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Nucleonics Takes Benitec Dispute to Europe; Opposition to Alnylam Patent Moves Forward

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Nucleonics said this week that it has taken its intellectual property battle with Benitec to Europe, filing with the EPO examples of prior art that the company says demonstrate why Benitec should not be awarded a European patent covering its core RNAi technology.

According to Nucleonics, the prior art citations provided to the EPO are relevant to Benitec’s patent application number 1071762, entitled “Control of Gene Expression.”

“Nucleonics’ submission provides relevant prior art documents that Benitec has not cited in its application, which show that the pending claims are invalid because they lack novelty and/or did not involve an inventive step at the time the patent application was filed,” the company said in a statement. “Nucleonics also believes that the claims are unclear and impermissibly extend beyond the scope of the application as filed, and that the application fails to provide adequate description or sufficient working examples to support the scope of the claimed subject matter.”

Nucleonics CEO Robert Towarnicki told RNAi News this week that the prior art filing made by his company was “written very much as a challenge [to Benitec’s patent application] in that it lists the prior art and makes the case why the claims [Benitec is] currently claiming are not inventive, are invalid, and should not be granted. It’s a very active challenge of the review process.”

Benitec has “continued to ignore prior art, [and] under EPO law we are allowed as a third party to submit prior art for the consideration of the patent office, so that’s what we did,” he added.

Nucleonics’ action comes amid an ongoing IP dispute between the companies triggered by a Benitec lawsuit charging Nucleonics with patent infringement. Rather than settle the matter out of court, Nucleonics has launched a number of counter-attacks: On Oct. 4, Nucleonics asked the US Patent and Trademark Office to review 22 claims in Benitec’s US patent, which covers the company’s core gene-silencing technology. The patent office recently agreed to conduct the re-examination, which is currently underway (see RNAi News, 12/24/2004).

Prior to this, Nucleonics requested that patent and trademark officials in Australia review two of Benitec’s patents in that country. That request has resulted in an Australian patent office official finding that all of the claims reviewed in the Benitec patent were not patentable (see RNAi News, 12/3/2004). Benitec has said that it will appeal the ruling.

According to Towarnicki, Nucleonics’ challenge to Benitec filed with the EPO differs from the ones in Australia and the US in that “we are actually required to be very specific about what we cite [and] how it impact’s [Benitec’s] application [in the EPO filing], so it’s a very detailed challenge of their pending claim. In the US … all we can do is file the art without much editorial,” he added.

In regards to Nucleonics’ filing with the EPO, Benitec Chairman and CEO John McKinley told RNAi News that “all such matters are being dealt with by our European patent attorneys.”

Elsewhere at the EPO

The dispute over Alnylam Pharmaceuticals’ European RNAi patent, which has been simmering since May 2003 when eight parties opposed the IP, took a step forward last month when Alnylam presented its side of the argument to patent officials. However, the matter is still far from being resolved, given the typical length of an opposition procedure with the European Patent Office.

In the Alnylam case, the patent in question is the so-called Kreutzer-Limmer patent • EP 1144623/WO 0044895. It carries priority dates of January and November 1999, and specifically covers “a medicament containing at least one double-stranded oligonucleotide (dsRNA) designed to inhibit the expression of a target gene.” The patent’s abstract notes that in the invention, “at least one strand of the dsRNA is at least in part complimentary to the target gene.”

Granted in mid-2002, the patent covers an invention made the by founders of the German RNAi company Ribopharma and became part of Alnylam’s IP estate when the two companies merged in July 2003. Eight parties • Sirna Therapeutics, Atugen, Aventis Pharma, Janssen Pharmaceutica, AstraZeneca, Isis Pharmaceuticals, Novartis, and Munich-based patent attorney Martin Grund • joined in 2003 to oppose the Kreutzer patent in Europe. Grund and Isis, however, have since withdrawn their opposition.

On Dec. 7, 2004, Alnylam’s patent attorneys sent to the EPO a written response addressing the objections of the opposition parties. The letter asks the EPO to reject the objections and to uphold the patent, including several new claims that were added after the application was first filed.

The letter also requests oral proceedings to take place in case the EPO’s opposition division upholds the opposition. It further asks the division to send an interim report detailing its preliminary stand on individual aspects of the objections.

Later on, the letter mounts a detailed response to the opponents’ objections, citing a number of scientific publications.

According to Alnylam’s patent lawyer, Wolfgang Gassner, the EPO might now grant the opposition parties the opportunity to respond to his letter, and possibly another round of response to Alnylam. He told RNAi News this week that oral proceedings are expected to take place later this year.

Neither the outcome nor the duration of the procedure is easy to predict at this point. According to the EPO, opposition procedures take about two years on average, but vary depending on the complexity of the case and the number of parties involved. In addition, the appeal procedure that might follow takes almost three years on average.

Compared to the US, a higher percentage of contested patents are rejected in Europe: In 2003, the most recent year for which data are available, about one-third of the 1,900 EPO decisions on oppositions resulted in revocations. In the other cases, the patent was either fully or partly maintained. By comparison, only ten percent of re-examined patents in the US lost all their claims in 2003, according to the US Patent and Trademark Office.

Oppositions to European patents are also more frequent than requests for re-examinations in the US. In 2003, 2,600 oppositions were filed with the EPO, while 60,000 European patents were granted. By comparison, the USPTO that year received just 400 re-examination requests and issued nearly 190,000 patents.

The procedure in Europe starts with the filing of an opposition by anyone except the patent owner within nine months after the patent has been granted. Once the EPO has checked that the opposition is admissible and informed the patent holder of any deficiencies, the patent holder is invited to file observations and, if necessary, amendments.

After that, the EPO’s opposition division examines the case and may ask the parties to file further observations. At this stage • which the Alnylam case has almost reached by now • oral proceedings may be called if they were requested by either party.

There are three possible outcomes: the patent is either upheld, revoked, or amended. The patent holder can contest the EPO’s decision at the board of appeal.

• DM, JK

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