Pharmaceutical Patents in India: Issues and Concerns

 

 

Conflicts on Indian Pharmaceutical Pat Patents ents   

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Contents

I. 

Introduction

II. 

TRIPS and its flexibility under Doha Declaration

III. 

Pharmaceutical Pharmaceuti cal patents under Indian Patent Act

IV. 

Issues over Indian position on Drug Patent

V. 

Developed World’s criticism on Doha declaration and Indian Patent system

VI. 

Conclusion

 

 

Introduction: A pharmaceutical drug, also referred to as medicine, is a chemical substance used in the medication or in the preparation of medication for treatment, cure, prevention or diagnosis of disease. The definition of the term drug includes articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or animals and articles, other than food, 1

intended to affect the structure or any function of the body of man or animals.   Patent is a monopoly right which promotes the progress of science and technology by conferring a title upon an inventor to make, use or sell an invention, for a limited period. Out of seven areas of intellectual properties, patent is the most important and controversial issue because of it wide 2

ranging implications to the drugs and pharmaceutical industries of the developing countries.   Patent play an important role in the cost of drugs developed after around 1980. They are, of course, critical to question raging around the world of how to provide affordable access to drug since without patents there would be far fewer drugs around for people to access. Moreover, the patent system is designed to require that those who need new drugs bear the cost of their development. 3  Drug patenting allows pharmaceutical companies to legally protect, patent, the components of the drugs they create in their research labs. Drugs that are patented are protected from competition, as other companies cannot use the same mixture of ingredients to create competing drugs. Drugs and pharmaceutical items may be patented but the exclusivity promised by a patent may cause hardship on the part of the public due to the higher price of the brand name drug. This has caused political strife across the world. 4  The patent system was first introduced in India in 1856 through the Exclusive Privileges Act, 1856. Later on, the Indian Patents and Designs Act, 1911, replaced the previous act and thereafter to encourage indigenous research in the Indian Pharmaceutical industry, the 1

  Section 201(g) of the Fede Federal ral food, Drug and Cosmetic Act, 1938.  Prankrishna Pal(ed.), Intellectual Property Property Rights in India: General Is Issues sues and Implications 95 (Regal Publications, New Delhi, 2008). 3   S.K. Verma and Raman Mittal, Intellectual Property Rights: Rights: A Global Vision 121 (Indian Law Institute, New Delhi, 2004).

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  Kochava R. Greene Greene,, “What is Drug Patenting?”, available at: http://www.ehow.com/about_5052330_drugpatenting.html (visited on February 12, 2011).  2011). 

 

government introduced a new system of patents through the Patent Act, 1970. This act regulates for products processed or manufactures in India. It provides product patents for non-chemical substances and process patents for chemical substances including pharmaceuticals, agro5

chemicals and food products.  Thus the then India Patent law allowed only process patents which provided little protection for those making long run investments in drug research and development. This helped much the companies in duplicating the western manufactured drugs and developing the generic industry to do the reverse engineering in drugs to produce the patented western drugs at low price. A generic drug is an identical copy of a branded proprietary drug which is exactly the same as their branded counterparts in dosage form, safety, strength, quality, performance characteristics and intended use and the only difference is in the cost. Then in the year 1994, The Agreement on Trade Related Aspects of Intellectual Property (TRIPS) came up with the minimum level of protection to be provided by the member states of the World Trade Organization (WTO). It mandates India to amend its local legislation before 2005 to provide patent protection to any inventions, whether product or process, if it is novel, involves an inventive step and capable of industrial application. In implementing TRIPS 6

agreement, India extended its patent protection to pharmaceutical products   and made the domestic drug industries to expand into original research and drug development, thus improving public health. By creating an environment that rewarded innovation, India was set to become a 7

world leader in medical technologies.  Though the pharmaceutical patent was granted to product as well as process after the 2005 amendment, the issues and oppositions are coming from the developed economies regarding the conflicts on low cost generic drugs and compulsory licensing, which is the practice of allowing third parties by the authorities to use the patented inventions without patentee permission. Hereafter this article will discuss and analyze the Indian position on these conflicts under the following heads.

