Is it a historical necessity for India's patent law to indulge drugs? Or choose protection?

Johnson When facing the "high price patented drugs", we can't help but think of India's "cheap drugs" and envy them for the high frequency of compulsory licensing / invalidation / rejection of drug patents However, what kind of transition has India experienced in its broad "connivance" towards drugs? Is it historical necessity or over protection? Should China learn to adopt? What are the advantages and disadvantages? Please read this article In chronological order, India's patent protection system has gone through the following five stages: In the first stage (1911-1970), the patent and design law issued by the United Kingdom during the colonial period was adopted to protect both the method patent and the drug patent in the pharmaceutical production process Results: more than 99% of India's drug patents and nearly 90% of its drug supply were controlled by multinational pharmaceutical companies, few of them were local pharmaceutical companies, and the drug prices remained high Stage II (1970-1995), the first patent law after the founding of the people's Republic of China was promulgated in 1970, which provides for the patent protection of pharmaceutical technology and the cancellation of product patent protection Results: Indian pharmaceutical companies were free to copy the high price patent drugs of multinational pharmaceutical companies without fear of infringement Stage 3 (1995-2002), India joined WTO in 1995 and signed TRIPS Agreement (member countries must include drugs and their production methods into the scope of patent protection) Results: in 2005, India amended the patent law and re protected the drugs In the fourth stage (2002-2005), the tightening of the patent system has posed a huge threat to the public access to drugs In order to balance the contradiction between the patent right of drugs and the public interest of the country, India has re regulated the compulsory license of drugs according to the Doha Declaration Results: Indian generic drugs under compulsory license can be exported to regions and countries without relevant production capacity Stage 5 (2005 ~ now), after the formation of the compulsory license system of drug patents, India has applied the compulsory license to anti-cancer patent drugs for many times to speed up the rapid listing of cheap anti-cancer generic drugs Results: multinational pharmaceutical companies were forced to reduce drug prices for many times, thus realizing the balance between drug patents and national public interests, and improving the accessibility of drugs In September 1970, the Indian government promulgated the patent law, which came into force in April 1972 (PS: This Law is considered to be the basis of the modern Indian Patent Law); in 1999, the patent law was revised for the first time, the design law was published in 2000, the patent law was revised again in 2002, and the patent law was revised for the third time in 2005 PS: in 1994, India amended the copyright law to protect computer software as a written work, and detailed the behavior and punishment of software piracy Under the new copyright law, any use of pirated software will be severely punished, and the use of Illegally Copied Computer software will be sentenced to seven to three years' imprisonment and a fine of between 55000 and 20 million rupees India's copyright law is even called "one of the most stringent copyright laws in the world" According to this, many scholars regard the patent law and copyright law of India as paradoxes to discuss According to the literature report: according to the statistics of the World Intellectual Property Organization (WIPO) in March 2015, the total number of invention patent applications in India in 2013 was 43031, and the number of design applications was 8497 Although there were no 825136 invention applications and more than 659563 appearance applications in China in the same period (China has greatly encouraged patent applications since 2000), the number of applications in countries with statistical data also ranked higher Among them, 10669 applications were submitted by Indian residents / enterprises, and 32362 applications were submitted by foreign residents / enterprises 1320 PCT applications In India, the number of foreign patent applications is nearly three times that of domestic applications India ranks sixth in the total number of foreign patent applications of all countries according to the world intellectual property organization, which shows the attractiveness of its market to foreign enterprises As of 2013, the number of effective invention patents in India is 45103 India's patent examination and approval efficiency is not very high and the backlog is serious, which can be clearly reflected from the application authorization ratio and the pending authorization ratio In 2013, there were 30988 patents under review in the Patent Office of India, and 141659 pending patents In 2013, the number of patents authorized by the Patent Office of India was only 3377, and the application authorization ratio was about 13:1, and the pending authorization ratio was about 51:1 The time of patent authorization is about 4 years from the date of request for substantive examination India's patent law emphasizes that "the establishment of patent granting standards, the issuance of compulsory licenses and the use of pre grant and post grant objection procedures by a government are all important flexibility measures for the purpose of safeguarding public health, in line with TRIPS Agreement" Moreover, India is not the only country to issue compulsory licenses for drugs Many other countries, including Brazil, Ecuador, Eritrea, Ghana, Indonesia, Malaysia, Mozambique, Thailand and Zambia, have issued compulsory licenses to ensure access to cheap drugs and meet public health needs At the same time, through lobbying to the government, enterprises in India have always kept an objection clause in the reformed India patent law, that is, any enterprise or individual can raise an objection to the invalidity of the patent to the patent Inspection Department of India Using this rule, Indian pharmaceutical companies put forward many objection applications, which makes the patents of foreign pharmaceutical companies unable to take effect in India For the first time in India, compulsory licensing was implemented for the product "togimer" Bayer, a famous pharmaceutical company, has developed a multi-target drug - dorgime (sorafenib) to