch patent resolution between originator and generic companies, reducing post-marketing litigation and ensuring a smoother environment for access to post-patent generics.

However, they having a supportive mechanism for innovation, the U.K. system remain having preventive for public health imperatives, make sure the affordability is not lost in the pursuit of exclusivity. U.S and U.K having similar kind of mechanism for efficient patent examination, having early dispute resolution and having a transparent market entry process for the generics.

U.S and U.K both mechanisms are majorly involved in international trade negotiations, such as the world trade organization (WTO) or in Bilateral trade agreements, in this they encourage or influenced to adopt similar international standard IP protections. In this developing national face the major issue, critical issue is to access of life saving medicines. After adopting international patent protection and stringent data exclusivity provisions globally, developed countries restricting the ability of lower- income to produce or import affordable generics. this problem has sparked in the controversy around TRIPS relaxation. Compulsory licensing and right to health.

CONCLUSION

Pharmaceutical patent has to maintain the delicate balance between incentivizing innovation and safeguarding public health. While TRIPS agreement adopted by India with the international IP standards, it has also curtailed the country’s capacity to supply affordable generics for underdeveloped countries. Make more strengthening TRIPS flexibilities streamlining opposition mechanisms and looking for prioritizing interest in patent policy are imperative. the true innovation must not come at the cost of access that must be inclusive, equitable and responsive in nature to global health needs.

Author: Rahul Kumar Gaur, in case of any queries please contact/write back to us via email to [email protected] or at Khurana & Khurana, Advocates and IP Attorney.

1. Reference
2. https://ipindia.gov.in/writereaddata/portal/ipoact/1_31_1_patent-act-1970-11march2015.pdf
3. https://ipindia.gov.in/writereaddata/Portal/IPOAct/1_69_1_patent_2005.pdf
4. https://www.nishithdesai.com/fileadmin/user_upload/pdfs/Patents_and_the_Indian_Pharmaceutical_Industry.pdf
5. https://globalizationandhealth.biomedcentral.com/articles/10.1186/s12992-019-0528-0
6. https://www.lexology.com/library/detail.aspx?g=1b13bcbb-27b9-4e51-a152-6abc53eb6f18