In the recent past, there have been several significant developments in India in the area of using TRIPS flexibilities for promoting access to health products. Several of these involve the Indian Patent Act (2005) especially Section 3(d) that defines the scope of patentability, limiting data protection, providing for government use and compulsory licenses to non-patentees etc. A major concern of several patent offices all over the world in respect of providing access is the growing prevalence of what are known as 'secondary' patents i.e., patents covering various ancillary features of existing medicines. In addition, there are also attempts toward filing numerous patent applications for the same medicine (to create what are called as 'patent clusters' or 'patent thickets', especially by global multinational companies (MNCs). The strategy called evergreening, that refers to patenting strategies to secure sequential and overlapping patents on a single object (qua invention) through trivial changes such as change in size, colour, dosage, delivery mechanism and composition of a patented drug. Broadly, there are two strategies to limit the scope of patentability: i) increase the threshold limit of patentability criteria by providing a definition of patentability criteria, viz. novelty, inventive step and industrial applications; and ii) exclude certain types of inventions, which do not satisfy any one of the patentability criteria, or those inventions which are in conflict with public morality, national security or affecting the health of humans, animals and plants. Section 3 of the Indian Patents Act (1970) lists 15 broad categories of knowledge as not inventions within the meaning of this Act. These include i) new uses of known substances [section 3(d)]; ii) new forms of known substances, without significant enhancement in efficacy [section 3(d)] providing for government use and compulsory licenses to non-patentees. This provision while excluding new forms of known substance, discovery of new property of known substance and new use of known substance, treats salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance as the same substance that do not confer significant enhancement in efficacy [section 3(d)]. The section 3(e) covers what are known as 'mere admixtures'. Other safeguards include the pre-grant opposition where any person may file opposition by way of representation to the Controller against the grant of Patent, at the appropriate office, at any time after publication of patent application u/s 11A, but before the grant of Patent on any of the grounds mentioned in Section 25(1). The potential impact of effective implementation of these initiatives for promoting access to health care with specific reference to India are discussed
Impact of the Amended Indian Patent Act (1970) on Access to Medicines in India
By Sadhana Srivastava*
and Kanikaram Satyanarayana**
Indian Council od Medical Research, Department of Health Research
(Ministry of Health & Family Welfare), New Delhi
It is widely believed that pharmaceutical patents promote monopoly and thus significantly delay the entry of generics. Due to the lack of competition, the prices of medicines rise. The current system of product patent protection due to the harmonized global intellectual property rights laws are widely considered to be a major barrier for the access to medicines, especially in the developing countries.1  Until such a time the poor and middle income countries became signatories to the World Trade Organization’s 1995 Trade Related Intellectual Property Rights (TRIPS) agreement, they had the freedom and flexibility to design patent laws that prohibited product patents.
With the enforcement of the TRIPS agreement in 2005, developing countries have been compelled to modify and introduce TRIPS-compliant national patent laws. The TRIPS Agreement harmonized the life of patent to a minimum of 20 years besides mandating the granting of patents in all fields of technology including food and drugs. The potential adverse impact of the new patent legislation on global public health has been widely studied and reported although some observers feel that the full impact is being felt only in recent years.1  Like, over the past decade, the global focus in this area is largely on India for at least two reasons. Firstly, India is considered to be global pharmacy for providing cheap drugs for diseases like the HIV/AIDS that brought a dramatic reduction of price from over US$ 10000 to about US$ 150. 2  Also, close to 80 percent of drugs for HIV-AIDS to low income countries in Africa are sourced from India 3  Secondly, a new battle is being currently fought in the Indian courts on issue of access to cancer medicines.
