Following the discovery of the mechanism of RNAi in the late 1990s, the race to apply the technology to a range of human diseases has been intense, and has seen significant challenges to several siRNA patents. With its unique ddRNAi technology, it is not surprising that Benitec Biopharma has not been immune from patent challenges.
In the mid 2000s following litigation in defense of our Graham family of patents Benitec was required to defend them in re-examinations in most major jurisdictions. When the litigation concluded, Benitec had prevailed and our patents had been re-examined and re-issued in all major jurisdictions, except Europe and the US.
A major landmark for the Company occurred in September 2010, when the US Patent and Trademark Office's Board of Appeal reversed all previous objections to the 099 US Graham patent. This was followed by the issuance of the Re-Examination Certificate in March 2011, the final formal step in reinstating the patent. Since then several other US-based Graham family patents have been issued, providing a very broad and robust patent position for use of ddRNAi in the human field (View our patent estate). For us, the episode was distracting, yet ultimately successful, indicating clearly the strength of our patent position for ddRNAi technology. Few RNAi patent challenges during the same period have proven to be as decisive.
In October 2010 Benitec Biopharma received a notice from the United Kingdom Patent Office that an appeal for revocation of Benitec Biopharma’s UK Patent no. 2353282 had been received from an unnamed claimant. CSIRO and Benitec comprehensively responded to the Claimant’s various submissions and in June 2012 following minor modification of the patent claims to provide greater clarity, in particular that the claims were to double stranded constructs, the Request for Revocation was withdrawn.