In a recent, rare case of a patent dispute between two domestic firms, a Tianjin-based pharmaceutical company was accused of illegally copying a major medicine used to help combat Hepatitis B.

Jiangsu Chia-tai Tianqing Pharmaceutical Co Ltd (CTTQ) recently filed a suit against the Tianjin Institute of Pharmaceutical Research Company Ltd (TIPR), saying Daiding Adefovir Dipivoxil Tablets made by the Tianjin-based company infringed upon its patent.

CTTQ says it owns the patent of one of the crystalline forms of adefovir dipivoxil and methods to prepare the crystal, and that it never authorized any other enterprise to use its patent. Daiding, according to CTTQ, uses the exact type of crystalline form that it invented.

Though Chinese pharmaceutical companies are often criticized by foreign counterparts over patent infringement, a dispute between two domestic companies is rare.

"This shows that Chinese pharmaceutical enterprises have started to be aware of patent protection and intellectual property rights," says Tang Xiaofeng, a lawyer with the China Council for the Promotion of International Trade (CCPIT) Patent and Trademark Law Office.

Hepatitis B is one of the most widespread infectious diseases in China. According to official statistics, China has 130 million HBV virus carriers and 30 million patients. Medical expenditure on HBV therapy amounts to 30 billion to 50 billion yuan a year in China.

Leading medicine

GlaxoSmithKline's Heptodin used to be the leading medicine for Hepatitis B with a 55 percent market share in China; it generated over $38 million in sales in 2003. With the introduction of new types of medicines made by other international pharmaceutical giants, sales of Heptodin have flattened recently.

In addition, the patent protection period of Heptodin in China expired in 2006. As a result, Adefovir dipivoxil became the most widely used medicine in treating Hepatitis B, having proven its effectiveness in Europe and the United States.

Adefovir dipivoxil was invented in 1991 by Giliead Sciences, a company based in the United States. GSK later purchased from Giliead Sciences the right of sales and promotion of adefovir dipivoxil in Asian and Latin American markets.

In 2000, GSK filed a patent application for four crystalline forms of adefovir dipivoxil and preparation methods in China; it did not get the approval for production until March 2005.

During this period, domestic enterprises had worked to find other crystalline forms of adefovir dipivoxil. The adefovir dipivoxil tablets produced by TIPR under the name of Daiding was first put into the market in May 2005.

TIPR was not the only one attracted by the large market potential of adefovir dipivoxil. By 2005, around 60 enterprises had applied to the State Food and Drug Administration (SFDA) to make adefovir dipivoxil. Around 10 of them applied for the patent through the State Intellectual Property Office (SIPO).

The patent application of CCTQ was passed by SIPO in July 2005, according to Wang Shuhua, a spokesperson of the Jiangsu-based drug manufacturer.

"We realize that adefovir dipivoxil will be a promising new type of antivirus medicine for Hepatitis B as early as 2000," says Wang, adding that they have concentrated on the research of adefovir dipivoxil since then.

The type of adefovir dipivoxil discovered by CCTQ, according to Wang, is the fifth crystalline form of adefovir dipivoxil. "Our experiment shows that it is more suitable for Asians in treating Hepatitis B," he says.

Currently, Daiding takes around 40 percent to 50 percent of the market share for anti-Hepatitis B drugs, the largest in China. Mingzheng Adefovir Dipivoxil Capsules of CCTQ only takes 10 percent of the market share.

"That is the main reason for us to file the suit," Wang says. "TIPR has not only infringed upon our patent rights, but also caused great economic loss to CCTQ."

CCTQ has studied the new crystalline form of adefovir dipivoxil for nearly six years, Wang says.

Invalid patent

While the spokeswoman of TIPR refuses to comment, a person close to the situation says TIPR claimed the patent owned by CCTQ was invalid, and planned to take the case to a patent review committee.

The Beijing News earlier quoted an official of TIPR as saying that they had applied for the patent years ago and did not receive approval. But "Daiding now sells very well," the official was quoted as saying.

GSK previously notified several Chinese enterprises on the possible patent disputes over adefovir dipivoxil before its medicine named Hepsera came into the market in September 2005.

"There are no patent disputes on adefovir dipivoxil between GSK and domestic enterprises," says a spokesperson of GSK, adding that the letter was only a reminder of the possible risks as GSK was applying the patent of Hepsera and planning to enter the Chinese market.

"Their notification is correct," says Wang, "as a caution it is very necessary."

Wang also calls for a tightening of the protection of intellectual property rights. "There is a misunderstanding that the Chinese will suffer from IPR protection since most of the time the patent is controlled by foreigners," he says.

"But only when we start to protect others' benefits can we protect our own interests," he says.

Tang, the lawyer with the CCPIP Patent and Trademark Law Office, says that Chinese enterprises need to work on technology innovation.

"Domestic enterprises still lag behind in terms of research and development due to technical reasons and lack of financial strength," he says.

For instance, CCTQ invested about eight percent of its sales to research and development, while Chinese enterprises on average spend less than two percent on research.

Experts also call for a more complete legal system in terms of patent applications and approval of new drugs. Under the current regulations, an enterprise without a patent may also get approval from the SFDA.

Tang reminds enterprises to do preparation work before using a certain technology and putting it into production. "The enterprises must learn to respect other's patents," he says, and "to start to produce a certain medicine before reviewing the patent can be very risky."

(China Daily 01/06/2007 page9)

2013-07-17