Research On Patent Protection Of Chiral Drugs

With the advancement of technology and the stricter requirements for drug marketing approval,chiral drugs have undergone a transformation from racemates to racemates,enantiomers,and coexistence of non-equivalent enantiomers.However,the patent protection of chiral drugs still lags behind the technological development,and there are still the following problems to be solved:First,the definition of the object of the racemate patent is unclear;second,the substantive examination of enantiomers faces legal obstacles;The infringement judgment rules for chiral drugs are unreasonable.Therefore,it is necessary to examine the examination practices of various countries,while taking into account the balance of chemistry and law,and to solve these problems with the order of scientific research and substance synthesis as a starting point.The specific scheme is as follows:First,the object of the racemate patent and the way of characterization are clearly defined.A racemate in a chemical sense is a mixture of two enantiomers,but the two substances have the same planar structure and almost the same physical properties and coexist in equimolar ratios.Racemates are very different from ordinary mixtures,especially when they are inseparable,and it is difficult to review them with the rules of composition.They should be regarded as "quasi-compounds",according to the requirements of the compound with the name,plane structure formula characterization.Second,improve the substantive examination standards for enantiomer patents.First,to implement the practicality review standards,the State Intellectual Property Office and the State Drug Administration will establish an inter-office review coordination mechanism to conduct joint review of drug efficacy when applying for a patent for drug use or when applying for a drug to be marketed.Second,the review criteria for innovative novelty,the racemate is used as the epistatic concept of enantiomer,and the plane structural formula of the racemate is used as the general formula of the enantiomer.According to the general formula,the novelty of the specific compound is not destroyed.The rules of sex make enantiomers novel.Third,relax the criteria for creativity examination,take the racemate of the compound as its closest comparison document,and no longer consider the factor of structural modification,and use kinetic or thermodynamic indicators to quantitatively judge the technical effect of enantiomers,and consider whether compounds with the same basic core moiety or basic ring as enantiomers provide technical insight.Finally,improve the rules for judging patent infringement of chiral drugs.According to the order of scientific invention and research,the racemate patent is given a larger scope of protection,and the racemate patent is regarded as the basic patent and the enantiomer patent as the improvement patent.When the two patents coexist,racemates,enantiomers,and unequal enantiomeric mixtures will fall within the protection scope of the racemate patent,while enantiomers and unequal enantiomers Enantiomeric mixtures also fall within the scope of the enantiomer patent.