TRIPS and its flexibility under Doha Declaration:

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  ICRA Indus Industry try Watch Series, The Indian Pharmaceutical Industry 25 (ICRA Limited, New Delhi, 1999).   Patents (Am (Amendment) endment) Act, 2005.

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http://www.aei.org/outlook/25566 (visited  (visited on March   Roger Bate, “In “India dia and the Drug Patent Wars”, available at: http://www.aei.org/outlook/25566 21, 2011).

 

 

As stated above the TRIPS agreement, introduced legislation in favour of the

pharmaceutical industries’ right to patent their drugs and its implementation has effected a huge impact on generic drug production. The obligation made on the developing countries to comply with patent laws has complicated the provisions of treatment for deadly diseases. Implementation of TRIPS agreement has been a painful process of many developing countries and least 8

developed countries.  The consequence of TRIPS is that the new, better drugs are only available in countries that have the capacity to cover the high cost. Poor countries are forced to wait until 9

their patent expires or the proprietary prices are forced down.  TRIPS Agreement stipulates that a compulsory license must be issued predominantly for the supply of the domestic market of the member granting the license. Consequently, many countries without a significant pharmaceutical sector have not been able to take advantage of the compulsory licensing provisions of TRIPS 10. In 2001, WTO members adopted a special ministerial declaration at the WTO Ministerial Conference in Doha to clarify ambiguities between the need for governments to apply the principles of public health and the terms of the TRIPS Agreement. Doha declaration on TRIPS and public health is termed as real victory for the developing countries like India who are demanding the WTO council to consider the public health measures in the developing and the least developed countries on TRIPS minimum standards for patent. In light of the issues and the increasing evidence that patent protection was negatively affecting world health b y erecting a barrier between sick people and the medication they need, the WTO amended TRIPS under the Doha Declaration to broaden the criteria to facilitate compulsory licensing of patented pharmaceuticals for countries facing a public health crisis. Furthermore, countries that lack domestic pharmaceutical production abilities may import these medications from countries that 11 produce the medications for them for this purpose.   The Declaration affirms that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health and it can and should be interpreted and implemented in a manner supportive of WTO member’s right to protect public health and, in particular, to promote access to medicines for 8

  Supra note 2   “AIDS, Drug Prices and Generic Drugs”, Drugs”, available at: http://www.avert.org/generic.htm (visited http://www.avert.org/generic.htm (visited on March 21, 2011). 10   Article 31(f) if the TRIPS. 11   Aileen M. McGill, “Compulsory Licensing of Patented Pharm Pharmaceutical aceutical s: Why a WTO Administrative Body 9

should determine what constitutes a Public Health crisis under the Doha Declaration”, 10 Wake Forest Intellectual Property Law Journal 73 (2009).

 

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all.   The realization of public health becomes, with the Doha declaration, a clearly stated purpose of the agreement. Spelling out some of the available flexibility was the main objective of the declaration. The confirmation that the TRIPS Agreement has left room for flexibility at the 13

national level has important political and legal implications.  After Doha declaration, about 52 countries have issued compulsory licenses includes Brazil, Thailand, Malaysia, South Africa and 14

Kenya.  

Pharmaceutical patents under Indian Patent Act: Regarding the drug patents, it is better to start directly with the last amendment to the Indian patent act which implements the TRIPS agreement and provides patent for pharmaceutical products, as it brought many changes and conflicts into the act of 1970. This amendment was enacted in order to comply with the terms of TRIPS agreement and WTO decision15 which was against the Indian rejection of product patents. The amendment has made significant change in many fields like the patentable subject matters, period of patent production and compulsory licensing. A new definition to the term ‘inventive step was substituted by the 2005 amendment which explains the term as a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.16  The definition of inventive step along with the ‘pharmaceutical substance’ which was defined as any new entity involving one or more inventive steps, leads to many controversies. Another major change made by the amendment regarding the pharmaceutical patent is the substitution of section 3(d) with a new provision, which excludes from patentability mere discovery of a known substance unless there is 17

significant enhancement in the efficacy or a new use of a known substance.  

