{"id":57993,"date":"2023-07-01T10:00:00","date_gmt":"2023-07-01T04:30:00","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=57993"},"modified":"2023-06-09T18:02:05","modified_gmt":"2023-06-09T12:32:05","slug":"pharmaceutical-patenting-in-india-problem-of-public-access-to-health","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/pharmaceutical-patenting-in-india-problem-of-public-access-to-health\/","title":{"rendered":"Pharmaceutical patenting in India-problem of Public Access to Health"},"content":{"rendered":"\n<p>Patents have played a significant\nrole in transforming the innovation landscape both nationally and globally.\nThey are intellectual property owned by individuals, companies, or even\ngovernments. Despite the importance of IPR, the current IPR culture in India\nneeds to be improved. It requires more interest, knowledge, and practical\nstrategies to encourage and promote scientific and industrial research and innovation\nin the country.<\/p>\n\n\n\n<p>For a long time, India has been a leader among developing countries in trying to modify pharmaceutical patent law to meet the health needs of its people, with a focus on the common person and in line with its development goals. India is facing a healthcare crisis with inadequate accessibility, affordability, and availability of healthcare services. A large part of its population lives below the poverty line, and healthcare expenses are not covered by insurance.<\/p>\n\n\n\n<p>The Indian patent law has a unique\nprovision called Section 3(d), which strikes a balance between the requirements\nof the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement\nand the protection of access to medicine for people experiencing poverty,\nmaking India a leader in the pharmaceutical industry. The issue of access to\nmedicines has become a global concern since India is a signatory to the Doha\nDeclaration on TRIPS Agreement and Public Health, 2001, and its pharmaceutical\ncompanies are important suppliers of low-priced generic drugs. India has been leading the global movement for access to medicines\nwith a thriving pharmaceutical industry that is growing in its exports, backed\nby the advocacy of civil society.<\/p>\n\n\n\n<p>The recent decisions on patent law, including the Novartis case, by India&#8217;s Supreme Court indicate that India continues to prioritize public health in its pharmaceutical patent law decisions. Pharmaceutical patenting patents restrict generic competition, increase prices, and are believed to be a significant obstacle to medicine accessibility in developing countries.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">Page Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/pharmaceutical-patenting-in-india-problem-of-public-access-to-health\/#Intellectual_Property_Rights_IPR_in_India\" >Intellectual Property Rights (IPR) in India<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/pharmaceutical-patenting-in-india-problem-of-public-access-to-health\/#What_is_Pharmaceutical_Patenting\" >What is Pharmaceutical Patenting?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/pharmaceutical-patenting-in-india-problem-of-public-access-to-health\/#Patent_Law_and_Pharmaceutical_Patenting_in_India\" >Patent Law and Pharmaceutical Patenting in India<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/pharmaceutical-patenting-in-india-problem-of-public-access-to-health\/#Why_and_how_do_Pharmaceutical_Patents_cause_Problems_in_Public_Access_to_Health\" >Why and how do Pharmaceutical Patents cause Problems in\nPublic Access to Health?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/pharmaceutical-patenting-in-india-problem-of-public-access-to-health\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Intellectual_Property_Rights_IPR_in_India\"><\/span>Intellectual Property Rights (IPR) in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><a href=\"https:\/\/corpbiz.io\/learning\/basics-of-intellectual-property-rights\/\"><strong>Intellectual Property Rights<\/strong><\/a> (IPR) have become a critical element in modern business and commerce. IPR protects the rights of individuals and companies over their creations of the mind, giving them an exclusive right to use their intellectual property for a certain period of time. IP is a valuable asset of a company, and it encourages healthy competition in the market, enabling manufacturers, traders, and owners to develop their products more efficiently.<\/p>\n\n\n\n<p>The output of human intelligence,\ncommonly known as intellectual property, can be protected by exclusive rights\nthat allow its owner to profit from their intellectual work by having a\nmonopoly over it. However, this benefit is only sometimes a natural right but\nrequires recognition by a statute.<\/p>\n\n\n\n<p>The different types of Intellectual property include inventions, literary and artistic works, designs, symbols, names, and images used in business and commerce. The various Intellectual property Acts in India include The Copyright Act, 1957 , <strong>The Patents Act, 1970<\/strong><sup><a href=\"https:\/\/ipindia.gov.in\/writereaddata\/Portal\/IPOAct\/1_31_1_patent-act-1970-11march2015.pdf\"><strong>[1]<\/strong><\/a><\/sup>, The Trademarks Act 1999, The Geographical Indications of Goods Act, 1999, The Designs Act, 1999, Semi-Conductor IC Layout Designs Act, 2000, The Protection of Plant Varieties and Farmers&#8217; Rights Act, 2001, and The Biological Diversity Act, 2002.<\/p>\n\n\n\n<p>IPR plays a crucial role in modern\nbusiness and commerce, as it helps to protect the rights of individuals and\ncompanies and provides an incentive to create and innovate. The various types\nof IPR laws ensure that creators have the legal right to their intellectual\nproperty and that they can benefit from it. These laws also encourage\ncompetition and innovation, which ultimately drives economic growth and\ndevelopment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_Pharmaceutical_Patenting\"><\/span>What is Pharmaceutical Patenting?