Given the legal complexities of the enforcement of the TRIPS agreement, especially in middle income countries, and the critical role countries as India and Brazil play in the manufacture and supply of cheap medicines for their own people and also the needy in other poor countries, legal interpretation of many clauses has been frustratingly slow. Public health and legal scholars have suggested that developing countries might ameliorate the potential negative effects of TRIPS on access to medicines by exploiting TRIPS “flexibilities”3  which provide some room for manoeuvre while designing national patent laws. This is because the TRIPS Agreement provides for considerable discretion on how the obligations are interpreted and implemented by sovereign governments. Yet, several developing countries have faced obstacles when seeking to implement measures to promote access to affordable medicines in view of lack of clarity and/or willingness of developed countries and perhaps the lack of adequate expertise in the interpretation of international law. Thus, developing countries have been constantly seeking clarity about the provisions in the TRIPS Agreement that provide sufficient flexibility and discretion to ensure access to medicines. And in the light of public health beginning with the Doha Declaration which affirmed 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”. 4  TRIPS flexibilities include, for example, the ability to delay entry into TRIPS (developing countries had until 2005, and least developed countries have until 2016) and to grant compulsory licenses, among other provisions. Another flexibility is the scope to define patentability standards. While countries cannot, under article 27.1 of TRIPS, exclude entire fields from patenting, they do have the right to determine standards of patentability.5  This is considered essential due to the continued attempts by multinational companies (MNCs) to seek IP protection and monopoly to prevent the entry of generics. One of the major concerns relates to filing of frivolous patents in developing countries on so-called incremental modifications to drugs. 5 6  Such patenting is sometimes characterized as “evergreening,” since such patents are often filed late in the product life cycle and are used to temporally extend market exclusivity. 6 7  
Significantly, in the pre-TRIPS era due to absence of product patent protection, virtually all the HIV/AIDS programmes in countries like Brazil and Thailand were successfully run as several key pharmaceuticals could be produced locally at much lower costs. 8  These include the so called ‘1st line’ drugs, that are used when patients first begin AIDS treatment. The production of anti HIV drugs (antiretrovirals-ARVs) in Brazil also created a large market for ARV active pharmaceutical ingredients (API), making it possible for the Indian pharma companies to produce ARVs in large volumes. 9  The resulting scale of manufacture dramatically brought down the prices. In fact most of the currently affordable ARVs come from India. Like by 2008, an estimated 3 million people in low and middle income countries received ARV therapy for HIV/AIDS of which as much as 60% originated from India. 10  What is more, 70% of the medicines for AIDS purchased by the United Nations Children’s Fund (UNICEF), International Dispensary Association (IDA), the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) and the Clinton Foundation supplied to over 80 developing countries came from Indian suppliers. Similar is the case with purchases by the MSF and the US President’s Emergency Plan for AIDS Relief (PEPFAR).These efforts meant cost-savings of up to 90%. 11  As many as 91% of all the generic ARVs manufactured in India were in US Food and Drug Administration (US FDA) approved facilities in India.12  Significantly, as stated above these medicines could be brought in to the market in the pre-TRIPS era as they were not under product patent regime.
While the developing world is grappling with the issue of access to Types II and III diseases, there is a steady rise of non-communicable diseases (NCDs) like heart disease, stroke, diabetes and cancers in the middle income and poor countries. 13  14  In the next two decades a dramatic change on health needs of poor and middle income countries is anticipated. At present, lifestyle and behaviour are linked to 20-25% of the global burden of disease. In the developing countries, where four-fifths of the planet’s people live, NCDs such as cancers, heart disease, diabetes and mental health problems will replace the traditional public health problems such as infectious diseases and malnutrition, as the leading causes of disability and premature death. Also, by 2020, NCDs are expected to account for seven out of every ten deaths in the developing regions, compared with less than half today. 14  This is going to put the health care system of developing and least developed countries under more strain due to increased cost of medicines.
In the light of the dual disease burden, one of the most pragmatic solutions available for developing countries, including India, is to make prudent use of the flexibilities available in TRIPS. But it is also equally important that these TRIPS flexibilities are incorporated into domestic patent laws. This requires clear understanding of the TRIPS obligations and the techno-legal expertise to translate the flexibilities into the domestic patent law. For India it is important that the vibrant and dynamic domestic generic industry built over the last three decades is allowed to play its critical role for providing cheap medicines. 15 
Important Sections of Amended Patent Act
India has modified its Patent Act (1970) through three amendments in the years 1999, 2002 and 2005. The main objectives of these amendments are to ensure that the changes made are TRIPS-complaint and at the same time as many safeguards as possible are built-in to protect the interest of public health. Some main components of modified Indian patent law that address the above include i) scope of patentability [Sections 3(d)] and 3[e], ii) limiting data protection, providing for government use; iii) and compulsory licenses (Section 84) to non-patentees.
