Role of Intellectual Property Rights in the Pharmaceutical Industry

Abstract

This paper undertakes a review of the available studies to provide a perspective on the role of Intellectual Property (IP) protection in Pharmaceutical Industries. IPR gives certain ownership rights to the inventors or creators of that property so that they can reap commercial benefits from their creative endeavours or reputation. The key aspect of this work is to understand the IP rights in the international markets and the role of pharmaceutical industries in IP rights.

Introduction

The pharmaceutical industry is one of the most indispensable and evergreen industry in the world. It is the only industry that is not affected by the economy. No matter what happens, if the world is facing a pandemic, a world war, or an economic recession, it will continue its business as everyday individuals fall sick or may need essential health supplements for their day-to-day work.[1].

Perspective under International Scenario

Developing a new drug and marketing it successfully is a risky, long, and expensive venture. It costs around the US $750 million, and takes about 12–15 years to bring new chemicals to patients from the laboratory bench. As such, pharmaceutical companies can protect their patents globally until they expire. For many fields of technology, the US and Europe are the two most important areas for obtaining patent protection. Currently, there exist 33 European countries that are full members of the EPC, and it is practicable to procure patent protection in those countries through a unified consolidation process before the European Patent Office. Similarly, the Patent Collaboration Agreement currently allows applicants through a single consolidation process covering 172 countries. In general, patent law is broadly similar in the various member states of the Patent Cooperation Agreement. However, an important distinction between patent law in the United States and Europe and the rest of the world remains in determining who is entitled to patent protection, when two applicants apply for a patent and two individuals independently arrive at the same invention. The one who applies first in Europe can continue with their application and the second to file is restored after the first application. The lack of power is realized if a second application is filed at a later date. A different approach is used in the US. Unlike other countries in the world, the USA uses first to invent techniques. This means that the work of the person who is first to invent will be credited even if he files a patent application on a later date. However, such kind of techniques has often resulted in disputes between the parties.[2].

India has been a member of the World Trade Organisation (WTO) since the year 1995. This infers that if a person is doing business in the pharmaceutical industry in India, he will find some parallelism between local IP laws and enforcement procedures, and those in the force in the United Kingdom. The Patent Act of 1972 does not permit patents on pharmaceutical products & the Drug Price Control Order (DPCO) placed a large number of drugs under price control. The public sector is focused on the pharmaceutical industry and policies that imposed international controls on the area of ​​policy that was ready to grow domestic firms and established India as a major drug supplier worldwide pharmacy. In the pre- TRIPS regime, the lack of product patents allowed the production of local patented drugs for a fraction of the original cost while the patent process patents encouraged companies to cut a cot of drugs. India’s compliance with the TRIP state law that was repealed in 2005 also allows product patents to change the strategic options of Indian pharmaceutical firms.[3]

Summary of leading cases

Case 1: Cipla Limited v/s M.K. Pharmaceuticals MIPR 2007 (3) 170

Plaintiff manufactured “NORFLOXACIN” tablets which were oval in shape and orange in color under trademark ‘NORFLOX-400’ in blister packaging. Defendant used the same name ‘NORFLOX-400’ but it was not the name for which the plaintiff filed the suit rather plaintiff’s contention was that defendant copied shape, color, and blister packaging of tablets which created confusion. It is settled law that there can be no monopoly of color as no consumer asks for medicine by its color or shape or packaging. Blister packing is very common and prevalent and the shape of tablets is also commonly circle or oval. Therefore injunction was not granted[4].

Case 2: Neon Laboratories Ltd v/s Medical Technologies Ltd. & ors 2015(64) PTC 225 (SC)

The Appellant filed an application in 1992 for registration of a trademark. Appellants trademark ‘ROFOL’ was granted in 2001 but after registration they didn’t introduce the product in the market until 2004. In 1998 the respondent launched drug trademarked ‘PROFOL’. Therefore, we can see that respondent had a prior user date while the appellant had a prior registration date. The case was decided in favor of respondent as Respondent started manufacturing and marketing and also registered and meanwhile earned substantial goodwill also. Hence injunction was imposed on ‘ROFOL’ trademark. Two factors of an interim injunction that are the balance of convenience and irreparable loss both were in favor of respondent[5].

Case 3: DUSU Pharmaceutical, Inc v. Biofrontera Inc. et al

The plaintiffs filed a lawsuit against the defendant alleging that the defendants had been misappropriating confidential and trade secret information by obtaining it from its former employees and patent infringement of the plaintiff’s photodynamic therapy patents covering its products. The court ruled in favor of the plaintiff and an assessment of  both damages and  injunctive relief against the defendants was passed[6].

Suggestions

  1. There should be strong Trademark laws that cease pharmaceutical companies to adopt close trademarks in respect of other brands.
  2. Regulatory bodies should approve only those drugs which are distinctive to those already existing in the market so as to avoid confusion to buyers.
  3. The vigilance of rights holders is also important in protecting their pharmaceutical trademarks, as it can lead to the expulsion of the trademark market, confusion, and deception and adversely affect public health.
  4. Carrying out due diligence and risk assessment checks on any organization and market.

Conclusion

Like many other developing countries, the introduction of the TRIPS-compatible IP regime has caused much debate in India. In general, it has more focus on the pharmaceutical sector as it affects the health care system. Indian pharmaceutical companies have shown a greater propensity for innovations and patents, although their R&D focus may shift to Western markets. Although there are changes in favor of product innovations, many of these are not new chemical entities, such as new dosage forms and delivery systems. While it is not clear how much this will be affected by the new IP regime, there is much activity in the field of medical devices. There seem to be strategic opportunities abroad to acquire technology and consolidate in the domestic market to meet the growing technology-based competition.

References.

  1. O’Regan, M.The Protection of Intellectual Property, International Trade and the European Community: The Impact of the TRIPS Agreement of the Uruguay Round of Multilateral Trade Negotiations. Legal Issues of Economic Integration, (1995). 22(1), 1–50.
  2. Fernandes, A., & Nair, K.  ‘’Landmark pharma patent jurisprudence in India. Journal of Intellectual Property Right’s(2014)., 19, 79–88.
  3. Mazumdar, M. Performance of pharmaceutical companies in India. New York: Springer (2013). 
  4. Basant R. Intellectual property protection, regulation and innovation in developing economies. Innovat Develop. 2011;1(1):115–133
  5. Mohammad A, Kamaiah B. The Indian pharmaceutical industry in post-TRIPS and post-product patent regime. IUP J Appl Econ. 2014;13(1):47–61.

[1]Bayya Subba Rao, P. V. Appaji, Intellectual property rights in pharmaceutical industry (2nd edn,  BSP Books 2018)

[2] Editorial Dr Johnath DM Atkinson ‘’Intellectual property and its role in pharmaceutical company’’(first published 2009)accessed 3 May 2020

[3]Basant R Srinivas S ‘’IP protection in India’’(12 April 2016)  accessed 5 May 2020

[4]Cipla Limited v/s MK Pharmaceuticals MIPR [2007] (3) 170, [2008] (36) PTC 166 Delaccessed 3 May 2020

[5]Neon laboratories Ltd v  Medical technologies Ltd & ors, [2015] accessed 3 May 2020

[6]DUSU Pharmaceuticals Inc V Biofrontera Inc et al [2018]  accessed 4 May 2020