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Benitec, Inex Pharmaceuticals, RXi Pharmaceuticals, Cold Spring Harbor Laboratory, NIH

Benitec Seeks More Time to Respond to Patent Office Over IP Rejection
Benitec last week reported that it has asked the US Patent and Trademark Office for a two-month extension on the time it has to respond to the agency’s decision to reject the claims in the company’s US patent No. 6,573,099.
Although Benitec said last week that it “believes it has strong arguments for overcoming the art of record” that led the patent office to reject the company’s IP, the company has been facing a cash shortage for some time and has been trying to raise the capital necessary to complete a corporate reorganization and continue ongoing legal battles.
Specifically, the company asked for the extension in order to “acquire certain documents and … consider the most expedient legal and commercial outcomes” before it responds to the agency’s rejection of the ‘099 patent.
The extension would also give Benitec enough time to complete a stock rights issue plan designed to raise as much as Aus$6.5 million ($5.1 million), which would more than compensate for a share-purchase plan that would have brought in Aus$500,000 but failed to its meet minimum investment level last year (see RNAi News, 3/1/2007).
Benitec said that the funds from the stock rights issue plan would provide the company with the capital needed to continue a reorganization, which included the closing of its US operations last summer (see RNAi News, 6/29/2006).
Proceeds of the plan would allow the company to continue its legal battle with rival Nucleonics, which is at the core of the US patent office’s rejection of the ‘099 patent.
In 2004, Benitec launched a series of lawsuits charging three companies with infringing the ‘099 patent. While two of the defendants settled by taking licenses to the IP, another — Nucleonics — chose to fight back (see RNAi News, 4/1/2004).
The dispute with Nucleonics was eventually dismissed at Benitec’s request, but Nucleonics has filed to reinstate the lawsuit in hopes of securing a judgment finding Benitec’s IP invalid (see RNAi News, 10/7/2005).
Nucleonics has also proposed or requested re-examinations of certain Benitec patents in several nations, including the US, where the USPTO first invalidated the IP in 2005 (see RNAi News, 9/9/2005)

Inex Posts Profit in 2006 on Lower Costs, Higher Revenues
Inex Pharmaceuticals this week reported its financial results for 2006, posting a net profit on higher revenues and lower expenses.
For the year, Inex’s net income was $21.1 million, or $0.55 per share, compared with a loss of $9.4 million, or $0.24 a share, in 2005.
Revenues in 2006 rose to $15.9 million from $15.4 million, in part reflecting a payment from Alnylam Pharmaceuticals from its license to Inex’s delivery technology (see RNAi News, 7/20/2006).
Inex’s research and development spending in 2006 fell to $5.3 million from $10.2 million the year before in part because of a reduction in R&D staff, reduced external costs for products in the firm’s pipeline, and reduced facility overheads.
In 2005, Inex also incurred $5.7 million in restructuring costs, versus no restructuring costs last year.
At the end of 2006, Inex had cash and cash equivalents totaling $5.6 million.
Looking ahead, Inex said that in the second half of the year it expects to announce a target for the first of three siRNA pipeline programs covered under its agreement with Alnylam.

RXi Licenses shRNA Technology from Cold Spring Harbor Laboratory
CytRx said this week that its pure-play RNAi subsidiary RXi Pharmaceuticals has signed a deal for access to shRNA technology from Cold Spring Harbor Laboratory.
Under the agreement, RXi will have a non-exclusive, worldwide license to shRNA technology developed by CSHL researcher and RXi co-founder Greg Hannon for research and therapeutic applications.
Additional terms of the arrangement were not disclosed.

Scientists Warn Weak NIH Funding May Strip US of Biotech Leadership Role
A group of scientists from top-tier medical research facilities in the US this week warned Congress that if current funding levels for the National Institutes of Health do not increase, aggressive research into many serious illnesses may begin to wane and the US may begin to lose its leadership role in the biomedical world, GenomeWeb News, RNAi News’ sister publication, reported this week.
The researchers, who testified at the Senate Appropriations Labor-HHS Committee, described findings from a report they published entitled “Within Our Grasp – Or Slipping Away: Assuring a New Era of Scientific and Medical Progress.”
Together with NIH director Elias Zerhouni, the authors, from Harvard University, the Johns Hopkins University, Columbia University, and elsewhere, said they represent “a group of concerned universities and research institutions” that claims that the “NIH budget has been virtually frozen since 2003 and has shrunk by at least 8 percent after inflation is considered.”
The report said that the doubling of the NIH budget between 1998 and 2003 fuelled many advances, but stagnant funding levels since then have stalled many research initiatives and forced many researchers to spend more time hunting for funds than in the lab.
The report claims that the proposed fiscal 2008 budget will effectively erase what the NIH received in fiscal 2007 and suggests that decreased NIH funding has discouraged innovation by channeling less money to young scientists.

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