Close on the heels of falling prey to pre-grant oppositions in August-September 2009 for two of its key anti-retroviral drugs, Gilead Sciences, Inc., has filed an appeal with the Intellectual Property Appellate Board in India to challenge the two IPO decisions against tenofovir disoproxil fumarate (TDF).You will recall Shouvik had posted on the opposition proceedings not too long ago. By way of a quick run-through the key issues raised in the opposition, lead by the Alternative Law Forum, these were:
1. TDF is created by the addition of a salt (fumaric acid) to an existing compound (tenofovir disoproxil). Publications pre-dating Gilead’s application for TDF were cited showing that fumaric acid is a suitable pharmaceutically acceptable salt for phosphonate nucleotide analogues and their esters, like TD, in order to achieve better bioavailability and stability.
2. Gilead’s application was simply claiming the salt of TD and the specification filed failed to show any therapeutic efficacy, failing therefore to overcome 3(d) issues.
3. Also highlighted were procedural flaws in Gilead’s application and misrepresentations in the patent specification regarding the claimed advantages of the invention, in particular as to why the fumaric acid salt performs better than other salts.
On its part, Gilead has chosen to highlight, through its note announcing the IPAB appeal, its licensing models particularly in the ARV space. Specifically, Gilead says its licensing model, a collaborative market-based model that Shouvik had blogged about earlier “demonstrates that the responsible use of intellectual property can enhance patient access to medications – not hinder it – while helping pave the way for future medical innovation.”
This news isn’t at all surprising, as Gilead’s appeal was an impending one, and something we have been tracking on the blog for some time now. Watch this space for more updates on the appeal, as and when we get information.
2. Gilead’s application was simply claiming the salt of TD and the specification filed failed to show any therapeutic efficacy, failing therefore to overcome 3(d) issues.
3. Also highlighted were procedural flaws in Gilead’s application and misrepresentations in the patent specification regarding the claimed advantages of the invention, in particular as to why the fumaric acid salt performs better than other salts.
On its part, Gilead has chosen to highlight, through its note announcing the IPAB appeal, its licensing models particularly in the ARV space. Specifically, Gilead says its licensing model, a collaborative market-based model that Shouvik had blogged about earlier “demonstrates that the responsible use of intellectual property can enhance patient access to medications – not hinder it – while helping pave the way for future medical innovation.”
This news isn’t at all surprising, as Gilead’s appeal was an impending one, and something we have been tracking on the blog for some time now. Watch this space for more updates on the appeal, as and when we get information.
An interesting aspect here is that “Gilead” has preferred an appeal from the order of the Controller under Section 25(1). Has the IPAB admitted the appeal; set a date for a hearing etc?While, it has been argued that decisons in pre-grant oppositions ought to be appealable before the IPAB(when read together with Section 15), there has been no clear Court direction so far.It would be helpful, if we know if the IPAB has entertained the appeal and if so, if it has given any reasons for doing so…
Yes, to monitor for whether IPAB accepts or not. When controller reject patent application U/S 25(1), it becomes power of controller U/S 15 and appeal able to IPAB