Written By Yang Hongjun, Partner
The recent decision by the Beijing Higher People’s Court revoking the Patent Reexamination Board (PRB) invalidation Decision of Pfizer’s Viagra Patent in China has put an indefinite end to a drawn out battle between domestic drug companies and Pfizer. This case, while not firmly establishing any foundation for patent examinations, has revealed many of the risks associated for all parties in proceeding into a legal dispute regarding patents in China.
At the heart of this dispute was the reexamination of Pfizer’s patent for Viagra. The courts revoked the invalidation decision with respect to the Viagra Patent and as a result, the PRB was requested to render a new decision on the validity of Viagra patent. The judgment was final, but I believe that the grounds for the rulings are highly debatable.
The final ruling does not provide new reasoning for why the Viagra Patent application satisfies the requirements set forth in the Patent Law, it simply repeats the Intermediate Court’s previous ruling and leaves me unconvinced. Although the Guidelines on Patent Examination ("Guidelines") provides no specific provisions regarding the necessity of identifying specific compounds used in the pharmacology tests in a patent application, a clear and complete description of an invention is the basic requirement for the patent specifications. At the very least, the specifications should be consistent and self-explanatory. In this case, the applicants only provided one pharmacology test result and failed to specify the specific compound used in performing the test. It is impossible for the technicians in the industry to identify the relevant compounds to be used. If tests cannot be reproduced, then there are serious issues with the patent.
It is reasonable to say that the specification of the subject patent application did not satisfy the requirements of "providing clear and complete description of invention features". The final judgment reflects more or less a compromise between the Chinese and the US governments. As China is not a country that follows precedent, this has no practical significance for future patent drafting and examinations. I recommend that patent applicants, especially foreign applicants, should not be influenced too much by this court decision. Instead, patent applicants shall always provide clear specifications regarding the compounds applied in the pharmacology test in their patent specifications, as there won’t be political compromises between governments for every patent. The viagara decision should be considered a stand alone ruling.