treat advanced renal cancer It was patented in India in 2008, but the monthly treatment cost is up to 5700 US dollars, while the average annual income of India is only about 1K US dollars, which is obviously unaffordable for the people According to statistics of India's imitated pharmaceutical company NATCO, Bayer's supply of the drug only meets the needs of 1-2% of India's adaptive patients Therefore, in 2010, NATCO sent a letter to Bayer that it was willing to obtain Bayer's voluntary license on reasonable terms and conditions, but it was rejected by Bayer, so NATCO filed a compulsory license application with the Patent Office of India On August 9, 2011, NATCO submitted preliminary evidence to the Indian patent office that the patent medicine provided by Bayer failed to fully meet the needs of the Indian people, the price was far beyond the public's affordable range, and Bayer did not produce the medicine in India but provided the medicine through import On the same day, the Patent Office of India accepted the application of NATCO and published its application in the Gazette of the patent office At the same time, NATCO provided Bayer with a copy of the application On November 18 of that year, Bayer filed an application for objection with the Patent Office of India On January 13, 2012, the national patent office of India held a hearing to hear the facts and reasons stated by both parties Based on the fact that Bayer company did not price the drug according to the available and affordable standards, and could not guarantee the sufficient and sustainable supply of the drug in India, the Patent Office of India made a decision on March 9, 2012 to grant NATCO a compulsory license Bayer filed an appeal with the intellectual property Appeal Board (IpaB) on May 4, 2012 against the compulsory licensing decision of the Patent Office of India, but the appeal was rejected According to the compulsory licensing decision of the Patent Office of India, NATCO can produce and sell the drug in India before the expiry of solafeni patent in 2020 At the same time, the patent office has made corresponding regulations on NATCO, including: 1) the price of the drug does not exceed $176 per box; 2) relevant records including the sales account shall be kept, and sales details shall be reported to the patent office and the Licensor every quarter; 3) 6% of the net sales must be paid as the license fee; 4) the drug must be provided free of charge to 600 patients who need and meet the conditions every year From the perspective of implementation effect, the price of solafeni in India decreased by 97% after the implementation of compulsory license, which greatly increased the availability of drugs Trocaine (erlotinib hydrochloride) is an inhibitor of epidermal growth factor receptor tyrosine kinase produced by Roche Pharmaceutical Co., Ltd In recent years, trocaine has been approved for treatment of EGFR positive lung cancer and other cancers In 2006, Roche introduced erlotinib into the Indian market under the brand name of trokai In February 2007, Roche obtained the patent authorization of erlotinib n - (3-ethynylphenyl) - 6,7-bis (2-methoxyethoxy) - 4-quinoline amine hydrochloride in India Because erlotinib can be used in the treatment of many kinds of cancer, in January 2006, India's sipura company announced its intention to sell erlotinib generic erlocip, which is under development In January 2008, erlocip was listed Later, Roche sued sipura for patent infringement and hoped to issue a temporary injunction to prevent sipura from producing, selling and exporting erlocip Sipura company filed a counterclaim that Roche's patent was invalid The high court of New Delhi held that it refused to issue an injunction against erlocip for the sake of public interest, while the court rejected sipura's request for invalidation of Roche's patent Roche then appealed On September 7, 2012, after several decades of hearings for four years, Indian courts rejected Roche's patent infringement lawsuit against Troika patent The court held that Roche's main claim was the compound itself, erlotinib hydrochloride (described in the formula), and that the claim covering the compound did not limit the specific variant of the polymorphic form Because Roche sells the special form of erlotini (polycrystalline A and b), while the erlocip sold by sipura is only polycrystalline B, so sipura does not constitute an infringement In addition to the above-mentioned and related compulsory licensing and patent invalidity, in recent years, India has adopted more rejection and non authorization measures for foreign identified and potential high-value patent drugs; the most typical one is rejection of the patent application for β crystal form of Gleevec Gleevec (imatinib mesylate) is a leukemic drug developed by Novartis, a Swiss pharmaceutical giant In 1998, Novartis filed a patent application for imatinib mesylate β crystal in India In January 2006, the Patent Office of India rejected the application on the grounds that the application failed to meet the novelty and non obvious To this end, Novartis appealed to the high court, which referred the case to the appeal board In June 2009, the Appeal Board issued a ruling amending the statement of the Patent Office of India on the novelty and non obviousness of the ingredient in the field, but rejected Novartis' Application on the grounds that the drug is not a new substance but an improved type of known compound, and Novartis failed to show a significant increase in the efficacy of the drug After that, Novartis appealed to the Supreme Court through the petition of special permission in accordance with Article 136 of the constitution of India, accusing India of violating the patent rules of WTO and infringing its own interests On April 1, 2013, the Supreme Court of India rejected Novartis' request for patent protection of imatinib mesylate crystal, on the grounds that the substance patented by Novartis is a known substance, so it does not meet the requirements of Indian patent law and does not have the qualification to obtain an invention patent; in addition, the Supreme Court also examined the treatment of imatinib mesylate crystal and imatinib mesylate or imatinib mesylate There was no significant difference in the effect Final rejection There are always positive and negative evaluation on any existing thing The positive effect of India's "connivance" attitude towards drugs is still obvious: the price of drugs has been greatly reduced and the accessibility has been greatly improved