According to information from the American lobby group I-MAK, the patent application of the super Hepatitis C drug of Gilead is rejected by the SIPO of China, which is a decision made after the I-MAK raises an objection before patent right grant. The I-MAK also challenges the patent applications of the drug in other markets such as European Union, India and Russia, in cooperation with other none government organizations. The core patent of Sovaldi has been rejected in India and Egypt.
The patent application No. CN200880018024.2 was filed on March 26, 2008. The prodrug itself has no pharmaceutical activity, but it can be metabolized into active ingredients after entering the human body. The I-MAK considers that the phosphoramidate prodrug of Sovaldi is just improved based on the original compound, and hence has no innovation.
Although the SIPO does not give a formal announcement or explanation, its patent examination daily announcement shows that the patent application of Sovaldi has been rejected. Gilead has not released any declaration till now. The Sovaldi compound basic patent applied for a patent right grant in China is not influenced, and the deadline is still 2024.
The judgment may further cause chain reactions in other emerging markets, particularly those countries excluded by the drug admission agreement. At the beginning of this year, Gilead came to market admission agreements with some countries for the high price drug Sovaldi. The price of the drug is 1,000 dollars/piece in the United States, and the fee of a treatment course of 12 weeks reaches 84,000 dollars.
In September of last year, Gileda signed an agreement in India, as a part of action of providing low price drugs to more than 90 developing countries, by largely decreasing the price of Sovaldi to 300 dollars/bottle, i.e., about 10 dollars/piece, and 7 Indian pharmaceutical enterprises are allowed to produce low price drugs.
To be noted, in some emerging markets where the morbidity of Hepatitis C is high, such as China, Russia, Brazil, Mexico and Ukraine are excluded by the agreement. Particularly in China, there are nearly 30 million Hepatitis c virus (HCV) infections, and the number of hepatitis c patients is the largest all over the world. The exclusion of those countries is strongly opposed by patients' rights advocacy organizations including the Medicines Sans Frontiers (MSF).
Regarding the decision of China, the MSF comments that Sovaldi is sold at a sky-high price in many countries, while there are about 150 million hepatitis c patients worldwide, and the hepatitis c complication will take the lives of 0.35 to 0.5 million people. The MSF also points out that China shall also serve as an important supplying country of Sovaldi raw materials and drugs, which helps to reduce the global drug price.
Mr. Rohit Malpani, the policy and analysis director of the MSF states that the decision of China shows that the significance of the drug patent is seriously questionable, and also gives a strong signal to other countries which are examining the patent application of the drug.
Generic drugs are ready to be produced in China
In the dispute where China rejects the Sovaldi prodrug patent, many local pharmaceutical enterprises have gone into actions to commence launching Sovaldi generic drugs in the globally second largest pharmaceutical market.
According to information from the SIPO database, three pharmaceutical enterprises including Zhejiang Huahai Pharmaceutical Co., Ltd. have obtained the patent of producing Sovaldi tablets. Sichuan Kelun Pharmaceutical Co., Ltd., which has come into the market at Shanghai Stock Exchange, asserted at the end of last year that the State Food and Drug Administration had accepted its clinical trial application for Sovaldi generic drugs. But the industrial observers point out that even if all necessary researches are finished, the generic drugs of Sichuan Kelun Pharmaceutical Co., Ltd. still cannot be approved to come into the market because of the patent protection. But some people consider that this situation may be turned because the Solvadi patent is rejected by the SIPO, which opens doors for Chinese national pharmaceutical enterprises to challenge the patent.
the MSF considers that as the globally largest country for producing active pharmaceutical ingredients, China is restricted in the application of Sovaldi active pharmaceutical ingredients, and the source lies in the patent barrier. But the rejection of the second patent application of Sovaldi makes the Sovaldi generic drugs more possibly enter the Chinese market soon.
In another patent litigation not long ago, Beijing high people's court judges that the patent of the moxifloxacin hydrochloride and sodium chloride injection is invalid. The plaintiff, Founder Medical Research Institute of PKU Healthcare Group, won in the patent challenge. The drug with a trade name “avelox” has an annual sales volume up to 700 million CN (120 million dollars) in China.
Compulsory license will be common?
The Chinese health department also considers taking the compulsory licensing measure to help the patients to obtain some expensive drugs. The National Health and Family Planning Commission of China has listed the compulsory license as a priority issue in the monographic studies of 2015. Although China has released an explicit approach for related enterprises to apply for the compulsory license, and pave the way for the drugs imitation and innovation. But no enterprise takes the measure till now. On the other hand, the State Council of China recently issues a policy that encourages innovation, including measures for motivating the reformation of the intellectual property and for the key area breakthrough.