This post was first published on 5th March, 2011.
Authored by Mr. Vijaykumar Shivpuje.
Patent Linkage with regulatory approval procedure is a sensitive issue for Indian pharmaceutical industry which includes mainly generic companies. This essay discusses the implications of patent linkage and the current scenario in India. Further, the recent developments related to patent linkage including the Bayer v/s Cipla decision and India-EU free trade agreements are discussed.
Patent Linkage refers to the communication between the national regulatory authorities and the Patent Office to prevent marketing approval of generic drugs until after the expiration of patents covering the drug product or approved use1. This practice requires that “second applicants” usually generic companies seeking marketing approval demonstrate that the pharmaceutical product for which they are applying is not protected by a valid patent. Under this kind of regulation, national regulatory authorities have an obligation to prevent registration and marketing of generic pharmaceuticals when patent covers the product2.
Under the TRIPS Agreement, there is no requirement for WTO Member States to recognize this practice. However, it ensures that one governmental agency does not undercut the efforts of another agency to provide effective patent protection. A successful linkage system reduces wasteful and unnecessary litigation by requiring third parties to assess whether their drug product is subject to a patent prior to seeking drug approval; and ensuring that the drug approving authority does not approve the product until any patent issues are resolved. The aim of patent linkage is to create a second tier of protection for patent monopoly.
Problems with patent-linkage system:
Patent linkage creates problems if national patent office grants low quality patents.
Patent law typically requires patentees to actively enforce their rights, but linkage uses government regulatory authority to inhibit infringement.
Regulatory agencies may not be competent enough to determine validity and relevance of patents. This adds burden on them. Legally, only a court or tribunal, depending on a country’s law, can decide whether there is a patent for that particular medicine.
The task of the regulatory bodies is to verify whether a medicinal product is safe, effective and of good quality. Their main function is to ensure that the pharmaceutical products reaching market are not harmful to public health. Other factors, such as the patent status of product, should therefore not be taken into account when assessing risk/benefit balance of medicine.
Regulatory issues do not fall within the scope of definition of infringement.
A generic medicine imported or manufactured under a compulsory license may not be able to get registered until the patent has expired.
In India, there is no patent linkage and courts have rejected attempts by big pharma companies to create such linkages. The patent system and the drug regulatory system in India are two separate and independent mechanisms created under different laws and this is the legislative intent.
A proposal made by the Drugs Controller General of India (DCGI) to incorporate the status of patent(s) of drugs, in its marketing proposal, was abandoned, pursuant to an intense debate, with perspectives from the industry factions and public health advocates3.
DCGI and Indian Patent Office are having a hard time co-ordinating their own offices. DCGI in India is not even in a position to effectively carry out its own work of drug regulation. The Patent Office is in no better a position, since, it is so strapped for resources that it cannot even co-ordinate its four offices properly leading to debacles4.
There are various attempts done by pharmaceutical multinational companies for the introduction of patent linkage in India. These include strong lobbying through free trade agreements, various court cases amongst others.
Recent developments relating to patent linkage:
Bayer v/s Cipla and Union of India5
Indian patent office had granted a patent bearing number IN 215758 which covered Sorafenib tosylate. Bayer, the assignee of the patent filed a writ petition restraining DCGI from granting a license to Cipla “to manufacture and market, to imitate/ substitute sorafenib tosylate protected under this patent”.
A further request was for a direction to Cipla to furnish an undertaking that the drug for which it has made an application before DCGI was not an imitation of or a substitute for Bayer’s patented drug “sorafenib tosylate” and consequently would not result in an infringement of subject patent.
Further Cipla’s product was said to be a spurious drug under section 17 (b) and DCGI would exceed its jurisdiction in granting marketing approval to Cipla’s generic product. It was contended that since it was known at the time of Cipla’s application for marketing approval that Bayer held patent for Sorafenib tosylate, DCGI was under an obligation, flowing from collective reading of Section 2 of Drugs and Cosmetics Act (DCA) and Sections 48 and 156 of Patents Act, to decline Cipla’s application for marketing approval for Soranib.
