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Benitec Patent Revoked by EPO; Company Licenses IP from Galapagos

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NEW YORK (GenomeWeb) – Benitec Biopharma last week announced that the European Patent Office has upheld its previous decision to revoke one of the company's core patents based on opposition filed by biotech firm Galapagos and chemical giant BASF.

Following the EPO's ruling, Benitec said that it has now taken a non-exclusive license to a Galapagos patent covering the use of siRNAs to lower target RNA levels in cells, which it said will give it the freedom to develop its pipeline of expressed RNAi therapeutics in Europe.

Benitec also said that it does not expect the EPO's ruling to materially affect its business operations, noting that the patent was set to expire in 2019. The company added that it is considering appealing the EPO's decision.

Notably, the EPO ruling comes in contrast to the findings of the US Patent and Trademark Office and the UK Intellectual Property Office, both of which upheld corresponding patents issued in those countries after they were challenged. It also suggests that the EPO may rule against Benitec on two other European patents currently being opposed by BASF and others.

The Benitec IP at the center of the EPO decision — EP1555317 — is assigned to Australia's Commonwealth Scientific and Industrial Research Organization and stems from the pioneering work on RNAi by CSIRO researcher and Benitec co-founder Michael Graham. Benitec holds the exclusive rights to the patent and related IP for human health applications.

According to its abstract, the now-revoked patent claimed the use of recombinant DNA to "post-transcriptionally modify or modulate the expression of a target gene" via RNAi. Granted in 2011, the patent was opposed by BASF and Galapagos, which had filed its opposition under the name "Strawman Limited," the next year.

Benitec said that, prior to the opposition hearing, an EPO panel had issued a favorable opinion on the patent, but that the patent office ultimately revoked the IP because one claim was "not clearly and unambiguously disclosed" in a particular patent specification. The novelty and inventiveness of the patented claims were not reviewed, the firm noted.

"While we are obviously disappointed with this decision, we remain confident that it will have minimal impact on Benitec's commercial activities and R&D programs," Benitec CEO Peter French said in a statement. "We have a number of other pending European applications in the RNAi patent estate licensed from CSIRO, which we continue to pursue."

The company pointed out that the EPO decision is inconsistent with the findings of the US and British patent offices, which had previously maintained patents from the Graham IP family. Indeed, Benitec scored one of its biggest victories when its US patent No. 6,573,099 was validated by the USPTO after a protracted reexamination battle that saw the patent rejected but later upheld during appeal.

Previously, French had told Gene Silencing News that Benitec's success defending the '099 patent boded well for the company's efforts to defend its IP in Europe. The EPO's latest ruling, however, suggests that Benitec may face similar defeats with two other patents licensed from the CSIRO that are currently under scrutiny.

The first of these, EP1068311, is entitled "Method and Means for Obtaining Modified Phenotypes" and relates to the use of double-stranded RNA to reduce the expression of a nucleic acid sequence of interest in eukaryotic cells, particularly as a means to establish viral resistance. It is being opposed by BASF, ag-bio firm Syngenta, and Galapagos.

The second, EP1624060, is entitled "Control of Gene Expression" and, like the '317 patent, claims recombinant DNA for the post-transcriptional modification or modulation of target gene expression via RNAi. It is being opposed by BASF and Galapagos.

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