In This Issue

IPOs Rejection to Xtandi

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IPOs Rejection to Xtandi


Generic 1: (happily) Hey, did you hear about another rejection from IPO??

Public 1: (blah) Surprise me!

Indian Patent Office, who keeps the Pharma world rocking (wink) has come up with another rejection to big fat recent step mother Pharma Giant Pfizer. The application was claiming diarylhydantoin compounds including diarylthiohydantoins, and methods for synthesizing them which are be able to use for the treatment of hormone refractory prostate cancer. Prostate cancer is the second most disease in males where the cost of the treatment eats up a hefty amount of money where only about 8-10% public can afford it. November 10, 2016, the IPO has revoked Pfizer’s application for the grant of a patent for it’s another wonder cancer drug; “Xtandi” which is marketed by Japanese Astella Pharma. The application was suffering from three consequent opponents; Fresenius Kabi in 2012, Mumbai-based BDR Pharma in 2013, and Indian Pharmaceutical Alliance, an organization of 20 research based Indian drug companies in 2016. Keeping an eye on the grounds, the opposition was made over the grounds that the subject matter of the application was not novel; that it did not involve an inventive step; and it did not constitute an invention on account of doodle of Section 3(d). The question of Novelty was rejected by the IPO as none of the prior arts had disclosed the structure of enzalutamide’s compound claimed in the application. Notwithstanding, the Controller has refused the application stating that the claimed invention is lacking inventive step under section 2(1)(ja) and also not patentable under section 3(d) and 3(e).

As per the survey the drug is costing 3.35 lakh per month sold by Japanese Astellas Pharma which is roughly $180 or Rs. 11,000 per day, which is now having rejected, assumed to be welcome by the generics probably resulting in 70 percent less in existing price for monthly dosage.

There is again a constant stress between the public and the Pharma companies where cost of R&D incurred by the Pharma companies were affected and cost of drug affects the patients. The denial of a patent obviously opens the door for generic manufactures but still there is nothing to loose faith on the Patent Office because the IPO is ready to award you with genuine reward if law allows doing so.

Generic 1: Surprised??

Public 1: Can you do it at 50?? (Smirk)

UNDP issued Guidelines for Examination of Pharmaceutical Patents

In the early June 2016, UNDP has published the Guidelines for the examination of the Pharmaceutical patents for encouraging and promoting the countries to provide crystal clear and efficient patent system for life saving drugs. The Guidelines were adopted from the recent Indian Draft Guidelines prepared for the Examination of Patent Applications related to Pharma for the public good and to eliminate the superficial patents in the field. The Guidelines were drafted by Prof. Carlos M Correa to determine and clarifying the criteria for patentability and to encourage the domestic Pharma industries.

“Access to medicine Index” – The award goes to “GSK”

A well-known biennial study that ranks the top 20 innovator companies on 7 parameters related to access has released the latest ‘Access to Medicine Index’, for the year 2016. It is brought out by ‘The Access to Medicine Foundation’ funded by the UK Department of International Development (UK aid), the Bill & Melinda Gates Foundation and the Dutch Ministry of Foreign Affairs. The Index evaluates and measures research-based pharmaceutical companies over their efficiency of making medicines, vaccines and diagnostics more accessible in the middle and low income countries. Being consistent in the race in the fifth year, the GlaxoSmithKline (GSK) has been awarded with the first stand leaving behind companies such as Johnson & Johnson, Novartis, Merck KGaA and Merck & Co. Inc.

Source: Manupatra



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