Section 3(d) of India’s Amended Patents Act of 2005 aims at reducing the scope of taking patent protection on grounds of new use of known compounds without establishment of significant enhanced efficacy: “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 or new use for a known substance or 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.” Section 3(d) specifically states that for the patenting purposes, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.16 
Section 3 of the Indian Patents Act, 1970 lists 15 broad categories of knowledge as ‘not inventions’ within the meaning of this Act particularly relevant in the pharmaceutical context. The Section 3(d) also aims to address the issue of evergreening, a strategy through which companies aim at securing sequential and overlapping patents on a single invention through trivial changes or ‘improvements’. It may involve changes in size, colour, dosage, delivery mechanism and composition. A particular salt form of a drug may establish improvements along a number of important parameters, including bioavailability, stability, ease of manufacture, and other solid-state properties.17  While these improvements may be useful, they may not necessarily be particularly inventive falling short of the criteria of patenting. Like there are a limited number of known acids employed by pharma companies to produce pharmaceutically acceptable salts through well known processes. These therefore cannot fulfil the criteria of patentability. Some other common practices include the discovery that a previously known compound in another stereoisomeric configuration (e.g., as enantiomers) may be more biologically active. Or it could even be a more pharmaceutically active metabolite of a known compound. There have been several cases where applications have been filed with claimed improvement in physiochemical and pharmacokinetical properties like better solubility and improved plasma stability etc. Sometimes a claimed ‘new drug’ may not be new at all like the active substance in the ARV drug zidovudine (AZT) that is known since the 1960s investigated as an anti-cancer drug. 18  In fact over 75% of the patented drugs were reportedly modifications of known substances, with a study concluding that only 15% of drugs approved by the US Food and Drug Authority during 1989 and 2000 can be considered âhighly innovativeâ. 19  The Glivec case is a more recent and appropriate example on the issue of legal interpretation of Section 3(d).
An Indian application “Crystal modification of A N-phenyl-2 Pyrimidineamine derivative, processes for its manufactures and its use” was filed by Novartis on July 17, 1998. (1602/MAS/1998). Glivec (Imatinib mesylate) is a patented product by Novartis for Chronic Myeloid Leukemia in 35 countries. Various generic pharmaceutical companies including Ranbaxy, Cipla, Natco Pharma and one patients group - the Cancer Patient Aid Association (CPAA) filed a pre-grant opposition to this Indian application under the provisions of section 25 (1) (e) & (g) of the Indian Patents (Amendment) Act 2005. The Chennai patent Office rejected the Glivec patent application in January 2006, on the grounds that the application claimed ‘only a new form of a known substance’. This Indian patent application is directed to the beta-crystal form of methanesulphonic acid salt, commercially called Imatinib Mesylate. Two polymorphs of imatinib mesylate are claimed: alpha and beta (Original molecule imatinib is disclosed in US 5521184 titled “Pyrimidine derivatives and processes for the preparation thereof” in 1993). The patent office rejected patent application because the invention claimed only a new form of a known substance without making any significant improvements in efficacy, and hence constituted non-patentable subject matter.
Novartis appealed against the decision of the Chennai Patent Office before the Madras High Court. In addition to appealing against the rejection of the patent, Novartis also challenged the very validity of section 3(d), claiming that the provisions of the section are not consistent with India’s obligations under the TRIPS Agreement and therefore unconstitutional. The Madras High Court dismissed the appeal of Novartis challenge on all counts. The Court clearly distinguished between ‘efficacy’ as ‘therapeutic efficacy,’ and between drug’s ‘potency,’ indicating that a very high threshold would have to met before the ‘efficacy’ requirement is fulfilled under section 3(d). However, the Madras High Court decided only on the matter of section 3(d)’s validity and not the Chennai Patent Office’s rejection of its patent application. Subsequently, during the pendency of the appeal, the Indian Patent Appellate Board (IPAB) which has exclusive jurisdiction to hear appeals against decisions of all Indian patent office decisions was notified and created. The IPAB endorsed the Madras High Court’s interpretation of the meaning of ‘efficacy,’ and made a clear distinction between “advantageous properties” and “therapeutic efficacy”. The IPAB specifically excluded improved bio-availability; better stability; improved flow properties; and lower hygroscopicity from the “advantageous properties”. In 2009, Novartis appealed to the Supreme Court. On 1st April, 2013, the Supreme Court rejected the Glivec patent. 20 
From the above it becomes clear that i) the legislative intent of Parliament in enacting section 3(d) was to protect public health and prevent ever-greening was recognized; ii) Indian patent offices must recognize that “pharmaceutical product [patents] in India should be granted with utmost care and should be granted only to very genuine cases;” iii) while interpreting the meaning of ‘efficacy,’ extremely high standard have to be applied; iv) an ‘advantageous property’ is not the same as efficacy in that ‘new forms’ that result in advantageous properties with respect to bioavailability, stability, etc., are not patentable; and v) ‘mere admixtures,’ compositions, dosage forms, formulations, and combinations are not patentable unless there is a demonstrable synergistic effect between the components. 21 
Section 25(1)- Pre-Grant Opposition
Pre-grant opposition is another unique safeguard to promote accessibility and affordability through preventing of granting patents to inventions that do not fulfil the criteria of patenting by way of representation to the Controller at any time after publication of patent application but before the grant of patent. There are 11 grounds under Section 25(1) under which an application can be challenged. There are at least 10 instances where, using this provision, patents filed have been challenged in India.
