This post was first published on 18th January, 2011.
In a recent case, reported here by Sandeep, the patent office denied patent grant to Abbott’s HIV drug application (application No:339/MUMNP/2006, WO2005/039551), stating that the subject matter did not constitute an invention. Abbott’s application was rejected as a result of the pre grant oppositions filed by Initiative for Medicines, Access & Knowledge’ (I-MAK), Cipla (Mumbai), Matrix Laboratories (Secunderabad) and Okasa Pharmaceuticals (Mumbai).
The complete specification of Abbott’s application was entitled “SOLID PHARMACEUTICAL DOSAGE FORM” and had the conventional priority of US application No. 10/650,178 dated 28th August, 2003. The complete specification had 37 claims out of which, claims 1-18 and 22-36 claimed a solid pharmaceutical dosage form, claims 19-20 claimed a method of preparing the solid pharmaceutical dosage form, claims 21 and 37 claimed a method of treating an HIV infection. The application provides dosage forms of ritonavir and/or lopinavir with specific water-soluble polymers (polvinlpyrrolidone) and surfactant. Although the use of ritonavir and/or lopinavir is already known, the application provides a drug whose bioavailability is enhanced by the use of the specific water-soluble polymers and surfactant. In other words, the application discloses a system which provides better availability of ritonavir and/or lopinavir in HIV positive patients.
Well, the opponents adorned their pre grant representation with references to support their allegations that Abbott’s application was insufficient, was not patentable under section 3(d) and 3(e), and was not an invention. Additionally, they stated that the invention was not patentable because of non intimation of information under section 8 to the controller and since the application was not made within 12 months.The opponents argued that the subject matter was not patentable due to lack of inventive step and novelty. References including WO01/22938, WO97/44014, WO01/034119 and US 6599528 were referred to the patent office for comparison with the subject matter of Abbott’s application.
Abbott’s application was rejected as the patent office held that the patent was “not an invention” in the light of Abbott’s own applications WO01/034119 and US 6599528. Section 2(1)(j) of the act reads; “invention” means a new product or process involving an inventive step and capable of industrial application. The patent office stated that the subject matter of claim 22 was not new and claims 1-21 did not involve inventive step in the light of ‘119 and ‘528. ‘119 discloses the use of the water soluble carrier, polvinlpyrrolidone, and a suitable surfactant in a pharmaceutical composition comprising ritonavir. ‘528, on the other hand, provides the use of polvinlpyrrolidone with a suitable surfactant to obtain a pharmaceutical composition comprising ritonavir with better bioavailability. Therefore, in light of references ‘119 and ‘528, the subject matter of Abbott’s application was reckoned not to constitute an invention.
Further,in response to the opposition ground that the invention is not patentable under section 3 (d) and 3 (e). The patent office stated that the pharmaceutical composition and the invention in Abbott’s application lies in the selection of suitable surfactants and in the pharmaceutical composition which has been arrived at after selecting the constituents. Therefore, although the individual components have been used and disclosed earlier, it cannot be a mere admixture and not a mere discovery of a new form of a known substance.
Well, with this rejection of Abbott’s application and to the subsequent delight of the generics, Abbott has given to public a dosage form to treat HIV with better bioavailability.
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