The US Patent and Trademark Office has rejected all of the claims contained within Benitec's key US patent in light of multiple examples of prior art, RNAi News has learned.
The decision is the latest setback for Benitec in an ongoing legal battle with rival Nucleonics that began last April when Benitec sued the company for allegedly infringing the US patent.
However, the patent office's decision, which was based on a re-examination conducted at Nucleonics' request, is not final. The USPTO noted that Benitec may submit amendments, affidavits, declarations, or other documents to support its patent before a final ruling is made.
Sally Brashears, vice president of intellectual property for Benitec, told RNAi News that the USPTO decision was "not unexpected. When [a re-examination request] is filed, it isn't very often when the patent office looks at it as says, 'We don't need to … look at this again.'"
She added that Benitec intends to respond to the USPTO in order to make sure the patent is ultimately upheld.
The USPTO decision was "not unexpected. When [a re-examination request] is filed, it isn't very often when the patent office looks at it as says, 'We don't need to … look at this again.'"
The patent claim rejections come as Benitec and Nucleonics move forward on a dispute that began when former Benitec Chairman and CEO John McKinley sued Nucleonics for alleged infringement of Benitec's US patent No. 6,573,099, which covers the knocking down of gene expression using DNA that transcribes double-stranded RNA, one strand of which has a sequence complementary to that of the target gene (see RNAi News, 4/2/2004).
In response to the suit, Nucleonics asked various patent offices worldwide to invalidate pieces of Benitec's intellectual property estate. Most recently, the European Patent Office in August rejected a Benitec patent application after conducting a review of the application's claims based on a Nucleonics request (see RNAi News, 8/5/2005).
Benitec, however, scored a victory of its own that month when the Australian patent office upheld two of the company's patents in that country despite having previously ruled that the claims in these patents were not novel (see RNAi News, 8/26/2005). Benitec made amendments to those patents following the patent office's original determination.
Now, Benitec is hoping to achieve similar ends in the US by turning an initial patent office rejection into a validation of its IP.
The review process "isn't something that a patentee looks forward to, but it gives us a position to take a look at our patent and do what we need to do to make sure it's strong and something that we can enforce," Brashears said.
Robert Towarnicki, president and CEO of Nucleonics, told RNAi News in an e-mail this week that Nucleonics' request for re-examination of the Australian Benitec IP was "clearly justified as all claims were found to be invalid at re-examination," and that his company considers the Australian patent office's allowance of the "revised claims … to be an inexplicable outcome."
He added that although Nucleonics "strongly believes that the newly allowed claims are still not novel and are therefore invalid over the prior art listed in the re-examination request," his company is not pursuing the matter further "because of the limitations of the Australian re-examination process."
Instead, Nucleonics will focus on the US re-examination process.
"Nucleonics is pleased with the outcome of the re-examination and believes we will prevail in the US as we have recently in the final rejection issued by the European Patent Office of Benitec's EPO application," Towarnicki added in his e-mail.
Doug Macron ([email protected])