http://www.nature.com/drugdisc/news/articles/nrd1595.html Patent fights rumble in China fromby Ken Howard Opinions differ in interpretations of patent prosecution and infringement litigation
Two recent patent decisions in China against the top two pharma companies could be the murmurings of its patent system becoming more firmly entrenched in domestic economic growth, while international companies are attempting to achieve a favourable intellectual property position in a potentially huge market.
In August, GlaxoSmithKline voluntarily abandoned a formulation patent in China for its diabetes treatment rosiglitazone maleate (Avandia), after it was challenged by four Chinese companies. And Pfizer is appealing against a decision by China's patent review board, which in July revoked its method of use patent for Viagra.
"The [Viagra] patent was rejected because it didn't contain information that was not required or asked for" at the initial filing, says Bryant Haskins, a spokesperson at Pfizer. "We think this type of ruling undermines the patent process in China [and it] certainly gives us cause for concern."
China joined the World Trade Organization (WTO) three years ago, and since then its legal system has made enormous strides to harmonize its laws and procedures with other WTO countries.
The Chinese government's decisions on the Viagra and Avandia cases were based on Chinese patent law, says Rongling Deng, a World Health Organization fellow who is now with the Chinese regulatory authority, SDA, although her comments were not made in an official capacity.
"In 2001, Pfizer received the Viagra patent of method of use in a great argument," says Deng. "It was said there were political reasons, since from Chinese law's perspective, Pfizer should not have been granted this patent." Deng says this challenge is no different to when Pfizer lost the same Viagra patent in the UK to Lilly with Cialis.
"GSK gave up its formulation patent on rosiglitazone, but still holds the compound patent and the manufacturing process patent on Avandia until 2013," says Deng. "I guess GSK made its decision because of the weak defences of novelty and fairness of the patent."
The recent cases could actually signal the emergence of a robust local patent system, says Ronald Eisenstein, a partner in the biotechnology and intellectual property group at Nixon Peabody, based in Boston, Massachusetts. "If you look at Taiwan, the patent system is notorious for decisions that give home court advantage to local companies," he says.
Because Chinese law is different than US, the Pfizer and GSK decisions might be correct based on the reading of local law, says Eisenstein. Additionally, he points out, if a patent is written on the basis of laws of the country from which it emerged, you can hit road blocks in other countries whose laws and processes differ even slightly.
From the Chinese market perspective, counterfeit drugs are still a problem that both international and local drug companies face, says Deng. "However, from the local drug maker perspective, international drug companies somehow have better treatment than local drug companies, especially international giants."
To help accelerate the harmonization process in China, the United States Patent and Trademark Office (USPTO) has for the first time stationed an attorney-advisor, Mark Cohen, overseas.
The USPTO's main goals with respect to pharmaceutical drugs are to work with the Chinese government to improve enforcement against counterfeit products; to help streamline China's patent application process; to assist in implementing laws and regulations to protect clinical data that must be submitted to regulatory agencies in China; and to help develop a system to ensure that government agencies in China are coordinating efforts against approval of generics on patented pharmaceutical products without the consent of the patent owner, says USPTO spokesperson Brigid Quinn.
All parties acknowledge that despite the difficulties China represents such a potentially huge market that this will motivate both local pharmaceutical companies, as well as international corporations, to continue to pay close attention to China's patent system.
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