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  Para 4 of the Declaration on the TRIPS Agreement and Public Health.   Carlos M. Correa, “Implications of the Doha Declaration on the TRIPS Agreement Agreement and Public Health”, available   (visited on March 21, 2011). at: http://www.who.int/medicines/areas/policy/WHO_EDM_PAR_2002.3.pdf  (visited 14   Discussion Paper on Compulsory L Licensing icensing by Department of Industrial Policy and Promotions(DIPP) available at : http://dipp.nic.in/CL-DraftDiscussion.doc (visited http://dipp.nic.in/CL-DraftDiscussion.doc  (visited on March 2, 2011). 15   USA in the year 1996 made a complaint against India in the WTO dispute settlement body on the Indian omission of product patent on agricultural and pharmaceuticals. 16   s. 2(ja) of The Patents Act, 1970(as amended on 2005), herein after referred as ‘‘The The Act’ 13

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  s. 3(d) reads as : “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 or the mere discovery of any new property pro perty or new use for a

 

 

Compulsory Compulsor y licensing was an essential ingredient of Indian patent act and the 2005

amendment has made lot of changes in the provisions of the compulsory licensing. These 18

changes were made in light of the Doha declaration on public health.   The new amendment permits the controller general of patent to grant license to any person who applied for it after expiry of three years from the date of grant of that patent, if the grounds prescribed under the act are satisfied. In case where reasonable requirements of public in respect of patented invention are not been satisfied or not made available to the public, or the patented inventions are not worked in the territory of India, any person can file an application before the controller for grant of compulsory license only after posting such request before the patentee and unable to get it from him.19  The burden of proof is on the applicant to show that the grounds for the grant of compulsory license exist.20  The act further provides important points to be taken into consideration by the controller before granting a license to an applicant that as to the capacity of the applicant to work the invention to the public advantage and the financial capacity of the 21

applicant in working the invention.  The act permits a licensee of a compulsory license to export the patented product, in accordance with the provisions of section 84. The purview of compulsory licensing for export has been widened to cover all patented products, not just patented pharmaceutical products. This goes much beyond the intent of the Doha mandate. Further under Indian patent act, when a compulsory license has been granted in concern to a patent, any person including the central government can apply for the revocation of that patent 22

after expiry of two years from the grant of compulsory license.   The grounds for applying revocation, as same as of the application for compulsory license, should be stated in the application before the controller general of patent. The practical aspect of the patent act in the pharmaceutical industries in India was been praised by many nations but also faced many oppositions from the developed front. The pharmaceutical industry is one of the few success stories on Indian industrial scene. In terms of known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant” are not an invention within the meaning of the Act. 18   Supra note 2 at p. 102. 19   s. 84(1) of The Act. 20   Feroz Ali Khan, The Law of Patents- with a special focus on pharmaceuticals in India 716 (Lexis Nexis, New Delhi, 2007). 21

  s. 84(6) of The Act.   s. 85(1) of The Act.

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volume of production, it is the second largest pharmaceutical industry in the world, with exports 23

reaching about 200 countries of the globe.   India has tremendous potential in area of biotechnology because of its abundant scientific and technical manpower. The current industry players comprise several privately owned Indian companies that captured a substantial share in the domestic pharmaceutical market due to factors such as favourable government policies and limited competition from overseas. The liberalisation of the Indian economy is revolutionising Indian industries as they begin to emerge from domestic markets and prepare for international competition. New biotech industries in India are amongst the best in the world. This becomes possible simply because of their increasing investment in Research & Development (R&D) activities, which result more and more inventions and increasing number of patents granted. Dr. Reddy’s laboratory, CIPLA, Ranbaxy, etc. are some of the examples of present generation of Indian drug Multi-National Companies(MNCs), which have international presence due to technological excellence.24  These well-established Indian companies have excellent skills in applied chemistry and the lowest manufacturing costs. India pharmaceutical industry had already broken the monopoly of the developed pharmaceutical groups and made available essential drugs at affordable prices. At present India provides for 20% of the world generics market. In particular it provides 90% of the developing world’s AIDS medicine supply and 50% of the 25

world’s AIDS medicine needs.  Both the Indian central and state governments have recognized R&D as an important driver in the growth of their pharma businesses and conferred tax 26

deductions for expenses related to R&D.  

