Gilead to appeal Sofosbuvir patent rejection

Following on from our post yesterday, where I’d mentioned there were some potential issues with the patent office’s rejection of Gilead’s patent application over Hepatitis C drug, sofosbuvir, it appears Gilead will be appealing the decision due to the patent office’s handling of section 3(d). Also, its worth noting that besides Gilead’s patent application for sofosbuvir rejected, 13th January also saw India become the first Asian country to grant regulatory approval to sofosbuvir.

Gilead’s response is as below:

“Gregg Alton, executive Vice President, Corporate and Medical Affairs Gilead Sciences said:

The main patent applications covering sofosbuvir are still pending before the Indian Patent Office. This rejection relates to the patent application covering the metabolites of sofosbuvir. We are pleased that the Patent Office found in favor of the novelty and inventiveness of our claims, but believe their Section 3(d) decision to be improper. Gilead strongly defends its intellectual property. The company will be appealing the decision as well as exploring additional procedural options.

These proceedings do not impact our commitment to enabling access to our hepatitis C medicines in India and other developing countries, and our generic licensing program with our Indian partners continues as normal. We welcome the news that on the 13^th January 2015 the authorities in India granted sofosbuvir regulatory approval in an unprecedented four months – the first country in Asia to approve sofosbuvir – recognizing the need to bring this innovative new medicine to patients in India as quickly as possible.”

We’ll try to put forth a more detailed Section 3(d) analysis soon. I had evidently missed the news that regulatory approval for sofosbuvir had been granted in such a quick span – this is no doubt good news regardless of which stakeholder’s perspective you take. Regarding ‘the main’ patent applications that are still pending before the IPO, I’ve not yet looked at it myself but we did have an anonymous comment yesterday which seems to refer to it, indicating that Gilead Pharmasset has a weak case for it. I’m pasting the relevant part below.

The data provided in the table as submitted with the application only relates to the cytidine analogs, not the uridine analog which forms the base of sofosbuvir in its prodrug form (subject of the application 3658/KOLNP/2009). Pharmasset itself has said in earlier publications that (see Clark 2005) that the uridine base demonstrated no activity (which could translated to efficacy) or cytoxicity. This is the case also against the known forms which Gilead Pharmasset compound and the uridine analog derives from. It’s for this very reason Gilead Pharmasset cannot show how the uridine analog is more efficacious than the known forms.

[Full comment available here. You can also find I-MAK’s Opposition Documents for the above mentioned patent applications on this page].