Article 20 Where process or treatment is made to a follow-up product, which was obtained by further processing or treating a product directly obtained by a patented process, the People’s Court shall determine the action does not belong to “using the product directly obtained by the patented process” prescribed in Article 11 of the Patent Law.

This article is a supplement to Article 11 of the Patent Law [1]and Article 13 of the Judicial Interpretation I[2]. Article 11 of the Patent Law intends to extend protection of process patent to the product directly obtained by the patented process, so as to remedy weak protection on process patent due to difficulty in obtaining evidence. In the Judicial Interpretation I, the key concept “the product directly obtained by the patented process” is defined as the original product obtained by the patented process. In addition, it is further clarified that the action to process and treat such an original product to obtain a follow-up product belongs to the action of “use” defined in Article 11 of the Patent Law, i.e. belongs to infringement. Article 20 of the Interpretation II clearly excludes the action of further processing or treating a follow-up product from infringing actions. The purpose of Article 20 of the Interpretation II is to limit extension of protection from patented process to product in a reasonable scope, so as to avoid disturbing normal downstream business actions.

In the judgement of Zhangxitian vs. CSPC OUYI Pharmaceutical Co., Ltd.[3], the Supreme People’s Court clarified that the protection scope of a process patent can ONLY be extended to the product directly obtained by the patented process, i.e. the immediate product obtained by the patented process; the protection cannot be extended to the follow-up product obtained by further processing and treating of the immediate product. According to the patented process of claim 1 of the patent, the immediate product directly obtained after the final step is an intermediate product used to produce (S)-Amlodipine, but not (S)-Amlodipine itself. Therefore, (S)-Amlodipine maleate, tablets of (S)-Amlodipine maleate and (S)-Amlodipine produced by the alleged infringer all belong to the follow-up product obtained by further processing and treating of the above mentioned immediate product. None of them belongs to products directly obtained by the process of the patent. Therefore, the protection scope of the patent cannot be extended to (S)-Amlodipine maleate, tablets of (S)-Amlodipine maleate and (S)-Amlodipine.

Based on the current law and regulations as well as related cases, we recommend drafting claims according to possible patterns of infringement, insofar as the scope of protection is extended from patented process to product.

First of all, because the protection on patented process cannot be extended without limit, various patterns of infringement should be considered in the draft of claims on manufacturing processes to avoid unnecessary lost.

For example, lead active compounds (immediate product) initially discovered are normally not suitable to be used as medicines. In most cases they need to be optimized into active pharmaceutical ingredients (follow-up product), and then processed by several formulation means into medicines (final product) and sold to end consumers. In drafting of claims, it is recommended to protect various forms of the immediate product, the follow-up product and the final product by different claims. In order to protect the manufacture process of the medicines, process claims should be drafted accordingly for these products.

In addition, the determination of “the product directly obtained by the patented process” is not based on the title of the claim, but based on the product obtained directly after the final step defined in the claim[4]. Therefore, attention should be paid to wording of process claims.

[1] Article 11 of the Patent Law

“After the grant of the patent right for an invention or utility model, except where otherwise provided for in this Law, no entity or individual may, without the authorization of the patentee, exploit the patent, that is, make, use, offer to sell, sell or import the patented product, or use the patented process, and use, offer to sell, sell or import the product directly obtained by the patented process, for production or business purposes.

[2] Article 13 of the Interpretation by the Supreme People’s Court on Some Issues Concerning The Application of Laws in the Trial of Patent Infringement Dispute Cases (I)

The original product obtained using the patented process will be recognized by the people’s courts as “the product directly obtained by the patented process” under Article 11 of the Patent Law.

The action of further processing or treating the above mentioned original product to obtain the follow-up product will be recognized by the people’s courts as “using … the product directly obtained by the patented process” under Article 11 of the Patent Law.

[3] Judgement (2009) Min-Ti-Zi No. 84 of the Supreme People’s Court

[4] Judgement (2009) Min-Ti-Zi No. 84 of the Supreme People’s Court

“According to claim 1 of the implicated patent, the subject matter is “a method of isolating (R)-(+)- and (S)-(+)- isomers of Amlodipine from mixtures….However, according to the content described in claim 1, the product directly obtained from the patented process is ‘D-tartrate of (S)-(-)-Amlodipine combined with a DMSO-d6’ or ‘L-tartrate of (R)-(+)-Amlodipine combined with a DMSO-d6’…