Some of these include: 22 
Darunavir (Tibotec v Cipla) Polymorph 3598/DELNP/2004 Section 3(d). In the matter of Application for patent no 3598/ DELNP/ 2004, Delhi Patent Office, 6 July 2009.
Adefovir dipivoxil (Gilead v Ranbaxy) Crystal Form 712/DEL/2002 on the basis of 3(d) In the matter of Patent application no. 712/del/2002 filed on 03/07/2002, Delhi Patent Office, 18 March 2009
Amlodipine-atorvastatin combination (Pfizer v Torrent) 2571/DEL/1998 Section (3d and 3e). In the matter of the application for Patent No. 2571/del/1998 filed on 28th Aug. 1998, Delhi Patent Office, 3 February 2009.
Rosiglitazone (Smithkline Beecham) Sulphonate Salt 295/DELNP/2003 on the basis of 3(d) Patent Application No.00295/DELNP/2003 - Hearing U/S 14 read with 15 of the Patents Act, 1970, Delhi Patent Office, 6 January 2009.
Erlotinib polymorph (OSI v Cipla) Crystal Form IN/PCT/2002/507/DEL. Section 3(d) In the matter the application for patent No. IN/PCT/2002/507/DEL filed on 14th May,2002, Delhi Patent Office, 15 December 2008.
Crystalline Macrolides (Novarts v Ranbaxy) Crystal Form 1440/MAS/1998. Section (3d) In the matter of Application for Patent bearing the number as 1440/MAS/1998 filed on 29th June 1998 by Novertis AG of Schwarzwaldallee 215, 4058 Basel, Switzerland,, A Swiss Company, Chennai Patent Office, 13 July 2007.
Atorvastatin (Warner-Lamber v Torrent) Crystal Form 1577/DEL/1996 Section (3d) In the matter of the Application for patent No.1577 /DEL/1996 filed on 19th April, 1998, Delhi Patent Office, 12 June 2007.
All these cases of pre-grant opposition were successful as the applicants failed to fulfil the conditions required under section 3(d), 3(e) and section 2(1.j) of the Patent Act. The main objective of such opposition is to improve the quality of patents or to prevent frivolous and unworthy patents from being granted. The rejection of these patent applications is considered a big step in towards ensuring access to cheap life-saving drugs.
Section 84(1) and 92 A (1)- Compulsory Licensing
Compulsory Licensing (CL) is a procedure whereby a Government can allow any company, agency or designated person the right to make a patented product, or use a patented process under licence, without the consent of the original patent holder. CL is an important legal tool to promote competition to increase the affordability of drugs at once compensating the patent owner for the use of the invention. Section 84 of the Amended Indian Patents Act (2005) deals with compulsory licenses and allows any interested person to apply for a CL but only after the patentee rejects the request of applicant for issuance of a voluntary license. The Indian Patent Law provides sufficient powers to the Controller of Patents to issue compulsory licenses to deal situations that warrant intervention. Two sections directly address the requirement of essential drugs for domestic use and countries which do not have the manufacturing capacity for these drugs. Section 84 mandates prevent the abuse of patent as a monopoly and facilitate manufacturing of invention by any interested person. Sections 92 (1) and 92 (3) lay down circumstances of national emergency or extreme urgency while Section 92(a) is meant for exporting pharmaceutical products to other countries that need such products for public health purpose. The grounds broadly could be: i) reasonable requirements of the public with reference to patented invention are not met; ii) the patented invention was not available to public at an affordable price; and iii) patent is not worked in the territory of India to the fullest extent that is reasonably practicable. Generally, such a license can be applied after three years of the grant of a patent: “At any time after the expiration of three years from the date of the grant a patent, any person interested may make application to the Controller for grant of compulsory license.” In addition, a ‘reasonable time period’ of up to six months has been introduced, before the Controller considers request for grant of a compulsory license in cases where the applicant fails to obtain a licence from the patentee on reasonable terms and conditions. 23
First Compulsory License by the Indian Patent Office was granted for Nexavar
‘Sorafenib Tosylate’ is a compound patented by Bayer Corporation, USA and marketed as Nexavar. The drug is life-extending drug used in the treatment of advanced stages of kidney cancer (Renal Cell Carcinoma) and liver cancer (Hepatocellular carcinoma). Sorafenib can extend the life of kidney cancer patients by 4-5 years and in liver cancer patients by 6-8 months. 24  Bayer was granted a patent (No. 215758) as well as regulatory approval for importing and marketing the Drug in India in the year 2008. Bayer charges approximately US$66,812 per patient per year/ over US$5,500 per month in India for this drug.25 
