Category: Research Paper
Paper Code: RP-KK-05
Page Number: 77 - 90
Date of Publication: February 10, 2021
Citation: Dr. Kakumani Kataky, A Comparative Study on Secondary Patenting on Pharmaceutical: Striking A Balance Between Competition Law and IPR, 1, AIJACLA, 77, 77-90, (2021).
Details Of Author(s):
Dr. Kakumani Kataky, Faculty of Law, Gauhati University
ABSTRACT The Supreme Court of India made a historical judgment in April 2013 which denies a secondary patent from the Swiss pharmaceutical company Novatis and hence allowing the manufacturing of generic medicine in India. This approach promotes competition and access to medicine in developing countries but at the same time, it may hamper the development of new inventions. The restriction of competition law by delayed entry into the market of generic companies and the reason behind it is the secondary patenting, a form of evergreening of patents. The focus will be more on the conflict between competition law taking into account access to medicine and intellectual property rights in the United States, European Union, and India. The IPR legislation is mostly regulated and managed by country to country. However certain harmonization also exists especially concerning the standard of patentability. The issue will be considered comparing the situation in the United States, the European Union, and India. Harmonization exists concerning competition law. However, differences are present particularly concerning the case law, when a conflict of patent protection and competition law comes into the picture. Concerning competition law, there will not be a depth analysis on the country level but rather comparing the situation more generally by examples of the United States, the European Union, and India, as one of the biggest generic manufacturers of the developed world. KEYWORDS Competition Law, Evergreening, Generic, IPR, and Pharmaceutical
INTRODUCTION In the year 2013, the Indian Supreme Court made a historic judgment while denying a secondary patent from the Swiss pharmaceutical company Novartis and hence allowing the manufacturing of generic pharmaceuticals in India.  This promotes competition and access to medicine in developing countries but at the same time may hamper the development of new inventions. In this paper, the discussion will be on the restriction of competition law by delayed entry into the market of generic companies and of one of the reasons behind it, being secondary patenting, a form of evergreening of patents.
PATENT RIGHTS IN PHARMACEUTICALS Patent Life Cycle Patent protection can be granted to a pharmaceutical product for a certain period, during which the patented product is under the exclusive ownership of the inventor and cannot be commercially used, made, sold, distributed, or otherwise exploited by others. Under the World Trade Organization’s (hereinafter “WTO”) Agreement on Trade-Related Aspects of Intellectual Property (hereinafter “TRIPS”) a patent can be granted for a maximum of 20 years from the date of a patent application. The Preliminary Report on Pharmaceutical Sector Inquiry by the European Commission divides the product life cycle into three distinct categories. The first phase is the research and development (hereinafter “R&D”), during which huge amounts of investments are needed for the development of the product, including clinical trials, national application processes, and marketing approvals in countries, where the pharmaceutical company is willing to enter with its product. The second phase takes place from the moment the product is brought to the market until the expiration of the patent. This phase is the period when the patentee has the time to sell the product to compensate the investors. The last phase of the patent life cycle consists of the period after the patent has expired, following by the entry into the market and competition between the generic manufactures.
Research and Development As already stated, before a pharmaceutical product can be marketed and sold, huge amounts of investments are needed to enable the time-consuming R&D phase. This often composes the ground for the justification of patent protection. The development of a new chemical or biological entity to make a new pharmaceutical product may require on average up to € 1,059 million. The average time to get the product on the market from the first patent filing takes up to 7-14 years. Before this, the product practically cannot be marketed and thus may not produce any profits for the company. Hence early patenting is important to encourage patentees to innovativeness as well as to use patent rights according to the legislation. If the patents were granted only later on (after the clinical trials) the investment could be too risky for the patentee as there is always a possibility that the pharmaceutical will not pass the necessary clinical trials and other tests. The insecurity and possibility that the product could fail the obligatory tests would moreover slow down R&D as well as the actual innovativeness and development of new, necessary pharmaceuticals. Therefore, during the patent term, the prices may be held relatively high to enable the reward from the R&D. Originator and Generic Companies Companies behind the R&D of new chemical entities (hereinafter “NCEs”) and the improvement of already existing pharmaceuticals are called Originator Companies. Originator companies are usually multinational pharmaceutical companies that act worldwide. Generic Companies on the other hand aim at developing an identical/equivalent product of the originator company. Their goal is to get the product to the market as soon as the patent of the originator company has expired. A generic medicine can be defined to have consisted of the same substances in quality and quantity and is in the same pharmaceutical form as the originator medicine. In the EU generic companies are relatively small compared to the multinational originator companies, whereas in Asia the generic companies play a much bigger role. The idea with generic companies is that since they do not have patent protection on their products, they can compete on the market with other generic companies and provide medicines at a reasonable price enabling governments to keep up with their budgets and allowing individuals to buy cheaper medicines.
