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In a relief to the US pharma major Pfizer, The Intellectual Property Appellate Board (IPAB) has set aside the Assistant Controller of Patents and Designs order, which rejected the Patent Application the pharma company for a drug Tofacitineb treating rheumatoid arthritis.
The Board has also remanded back the patent application to the Patent Office with a direction that a new assistant controller, other than the one who authored the impugned order, should consider the matter afresh, in next three months' time.
This is the second positive news the pharma company gets in the last two months, earlier it had received a patent for its antifungal drug Voriconazole, which it is selling in US under the brand name Vfend, overcoming opposition filed by companies including Ranbaxy Labs Ltd and Natco Pharma.
The IPAB bench, consists of Justice K N Basha, chairman and D P S Parmar, technical member - patents - has asked the assistant controller to reconsider the matter afresh, providing ample opportunity to present Pfizer's case.
She argued that the assistant controller had reje
cted the patent application without giving the objections to them in advance thereby depriving the opportunity for counter argument and erred in many aspects.
She submitted that it is classic case of flagrant violation of principles of natural justice and pleaded that the patent application be moved for patent registration.
Last month, IPAB allowed a condonation of delay (CoD) petition of Pfizer Products Inc, clearing the way for its appeal against a decision of Patent Office rejecting patent for its rheumatoid arthritis drug Tofacitinib. Pfizer sells the drug in the brand names Xeljanz and Jakvinus.
Pfizer's application for the patent, entitled Chiral Salt Resolution was rejected by the Patent Office in an order dated June 9, 2011, as the Assistant Controller of Patent and Design stated that the claim is not patentable under section 3 (d) of the Patent Act and it lacks novelty.
The company then filed a review application, which was rejected by the Patent Office on March 27, 2014. With this, the company approached the IPAB with an appeal, on which the Board asked the reason for the delay as the impugned order is dated June 9, 2011 and the appeal is being filed now.
Archana Shanker earlier argued that the delay of 33 months and 12 days was due to the filing of the review application and its disposal and the delay is neither wilful, nor wanted.
According to the copy of the order under challenge, the application was for a pharmaceutical composition comprising a compound, or a pharmaceutically acceptable salt along with a pharmaceutically acceptable carrier used for treating or preventing a disorder or condition selected from organ transplant rejection, lupus, multiple sclerosis, rheumatoid arthritis, psoriasis, Type I diabetes and complications from diabetes, cancer, asthma, atopic dermatitis, autoimmune thyroid disordersand other autoimmune diseases, among others.
Pfizer has filed in Patent Office Mumbai, on October, 2003 and the First Examination Report was issued on March 13, 2008. Pfizer filed reply and amended claims on January, 2009, stating that they have complied all the requirements of FER and requested grant of patent to the application.
The second Examination Report was issued on March 14, 2011 with a hearing notice fixing a date on March 29, 2011. After the necessary procedures, the official issued an order rejecting the application "Chiram salt resolution" stating that it "is not considered as an invention under the provisions of the Act..."
Section 3(d) of the Patent Act, 1970 states, "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant."
According to an announcement of Pfizer in June this year, the Xeljanz, a new class of medicines known as Janus kinase (JAK) inhibitors, has been approved in more than 20 countries for the treatment of patients with moderately to severely active rheumatoid arthritis who had an inadequate response to existing therapies. The company is carrying out various studies to establish the benefit risk profile in rheumatoid arthritis, a disease which affects more than 23 million people worldwide, it said.