In a recently uploaded decision in ipindia which is related to Humira dosing regimen patent, patent applicant successfully traverse 3(e) and 3(i) grounds of opposition. Patent application no 6618/DELNP/2006 and titled: “MULTIPLE-VARIABLE DOSE REGIMEN FOR TREATING TNF -RELATED DISORDERS“, Patent applicant is Abbott and opponent is Glenmark.
Inventive step of this application is related to multiple variable dosing method for treating TNFa disorders (pls refer PCT claims) and their Indian national phase application claims are amended to contain claim preamble of “pharmaceutical composition” with dosing restriction.
This 6618 application is opposed on various grounds including 3(e) and 3(i). As per controllers opinion, opposing under 3(i) is not applicable, since claims are related to pharmaceutical composition. Opposition under 3(e) is traversed by submitted expert evidence (Dr. Hoffman affidavit who is one of the inventor) and synergism between TNFa inhibitor and methotrexate.
Indian patent office grants such use/dosing regimen invention in a claim format of “pharmaceutical composition”. Another example is recently published patent grant of 249114 (1693/DEL/1998) assigned to smithkline beecham. This application is filed with claim preamble of “method of treating” and subsequent granted claims preamble is “Pharmaceutical composition for use in the treatment of“.
Important message here is invention related to use/dosing regimen/combination can be patented by pharmaceutical composition claim format such as pharmaceutical composition comprising X for the treatment of disorder Y with dosing/combination/ratio/some inventive step limitation.