Issues over Indian position on Drug Patent: In India, very few numbers of cases were reported in respect of the grant of patent on drugs. Of which very important one regarding the non-patentable subject matter and the Indian 27

position in granting pharmaceutical patent was Novartis AG v. Union of India.  The facts of the case itself will explain the procedure for availing drug patent in India and the link between pricing and public interest. In this case the Novartis, a Switzerland based pharmaceutical 23

  supra note 2 at p. 144.   Id at p.121. 25   available at: http://donttradeourlivesaway.wordpress.com/2011/03/04/stop-the-india-eu-fta-decimator-of-thepharmacy-of-the-world/  (visited  (visited on March 23, 2011). 24

26  27

available at: http://en.wikipedia.org/wiki/Pharmaceuticals_in_India (visited http://en.wikipedia.org/wiki/Pharmaceuticals_in_India (visited on March 21, 2011).   (2007) 4 MLJ 11 1153. 53.

 

company engaged in manufacturing anti-cancer drug- Glivec (known as Gleevec in USA) and got it patented in many countries from 1994. It started selling Glivec in India in the year 2002 after obtaining marketing approval, though it filed patent application in the year 1998 before the 28

Chennai(madras) patent office . After hearing the oppositions from many domestic industries like Ranbaxy, Cipla and considering the then amended Patent act, 1970 the Assistant controller of patents and designs passed order of refusing the grant of patent in the year 2006. Aggrieved by 29

the order, the Swiss company filed writ petitions before the High Court of Madras . The main prayers of the appellant are to declare section 3(d) of the Patent Act as unconstitutional and to direct the controller to allow their patent applications. Then the court converted the part of the case, the challenge to the patent office’s decision to not grant a patent for Glivic from a writ petition to an appeal. During the pendency of the writ and the appeals, the central government brought into force the provisions of the patent act on appeals regarding the grant of patent, by establishing the Intellectual Property Appellate Board (IPAB) in the year 2007. The court then transferred the Novartis’s appeals matter on the Glivec patent to the IPAB. The high court started hearing the writ on constitutional validity of s.3(d) of the Act and the IPAB on the appeal matter. Novartis challenged the s.3(d) on grounds, one, it is not compatible to the TRIPS and it is arbitrary, illogical, vague and offends article 14 of the Constitution of India. The madras high court, very well, observed that the courts in India cannot check or the validity of the amendment section or stuck it down, in the backdrop of such alleged violation of TRIPS. On deciding the second issue, the court considered the main grounds of attack to the validity of the amended section that it is vague, arbitrary and confers uncanalised power on the statutory authority. Finally the court came to a conclusion that the amended section of the Act is constitutional as the patent controller, the statutory authority in the case, is exercising a quasi-judicial function. According to the act, he considers the patent claim application in the context of the objections received; hears parties on both sides and then passes an order, either granting the patent or rejecting the patent application, by giving reasons. The Court also stated “ we have borne in mind the object which the amending Act wanted to achieve namely, to prevent ever greening; to  provide easy access to the citizens of this country to life saving drugs and to discharge their

28  29

Application No. 1602/MAS/1998. 1602/MAS/1998.   Writ Petition No. 24754 to 24758 of 2006.