Patent Rights in the European Union At the EU level, at the moment, patents are regulated nationally. A patentee must in practice apply for patent protection according to the national procedure in each European Union member state, where the patentee wishes to obtain protection. Upon obtaining patent protection in the country in question, the patentee has the exclusive rights to the patented product only in the countries where the patent protection has been granted. In case of infringements, the patent holder may need to go through several different litigations in different countries. At the moment, however, a common patent criterion already exists in the EU. Under Article 52(1) of the European Patent Convention (hereinafter “EPC”), a patent will be granted if: 1. The invention is new; 2. The invention involves an inventive step; and 3. The invention is susceptible of industrial application.
Patent Rights in the United States In 1984 The US Congress adopted the Hatch-Waxman Act (The Drug Price Competition and Patent Term Restoration Act). The goal of the act was to balance between the patent protections granted for the innovators and to ensure a sufficiently effective period of protection taking into account the efforts put on the R&D of the pharmaceutical. The balance was to be found between the IPR protection and the availability of lower-priced pharmaceuticals after the expiration of the patent period. Before the Hatch-Waxman Act, it was required from both the generic drug companies as well as from the original producers to go through the same safety and efficacy tests. After the Hatch-Waxman Act, the process was made easier for the generic producers. This probably also increased the manufacturing of generic products, since they were no longer obliged to go through expensive clinical tests. Before the Hatch-Waxman Act, the patent protection period was approximately 17 years but often even shorter, since it took years to conclude the Food and Drug Administration’s (FDA) approval for the patent protection. During this time, it is not possible to market the product and thus the effective period becomes shorter.
Patent Rights in India Compared to the United States, patent protection in India as in many other developing countries stayed for many years on a relatively poor level from the pharmaceutical companies’ perspective. The Indian Patents Act came into force in 1970 and since then, it has been amended three times for instance to comply with the TRIPS Agreement. The latest amendment was made in 2005 after India became a member of the TRIPS Agreement. Before 2005 the Patents Act of 1979 determined that patent protection is possible if it promotes innovation and is not only a method to guarantee the patentee a protection through which the patentee can merely benefit in the form of obtaining a monopoly. The Indian Patents Act excluded product patents such as medicines from the scope of applicability of the Act. This among other things has enabled India from the beginning to manufacture generics at a whole different level and way compared to Europe. However, in 2005 when India became a member of the TRIPS Agreement it had to agree to comply with the TRIPs criteria of patentability (non-obviousness, utility, and adequate disclosure) meaning that protection could be granted to products as well and thus medicines themselves could be included in the scope of protection and not only the methods. Article 28 of the TRIPS Agreement provides that the members of the TRIPS Agreement shall enable both product and process patents available in their countries. Article 28 also includes certain exclusions that a country may make, yet pharmaceuticals were not included in the exclusions. Secondary patenting was yet limited from the scope of protection by section 3(d) of the new Indian Patent Act stating that patents can be granted only to entities that have at least one new reactant. Section 3(d) states that “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance...” is not patentable. Section 3(d) underlines that substances or derivatives will not be granted patent protection if they are merely modified substances or products of an already existing patented product and has the purpose of merely extending the patent life of the product. To provide essential medicines at an affordable price for people in developing countries, India has allowed the manufacturing of generic products, which has not been allowed to such a wide extent anywhere else in the world. There has been a lot of argumentation for and against it. On one hand, the idea behind the allowance of generic products to the market is to promote health for all around the world. Yet, on the other hand, competition in general stimulates innovation and encourages the creation of new, and thus denying protection to the innovators may impede innovation and development of new, essential products and methods.
