Failure of foreign companies in patent invalidation cases of tenofovir will usher in the era of parity

Source: People's daily 2017-05-10 in March last year, a patent invalidation case involving tens of millions of hepatitis B and AIDS patients nationwide was appealed to Beijing Higher People's court After a tense court hearing, the court finally ruled that the State Intellectual Property Office's ruling on the invalidity of the patent for tenofovir of Gilead company in the United States should be upheld So far, this patent invalidation case, which lasted for more than five years, ended in the defeat of foreign companies, which also means that tenofovir ushered in the "era of parity" Tenofovir is a new type of nucleotide reverse transcriptase inhibitor produced by Gilead company It is currently the first-line antiviral drug for the treatment of hepatitis B and AIDS Due to the patent monopoly of Gilead company, a bottle of tenofovir once sold to about 1500 yuan in China, 18 times of the domestic drugs, making the domestic hepatitis B patients unbearable A data shows that the average annual treatment cost of hepatitis B patients in China is 18000 yuan, while the annual treatment cost for hepatitis B in China is up to 100 billion yuan Many domestic patients can only go far and find ways to buy cheap drugs from abroad Talking about the case, Wang Zhibang, chairman of Anhui Baker United Pharmaceutical Co., Ltd., described it as "a wave of ten fold" "In 2011, domestic enterprises successively filed invalid applications for compound patents, preparation patents and divisional patents of Gilead tenofovir, and the National Patent Reexamination Board ruled that all patents of Gilead Science Co., Ltd for the treatment of hepatitis B and AIDS were invalid Gilead filed a lawsuit for the purpose of not willing to fail and deliberately delaying domestic drugs " Wang Zhibang said that Gilead only added some auxiliary absorption ingredients in addition to the already disclosed active ingredients of PMPA of antiviral mother nucleus, and any other company can do it through different processes According to Wang Zhibang, the technology that has been made public should be enjoyed by ordinary people instead of applying for patents The maternal PMPA of tenofovir's anti-virus active component was published at the International AIDS conference as early as 1997 "Although the molecular formula is the same, the process must be different Through the decomposition of the molecular formula, the raw materials, intermediates, catalysts and reaction conditions may be different Here are the innovations of Chinese enterprises." Wang Zhibang said that the starting price of monopoly drug companies is 1500 yuan If half of the domestic AIDS patients and hepatitis B patients take tenofovir tablets, that is tens of billions, so they have motivation, reason, conditions and domestic drug companies to go on litigation and drag on After Gilead company sued to Beijing No 1 middle court, a company that had been fully prepared encountered "Waterloo" due to a small mistake, that is, the key evidence was not notarized by "lawyer" "The Chinese Academy of Sciences hereby rejected the ruling of" patent invalidity of geelide company made by the State Patent Reexamination Commission " In this case, domestic enterprises and the Reexamination Committee can only appeal to the Beijing high court " Wang Zhibang said After arduous evidence collection and litigation, the new evidence was finally accepted, and the Beijing high court sent the case back for retrial However, Gilead company refused to accept the judgment of the intermediate court after retrial, and appealed to the Beijing High Court, which finally made the final judgment Before that, another pharmaceutical company in China also had a lawsuit with Glaxo for the treatment of hepatitis B drug lativudine After losing the lawsuit, Glaxo soon reduced the price of the drug in China "To support and protect the technological innovation of pharmaceutical enterprises and benefit more ordinary patients, the court's ruling has given us strong confidence and strong legal support." Wang Zhibang said Patent is the most direct threshold for domestic enterprises to produce and sell drugs Some experts said that effective patents should be firmly protected, and invalid patents should be challenged Relevant departments should support domestic enterprises in policies, funds and other aspects to dare to challenge invalid patents It is understood that the winning of this lawsuit also makes the final listing prospect of tenofovir produced by domestic pharmaceutical companies bright.