Introduction

Some people put years of experience and hardship into innovating new things and technologies for the people, and they should be the ones who should get all the credit and profits out of that innovation. Patents are one of the techniques of protecting these innovations so that no one else can take false credit and profits from the innovations of others. A patent assures that no other person can make the same product or sell the product in their name without the consent of the innovator.

But in the pharma industry, patent protection could compromise the general interest of the public, as it would prevent the generic manufacturers of the drugs from making good alternatives to the drug at an affordable price to the public. Medical bills attract the most expenses of a household compared to others, and not everyone can afford the expensive treatments or drugs; that is why it becomes important to have quality alternatives at a cheaper price. A generic drug is a drug made up of the same chemicals as the original drug and is like the original in terms of nature and performance, etc.

A patent linkage is present only in the pharma and agrochemical industry, and it is still an issue whether it should be implemented in these countries or not.

What Is A Patent?

A patent is provided by the state to give a limited monopoly to the innovator for its exclusive use or sale. In India, protection under a patent is provided for 20 years. A patent protects the interests of the innovator in his innovation by preventing others from copying or selling the innovated product without his prior consent. But there are certain innovations which are non-patentable in India, for example, an invention whose commercial exploitation might be against the public interest, innovations contrary to natural laws, methods of agriculture and horticulture, etc.

What Is A Patent Linkage?

“Patent linkage refers to the practice of linking the granting of MA, the pricing and reimbursement status, or any regulatory approval for a generic medicinal product to the status of a patent (application) for the originator reference product. Under EU law, it is not allowed.” [1]

In simple terms, patent linkage is when the drug regulatory and approval authority of a country works hand in hand with the patent-granting authority of the country to find out whether the drugs applied for approval have already been patented or not and to restrict such drugs on the grounds of patent infringement. If they are already patented, then the original proprietor is notified, and he is free to take legal action against the subsequent manufacturer.

India does not have such a system where both these authorities are interlinked. That is, patent rights and marketing approval of drugs are not interlinked in India. This means that a generic version of the patented drug would not be prevented from market approval on the basis that the patent of the original drug is in force or is in someone else’s name. In Bayer Corporation and Ors v. Cipla of India (UCI) and Ors. [2], the court stated that patent linkage is absent in India, and thus, a company cannot be refused the market approval of its version of the already patented drug if it meets all the provisions and quality requirements of the drug regulatory authority.

In many countries, there is no patent linkage, and this is because it would not be correct for the government to prevent the people from making a better or cheaper version of the patented drug, which could save the lives of people at large. Thus, in the public interest, India does not have such patent linkage.

What Does A Patent Linkage Involve?

Most of the time, a patent linkage includes [3]:

• Notice to patentee about the launch of the generic drug
• Denying the approval to a generic drug when the original drug’s patent is in force
• Verification of the patent status before granting market approval to the drug
• Allowing the generic manufacturer to challenge the validity of the patent

Different Types Of Patent Linkage [4]

MA (Marketing Authorisation) Treated As Patent Infringement

In this, generic medicines are not given market approval for their drugs to be sold to the public. Their application is rejected or held back on the grounds of patent infringement of an already existing patented drug.

P&R (Pricing & Reimbursement) Treated As Patent Infringement

In this, a generic manufacturer may be prevented from listing its products “until patent expires.”

Prescription Listing As Patent Infringement

Prescription listing is just for the knowledge of the public that this product will be available in the market in future. It may become the ground of patent infringement if, at the time of listing, the product is already available in the market.

Procurement As Patent Infringement

In this type of patent linkage, people are not allowed to participate in tenders when there exists a patent.

Is Patent Linkage a Necessity?

The concept of patent linkage was first introduced by the US in 1984 through the Drug Price Competition and Patent Term Restoration Act of 1984, famously known as the “Hatch-Waxman Act”, to protect the interests of the patent holders on one side and the interests of the generic manufacturers on the other. A patent linkage safeguards the patent rights of the original manufacturer of the drug. Its absence often leads to infringement of others’ patents by generic manufacturers of the drugs. Countries having a patent linkage system include the US, Canada, Australia, Japan, South Korea, China, Taiwan, Russia, Ukraine, Singapore, Jordan, Mexico, and the UAE.

Some of the Benefits of Patent Linkage Are:

• Patent linkage makes generic drug manufacturers aware of already existing patented drugs so they can legally get licenses without infringing the original patent.
• It leads to early dispute resolution, crucial for public interest, ensuring timely access to essential medicines.
• It obliges the government to protect knowledge of patented drugs against unfair commercial use by generic manufacturers.
• It ensures patent security, promotes innovation, and protects innovators from unlawful exploitation.

Thus, one cannot neglect the benefits of the Patent Linkage System. It was initiated by the US and has now been adopted by many other countries based on the US model.

Is Patent Linkage a Potential Disaster?

Many developed countries have realised the importance of generic medicines in the pharma industry. The European Generic Medicines Association has stated, “Removing the obstacles to the entry of generic medicines will benefit the pharmaceutical sector at large by generating greater competition and ensuring much-needed savings on pharmaceutical expenditure.” “Generic medicines provide an opportunity to obtain similar treatments at lower costs for patients and payers, while liberating budgets for financing new innovative medicines.”

