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Benitec Looks to Outlicense IP While Avoiding Litigation Mistakes of Its Past

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Two years after the US Patent and Trademark Office reinstated its core patent, Australia's Benitec Biopharma has once again set its sights on finding licensees for its expressed RNAi intellectual property.

The company has already inked a pair of deals in recent months, and has identified certain other companies, including clinical-stage RNAi drug developer Gradalis, as in need of access to its IP, according to Chief Business Officer Carl Stubbings.

However, Benitec is not looking to repeat the mistakes of its former management, which nearly destroyed the company in its infancy by taking it down a costly path of patent-infringement litigation, he cautioned.

Benitec now has “a completely new executive team,” Stubbings noted. “Our goal is not to litigate; our goal is to get this technology commercialized and into patients.”

This attitude comes in stark contrast to the one held by Benitec's original management, which told Gene Silencing News in early 2004 that the firm was intent on protecting its IP and would file infringement litigation against a handful of other companies if they did not strike licensing deals (GSN 1/30/2004).

Just a few months later, Benitec made good on its promise and sued two reagent firms, Ambion and GenScript, and one expressed RNAi drug developer, Nucleonics, for infringing its primary US patent (GSN 4/2/2004). One of the first RNAi-related patents ever issued, the IP — No.6,573,099 — essentially claims the knockdown of gene expression using DNA that transcribes double-stranded RNA.

Although GenScript and Ambion licensed the patent, Nucleonics opted to fight back, asking the court hearing the case to invalidate the IP, while seeking its re-examination in the US and abroad. Although Benitec eventually replaced its litigious CEO with its COO, who was able to bring an end to the lawsuit, the protracted legal battle drained the company's coffers and damaged its reputation.

By 2006, Benitec had shuttered its US operations and re-organized as a much smaller firm. Meanwhile, the patent re-examination begun at Nucleonics' request continued, and the USPTO repeatedly rejected claims in the '099 patent. Although these rulings were never final, the uncertainty made it difficult for Benitec to raise money or find partners, and its future seemed very much in doubt.

In late 2010, however, Benitec's fortunes changed when the USPTO reversed all of its previous rejections of claims within the '099 patent, effectively ending the re-examination process and confirming the validity of the IP (GSN 9/30/2010). The company has since been able to close a series of financings; has established a broad internal pipeline; and recently acquired Tacere Therapeutics, which had previously licensed the hepatitis C program Benitec was unable to advance while it was struggling in years past (GSN 10/11/2012).

At the same time, Benitec has been reaching out to other players in the expressed RNAi space, offering licenses to its patent estate. In March, it signed a deal with privately held CalImmune, which is moving an HIV/AIDS therapy toward clinical testing in 2012 (GSN 3/8/2012).

A few months later, Genable Technologies licensed Benitec's IP for use with its investigational treatment for the rare ocular disease rhodopsin-linked autosomal dominant retinitis pigmentosa (GSN,/em> 7/19/2012). Stubbings added that Benitec is currently in conversations with two other companies about licenses, as well.

According to Stubbings, Benitec has been hoping to add Gradalis to its licensee list, but has not had contact with the firm following an initial letter describing Benitec's IP position. Gradalis acknowledged receipt of the information, but has yet to respond, he said.

Stubbings said that Benitec's US patent attorneys have determined that Gradalis' drug candidates do fall under Benitec's IP, but conceded that, as a development-stage company, Gradalis remains within the safe harbor provisions of US patent law.

Still, “we think that the ['099] patent covers the area they are working in,” he said. “What we'd love to be able to do is have a conversation about a relationship. We can give what we believe is the freedom to operate that they need.”

For its part, Gradalis disagrees. In a recent interview with Gene Silencing News, David Haselwood, Gradalis' head of business and corporate development, said that his company is aware of Benitec's IP, but “we have not felt the need at this point to license any additional technology ... when it comes to interfering RNA” (GSN 10/11/2012).

Gradalis has a number of expressed RNAi cancer treatments in clinical trials, including its so-called FANG cancer vaccine that also incorporates a non-RNAi immunostimulator component, and a purely shRNA-based drug that is designed to inhibit stathmin-1.

The company also recently received its own US patent, No. 8,252,526, which covers its bi-functional shRNA technology, and has filed a variety of patent applications with the USPTO.

Haselwood declined to make any additional comments for this article.

Despite the current difference of opinion between the companies, Stubbings stressed that Benitec isn't looking to go back to its old ways.

“Our intent is to work with people, develop commercial relationships, and help validate our shRNA technology,” he said, adding that “we would prefer to explore every reasonable commercial avenue” to achieve this, rather than legal ones.

He did not, however, entirely rule out the possibility that Benitec would pursue litigation, or that it would seek a re-examination of Gradalis' IP with the USPTO. Any such decision, he noted, would be made “in conjunction with our patent attorneys.”

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