The patent of tenofovir was judged invalid and domestic enterprises seized the market of hepatitis B drugs

Recently, the National Patent Reexamination Board ruled that the patent of tenofovir, a drug for hepatitis B and AIDS treatment by Gilead science company, was all invalid So far, domestic pharmaceutical companies have won the first battle for this market, and patients are expected to use cheap drugs in China Peng Zhien, chairman of the board of directors of oritech, who challenged the patent of tenofovir, told the daily economic news that due to the patent monopoly of Gilead company, domestic enterprises are still unable to intervene in the production and sales, and the price of imported drugs is 20 times that of domestic drugs However, it is still unclear whether domestic enterprises will win the final victory, as Pfizer's Viagra appeals and revokes the Patent Reexamination Board's judgment The patent dispute has long been that tenofovir is a nucleotide antiviral drug developed and listed by Gilead In 2001, it was approved by FDA to treat human immunodeficiency virus (HIV) infection According to the results of a large number of clinical trials, in April and August 2008, the European Union and the U.S FDA approved it respectively for the treatment of hepatitis B (hepatitis B) Sales of tenofovir have been expanding According to 2010 annual report of Gilead company, sales of tenofovir and its compound preparations in that year have exceeded 6 billion US dollars According to the official website of the State Food and drug administration, tenofovir is an imported drug and obtained the drug approval number in 2008 The patent of tenofovir in China will expire in 2017 Peng Zhien told the daily economic news that the patent of tenofovir has great defects Its core active ingredient, PMPA, is an earlier known antiviral parent core (Czech patent 1985) Gilead company only added some auxiliary absorption ingredients in addition to the core ingredients, without great innovation, which is not enough to get patent protection After repeatedly weighing the opinions of Gilead and patent challenger, the National Patent Reexamination Board determined that the patents of tenofovir were all invalid In fact, the patent of tenofovir is controversial in some countries Cipla of India challenged Geely's benign patent application in India, believing that it was not original enough, which was accepted by the Patent Office of India, which directly led to Geely's patent application being rejected As early as 2007, non-profit organizations applied for four patents of tenofovir that could not be authorized In 2008, the U.S Patent Office declared the patent invalid, but half a year later, after modification, the patent remained valid At present, due to Gilead's patent before, domestic enterprises are still unable to intervene in production and sales "If domestic companies produce, the price will be one twentieth of the price of imported drugs." Peng said The prospect of registration is still uncertain In fact, it is the epitome of domestic and foreign enterprises competing for the market According to the statistics of the World Health Organization, there are 2 billion people infected with hepatitis B virus in the world, and more than 350 million people suffer from chronic (long-term) liver infection diseases, of which about one third are hepatitis B patients in China At present, the total cost of hepatitis B treatment in China exceeds 100 billion annually, which has become the largest hepatitis B drug market in the world At present, because hepatitis B can not be completely cured, antiviral therapy is considered to be the most basic and important treatment There are two kinds of hepatitis B antiviral drugs recognized in the industry, namely interferon and nucleoside Although interferon is used early, it has many adverse reactions and is expensive Nucleosides have been widely used since the middle and late 1990s and are gradually monopolizing the market Tenofovir, as a rising star of nucleoside drugs, is gradually occupying the market Another indication of AIDS, tenofovir's market potential can not be ignored According to the statistics of 2012 national legal infectious diseases released by the Ministry of health, AIDS has become the number one killer among legal infectious diseases In 2012, 11575 people died of AIDS, an increase of 24.89% over 2011 Even in terms of domestic product prices, tenofovir's market will exceed 1 billion in the future, according to Peng Several Chinese companies, including oret, have also targeted the market According to the data of the national drug review center, many companies, such as Qilu pharmaceutical and Chengdu Beite pharmaceutical, are carrying out clinical research and development of tenofovir Patent is the most direct threshold for domestic enterprises to carry out production and sales Within the validity of the patent, domestic enterprises can not obtain the approval number for sales even after completing the clinical research However, it is still unknown who can laugh till the end when the patent of tenofovir is judged to be all invalid only when the domestic enterprises succeed in the first battle In 2004, Pfizer's patent for the star drug Viagra was found invalid However, Pfizer filed an appeal with Pfizer The Patent Reexamination Board's decision was revoked and its patent was maintained until 2014 The Patent Reexamination Board said in the document that Geely could appeal against the decision if it was not satisfied with the result.