As a subsidiary company of Pfizer, WARMER LAMBERT CO(“LAMBERT”) owns an invention patent for atorvastatin.  

Beijing Jialin pharmaceutical co., ltd. (JIALIN) and natural person ZHANG Chu filed an invalidation request against the above patent before the Patent Reexamination Board (PRB) under Article 26(3) of Chinese Patent Law for its Insufficient Disclosure.

This patent was declared invalid by the PRB and the court of first instance (Intermediate Court ofBeijing City) supported the decision of the PRB based on the following grounds:  

1) The Description does not provide any precise data to prove that the I-crystal of atorvastatin does contain 1-8 mole of water, thus the product to be protected cannot be determined;

2) The person skilled in the art cannot make sure how to produce the I-crystal of atorvastatin containing 1-8 mole of water.

LAMBERT appealed to High Court of Beijing City for second Instance, and the High Court of Beijing City overturned the invalidation decision of the PRB because the High Court thought that the PRBdid not consider the technical problem correctly.

Finally, the PRB filed a retrial with the Supreme Court and the Supreme Court affirmed that:

1) The Description of a chemical compound patent shall record the identification, preparation and use of the chemical compound.  In particular, when the invention is related to a composition, the description shall introduce the chemical construction and the parameters of the chemical and/or physical property of the composition so that the person skilled in the art can identify the composition.  In addition, the Description shall also disclose at least one available method for preparing the composition.

2) The identification of reproduction of technical solution shall be prior to that of the technical problem.  

3）The experiment data submitted after filing date can be took into account if it can prove that the person skilled in the art can implement the invention according to the disclosure of the description.

Eventually, the Supreme Court overturned the judgment of the second instance and upheld the judgment of the first instance to invalidate the patent of LAMBERT.  

This case involves how to evaluate whether the disclosure of the chemical patent is sufficient or not.  The Supreme Court exemplified with some basic rules regarding sufficient disclosure and these rules will be significant guidance for drafting of chemical patent application.