 

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constitutional obligation of providing good health care to its citizens…”   The judgment of

Madras High Court rejecting Novartis patent case enabled Indian companies to manufacture cheaper generic medicines, providing patients from India and third world countries an affordable medicine and treatment for blood cancer. At the same time, the appeal against the refusal to grant patent for Glivec was also heard by the IPAB with Z. S. Negi as the Chairman and Dr. P. C. Chakraborti as a technical member. There are many arguments made by both the appellant and respondents and five main issues were framed by the appellate board, most of the issues are based on s.3(d) of the Act. The IPAB after considering the Madras high court’s explanation given to the said section, held that the appellant’s invention is novel and possesses inventive step, which is additionally satisfied by way of inventive selection, but the enhanced bio-availability of 30% was not same as the therapeutic efficacy as required under section 3(d) and by not satisfying s.3(d) the claims are not patentable, because the invention was termed as same(known) substances. The appellate board also observed that the different public interest provisions permissible under TRIPS which gives India the right to protect public health and to promote access to medicine for all. On the Exclusive Marketing Right (EMR) over Glivec, the appellant used to charge Rs.120000 per 31

month for a required dosage , which was remarked by the board as too unaffordable to the poor 32

cancer patients in India.  On this observation it notes that granting patent for Glivec will cause ‘public disorder’. The order was praised by many developing nations and tends to get support from article 27(2) which permits members to exclude certain inventions which is necessary to protect public order or morality and to protect human. Another major reported case which attempting patent linkage, which is the practice of linking drug marketing approval to the patent status of the originator’s product and not allowing the grant of marketing approval to any third party prior to the expiration of the patent term, 33

unless consented to by the patent owner,   in India was  Bayer Corporation & Others v. Cipla,

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  supra note 26 at para 19.   The same in case of generic version was Rs.10,000 only. 32   Order No.100/2009 of the IPAB, Chennai.

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Anshul Mittal, “Patent Linkage in India: Current Scenario Scenario and Need for Deliberation” 15 Journal of Intellectual Property Rights 187(2010).

 

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UOI & others . In this case the petitioner Bayer was a corporation which got patent on its renal 35

cancer drug ‘Sorefenib tosylate’   filed a petition to restrain grant of license to Cipla to manufacture, sell and distribute its drug ‘soranib’. The Delhi high court in this case has framed two issues, one on the patent linkage and the other on the generic drugs and spurious drugs. The Court held that the system of patent linkage could not be read into the provisions of the Drugs Act and the Patents Act and such system is undesirable in the Indian Context. The Delhi high court indicated its strong disapproval of Bayer's intention to use the judiciary to sneak in a drug patent linkage mechanism m echanism by b y imposing costs of o f Rs.6.75 lakhs. This cost cos t was awarded to both Cipla and the Union of India and was to be shared equally between them. Bayer Corporation filed a special leave petition before the Supreme Court against the order of the Delhi high court and the same was dismissed by the Supreme Court, taking into account that the Drug Controller General of India had already granted marketing approval to Cipla and the Bayer’s infringement suit was pending before the high court. At a time when India is negotiating Free Trade Agreements (FTA) with several countries, the Supreme Court's observations sends a good signal and could boost the Indian government's position particularly since some regions were pushing for patent-linkage to be included in the FTA. The Supreme Court order also appears to have effectively put a lid on the patent-linkages controversy would have delayed entry of generic versions of medicines in the market, there-by adversely affecting access to medicines.

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As like Bayer, Novartis also filed a petition for special leave to appeal against the order of the IPAB before the Supreme Court37, which was lastly heard on 4 th February 2011 and was posted for final disposal on April 19, 2011. Recently Indian Patent office rejected a patent applications filed by Abbott Lab, a US based company, for the anti-HIV drugs Lopinavir, Ritonavis and Atazanavir. Primarily this application was challenged by Cipla, Matrix and IMAK, 38

that Abbott has a history of pricing this drug much higher in developed countries that it should.   34

  2009(41) PTC 643 (Del).   Bayer sells it for Rs.2,85,000 for one month dosage. dosage. 36   P.T. Jyothi Datta, “Apex Court dismisses Bayer’s appeal in patent linkage case” available at: http://www.thehindubusinessline.com/todays-paper/tp-corporate/article1027483.ece (visited http://www.thehindubusinessline.com/todays-paper/tp-corporate/article1027483.ece (visited on December 1, 2010). 37   SLP(civil) No. 2053920539-20549/2009(Supreme 20549/2009(Supreme Court, Court, India). 35

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available at: http://www.ndtv.com/article/india/india-rejects-us-companys-patent-for-anti-hiv-drugs-78219v (visited on March 21, 2011).  2011). 

