Extending the market exclusivity of therapeutic antibodies through dosage patents.
Dosage patents are one way to extend the market exclusivity of an approved drug beyond the lifetime of the patent that protects the drug as such. Dosage patents may help to compensate the applicant for the long period where the active pharmaceutical ingredient as such is already under patent prosecution, but not on the market yet, due to lengthy development and approval procedures. This situation erodes part of the time the drug is marketed under patent protection. Dosage patents filed at a later date can provide remedy for this problem. Examples of successful and unsuccesful attempts, and the reasons for the respective outcomes, are provided in this article.
a Senior Partner, Michalski · Hüttermann & Partner Patent Attorneys , Düsseldorf , Germany.
Ulrich
U
Storz
D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods*; D006801:Humans; D007167:Immunotherapy / Q000331:legislation & jurisprudence*
D000911:Antibodies, Monoclonal
Dosage; fractionation; inventive step; patent; rituximab; trastuzumab