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Amendment of Patent Examination Guidelines on Pharmaceutical-Related Invention



The amended Patent Examination Guidelines on Pharmaceutical-Related Invention (hereinafter referred to as the "Guidelines") were published on 5 November 2019 and took effect on 1 January 2020.

 

The main amendments include:

 

(1)  Addition of examples for determining therapeutic method inventions

The amended Guidelines provide seven examples for determining therapeutic method inventions.  The criteria for determining whether "an ex vivo therapeutic method (for example, a method for processing biological sample ex vivo)" is unpatentable lies in whether the method explicitly or implicitly includes an in vivo step of treating humans or animals after the ex vivo steps; the time interval between the ex vivo step and the in vivo step is not critical. 

 

(2)  Pharmaceutically acceptable salts, esters, stereoisomers, hydrates and the like of a compound are deemed acceptable derivatives

The previous Guidelines (i.e. the 2013 version) only provide examination criteria for compounds, not their derivatives.  According to the amended Guidelines, pharmaceutically acceptable salts, esters, stereoisomers, hydrates and the like of a compound are deemed acceptable derivatives if the specification clearly discloses that there are derivatives of a compound, and the derivatives can be arrived at by persons of ordinary skill in the art based on the disclosure of the specification without undue experimentation.

 

(3)  Enantiomers, polymorphs and hydrates do not have an inventive step in principle

The amended Guidelines make clear that enantiomers, polymorphs and hydrates do not have an inventive step in principle, unless the patent applicant explains that the claimed enantiomers, polymorphs or hydrates cannot be easily produced or have unexpected effects.

 

 

 

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