Pricing of Pharmaceuticals in Europe In Europe, the pricing of pharmaceuticals is widely influenced by the governments’ actions. In many European countries, the social security system by the state covers part of the expenses of the necessary pharmaceutical products. In eleven of the Member States of the EU, prices of pharmaceutical products are determined by the national authorities based on the information from the manufacturers. Whereas, in eight of the Member States, the prices are rather determined by the competition between the pharmaceutical companies i.e. they are based on the market conditions. In the evaluation of granting a patent, the efficacy of the substance seems to be in an important role from the point of view of the Indian Patent Act. It is stated that a substance that has new technical creations but is not increasing the efficiency of the substance, will not be granted protection.
PRICING OF THE PHARMACEUTICALS IN DEVELOPING COUNTRIES The ultimate purpose of companies is to make a profit. In that sense, it is clear that pharmaceutical companies among others are principally seeking profit. A tool to enable pharmaceutical companies to do so is IPR protection granted for inventions. However, this usually means that drugs are not invented for third world diseases since the markups will not be high enough due to the lack of funding. In developing countries, demand for pharmaceuticals would be high but the price level for the product would have to be lower, which makes it hard for companies to get a good value for their drugs. A huge difference between many developing and developed countries is that the state is not covering in any part the expenses related to necessary medicines neither do individuals have insurances that would cover parts of the costs of the drugs.
TRIPS AGREEMENT The Agreement on Trade-Related Aspects of Intellectual Property (hereinafter “TRIPS” Agreement) was negotiated during the WTO Uruguay Round multilateral negotiations (1986-1994). The purpose of the Agreement was to harmonize minimum standards for IPR protection in the member countries to the TRIPS. The ultimate goal of the TRIPS Agreement is to find a balance between the protection of intellectual property and the same time to enable the exploitation of already existing developments and inventions. The TRIPS Agreement sets out the minimum requirements for patent protection under article 27. It states that “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application”. Article 27 also covers an exclusion clause; however, pharmaceuticals are not included in it and therefore are patentable subjects in all TRIPS member countries.
SECONDARY PATENT AS A FORM OF EVERGREENING OF PATENTS Secondary patenting or Evergreening of patents is a strategy, by which patent holders manage to extend the patent life by incremental changes when the patent protection is about to expire. The methods used can be “seeking subsequent patents on derivatives of existing drugs, altering the mixture of isomers, identifying compounds with the same molecular formula but different structural formulas, or patenting methods of administration of an existing drug”, for instance. By secondary patenting pharmaceutical companies can maintain their market position and restrict competition on the market for a longer period. IPR related issues are under the competence of nations and therefore it depends on the country and its legislation whether such use of derivatives in this context is permissible or not. Today a serious problem lies on the shoulders of different stakeholders, since the situation with the pharmaceutical industry conflicts crucially by hindering the promotion of public health in the developing countries and competition worldwide. Too much energy is being concentrated on the planning of patent strategies such as secondary patenting, compulsory licensing, etc. to obtain as long patent protection as possible instead of keeping up the essential innovation work and development of new drugs. Upon restricting patent protection, companies could start keeping their innovation away from the public before they can guarantee somehow the monopoly on the market. This would lead to the fact that some vital drugs would not be made available for the public and this hence would hamper the incentives to new inventions. On one hand, it has been stated that allowing generic production, hampers innovation. On the other hand, it has also been said that allowing the evergreening of patents will hinder the development of new inventions since companies can get the profits and markups by not significantly amending the already existing products and thus do not have any trigger to invest in R&D to innovate new, life-changing products. The effects of evergreening have been evaluated among others by the European Commission. It has been stated by the Commission that evergreening among other misuses of patents have caused a loss of three billion Euros in 2009 through hampering the entry into the market of the generic products. According to the Commission’s Preliminary report, many of the most successful medicines of pharmaceutical companies in the EU were going to expire in the upcoming few years in 2008, which has logically encouraged the companies to try to extend the patent lives of their pharmaceutical blockbusters. Under the Commission’s preliminary report it was also that the generic companies felt that patents were often granted by too light reasons enabling secondary patenting of pharmaceuticals and thus enabling the originator companies to sell the “newer versions” to buyers before the generic companies were able to enter the market.
