Benitec to fight patent claims

Brisbane-based gene therapy company Benitec (ASX:BLT) will continue to defend itself against what it today described as "baseless attacks" on its patent position by US company Nucleonics.

The verbal war between Benitec and anti-viral therapeutics developer Nucleonics was ramped up another notch today, after Nucleonics claimed it had succeeded in its second request to the Australian Patent Office (IP Australia) to re-examine a key gene-silencing patent owned by CSIRO and and Benitec.

Nucleonics CEO Robert Towarnicki said IP Australia's examiner had found that all claims in Australian Innovation Patent 2001100608 lacked novelty, and did not involve an inventive step. Benitec and CSIRO now have two months from the date of the examiner's letter -- November 26 -- to defend their innovation patent, before proceedings to revoke the patent begin.

But in a statement to shareholders today, Benitec said that: "It should also be noted that Benitec's patents and claims differ in each jurisdiction and that any alterations made to the Australian patent through the re-examination process will have no effect on its patents in other jurisdictions.

"It is precisely because of the importance of ddRNAi that Benitec's issued patent estate has come under attack from Nucleonics, which depends upon Benitec's technology to progress its drug development activities," the company said. "Benitec is committed to enforcing its leading position over ddRNAi and to ensuring that its shareholders will receive appropriate benefit for the investment they have made over a number of years in bringing this revolutionary technology to market. Benitec firmly believes that the re-examination proceedings will ultimately serve to strengthen Benitec's patent portfolio and confirm the novelty of Benitec's pioneering ddRNAi technology."

Earlier this week, IP Australia found CSIRO and Benitec's jointly owned Australian Patent No 743316, 'Control of Gene Expression', after Nucleonics had submitted 24 prior-art documents in support of its claim that the patent lacked novelty and an inventive step.

But the most recent finding was essentially a formality, because the two patents relate to the same invention: the use of 'designer' gene constructs to generate double-stranded RNA molecules that suppress expression of target genes.

When Benitec filed the original patent, it also filed for an innovation patent on the same invention. IP Australia offers innovation patents as a simplified, backup system for patenting inventions, so re-examination requests must be lodged for both patents if the disputant is to succeed.

Benitec CEO John McKinley pointed out that Australia was among only a few a few jurisdictions that permitted disputants to request a patent re-examination. But Towarnicki said US system gave disputants the same right, and that Nucleonics had filed a similar request with the US Patents and Trademarks Office on October 4 to examine the equivalent CSIRO-Benitec patent in the US (patent no 6,573,099, 'Genetic Constructs for Delaying or Repressing the Expression of a Target gene') and would receive a decision within three months.

He also said Nucleonics would "vigorously defend" itself in the lawsuit brought by Benitec in the US courts alleging infringement of its US patent.

In its statement today, Benitec said it currently has 10 issued patents, including one in the US, and two in Australia and the UK, and "such issued patents have been through a process of examination prior to their issue in the countries concerned".

Insurance

The company also said it had held patent insurance for the past three years, through Lloyds of London, for its DNA-directed RNA-interference (ddRNAi) technology, held in co-ownership with CSIRO. The company said it had initiated infringement actions against three companies using Benitec's technology without a licence, and two (Ambion and Genscript) had already settled by taking licences.

Benitec said it commenced proceedings against Nucleonics in March after being advised that Nucleonics was raising more than US$40 million from US investors, predicated on using Benitech's patented ddRNAi technology.