The issues that arose for consideration were6:
(a) Whether DCGI can grant marketing approvals under DCA to generic versions of patented drugs,
(b) Whether grant of such marketing approvals to generic versions of a patented drug is in derogation of the Patents Act, and
(c) Whether generic drugs are spurious drugs in terms of DCA?
The court rejected Bayer’s arguments and confirmed that there is no ‘patent linkage’ regulation in India. Parliament has not intended to link the two legislations. Further, an explicit legislation is required for patent linkage.
DCGI can grant marketing approvals under DCA to generic versions of patented drugs. Determination of patent infringement is exclusive jurisdiction of Courts and this adjudication is beyond jurisdiction from DCGI.
The court also rejected spurious drug argument stating if Bayer’s contention were to prevail, every generic drug would amount to be ‘spurious drug’.
India-EU FTA and patent- linkage:
Having failed to achieve all they sought in the TRIPS negotiations, developed nations almost immediately began negotiating for inclusion of Patent- linkage in Free trade agreements (FTAs)7. FTAs have recently been used as one of the mechanism used to implement provisions of IPR by developed countries.
India is likely to sign a Free Trade Agreement (FTA) with the European Union by the end of the year 2010, with the sides expected to conclude the talks8.
One of the major concerns with India-EU FTA is about patent linkage. The European Union has been very aggressive on patent linkage during negotiations.
Solution for patent- linkage:
Given the stakes related to this debate in Indian scenario including the health concerns and the business of multinational companies and the domestic pharmaceutical industry, it is a tricky situation to decide whether patent linkage regulation be implemented in India or not. However, it would be possible to make a balance in the system to protect interests of both Innovators and Generic industries.
One such solution has been provided by ‘notification mechanism’9. In this, DCGI can list all new applications on its website. An aggrieved originator drug firm can track this database and move court if it apprehends that a generic product, for which a drug approval application has been filed, is likely to infringe its patent. Do note, however, that originator would only be able to prevent introduction of a generic drug in the market — not stop the drug regulator from processing application of the generic or even granting approval.
The innovator can ask the court to declare that the generic product, if introduced, would infringe its patent. If court finds a prima facie case that the patent is valid and would be infringed by introduction of the generic product, it can issue a declaration to this effect. Importantly, issues of patent infringement can be decided solely by courts and DCGI is thus not involved.
India currently does not have any regulation which recognizes patent linkage. The high court has already decided the absence of patent linkage as discussed above. If India implements patent linkage regulation, then the system should be such that it should make a balance of the interests of public health, domestic pharmaceutical industry and multinational pharmaceutical industry.
1. Overview on Patent Linkage, August 7, 2006 www.finstonconsulting.com
2. Response to 2006 PhRMA “Special 301” Submission for Chile, Consumer Project on Technology, March 2006.
3. ‘Group Report – India’. Compiled by: D.C. Gabriel, Sharad Vadehra and M. A. Jose for the Indian Group.
4. Prashant Reddy, Why is the DCGI trying to implement a ‘patent-registration’ linkage system in India?
5. Bayer Corporation & ANR v/s Union of India & ORS (Delhi High Court, LPA 443/2009, Judgment pronounced on: February 9, 2010)
6. Anshul Mittal, Current scenario and need for deliberation. Journal of Intellectual Property Rights, Vol. 15, 2010, PP 187-196
7. Bryan Mercurio, TRIPS-Plus Provisions in FTAs: Recent trends. Regional trade agreements and the WTO legal system, Lorand Bartels, Federico Ortino, eds., pp. 215-237, Oxford University Press, 2006.
8. India-EU FTA by year-end: Sharma
9. Shamnad Basheer, The potency of a middle path, Jul. 9, 2008. http://www.livemint.com/2008/07/09215015/The-potency-of-a-middle-path.html (As obtained on 3rd November, 2010).