ACCESS TO MEDICINES IN DEVELOPING COUNTRIES The right to access to medicines has been widely regulated in international treaties and agreements. Access to essential medicine is guaranteed in the Universal Declaration of Human Rights (1948) under article 25 laying out that “Everyone has the right to a standard of living adequate for the health and well-being of himself and his family, including … medical care...”. Access to essential medicines is also provided under the World Health Organization (WHO) Constitution (1946) in the right to the highest attainable standard of health. Patent protection to interfere with the access to medicine can be justified with the argument that patent protection increases and spurs future innovations and pharmaceutical inventions and is hence crucial for the development of new medicines.123 Since the R&D costs may fall somewhere between $115 m and $802m, it is rather inevitable to provide sufficient protection for the inventors in order them to get income streams for the product and to enable the development of medicines in the future as well. The U.N. Commissioner for Human Rights has suggested that if there are actual or potential conflicts arising from the patent rights and public health, the right to public health should prevail over the IPR. Also, the organization of Health GAP Global Access Project states the following: “[w]e believe that the human right to life and health must prevail over the pharmaceutical industry’s excessive profits and expanding patent rights”. It has been argued that the interest of public health in developing countries should be a detrimental question when granting a patent instead of giving profits to private companies for their product. As seen, the subject raises a lot of debate and conflicts arise since both of the rights should be equally guaranteed by state regulations and interference. In many of the developing countries, the social security system is not on quite the same level as in the developed countries, where the state funds the access to medicine at least to some extent, whereas in developing countries citizens most commonly pay for their medicines themselves. The price level is relatively low in the developing countries thus the salaries are lower and the public cannot afford the highly-priced medicines they would need. The instant need for medicine in developing countries is urgent since diseases such as HIV/AIDS, malaria, and tuberculosis are still relatively common, whereas in the developed world the most crucial illnesses include lifestyle diseases. Thus the market in developing countries for diseases such as HIV/AIDS, malaria, and tuberculosis would be abundantly large, the high prices prevent people from buying these medicines and thus on the other hand hamper the competition and development of these medicines. Some improvements have yet taken place since the World Health Organization (WHO) declared certain necessary drugs such as medicines for malaria and tuberculosis to be “off-patent”, which partly ensures access to these essential medicines in the developing world. Even though the purpose of the TRIPS Agreement may have been to help to provide and improve future inventions and on the other hand to simplify and promote access to already existing inventions, the Agreement has however perhaps even increased the inequality between the industrialized countries and the developing world. Member countries to TRIPS Agreement consist not only of the EU member states but moreover include developing countries such as India, Pakistan, Philippines, and Armenia, just to mention a few. The problem is that some of the developing countries have not been able to comply with the TRIPS neither have they benefited from the Agreement to the same extent as the developed countries. Developing countries may lack innovation or pharmaceutical companies and therefore are not benefiting from possible patents, which are usually granted to multinational companies having their principal place in Europe, for instance. Developing countries do not have such a high-level technological development and capacity to produce patented products or other intellectual property. This way developed countries may benefit from intellectual property protection in both in developed countries as well as in the developing countries, whereas developing countries are not even able to provide adequate competing products to the markets of the developing countries. This causes a lot of setbacks in the developing countries and hinders their opportunities to become equal alongside with the developed countries. Recently, however, the WIPO development agenda as well as the World Trade Organization (“WTO”) Doha Declaration on the TRIPS Agreement and public health have taken into consideration the differences in the levels of development in different regions, also from the point of view of global public health. Since the standard of living varies greatly between the developed and developing countries, the public in the developing countries are not able to pay the high prices for patented medicines that would guarantee their well being. This makes it difficult to strike a balance between the patent rights of undertakings on one hand and the rights of the public and their interest, especially in the developing countries, which are not able to provide the same level of healthcare and standard of living to