The following outcomes have recently been achieved:
- Further to the announcement of 17 February 2011, the re-examination certificate for the Graham '099 patent [US Patent No. 6,573,099: "Genetic Constructs for Delaying or Repressing the Expression of a Target Gene"] has now been issued by the US Patent and Trademark Office (USPTO) and received last week by Benitec. This effectively reinstates the patent which had been subject to challenge and provides Benitec with the exclusive US rights to ddRNAi technology for research use and as human therapeutics.
- Substantial progress has been made with the Graham patent applications in Europe, where we have recently been informed that all outstanding objections to the pending claims by the European Patent Office have been overcome. Allowance in Europe will result in allowance of the Graham patent applications in every major Western jurisdiction in which it was being pursued.
- On 10 March 2011, Benitec was advised that Australian Patent Application No. 2008249157, a divisional application of Australian patent 2005209648, "Control of gene expression" (a member of the '099 Graham patent family), had been accepted by IP Australia. This patent has similar claims to those in order for allowance in Europe, further strengthening the Company's existing patent protection in Australia.
- In the UK, CSIRO and Benitec have responded to the Applicant's request for revocation of the GB2,353,282 (receipt of the request for revocation was announced on 5 November 2010) and a timetable for evidence and a date for hearing of the request is now pending. The hearing date is expected to be in the middle of this year, with resolution shortly thereafter. Benitec remains optimistic of a positive outcome from this action, as has been the case in the USA and other jurisdictions where similar arguments have been successfully rebutted.
- A further Graham patent (3413/DELNP/2005) has been granted in India (March 2011) to complement existing patent protection in the Asia region, which already includes patents in Japan, China, Hong Kong and Singapore for which Benitec is the exclusive licensee in the human field.
- In the USA, several patent applications (10/821,726, 10/346,853, 10/759,841 and 11/218999) that are continuations of the '099 Graham patent family are progressing well and will serve to further strengthen our patent position in this key jurisdiction when granted.
- Benitec also has a number of Graham patent applications pending in several other jurisdictions, including Canada and China, and are progressing those as appropriate.
Commenting on the progress made in its patent estate in the last six months, Dr Peter French, Benitec's CEO, said: "The significant progress made in the Graham patent family in a range of countries reinforces Benitec's dominant worldwide position in the field of ddRNAi and enables us to execute our strategy of building a pipeline of novel ddRNAi-based therapeutics whose commercial potential is protected by a robust intellectual property position."
Benitec Biopharma Limited