Release date: 2015-07-20
At present, the only drug in the world with a cure rate of 90% of hepatitis C, “Sophie Buweiâ€, was rejected when applying for a patent for pharmaceutical prodrugs in China.
    Sofibuvir is a new drug developed by Gilead for the treatment of chronic hepatitis C. It was approved by the US Food and Drug Administration (FDA) for listing in the US on December 6, 2013, and the European Medicines Agency on January 16, 2014. (EMEA) approved for listing in EU countries. Sophie Weiwei currently sells for $1,000 in the United States and $84,000 for a course of treatment.
    Refusing patents to impersonate imitation?
    On the official website of the State Intellectual Property Office, the patent application of Gilead's "nucleoside phosphoramidate" (a prodrug) was recently rejected. What China refuses is a patent application for a prodrug (which is itself inactive and converted to a chemically active drug in the body). However, Gilead still holds the foundation of Sovaldi (sofosbuvir, generic name "Soofibwe"). The patent of the compound in China, and the rejection of this patent does not mean that China has opened its doors to the generic drug of Sofbwe.
    "But the patent as a precursor, that is, after the rejection of the API patent, China can sell it to other countries for the production of generic drugs, which can also be used to promote the price decline of patented drugs," said Ms. Chen Bingding, a project representative for MSF.
    "This is good news for patients with hepatitis C. In developing countries, more patients are expected to get cheap Sophie Buwei. Whether in rich countries or in poor countries, Gillette's high prices prevent patients from gaining access to The treatment needed. If no one can afford the cost of treatment for hepatitis C, this treatment will be useless," said Chen Youding.
    China is the world's largest supplier of active pharmaceutical ingredients (APIs). Patent barriers limit the use of Sofibovir APIs. China's ability to produce medicines and vaccines is growing. Under the decision to dismiss Sophie's second patent application, Sophie's patents are expected to enter the Chinese market as soon as possible.
    “China’s rejection of the Sofibwe patent application shows that there are serious problems with the patentability of the drug, and it also sends a strong signal to other countries that are currently reviewing the drug patent application. China will likely become a raw material for Sophie Buwei. An important supplier of medicines and finished medicines. Competition from Chinese manufacturers can drive down the price of medicines and allow more patients to get the medicine. We hope that other countries that also accept Girard’s Sophie Breve patent application can see it clearly. "The MSF Policy and Assessment Director Rohit MALPANI said," said MSF.
    Hepatitis C is a global public health crisis, with more than 150 million people suffering from hepatitis C, and between 350,000 and 500,000 people die each year from complications of the disease.
    In fact, the US Gilead Science has previously announced that the company has signed a non-exclusive licensing agreement with seven Indian generic drug manufacturers to allow it to produce sofosbu but not China.
    But it seems that it is not so easy for the expected generic drugs to enter China. The reporter has inquired from the National Patent Office that Gilead has obtained a patent for the basic compound in China. After possessing this patent, it is difficult for Chinese manufacturers to produce generic drugs. If the imitation is also valid after the patent is 2029 years.
    Although there are already 11 pharmaceutical companies in China applying for research and development, including Sichuan Kelun, Jiangsu Haosen, Zhengda Tianqing, Shijiazhuang Group and other companies continue to wait for a long time, not to mention domestic companies must wait for long-term patents of original products. Period, or solve the patent problem, in order to benefit from the market.
    Far from the sky to go to India?
    "Sophie Weiwei, the current sales price is $1,000, and the cost of a treatment is $84,000, which is a price that many patients can't afford. But this medicine is a life-saving medicine for patients with hepatitis C." Said.
    "There is no new drug in China, but we have 8 million people infected with hepatitis C. Currently, the drug for treating hepatitis C in China is 40% to 95%, and the curative effect is much worse." An expert on hepatitis virus research said .
    However, as a drug cost of only about 4 US dollars, Sophie Weiwei, the sales price is as high as 1,000 US dollars, so the gap only proves the exclusiveness of this drug.
    The drug has not yet been listed in China and can only be obtained from foreign hospitals. So there was a hot Indian medical tourism, Kang'an Road, which was specially made to go to India to treat hepatitis C.
    On the homepage of the website, “the domestic cure for hepatitis C is 40%, the total cost is more than 100,000, India treats hepatitis C, medical experts accompany the whole process, the cure rate is as high as 95%, and the total cost is as low as 48,000.â€
    According to a staff member of Kang'an Road, Sophie is not available in China and can only go to India for treatment. The entire package of 38,000 yuan, to protect air tickets, visas, accommodation and a course of medication, live in India for 1-2 days. In general, patients only need one course of medication, because the cure rate of a course of treatment reaches 90-95%. At present, a bottle of Sophie in India is worth 2,000 RMB, including 28 tablets per month. Generally, a course of treatment is three months, only 3 bottles are needed. More is a course of 6 months. "Because China has approved the patent for the active ingredient of this drug, it can't be copied in China, and patients can't wait until 2029," said the staff.
    “The key factors for how to expel hepatitis in China are the vaccine, treatment and liver cancer incidence. The vaccine has been proven to reduce the incidence by 10 times, but the treatment is not effective. We lack independent innovative drugs, and many major special projects. No drugs. For liver cancer, it is not only a scientific problem, but also a social problem. If you can have a liver test for patients with chronic hepatitis for half a year, most of the liver cancer can be found early, at least half of the mortality rate can be reduced." An authoritative hepatitis virus expert said.
    In fact, according to the data of the 5.1 million surveyed points he followed, it is found that liver cancer has been rising. Even if hepatitis B already has a vaccine, the effect of the vaccine is not shown because of the vaccine use. For 30 years, and the incidence of liver cancer is generally 40 years old, the vaccine prevention effect must be carried out at least three five-year plan to have results. What's more, without hepatitis C vaccine, treatment is still an important part of the current, and drugs are a life-saving medicine.
Source: Yicai.com
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