their citizens as provided in the industrialized world on the other. There are also arguments on behalf of a wider, international, and common patent regime. It has been argued that strong patent protection may encourage more innovations since it is known beforehand that a wide IP protection exists to secure the costs of R&D as well as to gain profit. A problem still arises as the innovations are more concentrated in the developed countries and therefore the drugs invented are also for diseases faced in developing countries. If secondary patenting was to be allowed, it would hinder effective competition since generic manufacturers would not be able to enter the market and hence it would deny access to cheaper medicines. In the developing countries, the reaction to the worldwide patent system has been cautious. Even though medical innovation and hard work on the background needs to be appreciated and protected by adequate intellectual property rights, at the same time it complicates the efforts that are made to improve public health in the developing countries as well as the access to medicine by the public in general. This is due to the higher pricing of the medicines that have been protected by patent rights. The importance of India’s role as the exporter of affordable drugs to developing countries cannot be highlighted too much. Also, India is the primary source of manufacturing affordable pharmaceuticals for HIV/AIDS in developing countries.
SOLUTIONS AND HARMONIZATION OF LEGISLATION A company is entitled to patent protection for an adequate period to compensate among others the huge investment costs rising from the R&D and marketing of the pharmaceutical. On the other hand, this restricts competition on the market and hence may keep the product out of the reach of consumers because of the high pricing.At the EU level, the restriction of competition is allowed as far as the company does not abuse its dominant position in the relevant market. Upon exceeding this limitation, competition becomes distorted to a wide extent and the interest of the public concerning access to affordable medicine becomes infringed as well. This is more or less the situation also in developing countries. If the competition is restricted to an extremely broad extent by the patenting rights or with secondary patenting, in this regard, the rights of the general public in form of right to health and access to medicine becomes restricted. TRIPS Agreement on one hand unites the developed and developing world and sets out the criteria for patentability. The worldwide situation of patenting rights seems at the moment quite unclear. The TRIPS Agreement sets certain standards for all its member countries on when a patent shall be granted. As already earlier stated the Doha Declaration simplified the criteria on one hand for the emerging markets enabling them to take into account the protection for public health, where necessary. Since the developing countries and the developed countries are not on the same level when it comes to e.g. standard of living, the harmonization of the patenting system becomes difficult as well, as has been seen during the last years. An important question at the moment arises around the area of whether other developing countries are going to follow the example of India concerning the Novartis ruling. If so, applying for a patent may become more difficult for pharmaceutical companies when applying for secondary patents. This then clearly shows how the purpose of the TRIPS Agreement has to some extent failed to fulfill its purpose. On the other hand, now that the results of the TRIPS Agreement have been seen in some parts, perhaps a clearer harmonization of the patent system around the world would clarify the rights of a patent holder and enable patentees to cover the expenses and profit from the inventions. At the same time, it should however take into account the different standard of living around the world and the need for access to cheaper medicine in developing countries. Another important thing to consider is that the poorest countries in the world do not have such resources in R&D and funding as the Western world has, thus developing countries would easily fall into the same situation - be in an unequal position compared to the developed countries, since patent protection would most probably not be granted for the poorest countries due to the lack of resources to invent the products and to take care of the marketing, IP protection, etc.  An effective patent system that finds a balance between the needs of the developing countries for affordable medicine to promote public health and the living standards and on the other hand equal protection to the developers and innovators behind the pharmaceutical products would be highly needed. As already discussed the Commission’s Preliminary report found out that there are some lacks in the pharmaceutical industry concerning competition and this should be more harmonized at least at the EU level. There has also been some argumentation after the preliminary report on whether there should be any harmonization or not. The president of the EFPIA (Pharma industry federation) has, for example, been arguing against the preliminary report and stated that the report “focused on the wrong issues” and blaming originator companies for delaying market entry of generic products and therefore hampering