 

This decision show how India’s patent law, which prevents routine improvements from being patented, works in favour of public health by only granting patents for drugs that are truly innovative. These decisions also illustrate the need to safeguard India’s role as ‘pharmacy of the developing world’. Abbott is also expected to challenge the patent rejection. Indian patents act contains a number of provisions that allow generic manufacturers to produce affordable medicines, including rigorous standards to ensure that only new medicines are granted a monopoly. Affordable medicines produced in India have played a major role in helping expand 39

AIDS treatment to more than five million people across the developing world.   Natco, India’s first generic drug makers seeks compulsory license to supply medicines to a least developed country, also plays a major role opposing patent applications of Multinational pharmas and applying for grant of compulsory license.

Developed World’s criticism on Doha declaration and Indian Patent system: There are so many criticism coming from the developed fronts that the Doha declaration which permits the compulsory licensing for different reason, as they think of much important, to protect their multi-national pharmaceutical companies. While developing countries have pressed for a broad interpretation of the Doha Declaration, and thus a large list of diseases for which patent rules will be relaxed, drug companies and their respective governments have advocated 40

for a narrow interpretation of the Declaration.  Here we will discuss some of the arguments puts forth by them against the grant of compulsory licensing, particularly against India, who is the top manufacturer and exporter of generic drugs. One of the arguments against the Doha declaration is that it has not served countries most in need of inexpensive medications: least developed countries with high rates of HIV/AIDS. The terms of the Doha Declaration are too broad, allowing countries to issue compulsory licenses for medications that do not treat life-threatening illnesses, such as Viagra and Plavix. Many countries have seen a dramatic drop in Foreign Direct Investment (FDI) as a result of extensive compulsory licensing of patented pharmaceuticals, making least developed countries hesitant to invoke the terms of the Doha Declaration for fear of

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  available at: http://www.msfaccess.org/media-room/press-releases/press-releasedetail/index.html%3ftx_ttnews[tt_news]=1662&cHash=957225c137 (visited on March 21, 2011).  2011).  40  Collen Chien, “Cheap Drugs at what price to innovation does the compulsory licensing of pharmaceuticals hurt innovations” 18 Berkeley Technology Law Jorunal, available available at: http://www.law.berkeley.edu/journals/btlj/articles/vol18/Chien.web.pdf  (visited  (visited on February 20, 2011).

 

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similar losses in FDI.  They started discussing on the effect of compulsory licensing provisions against the inventor of a product in economic aspect, but they failed to consider the health of the globe and how can the poor section of the globe purchase such a high cost medicines to save their lives. When I say high cost medicine, it cannot be denied that the research and the investment made by the inventor should enjoy its benefit, but when the same drug available at low price why can’t the inventor himself provide it at an affordable price, which may bring economic progress for him, instead of selling it in an inflated price. Some of the western scholars went on the check the legal status and the applicability of the Doha declaration. Their argument is that the Doha Declaration captures the middle ground between the positions adopted by developing and developed countries. It embodies commitment to patent protection for the development of new drugs and to availability of these drugs for indigent populations. The fourth paragraph of the Declaration fortifies this middle ground by affirming that the “TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all” This language cast in terms of member’s rights to protect public health introduces an interpretation not expressly provided in the TRIPS Agreement. Hence these rights are not expressly derived from the TRIPS Agreement, but are exercisable in light of 42

contemporary international concern regarding the HIV/AIDS pandemic.   Generally, countries with relatively few patents view the patent system as a means to promote the transfer of technology from other countries. Compulsory licensing provides an important safeguard to 43

ensure that technology transfer happens in the event of non-working or high prices.  The United States has maintained that Doha was a political declaration with no legal authority. The United States Trade Representative's Fact Sheet summarizing the results of the Doha meeting refers to the Doha Declaration on TRIPS and Public Health as a political declaration. From this perspective, the Declaration is not a fait accompli for countries seeking to facilitate access to essential medicines. Rather, it is an implicit reciprocation by the West to developing country governments for their implementation of the TRIPS Agreement and their acquiescence to a new

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  Supra note 11.   James Thou Gaihii, “The Legal Status of the Doha Declaration on TRIPS and Public Health under under the vienna

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convention on the law of treaties,” 15(2) Harvard Journal of Law & Technology 292 (spring, 2002). 43   Supra note 39.