M/s Natco Pharma (Natco) tried for voluntary licence to manufacture and sell its generic version of drug in December 2010 for Nexavar from Bayer but the company rejected Natco’s proposal, saying it needed to reinvest its earnings from such patented products for future R&D. 26  After the lapse of 3 years since the date of grant of patent to Bayer Corp. for Nexavar, Natco filed an application in July 2011 before the Controller of Patents for grant of Compulsory License under section 84 in respect of Sorafenib.25 
The grounds on which the appeal was made were: i) reasonable requirements of the public with reference to the patented invention have not been met; ii) patented invention was not available to public at an affordable price; and iii) patent has not been worked in the territory of India to the fullest extent that is reasonably practicable. Also M/s Bayer charged for Rs. 2.85 lakhs for a one month’s course of the medicine while Natco proposed to sell its generic version, sorafenib tosylate, for about Rs. 8,800, which is a about 3 percent of the cost of the innovatorâs product. 27 
In a landmark decision the Indian Patent office on 9th March 2012 granted the country’s first compulsory license. The CL allowed Natco Pharma Ltd, an Indian generic drug maker to make and sell generic version of liver/kidney cancer drug Nexavar patented by M/s Bayer Corporation. The order of patent controller is significant because this is the first time India had invoked the compulsory licensing provision to increase citizensâ access to expensive, life-saving drugs. Itâs also the first time that an Indian company has been granted compulsory license to market a generic version of a patented drug. 27 
The CL is valid till the expiry of the patent i.e. up to 2021. The company has to fulfil certain conditions like maintaining account of sales, and payment of royalty at 6% of the net sales on a quarterly basis. The order also makes it mandatory for Natco to supply the drug free of cost to at least 600 needy and deserving patients per year. 28  Bayer appealed against this order to the Intellectual Property Appellate Board (“IPAB”). The IPAB held that the failure to meet the demand of the public on reasonable terms has to include both “quantity” and “price” i.e. the patentee has to work the invention in India on a commercial scale and the invention has to be available at a reasonably affordable price. 25 
In the recent past, the Indian Patent Act (2005), has been put to test with several sections challenged in the Indian Courts. The decisions of the courts have provided clarity on the interpretation in the decisions taken by the Patent Controller that comply with India’s obligations under the TRIPS agreements. This clarity should help India to make use of the safeguards available to limit the impact of the patent barriers towards promoting affordable health care. The uninterrupted supply of generic drugs from India has played a key role in lowering the price of essential drugs for poor both in India as well as many developing countries. It is also hoped that discussions as these will facilitate formulation of a cohesive policy. The significant participation of the civil society groups in the ongoing battle has been very important and such a pressure must be maintained. A robust legally enforceable mechanism is important as with time the effectiveness of CL is likely to be blunted and it is only competition among generic suppliers that would help India keep the supply channels of cheap medicines to poor countries open. 12 
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*Dr Sadhana Srivastava, a qualified patent agent was an intern at the Cornell University and Office of Technology Transfer, NIH, Bethesda. She was a Government delegate in the Inter-Governmental Working Group on Intellectual Property & Public Health, WHO, Geneva. Dr Srivastava is a senior scientist with the Indian Council of Medical Research, New Delhi looking after the IPR activities of the Indian Council of Medical Research.
**Dr Kanikaram Satyanarayana has been instrumental in the formulation of the guidelines and policies for IPR and technology transfer of the Indian Council of Medical Research, Govt of India. He advises the Ministry of Health & Family Welfare, Government of India on IPR, health and trade issues and also served as a temporary adviser for the Inter-Governmental Working Group on Public Health and Innovation (IGWG) for the WHO, Geneva and also the SEAR (WHO) for Consultative Expert Working Group (CEWG) meetings. He was a member of the International Editorial Board for the Technology Transfer Manual on Agriculture and Health of the MIHR, UK and founder-Secretary of the Society for Technology Management (STEM), India. Dr Satyanarayana is currently Co-ordinator in the Department of Health Research, New Delhi.