innovation because of strategic patent planning. Arthur J.Higgins the president of EFPIA further argued that "Patents only work if you have the right to defend them". On the EU level, under the planned unitary patent regime of the EU, once a patent application is filed at the EPO, it covers all the signatory countries to the Agreement on a unified patent court (hereinafter “UPC”). The new UPC aims at harmonizing the patent system in the EU thereby providing adequate protection to smaller enterprises as well to enable them to defend their patents once the patents are applicable in all EU member states. The UPC system would also enhance the processing of patent applications by reducing administrative work and by enabling all litigations and infringements to be handled in one court. The question is whether this could also enable a stronger preventing of strategic patents. Minna Aalto-Setälä, a patent lawyer in the Finnish Chamber of Commerce stated this month that the general political will concerning Unified Patent Court is strong at the moment, since the general opinion around Europe is that the EU has been left behind in patenting matters compared to the United States. In the United States, one single patent application covers the whole United States. On the international level, also taking into account developing countries, a suggested solution could be that generic manufacturing would be widened to those countries that allow generics from developing countries. Harmonization concerning patenting rights should be done in a way, which would benefit all of the stakeholders, taking a deeper look at the needs of the developing countries. Even though a global patent protection system would be good in many senses, it should be taken into account that it would not most probably work in an extremely differing world, where the conditions and backgrounds for a system that everyone would benefit, are not on the same level, in fact far away from each other. The Commission on Intellectual Property Rights has stated that “Developing countries should not be deprived of the flexibility to design their IP systems that developed countries enjoyed in earlier stages of their development, and higher IP standards should not be pressed on”.
CONCLUSION Evergreening of patents puts a question always, concerning slow down of development and innovations. It is well known that competition on the market is essential for development and new inventions. In one point patent rights are justifiable in cases, where a company has put a lot of effort into the research and development of a new product and hence with the help of protection as provided under the IP regime can recover the expenses put on the research and development. On the European Union level, the balancing between these two rights has been extremely difficult as the Commission’s preliminary report has demonstrated. In respect to the pharmaceutical sector in the European Union is highly regulated and medicines are mostly funded by state aid and hence consumers are not in the position to choose the product and compare them with other products. In the European Union as well as on the international level, protection of public health has become an important issue. On the European Union level, the upcoming changes to the Unified Patent Court will probably demonstrate how secondary patenting can be controlled more specifically and also whether a clearer balance will then be found to protect public health and competition together with Intellectual Property Rights (IPR). On an international level, more specifically in developing countries, the Novartis case allows people in developing countries to afford the previously highly expensive drugs by generic entry into the market and this way also allows individuals to obtain a better quality of life. Now in the present scenario, Indian companies are allowed to make cheaper copies of the medicines. The decision of the Supreme Court on Novartis affects the way of how the companies from other countries will behave and think about the Indian companies. As I have already discussed that research and development of new drugs becomes often expensive and in some cases, the companies may not even be able to get back the amount of money that they have in the first place invested in the development of the drugs. In these cases, the company perhaps wants to apply for secondary patenting to extend the life cycle of its patent, to which the company has put a lot of research, effort, and investments. To sum up, at its best, intellectual property protection for pharmaceuticals or other products alike, increases and promoting innovation and research and development, encourages the creation of new health-saving drugs, and thus improves the standard of life of human beings. On the other hand, however, the negative effects of patent protection cannot be ignored. At its worst patent protection hampers innovation and deprives access to health of people living in the poverty and hence deprives their human rights and worsens the living standards. Steps should be taken towards a clearer balance between patent protection and competition law both on the European Union level and on an international level. In the future, the Unified Patent Court will probably show a way to a better solution in this area, if it works as is wished.
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