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TWN
Info Service on Health Issues (Jul23/05) India’s Rejection of Drug Patent Term Extension in FTAs Will Promote Access By Chetali Rao and K M Gopakumar If media reports are accurate about the Indian Government’s stand to not go ahead with certain harmful intellectual property (IP) provisions in the Free Trade Agreements (FTAs) with the European Union and the United Kingdom, India has yet again upheld its position on those provisions that are detrimental to ensure access to affordable medicines. In recent times, many FTAs contain provisions which go much beyond the obligations of the Trade-related Aspects of Intellectual Property Rights (TRIPS) Agreement administered by the World Trade Organization, also known as the ‘TRIPS Plus’ provisions. Patent Term Extension (PTE) and Data Exclusivity (DE) find a place in almost all FTAs. FTA draft texts from developed countries especially the United States, EU, UK, and European Free Trade Association (EFTA, comprising Iceland, Liechtenstein, Norway and Switzerland) contain DE and PTE along with many other TRIPS Plus provisions related to the scope of patentability, enforcement of patent etc. It is a well-known fact that being a WTO member, India was required to amend or enact its patent laws to conform to the TRIPS Agreement. While enacting the Indian Patent Act, the Indian lawmakers incorporated some flexibilities in the TRIPS Agreement to mitigate its impact on pharmaceutical patents. These were mostly implemented to balance India’s public health concerns and dependency on its domestic generic industry to improve the affordability of medicines for the world’s poor population. The law and policy makers were conscious that mirroring the US patent system would not only limit India’s ability to supply affordable medicines both domestically and globally, but also jeopardize the interests of the generic industry and allow global pharmaceutical profiteering. Provisions like PTE that are present in the US patent system disproportionately favour the innovator pharmaceutical firms. PTE shrouds the date of patent expiration and creates legal uncertainty the launch of generic products into the market. This impedes competition and acts as a deterrent for an innovative pharmaceutical environment. Generic drug introduction plays a pivotal role in curbing rising pharmaceutical costs and increasing cost savings by considerably decreasing the price of originator drugs. India is currently negotiating FTAs with many countries including Australia, the EU, and the UK. The EU-India FTA intellectual property Chapter is available in the public domain and Chapter X.33 states: Extension of the period of protection conferred by a patent on medicinal products 1. The Parties recognise that medicinal products protected by a patent in their respective territory may be subject to an administrative authorisation procedure before being put on their market. They recognise that the period that elapses between the filing of the application for a patent and the first authorisation to place the product on their respective market, as defined for that purpose by the relevant legislation, may shorten the period of effective protection under the patent. 2. Each Party shall provide for further protection for a medicinal product which is protected by a patent and which has been subject to an administrative authorisation procedure, for a period being equal to the period referred to in the second sentence of paragraph 1, reduced by a period of 5 years. 3. Notwithstanding paragraph 2, the duration of the further period of protection may not exceed 5 years. 4. For the purposes of this Title, "medicinal product" means: (a) any substance or combination of substances presented as having properties for treating or preventing disease in human beings or animals; or (b) any substance or combination of substances which may be used in or administered to human beings or animals either with a view to restoring, correcting, or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. A leaked version of IP Chapter of the UK-India FTA text also reveals the proposal for patent term extension. Article E.12 of the leaked text reads: Extension of the Duration of Rights Conferred by a Patent 1. The Parties recognise that pharmaceutical products and plant protection products protected by a patent in their respective territories may be subject to a marketing approval procedure before being put on their respective markets. 2. Each Party shall provide an adequate and effective mechanism to compensate the patent owner for the reduction in the effective patent term resulting from that marketing approval procedure, through either: a. a period of additional sui generis protection conferring the rights conferred by the patent; or b. an extension of the patent term. 3. In implementing paragraph 2, a Party may provide for conditions, limitations, waivers, and exceptions provided that the Party continues to give effect to this Article. The following example of breast cancer drug Palbociclib shows how PTE can affect the price and compromises access. Curious Case of Palbociclib in India Pfizer’s blockbuster drug Palbociclib (‘Ibrance’) is used for the treatment of Hormone Receptor-positive (HR+), Human Epidermal growth factor Receptor 2-negative known as HER2-advanced or metastatic breast cancer. The patent term of this medicine in India ended in early January 2023. Palbociclib generated around USD 5.12 billion in global sales in 2022, making it Pfizer’s top selling drug in the oncology segment. Since the patent expiry several generic competitors have introduced generic versions of Palbociclib in the Indian market. The entry of generic players has reduced the price to almost 90% less than that of Pfizer’s drug Rs 95000 (USD 1157) per month. The cheapest generic is now available at a cost of less than Rs 4500 (USD 54.84) per month. The steep decline in the price has made the drug much more affordable and has enabled access for thousands of needy breast cancer patients in India. While Indian patients will now be able to access the drug at very cheap prices, their US counterparts will still be paying exorbitant prices for the same drug, courtesy of a PTE granted by the US Patent and Trademark Office (USPTO). Pfizer’s original Palbociclib patent was set to expire this year (2023), but the USPTO granted a Patent Term Extension Certificate (PTEC). The certificate extends the term of the US Patent No. RE47739 by more than four years until 5 March 2027. The PTE was granted under the Drug Price and Patent Term Restoration Act, 1984. In addition, Pfizer is seeking to block generic versions of Palbociclib from entering the US market until 2027. In March 2019, several generic companies notified Pfizer that they had filed abbreviated new drug applications (ANDA) with the Food and Drug Administration (FDA) seeking approval to market generic versions of Palbociclib. Under Paragraph IV on Patent Certifications, a company can seek FDA approval to market a generic drug before the expiration of patents related to the branded medicine. In November 2020, Pfizer filed patent infringement petitions in the US District Court of Delaware, enjoining Aurobindo and Dr. Reddy's from commercial manufacture, use, sale, offer for sale, or importation of the ANDA products, or any other drug product covered by its US patent, prior to expiration of that patent, including any extensions. This case of PTE granted to Pfizer clearly underscores the detrimental effect such provisions can have on the affordability and accessibility of drugs, which ultimately affects the patients and can have serious negative impact on health outcomes. PTE and Access: More Examples Not only Palbociclib, but several critical drugs have also been provided PTEs by the USPTO. The box below lists some of the key drugs that have obtained PTEs. The high prices of some of these (particularly the oncology drugs) have been a major challenge plaguing the Indian healthcare system and has pushed the patients on to the verge of poverty. Launch of generic drugs upon the patent expiries in the form of branded generics is one of the ways to provide affordable medicines in a timely manner to the burgeoning patients in need of these medicines.
*Source: USPTO; #Source: Drug price (except Brentuximab): www.1mg.com With patented drugs priced so much higher than their generic counterparts, the Indian population is unable to afford these life-saving patented drugs. In a country with a fractured health insurance structure, most of the health care expenses are either borne by the government or by the patients as out-of-pocket expenditures. As per the National Heath Accounts 2019-20, 52% of India’s Current Health Expenditure is borne out-of-pocket. Spiralling costs of newer patented medicines has put an excessive burden on Indian households. Ensuring access to affordable drugs has thus become a pressing issue for both the Central and the State Governments to address. Therefore, access to medicines at an affordable price is very important to keep the nation’s healthcare accessible to a higher percentage of the population. Further, the Indian Government’s healthcare programs like the National Health Authority under its flagship scheme of Ayushman Bharat Pradhan Mantri Jan Arogya Yojana and the Jan Aushadi Scheme launched in 2008 to increase access to affordable and quality medicines depend on generics medicines and these harmful intellectual property provisions would prevent the government from implementing these programs. Thus, there are sound and cogent reasons for the Indian Government to reject such unreasonable demands and prevent such provisions from playing havoc with the lives of millions of people in need of affordable medicines.
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