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A <strong><a href=\"https:\/\/corpbiz.io\/patent-registration\">patent<\/a><\/strong> is a special privilege awarded for a product or procedure that presents a novel method of doing something or offers a new technical resolution to a predicament. To acquire a patent, the technical details of the invention must be made public via a patent application.<\/p>\n\n\n\n<p>A patent gives the owner exclusive\nrights to prevent others from exploiting the patented technology, including\nmaking, using or selling it. It allows the owner to recover the costs\nassociated with developing the technology and to obtain a return on their\ninvestment.<\/p>\n\n\n\n<p>When a pharmaceutical company\ndevelops a new drug for a specific illness, it is initially marketed under a\nbrand name which doctors can use to prescribe the medicine to their patients.<\/p>\n\n\n\n<p>Pharmaceutical patenting is the process of obtaining legal protection for a new drug or medicine. It is a type of patent granted to pharmaceutical companies for their innovative research in developing new drugs or medicines. Pharmaceutical patenting provides the company with the exclusive right to manufacture, sell and distribute the drug for a certain period of time, usually 20 years from the date of filing the patent application. During this period, no other company can produce or sell the same drug without the patent holder&#8217;s permission.<\/p>\n\n\n\n<p>Pharmaceutical patenting is crucial for the pharmaceutical industry as it provides a financial incentive for companies to invest in research and development of new drugs. The patent enables companies to recoup the costs associated with research and development and to generate profits from their investment. The patent system also encourages innovation by protecting the intellectual property rights of companies that make significant contributions to the field of medicine.<\/p>\n\n\n\n<p>Once the patent expires, other\ncompanies can produce and sell generic versions of the drug, which are usually\ncheaper than the branded drug. It promotes competition in the market and can\nlead to lower prices for consumers. However, generic drugs must meet the same\nquality and safety standards as the branded drug. They must have the same\nactive ingredients, dosage form, strength, and route of administration as the\noriginal drug.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Patent_Law_and_Pharmaceutical_Patenting_in_India\"><\/span>Patent Law and Pharmaceutical Patenting in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Indian pharmaceutical industry\nhas a robust genetic base with over 60,000 generic brands in 60 categories. The\nindustry&#8217;s growth was due to the absence of patent laws in the 1950s, allowing\nit to rely heavily on imports. It led to the development of a solid domestic\npharmaceutical industry globally recognized for producing high-quality,\ncost-effective medicines. The industry exports over $1 billion annually, and\nthis success is attributed to the lack of a drug patent system in the past.<\/p>\n\n\n\n<p>The Law of Patents in India is\ngoverned by the Patents Act of 1970, which was amended in 2005 to comply with\nthe World Trade Organization&#8217;s Agreement on Trade-Related Aspects of\nIntellectual Property Rights (TRIPS). The Act provides for the grant of patents\nfor new inventions, including products and processes, that are capable of\nindustrial application. Inventions related to drugs, medicines, and chemicals\nare also eligible for patent protection under the Act.<\/p>\n\n\n\n<p><strong>Section 3(d)<\/strong> of the Patent Law states that a substance is not patentable\nunless it is a new form of a known substance that improves its efficacy or it\nhas a new property or method of using it. However, a known machine, device or\nprocess can be considered patentable under this section if no new product\nresult is obtained or at least one new reactant is not introduced into the\nprocess. Many countries follow technical research guidelines and comply with\nthe provisions of Section 3(d), which have been approved by the World Health\nOrganization&#8217;s 2006 Report on Public Health.<\/p>\n\n\n\n<p>However, the Act places certain\nrestrictions on the patentability of such inventions, including limitations on\nthe patenting of new forms of known substances, new uses of known substances,\nand methods of treatment. The Act also provides for compulsory licensing, which\nallows a third party to produce a patented product or use a patented process\nwithout the patent holder&#8217;s consent under certain circumstances. The Act also\ncontains provisions for the revocation and surrender of patents and for the\nfiling and examination of patent applications. The Indian Patent Office is\nresponsible for administering the Act and granting patents in India. There are\nother laws that govern aspects of pharmaceutical patenting, such as the Indian\nFDA&#8217;s approval process for new drugs and the Competition Act, which regulates\nanti-competitive practices related to patents.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Why_and_how_do_Pharmaceutical_Patents_cause_Problems_in_Public_Access_to_Health\"><\/span>Why and how do Pharmaceutical Patents cause Problems in\nPublic Access to Health?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Indian pharmaceutical industry\nis a significant player in the global market, ranking fourth in production\nvolume and comprising many pharmaceutical companies. However, there are\ndiffering perspectives on the industry&#8217;s impact on access to essential\nmedicines both inside and outside the country. While patents are necessary for\nstimulating innovation, the patent system can be complicated, and\npharmaceutical companies often abuse their monopoly power by charging\nunreasonably high prices for patented drugs. Product patents have reduced the\navailability of drugs, and a large number of generic medicines, including\nvaccines, are being patented in India, making it difficult for the industry to\nproduce life-saving drugs.