India grants patent to Gilead’s expensive hepatitis drug, Sovaldi (Sofosbuvir)
Sovaldi (sofosbuvir) had earlier faced a thumb down on the patent application by the Controller General of Patents, Designs and Trademark but the latest ruling overturns that decision.
Gilead has applied for patent numbered 6087/DELNP/2005 claiming the active metabolites of sofosbuvir on 27th March 2005 and was refused by IPO on 13th Jan 2015, then remanded back by Hon’ble Delhi High Court in writ petition on 30th Jan 2015. Several Oppositions were filed and opponents were Natco, Delhi Network of Positive People (DNP+); and The Initiative For Medicines, Access & Knowledge, Inc (I-MAK) INC, BDR Pharma, Optimus, Sankalp, India cares.
The IPO has granted the patent on 9th May, 2016 and Dr.Rajesh Dixit, Deputy Controller of Patents & Designs in the order mentioned
A new chemical entity (NCE) that is structurally dissimilar but functionally similar to an existing chemical entity is thus merely a substance under section 3(d). If the substance has an added layer of enhanced efficacy, then it will be treated as a ‘new product’ and would be eligible for assessment under Section 2(1) (j) to ascertain whether its formation involved an inventive step. If the new product involved one or more inventive step, then it will qualify as a pharmaceutical substance.
The patent application provides comparative activity and toxicity data in mice and monkey. Further, additional comparative activity data has been filed during the examination of the patent application. These data have been relied during the hearing. Further, Applicant also argued that the medicine prepared from the compounds claimed in the present invention has resulted in breakthrough treatment of HCV infection and the medicine is approved in many countries including USA and India. I am satisfied that claimed compound have added layer of enhanced efficacy. From the above, it is clear that claimed compounds are outside the prohibition of Section 3(d). As stated earlier claimed compounds are novel and inventive. (order: Click here)
The claims granted according to the order are finally amended claims 1 to 8 as filed on 29th April, 2016 by the applicant (Gilead) (click for granted Claims)
“We welcome news that the Indian Patent Office (IPO) of New Delhi has granted our patent application [No. 6087/DELNP/2005] claiming the active metabolites of sofosbuvir. The recognition of intellectual property (IP) is central to investment in pharmaceutical research and development, and this decision underlines the scientific innovation involved in the development of this breakthrough treatment for chronic hepatitis C,” spokesman Nick Francis, Gilead Sciences said in a statement.
“It is the company’s goal to enable access to these medicines for as many people as possible, as quickly as possible. In developing countries the issuing of patents is often cited as a barrier to access, however the company believes that if used responsibly IP does not hinder access, supporting a sustainable model of voluntary generic licensing for more than a decade. This licensing program enables the manufacture and distribution of high-quality, low-cost versions of the company’s medicines for HIV, hepatitis B and hepatitis C,” Francis said.
We will have to wait and see how the Indian Pharma Industry and Legal Experts react to this order.
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Source: Controller Decision (IPO) and fiercepharma
