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With Australian IP Upheld, Benitec s Legal Luck Improves in Ongoing Nucleonics Fight


Benitec announced this week that the Australian patent office has upheld the validity of two of its patents — No. 743316 and a follow-on patent No. 2001100608 — marking a major success for the company in its battle to protect its intellectual property estate from counterattacks by rival Nucleonics in the companies' ongoing legal saga.

"There has never been a doubt in our minds about the validity of our patents," Benitec CEO Sara Cunningham said in a statement. "In conjunction with the recent successful resolution of our contract dispute with Promega, this result will allow us to broadly license our issued patent estate and use ensuing revenue to focus on developing RNA interference-based therapeutics."

Separately, Benitec reported this week that it had settled out of court a legal dispute over the licensing rights to its expressed RNAi technology, called DNA-directed RNAi, with Promega (see related story in this issue). Under the terms of that settlement, Benitec reacquired the rights to sublicense its technology for human research applications.

The dispute between Benitec and Nucleonics extends back to April 2004 when Benitec, under the leadership of its former Chairman and CEO John McKinley, sued Nucleonics, Ambion, and GenScript in the US District Court for the District of Delaware for allegedly infringing a US patent (see RNAi News, 4/2/2004). While Ambion and GenScript took licenses to Benitec's technology in order to settle the matter, Nucleonics chose to fight.

"There has never been a doubt in our minds about the validity of the patents. This result will allow us to broadly license our issued patent estate and use ensuing revenue to focus on developing RNA interference-based therapeutics."

Nucleonics has long maintained that it does not require a license to Benitec's technology, and has gone so far as to reject a recent request from Benitec to dismiss the lawsuit without prejudice (see RNAi News, 8/5/2005). While Nucleonics had previously asked the District Court to dismiss Benitec's suit, it has said in court filings that it now wants to see Benitec's IP invalidated and the matter resolved once and for all.

In addition to pursuing a court battle, Nucleonics has been asking various patent offices worldwide, including ones in the US, Australia, and Europe, to review the validity of Benitec's key IP.

This strategy seemed to have been highly effective, bolstering Nucleonics' confidence in its decision to grapple with Benitec: Last November, the Australian patent office said that all the patent claims in the 743316 and 2001100608 patents were deemed to be "not novel" based on a review conducted at the request of and with information from Nucleonics (see RNAi News, 12/3/2004). Benitec was given two months to respond to the review.

Then, the European Patent Office last month rejected a Benitec patent application on the ddRNAi technology, in part due to examples of prior art Nucleonics had submitted (see RNAi News, 8/5/2005). Sally Brashears, vice president of intellectual property at Benitec, told RNAi News earlier this month that her company was considering dropping the application altogether in order to focus on another one under EPO review.

This week, however, the tables turned as Benitec scored a victory on its home turf in Australia when its patents there were upheld despite the agency's earlier findings.

In a statement, Benitec said that the patents "have been reviewed, published for opposition, and Benitec has received notice … that both re-examination proceedings have been successfully concluded."

Officials from neither Benitec nor Nucleonics were available to comment on Australian patent office's ruling.

The US Patent and Trademark Office's review of Benitec's US patent, No. 6,573,099, is still ongoing.

— Doug Macron ([email protected])

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