Drug industry concern as China breaks Viagra patent

Related tags Intellectual property Sildenafil Erectile dysfunction China

Much has been written on In-Pharmatechnologist.com about the
impact on China of accession to the World Trade Organisation and
the effects on the domestic pharmaceutical industry of the
resulting need to comply with international intellectual property
rules.

But the news that China has sidestepped patent protection for Pfizer's Viagra (sildenafil citrate) - used for the treatment for erectile dysfunction - suggests that the country's ability and will to come into line with WTO requirements may be lacking, writes Phil Taylor.

China's State Intellectual Property Office overturned the company's Chinese patent for sildenafil citrate, the active ingredient in the drug, following a challenge from several Chinese generic drugmakers.

According to Pfizer, the Chinese authorities have overturned the 'use' patent on Viagra - issued three years ago - on the grounds that some necessary laboratory data was not included in the original patent application. The US firm insists that at the time of filing there was no requirement for that data, and that to invalidate the patent on that basis is a flawed, retroactive judgment. It added that it is committed to appealing the decision.

China has offered full patent protection to foreign companies since January 1993, and more limited protection since 1986. However, many companies did not take advantage of this earlier legislation, and there is a legal loophole that allows Chinese companies to copy many products without a license.

The law in question is the Medicine Administrative Protection Statute of 1992, which says that holders of foreign pharmaceutical patents taken out between January 1986 and January 1993 could apply to the Chinese government for protection. As long as these products had not yet been sold in China, the government would grant a period of seven-and-a-half years during which Chinese companies were not allowed to copy them.

Pfizer's use patent in China was filed after 1993, so it should be subject to the WTO intellectual property regulations - although it is acknowledged that these still leave considerable discretionary powers to member companies.

The US drugmaker - currently the number one pharmaceutical company in the world - said in a statement that it was "extremely disheartened by this recent action."​ Pfizer has been marketing Viagra in China since it was awarded a patent there in September 2001 and while it was not prepared to disclose sales there, said it was a minor market for the drug. Worldwide Viagra sales were $1.8 billion last year.

The European Federation of Pharmaceutical Industry Associations sent a delegation to China last month to review progress on a number of issues, including intellectual property rights.

At the time, the trade body stressed that adherence to intellectual property rights "is key for the development of a strong China-based innovative pharmaceutical industry,"​ and pointed to the investments made by foreign companies in the country as a result of China's move towards respecting patents.

EFPIA told In-Pharmatechnologist.com​ that although the specific details in the case are not yet clear, "the Chinese decision does not appear at all in line with their formal intention to respect and enforce intellectual property rights as recently stated during our EFPIA visit in Beijing on 23-25 June."

EFPIA also points out that "strong enforcement of these rights should help to halt the significant increase of counterfeit pharmaceutical products in China."​ Viagra is particularly prone to counterfeiting in the country, where sexual potency aids are big business.

Similar patent challenges in Colombia and Venezuela have also resulted in the loss of patent protection for Viagra on those markets, although Pfizer insists that these cases rest on different issues than the Chinese case, and are also being appealed.

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