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TWN Info Service on Health Issues (Jan16/01)
27 January 2016
Third World Network 

Patent Reexamination Board of China’s Patent Office Invalidated Novartis’ Patent on Gleevec

A note by Third World Network

The Patent Reexamination Board of China’s Patent Office issued a decision on 23 October 2015, invalidating Novartis’ patent on Imatinib Mesylate (Gleevec) on the ground of lack of inventive step. This is one of the three requirements for patentability and provided in Article 22(3) of China’s Patent Law.

Imatinib Mesylate can be used for treatment of chronic myelogenous leukemia (CML), gastrointestinal strong tumor (GIST) and some other diseases. The use in GIST is protected by the invention patent ZL01817895.2 in China. The patent holders are Novartis, a giant Swiss pharmaceutical manufacturer, and three other foreign companies and institutions. The patent invalidation request was filed in September 2014 by Hansoh Pharmaceutical Co. Ltd, a Chinese company established in 1995 and based in Jiangsu Province.

The price of Gleevec in China has been prohibitively high, amounting to CNY 23,000-25,000 (USD 3,650-3,970) per box of 120 tablets. But generic “Imatinib Mesylate” produced in India is so cheap that the huge price gap between the two drug versions had strongly attracted Chinese patients to buy the generic drug from India at the price of only about CNY 200 (USD 32) per box.

Price of Novartis’ Gleevec in Some Countries and Region (120 tablets per box)

China Mainland

USD 3,650-3,970

Hong Kong SAR

USD 2,698-3,015

United States

USD 2,160

Australia

USD 1,685 (USD 30 if it is covered by medical insurance)

Japan

USD 2,610 (USD 990 if it is covered by medical insurance)

Republic of Korea

USD 1,545

Source: People’s Daily Online, http://world.people.com.cn/n/2015/0107/c1002-26344229.html

Coincidentally, in early 2015, more than 300 leukemia patients in China signed up a letter to call on the local court to exempt a Chinese citizen, Lu Yong, from serving his criminal sentence. Lu Yong is also a leukemia patient. He had been charged with committing the crime of selling fake drugs due to purchasing generic Imatinib Mesylate for Chinese patients from India and he was sentenced to a term of imprisonment. According to China’s Drug Regulation Law, where the drug is produced and imported without an approval granted according to this law, the drug shall be treated as a ‘fake drug’ or a counterfeit drug even if it is indeed a genuine drug. So the generic drug purchased from overseas without the approval number is equal to a fake drug or a counterfeit drug under the law. This is the first case where overseas drug purchasing had been criminalized.

It is noted that there is only one claim in this patent, to protect the use of Imatinib or its pharmaceutical salt in preparation of pharmaceutical compound for treatment of GIST. It is a typical ‘Swiss-type’ claim, a claim format devised to enable patent applicants to claim a second or further medical use of a known therapeutic substance. In such a claim, the format utilized the expression, ‘use of X for the manufacture of a medicament for use in treatment of Y’. 

Some commentators gave their analysis on the possible reasons why Hansoh filed the invalidation request with the Patent Reexamination Board in such a proactive and pre-emptive manner. The China Food and Drug Administration has approved Hansoh’s generic Imatinib Mesylate for a long time and the generic drug entered the market after 2013 and the current price is CNY 3,800 (USD 603) per box. In terms of Hansoh’s capacity, its generic Imatinib has already occupied a significant share in the market and it is very likely that Novartis would lodge a patent infringement suit against it to curb its access to the market.

In this invalidation case, when determining inventive step as one of three requirements for patentability as specified in China’s Patent Law, the Patent Reexamination Board opined that, as per a medical use invention, to determine whether the invention is obvious compared with prior art, it shall consider not only whether the person skilled in the art will consider to attempt using a known substance to treat a disease, but also whether there is reasonable expectation of success (not absolute expectation of success) in such an attempt. Therefore if the person skilled in the art will consider to attempt using a known substance to treat a disease and there is reasonable expectation of success, the medical use invention is not inventive. Based on the evidence submitted by the parties, the Patent Reexamination Board found that the granted patent does not meet the requirement in this regard, and concluded that the patent is invalid on the grounds of lack of inventive step.

The Patent Reexamination Board’s invalidation ruling will have significant impacts on the accessibility, affordability and distribution of Imatinib Mesylate in China’s market. However, this might be far from the end of the story. Novartis probably will challenge the invalidation ruling before the court and the judges may have a final say on the fate of many patients.

 


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