INTRODUCTION

Assessment of Patentability of combination/ composition patents at the Indian Patent Office (IPO)  is highly dependent on section 3(e) of the Patents  Act, 1970 (hereinafter the Act). A common strategy  adopted by applicants of pharmaceutical inventions  has been to draft a formulation/composition/ combination claim to move the application away  from the scrutiny of section 3(d). In case of a  formulation/composition/combination claim when  the overall effect of the combination claim produces  an unpredictable change from the individual  derivatives' functions, the result is termed  "synergistic." Synergism then is the combining of  known derivatives to produce unique result.

Section 3(e) precludes patenting of "a substance  obtained by a mere admixture resulting only in the  aggregation of the properties of the components  thereof or a process for producing such substance".  The following article is an analysis of IPO's  interpretation of synergism in light of Section 3(e) of  the Act.

SYNERGY AND NON-OBVIOUSNESS

As per the Guidelines for Examination of Patent  Applications in the Field of Pharmaceuticals  (October 2014), synergy means a surprising effect/ outcome of the combinations, prior art prejudice etc.  which usually demonstrates the non-obvious nature  of the invention. Synergy refers to therapeutic  activity in case of chemical composition claims, for  example, composition of compound "A" in claimed  range with pharmaceutically acceptable excipients  in claimed range provides therapeutic activity.

As per the manual of Patent office Practice and  Procedure (Version 3.0, 01 March 2019), "Synergistic  effect should be clearly brought out in the description  as per Section 3(e) by way of comparison at the time  of filing of the Application itself. The subsequent  submissions regarding synergism can be accepted in  a reply to the office action as a further support of  synergy". Therefore, post-filing experimental data  should be within the scope of the originally-filed  specification. IPO accepts post filing of experimental  data. However, when there is no mention of said  synergy in the specification but it is relied upon in  securing a Patent, then the originally filed claims  should possess everything that covers 'the synergistic  effect' and it must be described in the specification. There are a few instances where even though no data  regarding therapeutic efficacy or synergism was  produced nevertheless patents were granted by IPO.  In some cases, the decision granting the patent refers  to the IPAB decision in Ajantha Pharma Ltd v.  Allergan Inc1, which finds mention in the 2014  pharmaceutical guidelines.

The relevant extract from the order is as follows:

"The combination mentioned in the Explanation can  only mean a combination of two or more of the  derivatives mentioned in the Explanation or  combination of one or more of the derivatives with  the known substance which may result in a significant  difference with regard to the efficacy."

PATENTS THAT WERE GRANTED  WITHOUT SYNERGY DATA IN THE  CONTROLLER'S ORDER

  • In 255959, objection under section 3(d) was found not relevant and section 3(e) grounds were  not sustainable owing to synergy of delivery   However, the order doesn't provide any  reasons or data used to overcome the objections.
  • In 268726, objections under section 3(e) were waived as the applicant had shown different  unexpected results in the reply to FER. In  271316, Section 3(e) objection was raised not  under Section 15 but only in FER. The applicant  showed improved effects.
  • In 271352, it was shown that efficacy was better as a combination compared to individual ones.
  • In 272359 which is composition claim, synergism was explained to overcome section 3(e) without  any data to justify. Applicant argued against  section 3(d) here, suggesting this is a combination  of known active ingredient and an unknown  
  • In 273120, Composition claim, applicant mentions that having 3 active agents will have a  broader efficacy. The applicant amended the  claims to overcome sections 3(e) and 3(d). No  data was reproduced in the order of the  

PATENTS THAT WERE GRANTED  WITH SYNERGY DATA IN THE  CONTROLLER'S ORDER

  • In 262783, for objection regarding section 3(e) the composition of the present invention was  submitted as superior composition by the  applicant by producing comparison data,  however, efficacy was not demonstrated by  proper comparison.
  • In 262988, section 3(e) objection was overcome by the data submitted that demonstrated the  composition claimed shows superior stability  and provides a formulation which is suitable for  administration of voriconazole for the first time.
  • In 264718, data was submitted to show that the claimed composition is efficacious, effective,  and synergistic.
  • In 266487, the applicant showed that the present invention is a novel and inventive composition  and supplemented it with the pharmacokinetic  profile to show the improved treatment by the  instant composition, thereby satisfying the  requirements of sections 3(d) & 3(e).
  • In 268062, the specification shows the synergistic effect of the composition of the present invention.  The objection for section 3(e) is also waived in  view of the submission for inventive steps and  novelty and the affidavit submitted by the  
  • In 268331, the Controller concluded that the formulation of present invention is not a mere  admixture but shown synergism /surprising  
  • In 27116, claims that were amended after a hearing to overcome section 3(e) showed  improved technical effect showing structured  vesicular arrangement in the data submitted as  
  • Further in the granted patent numbers 273641, 274779 and 275630 synergistic effect data such  as pharmacokinetic data in the specification was  provided to overcome section 3(e) objection.

CONCLUSION

From the decisions above, it can be inferred that  there exists differing standards and inconsistencies  in granting or rejecting patents in case of  pharmaceutical patents. Such inconsistencies may  prove detrimental in providing access to drugs for  different diseases.

Footnote

1 Ajantha Pharma Ltd v. Allergan Inc, IPAB, ORA/21/2011/PT/KOL of  Order no. 173 of 2013.

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