Benitec's core patents and patent rights are based on this early research and are supported by subsequent filings that extend the scope and jurisdiction of its intellectual property.
Benitec's patent estate represents a dominant position in DNA-directed gene silencing, and potentially the dominant position in RNAi applications for humans and mammals. Benitec has over 60 filed patents and has licensed several additional patents that extend the scope of its patent estate and enhance the utility and value of ddRNAi.
Benitec's main patented technology is DNA-directed RNA interference (ddRNAI), whereby transiently transfected or stably integrated DNA constructs are transcribed to form double-stranded RNA that induces gene silencing. The issued claims cover the design of such DNA constructs, whether they are inverted repeats coding for hairpin RNA or sense and antisense sequences under the control of separate promoters and regardless of the means of delivery.
On June 4 and 5, 2003, Benitec was awarded the first US and UK patents for the application of RNA interference to mammalian cells.
In addition to the Graham patents licensed from CSIRO, Benitec has filed several additional patents covering specific applications and improvements to its ddRNAi technology. The Company has around 100 filed patent and patent applications, of which some 40 have been granted, and has in-licensed other patents that extend the scope of its ddRNAi platform.
A major distraction for Benitec resulted from litigation initiated by the Company against Nucleonics in defense of its Graham family of patents. While Benitec ultimately prevailed, the Company was forced to defend its patents in re-examinations in all major jurisdictions. Following the conclusion of this litigation in the mid-2000s, Benitec's patents were re-examined and re-issued in all major jurisdictions except Europe and the US. A pivotal breakthrough for the company's IP portfolio came in September 2010 when the US Patent Office's Board of Appeal reversed all previous objections and in effect re-issued Benitec's US patent. This was followed by the issuance of the Re-Examination Certificate in March 2011, which is the final formal step in reinstating the patent.
Benitec currently has more than 40 granted or allowed patents globally, including the key jurisdictions of the US, the UK, Japan, Europe, India, Canada and Australia. There are nearly 50 more patents pending. Benitec has the dominant patent position for the use of ddRNAi-based gene silencing for humans.
On 5 June 2003, Benitec Ltd was granted its core technology patents in the US and the UK. These patents, with priority dating to 1998, describe a method for silencing any gene in any cell using ddRNAi. US Patent 6,573,099 is entitled "Genetic constructs for delaying or repressing the expression of a target gene" and UK Patent 2353282 is entitled "Control of gene expression". Both patents contain world first claims that describe the effect of RNAi in human cells and the DNA constructs which trigger RNAi.
Benitec Ltd, originally founded in Australia in 1997 (listed on Australian Stock Exchange), pioneered ddRNAi and was the first company to demonstrate RNAi in human cells. It holds a dominant international intellectual property position in RNAi.
Benitec's technology has the potential to treat human disease as a form of gene therapy. The types of diseases amenable to treatment with the company's gene silencing technology include; cancers where the shutdown of oncogenes can lead to disease remission; autoimmune disorders where the knockdown of specific immune system genes can reverse the disease process; and chronic degenerative viral infections where programming cells to silence critical viral genes can prevent infection.
Published with permission from Professor Jain's report entitled "RNAi- Technologies, Companies and Markets, Jain PharmaBiotech, Basel, Switzerland, August 2006.