 

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round of WTO talks.  The reason given by the western countries is that encouraging innovation by rewarding innovators will only help to ensure that new and useful inventions are widely produced and the exclusive rights are necessary to incentive research and development of medications. But the authentic reason is that the United States economy relies on profits from innovation. Thus, the United States pushed heavily to pass a system of intellectual property protection that embodied their strong private property rights in patents and ensured its adoption worldwide by linking it to the benefits of the WTO. The TRIPS agreement, as adopted, reflects the broad property rights of the American intellectual property system. In fact, the agreement 45

parallels American law almost exactly   that’s why the western countries oppose the Doha declaration on public health. Further the developed countries, particularly the United States and Switzerland, have argued that the only flexibility in the TRIPS Agreement is the staggered implementation periods developing countries enjoy under the Agreement. Most of these countries have warned the use of compulsory licensing provisions to allow local companies to produce low-cost variants of patented essential medicines can adversely impact the flow of foreign direct investment in the pharmaceutical

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sector   and their primary concentration is only on their economy.

Pharmaceutical Research and Manufacturers of America (PhRMA) is an association which often cautioned the issuance of compulsory licenses only on the reason that the companies which are creating a medicinal product will be denied on their research investment and they will have less incentive to develop new lifesaving treatment options. They also warned that the compulsory licensing provisions may lead to a way to stop research by pharmaceutical manufacturers and the patients will be forced to use old drugs only. Many governments were also warned by the WTO on their decision to allow a generic drug producer to manufacture a lower cost version of patented drug, based on the emergency concepts. From the patent holder's perspective, a consumer who does not pay for the use of his invention has stolen his invention. From a developed nation's perspective, such consumers

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  Supra note 40.   Supra note 11. 46   Joe C Mathew, “Foreign drug firms against compulsory licensing” available at : http://www.business45

standard.com/india/news/foreign-drug-firms-against-compulsory-licensing-provisions/410508/  (visited on March 21, 2011).

 

undermine the governmental authorities of all of the WTO member nations, which guarantee patent rights to inventors. This is true regardless of whether the consumer is a government or a Patient. But all the things are about then developing and least developed nations that have only a little or no pharmaceutical infrastructure and thus do not have the manufacturing capabilities to produce sorely-needed medicines. From a pharmaceutical company's perspective, a life-saving medicine is a more worthy invention than a household device; therefore it should be given more incentives and protections. From a patient's perspective, a life-saving medicine is of foremost importance as well to the opposite conclusion: that the drug should therefore be readily available 47

to all in need.   Well said by the Prime Minister of India Manmohan Singh in his speech that “We have affirmed our commitment to the protection of intellectual property rights. But, the global economy, the global community cannot afford the complete privatization of research, of knowledge generation, especially in fields like medicine. We need to evolve mechanisms that protect intellectual property and at the same time, address the needs of the poor”.48 

Conclusion:  The patent system has the unique feature to encourage research and inventions and induce the inventor to disclose his new invented medicines instead of keeping them a secret. It is undeniable that the inventor’s contributions should be recognized by grant of a reward. But while considering the public health and nutrition, the patented medical products should be available at affordable or we can say reasonable price. Because the generic version of the same drugs are available at very low costs and it is possible for the inventors to sell them at such prices in the least developed countries. India, having large number of people below poverty line, is not in a position to give a complete importance and full protection to the inventors in order to save the life of thousands of poor people. Further in India, the largest medical sector is service oriented under government’s control and for providing good medical facility to the people it needs to spend crores and crores in drugs. The government is also framing policies often to recognize the need to ensure abundant availability of essential quality medicines at reasonable price. Right to health and medical care is one of the basic and well recognized human rights. Indian patent law though not in consonance with the TRIPS agreement in the developed front’s point of view, it 47

  Jaime B. Herren, “TRIPS and Pharm Pharmaceutical aceutical Patents: the Pharmaceutical Industry vs vs.. the World”, 14 Intellectual

Property Law Bulletin 43 (2009-2010).   at Fortune Global Forum, New Delhi in October 30, 2007.