<\/p>\n\n\n\n<p>The exorbitant pricing of drugs\nblocks access for ordinary people, particularly in a country like India, where\na large percentage of the population lives below the poverty line and\nhealthcare costs are excessive. It creates a significant medical-care\nemergency, highlighting the inadequacy of healthcare and the lack of\naffordability, availability, and accessibility of drugs in India. It is a\ncrucial challenge for the Indian government, which has taken several\ninitiatives to address the situation, such as compulsory licensing and parallel\ntrade policies. These alternative ways help developing country governments make\nessential medicines more affordable to their citizens by reducing prices\nthrough competition in the market for the patented good.<\/p>\n\n\n\n<p>To sum up, the Indian  Pharmaceutical patenting plays a vital role in producing essential medicines, but the patent system often creates barriers to access. The high cost of drugs blocks access for ordinary people, creating a healthcare emergency, particularly for those living below the poverty line. The Indian government has implemented various policies, such as compulsory licensing and parallel trade, to address this challenge and make essential medicines more affordable and accessible to all.<\/p>\n\n\n\n<p>The first benefit of this approach\nis that it offers an organizational structure for various pro-health measures\nin patent laws, which can encourage the implementation of these provisions in\ncountries that lack them. Secondly, it raises the issue of conflicting\ninterests between patent holders and consumers. For instance, in 1998, 4016\npharmaceutical companies contested against the South African government,\nclaiming that the revisions made to the Narcotics and Related Substances\nControl Act 17 violated their constitutional rights. The revised law, which\nincludes general alternatives to unpatented drugs, pricing transparency, and\nparallel imports of patented medicines, provides a legal framework for\naffordable medicines.<\/p>\n\n\n\n<p>It would have been interesting to\nsee how the court would have balanced the patentees&#8217; property rights against\ntheir healthcare rights if the case had gone to trial. The state is constitutionally\nobligated to take reasonable measures to realize citizens&#8217; right to health\nwithin its resources progressively. However, this issue remains unresolved as\nthe case was withdrawn before trial.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Indian healthcare system is failing to provide basic healthcare to the majority of its population, resulting in a gross violation of fundamental rights. The Indian patent law strikes a balance between the interests of common people and inventors. India&#8217;s implementation of the product patent regime allows for a diverse array of pharmaceutical products to be patented. Still, researchers must carefully consider patentability criteria before applying for a patent. Patented rights can be transferred through assignment or licensing, and organizations without manufacturing or marketing capacities can use patents for technology transfer. Compulsory licensing can provide an opportunity to market patented products under certain conditions. However, the monetary interests of big players in the drug industry threaten access to life-saving drugs at moderate prices in India. Innovation and patents are two sides of the same coin, and patents should not only serve to amass profits but also to serve humanity, particularly in the field of medicine.<\/p>\n\n\n\n<p class=\"text-left\"><b>Read Our Article<\/b>: <mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/patent-protection-for-drug-industry-in-india\/\">A Note On The Patent Protection For Drug Industry In India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Patents have played a significant role in transforming the innovation landscape both nationally and globally. They are intellectual property owned by individuals, companies, or even governments. Despite the importance of IPR, the current IPR culture in India needs to be improved. It requires more interest, knowledge, and practical strategies to encourage and promote scientific and [&hellip;]<\/p>\n","protected":false},"author":74,"featured_media":58107,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[282],"tags":[3765],"acf":{"service_id":"20"},"authorName":"Maithli Jha","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2023\/05\/MicrosoftTeams-image-1-22.jpg","authorDescription":"Maithli is a final-year law student at Guru Gobind Singh Indraprastha University (GGSIPU) with a keen interest in emerging legal fields. She is committed to constantly learning and utilizing her theoretical knowledge in practical ways within the field of law.","postViews":2514,"readingTime":7,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/57993"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/74"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=57993"}],"version-history":[{"count":10,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/57993\/revisions"}],"predecessor-version":[{"id":58106,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/57993\/revisions\/58106"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/58107"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=57993"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=57993"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=57993"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}