European countries have taken many initiatives to develop a sustainable healthcare model. Examples include the “G10 High Level Group on Medicines”, the “High Level Pharmaceutical Forum”, the Andalusia report, the “PPRI initiative” (final report in May 2008), and the sector inquiry into the pharmaceutical market by DG Competition. The European Commission in 2009 repeatedly stated that “patent linkage” is unlawful and that it would “strictly enforce the applicable rules and act against patent linkage”.

Countries without a patent linkage system include India, the EU, the Philippines, and Vietnam.

India has launched health programmes like Ayushman Bharat and PM Jan Aushadi Yojna, aimed at providing affordable medicines to all. Numerous “Janaushadhi Kendras” supply low-cost medicines to the poor. India is also the largest medicine exporter in the world, accounting for 20% of global exports. These services would not be possible if a patent linkage system were in place.

Some of the Benefits of the Absence of Patent Linkage Are:

• It enables individuals without funding for expensive research to create affordable alternatives without compromising quality.
• It ensures availability of essential drugs to the public.
• It prevents monopolistic pricing by innovators, keeping medicines affordable.
• It maintains healthy competition by allowing competitive drugs in the market.
• The absence of patent linkage reduces costly litigation, supporting smaller companies in providing affordable medicines.

Bolar Exemption

The concept of Bolar exemption originated in the US in 1984 under the “Hatch-Waxman Act”. Normally, a patent grants exclusive protection for 20 years, preventing others from even beginning research until expiry. This delays alternatives from entering the market after the patent ends. To tackle this loophole, the Bolar exemption was introduced.

Bolar exemption applies in the pharma and agrochemical industries, allowing research during the patent term, though commercialization is only allowed after expiry. This ensures generic alternatives are ready for launch immediately after patent expiration. In India, this provision exists under Section 107A of the Patents Act 1970, permitting use of patented technology strictly for public good, not commercial profit.

Patent Linkage at the International Level

TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement

• Came into force in 1995.
• Part of the WTO, applying to all its members.
• Protects IPR but allows exceptions for public good use of patented technology.

RCEP (Regional Comprehensive Economic Partnership)

• World’s largest FTA, effective since January 2022.
• Includes 15 countries, with 10 ASEAN nations.
• Japan and South Korea advocated patent linkage, but it was excluded.

CPTPP (Comprehensive and Progressive Agreement for the Pacific Partnership)

• Includes 11 APEC member countries.
• Provides provisions for patent linkage under Article 18.53 (Chapter 18) of the TPP.

Conclusion

Patent linkage could be detrimental to the greater public good, but without it, pharma companies may lack motivation to invest heavily in research and development of new drugs. This issue requires careful policy-making to balance protection for innovators with public health interests.

References:

• Pharmaceutical Sector Inquiry – Final Report, 8 July 2009, DG Competition, European Commission, p. 130. http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf
• 2014 (60) PTC 277 (Bom).
• Bryan Mercurio, Reflections on the expansion of Intellectual Property Protection in Bilateral and Regional trade agreements, WIPO-WTO Colloquium Papers, Asian Edition 2017, pg. 63.
• The Anti-Competitive Effects Of Patent Linkage, Medicines for Europe (May 2019) p. 2.
• 35 U.S.C. § 271(e) (2003).
• Munoz Tellez, V. (2022). Bolar Exception. In: Correa, C.M., Hilty, R.M. (eds) Access to Medicines and Vaccines. Springer, Cham. https://doi.org/10.1007/978-3-030-83114-1_5
• Raju, K.D. (2022). Patent Linkages and Its Impact on Access to Medicines: Challenges, Opportunities for Developing Countries. In: Correa, C.M., Hilty, R.M. (eds) Access to Medicines and Vaccines. Springer, Cham. https://doi.org/10.1007/978-3-030-83114-1_12
• Frank Bongers and Hugo Carradinha, How to Increase Patient Access to Generic Medicines in European Healthcare Systems, European Generic Medicines Association, p.8, June 2009.
• European Commission-Pharmaceutical Forum, Progress Report, 2007.
• Frank Bongers and Hugo Carradinha, How to Increase Patient Access to Generic Medicines in European Healthcare Systems, European Generic Medicines Association, p.10, June 2009.
• Pharmaceutical Sector Inquiry – Final Report, p. 475.
• A. Minhas, Indian pharmaceutical export value FY 2012-2023, STATISTA (Aug 31, 2023), https://www.statista.com/statistics/1038136/india-value-of-pharmaceutical-exports/#:~:text=India is the world’s largest, America had the largest share
• Ravikant Bhardwaj, K.D. Raju, M. Padmavati, The impact of patent linkage on marketing of generic drugs, Journal of Intellectual Property Rights 18, 316-322, 2013.
• https://byjus.com/free-ias-prep/trade-related-aspects-of-intellectual-property-rights-trips/
• https://www.wto.org/english/tratop_e/trips_e/pharma_ato186_e.htm
• Patent Linkage System for Intellectual Property Rights and Public Health Harmonisation, APEC Intellectual Property Rights Experts Group (July 2023) p. 4-5.
• Ibid., p. 5.