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was very well formulated subject to article 7 and 8 of the agreement after following the standards given in the Doha declaration to provide access to medicine to all. In all, the Indian Patent Act maintains a proper balance between the interest of the inventor of a drug and public health. In addition, my opinion is that the developing and the least developed nations should be given priority in negotiating WTO agreements.

Bibliography Books:

 

Feroz Ali Khan, The Law of Patents- with a special focus on pharmaceuticals in India   716 (Lexis Nexis, New Delhi, 2007).

 

ICRA Industry Watch Series, The Indian Pharmaceutical Industry 25 (ICRA Limited, New Delhi, 1999).

 

Prankrishna Pal(ed.), Intellectual Property Rights in India: General Issues and Implications 95 (Regal Publications, New Delhi, 2008).

 

S.K. Verma and Raman Mittal, Intellectual Property Rights: A Global Vision 121 (Indian Law Institute, New Delhi, 2004).

Articles:

 

“AIDS, Drug Prices and Generic Drugs”, available at: http://www.avert.org/ge http://www.avert.org/generic.htm neric.htm (visited on March 21, 2011).

 

Aileen M. McGill, “Compulsory Licensing of Patented Pharmaceutical s: Why a WTO Administrative Body should determine what constitutes a Public Health crisis under the Doha Declaration”, 10 Wake Forest Intellectual Property Law Journal 73 (2009).

 

Anshul Mittal, “Patent Linkage in India: Current Scenario and Need for Deliberation” 15  Journal of Intellectual Property Rights 187(2010).

 

Carlos M. Correa, “Implications of the Doha Declaration on the TRIPS Agreement and Public Health”, available at:

 

http://www.who.int/medicines/areas/policy/WHO_EDM_PAR_2002.3.pdf (visited on March 21, 2011).  

Collen Chien, “Cheap Drugs at what price to innovation does the compulsory licensing of pharmaceuticals hurt innovations” 18  Berkeley Technology Law Jorunal, available at: http://www.law.berkeley.edu/journals/btlj/articles/vol18/Chien.web.pdf

(visited

on

February 20, 2011).  

Discussion Paper on Compulsory Licensing by Department of Industrial Policy and Promotions(DIPP) available at : http://dipp.nic.in/CL-DraftDiscussion.doc (visited on March 2, 2011).

 

Jaime B. Herren, “TRIPS and Pharmaceutical Patents: the Pharmaceutical Industry vs. the World”, 14 Intellectual Property Law Bulletin 43 (2009-2010).

 

James Thou Gaihii, “The Legal Status of the Doha Declaration on TRIPS and Public Health under the vienna convention on the law of treaties,” 15(2)  Harvard Journal of  Law & Technology 292 (spring, 2002).

 

Joe C Mathew, “Foreign drug firms against compulsory licensing” available at : http://www.business-standard.com/india/news/foreign-drug-firms-against-compulsorylicensing-provisions/410508/ (visited on March 21, 2011).

 

P.T. Jyothi Datta, “Apex Court dismisses Bayer’s appeal in patent linkage case” available at: http://www.thehindubusinessline.com/todays-paper/tp-

corporate/article1027483.ece (visited on December 1, 2010).  

Roger

Bate,

“India

and

the

Drug

Patent

http://www.aei.org/outlook/25566 (visited on March 21, 2011).

Web Sources:

  http://www.dipp.nic.in

•

  http://www.ehow.com

•

http://www.legalservice alserviceindia.com india.com   http://www.leg

•

  http://www.ndtv.com

•

  http://www.patenteducation.com

•

  http://www.wikipedia.org

•

  http://www.wipo.int

•

Wars”,

available

at: