Pondering over the heavy patent medicine halberd brought by Indian market

2013-09-03 source: on August 8, the Indian patent appeal board of minenet revoked the patent of Allergan for the glaucoma drugs ganfort and combigan This is the latest blow to Western pharmaceutical companies in a series of intellectual property and drug pricing decisions in India In 2012, the Indian government launched the first patent compulsory license, forcing Bayer to license the anti-cancer drug Nexavar to its local NATCO company and launch cheap generic drugs The premise of patent compulsory license is that under the condition that it can not be obtained, paid or provided properly, domestic enterprises can produce and sell imitated products, but should pay royalties to companies holding patents In addition, last year India revoked patents on Pfizer's cancer drug SUTENT, Roche's hepatitis C drug Pegasys and Merck & Co's asthma drug aerosol suspension All of these reasons for being withdrawn include a lack of innovation In April, India's Supreme Court rejected a patent for Novartis cancer drug Glivec, calling it a revised version of the known molecule imatinib, the first to reject "incremental innovation." The so-called "progressive innovation" refers to the improvement and deepening of existing scientific and technological inventions, aiming to extend the protection period of the original invention results, which is an obstacle for imitators This is the traditional strategy and common practice of the pharmaceutical industry, but it is not allowed in India On August 2, India revoked a patent of tyverb / tykerb, a GlaxoSmithKline breast cancer drug On August 4, India announced the partial revocation of the patent of Roche's breast cancer heavyweight drug Herceptin These measures further thwarted the expectations of Western pharmaceutical companies seeking to grab more market share in India's fast-growing $13 billion drug market As the U.S economic recovery is faltering and the European debt crisis is hard to solve, the active emerging market has become the growth point of the profits of major international pharmaceutical giants, especially the huge profits of their patented original research drugs, which has made great contributions to the enterprises over the years How to maintain the glorious past of these original research drugs and extend their market monopoly, the major pharmaceutical enterprises have made every effort Mnet's multinational performance data shows that most of the above-mentioned heavyweight drugs reached a new high in global sales in 2012 Global sales of various blockbuster patent drugs Pfizer Roche Novartis GlaxoSmithKline Ericsson, a company affiliated to the drug name of sotan, rohinggreavel, shahsetin and combigan, has a peak sales of 1.236 billion US dollars 1.655 billion Swiss francs 4.675 billion US dollars 239 million pounds 5.889 billion pounds 453 million US dollars * peak time 2012, 2009, 2012, 2012 * sales volume of bromomonidine products including combigan in 2012 India is the second largest population country in the world With social progress, the life span of the population is longer and longer With the west wind moving eastward, people's lifestyle has changed, and diseases such as heart disease, diabetes and cancer have become the main killers Because of the long course of the disease, the cost of treatment has become a thorny problem In India, a course of trastuzumab costs more than $15000 than people's average annual wage, and there is no such alternative that specializes in specific types of breast cancer In order to treat diseases, people have to endure expensive life-saving drugs or give up treatment For pharmaceutical giants, most of their future growth will come from these emerging countries, so they are not willing to cut drug prices in middle-income countries such as India, China and Brazil In order to crack down on the attempt of pharmaceutical giants, India has formed a patent strategy suitable for the development of its pharmaceutical industry The patent law of India, which came into force in January 2005, only provides patent protection for the new drugs invented after 1995 or the drugs which can greatly improve the curative effect after improvement, but does not support the original drug mix or derivative drug patents This rule prevents multinational companies from extending the patent life of their products as much as possible (i.e by improving early products to obtain patents), leading to the frequent rejection of drug patent applications by pharmaceutical giants in India China and India share many of the same historical circumstances, and both belong to the BRICs countries with the most active economy In recent years, the economic development of both countries has been very fast, which has attracted global attention However, the two countries have a large population In 2012, the world's per capita GDP ranked second to that of China and India According to the social and economic development trend of 184 countries, the International Cancer Research Institute in Lyon, France, estimated that the number of new cancer cases in the world would increase from 12.7 million in 2008 to 22.2 million in 2030 And as developing countries gradually form the same way of life as western countries, the incidence of those common cancers in developed countries will also soar in these countries How to get cheap life-saving anticancer drugs has become a problem to be considered in front of every government Domestic bidding price of each heavy-duty patent medicine commodity name: sotan, paixin, gliclazide, general name: sunitinib malate, polyethylene glycol, interferon α - 2A, imatinitrastuzumab mesylate, dosage form, capsule, injection, powder injection, package specification: 12.5mg * 28 capsules, 0.5ml: 180mg * 1 capsule, 0.1 * 60 Tablets 0.44g * 1 price 12431 yuan 1120 yuan 11700 yuan 22148 yuan * taliza was approved to enter China in 2013, but there is no price temporarily Combigan has applied to CDE for export in China in 2012, May 1, 2012 The revised Measures for compulsory license for patent exploitation, which is implemented on April, stipulates that in case of national emergency or emergency, or for the purpose of public interest, the Chinese government may issue a compulsory license to the companies that have the conditions for implementation to produce the imitations of patented drugs It formally started to challenge unreasonable patent monopoly Recently, the Patent Reexamination Board of China's State Intellectual Property Office revoked the patents of Gilead's HIV and hepatitis B drug Viread (tenofovir fumarate) in China, and supported the invalidation request of the patent of Viread by the company, which was a blow to Gilead Earlier, Brazil and India had ruled that the patent for tenofovir was invalid Indonesia issued enforcement This patent incident in China is not due to the government's compulsory patent licensing, but to a successful challenge by a company and judged invalid, so that domestic pharmaceutical enterprises can copy Viread The decision makes the government stronger in pricing negotiations with pharmaceutical companies This is a quite groundbreaking decision The current situation in China is that in 2011, nearly 93000 HIV cases were reported, and 130 million hepatitis B virus carriers and 30 million chronic hepatitis B patients Due to the high price of Viread, most patients are unable to buy it In this case, the relevant departments have to face the issue of priority On the one hand, they hope to promote innovation by strengthening the protection of intellectual property rights; on the other hand, it is the key purpose to make medical expenses affordable for the common people A few days ago, some research institutions analyzed the global trend of new drug research and development in 2013 by studying the pharmapprojects / pipeline database of citeline company, and found that the share of new drug research and development market in the United States in 2013 was 49%, falling below the 50% mark, but still occupying the leading position The market share in Europe has increased Surprisingly, the Asia Pacific region has seen a decline in its share This indicates that the new drug development in the future is still dominated by the developed countries in the United States and Europe With the increasing difficulty and cost of new drug research and development and the increasingly fierce product competition in various major disease areas, the input-output ratio of pharmaceutical companies in the new drug research and development field is declining In order to save the cost of R & D for a long time in the future, more and more enterprises will try to extend the value of their brand products by increasing the new indications of products or using other life cycle management methods As the world's most populous China and India, facing the huge domestic drug demand, how to make good use of the rights given by the relevant national laws and regulations under the premise of protecting intellectual property rights to provide cheap and efficient life-saving drugs for the common people is worth thinking about in all pharmaceutical related industries.