Pfizer’s arthritis drug patent rejected in India
Pfizer’s arthritis drug Tofacitinib patent is rejected by Indian Patent Office.
Indian Patent Office had rejected Pfizer’s application to patent tofacitinib in 2011, but by the Pfizer’s Appeal, the Intellectual Property Appellate Board (IPAB) in October last year set aside an order by the patent office which rejected Pfizer’s patent for a new formula of the drug and directed it to re-consider the application.
On 3rd September, 2015, the Controller of Patents has rejected for the second time, the Pfizer’s patent application for its rheumatoid arthritis treatment drug Tofacitinib. Quoting a Supreme Court judgement NOVARTIS AG V/S UNION OF INDIA (CIVIL APPEAL Nos. 2706-2716 OF 2013), the order said that the applicant will have to establish the therapeutic enhanced efficacy of the claimed compound over the base compound.
Assistant Controller of Patents and Designs Bharat N S said:
“From the present amended claim 1, it can be concluded that the compound claimed in claim 1 is the enatiomer of compound of the cited document D1 and hence not novel and inventive as stated above. However, in absence of disclosure of any test result and comparative data over the base compound3-{4-Methyl-3-[methyl-(7H-pyrrolo [2, 3-d] pyrimidin-4-yl)-amino]piperidin-1-yl}-3-oxo-propionitrile (compound in D1), I do not admit that the claimed compound has enhanced efficacy over the base compound in D1 and hence not patentable under Section 3(d) of Patents Act. The applicant’s contention that D1 can’t be the document to assess the patentability aspect of the invention claimed, since not known only to the public is not acknowledged.
After having considered the submissions submitted by the applicant in the hearing, the written submission and amended claims filed, in view of the above discussions and findings by me, it is hereby ordered that the invention disclosed and claimed in the instant application i.e., “3-{(3R,4R)-4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1yl}-3-oxo-propionitrile or a pharmaceutically acceptable salt thereof” (amended claim 1 submitted on 30/01/2015) is not considered as an invention under the provisions of the Act as discussed above and I therefore, hereby refuse this Application No. 991/MUMNP/2003 to proceed further”
Cited Document D1 (WO0142246) discloses the claimed compound without reference to Stereo chemistry.
Full PDF: Tofacitinib Rejected_India
