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Sirna Again Opposes Alnylam Patent, SEC Filing Reveals Details About Deal with Max Planck

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Sirna Therapeutics is opposing an Australian RNAi-related patent obtained by rival Alnylam Pharmaceuticals through its July 2003 acquisition of German RNAi shop Ribopharma, marking at least the second time Sirna has challenged this international intellectual property portfolio.

Alnylam reported the opposition in a filing with the US Securities and Exchange Commission published last week. The filing also provided additional details regarding the company's amended IP deal with the Max Planck Society.

According to officials from IP Australia, the Australian patent office, Sydney-based law firm Spruson & Ferguson filed the opposition on behalf of Sirna.

The patent, No. AU778474, was originally filed in January 2000 by Ribopharma founders Roland Kreutzer and Stephan Limmer. According to its abstract, the application covers "a medicament containing at least one double-stranded oligonucleotide (dsRNA) designed to inhibit the expression of a target gene. … One strand of the dsRNA is at least in part complementary to the target gene."

In the SEC filing, dated Aug. 11, Alnylam noted that the Australian patent "derives from the same parent international patent application that gave rise to EP 1144623B9," the so-called Kreutzer-Limmer European patent.

Like its Australian counterpart, the European patent broadly covers the use of short dsRNAs as therapeutics. Further, it carries a priority date of January 1999, putting it alongside the Fire-Mello US patent as one of the earliest examples of RNAi-related IP and a seemingly essential piece of the puzzle for anyone developing RNAi drugs for the European market. However, seven companies • Sirna Therapeutics, Atugen, Aventis Pharma, Janssen Pharmaceutica, AstraZeneca, Isis Pharmaceuticals, and Novartis • jointly filed an opposition to this patent, calling into question its viability.

An eighth party, Munich-based patent attorney Martin Grund, had opposed the Kreutzer-Limmer patent as well, but withdrew his opposition in early May 2003. Isis Pharmaceuticals also pulled its opposition to the patent after inking an IP cross-licensing deal with Alnylam in March 2004 (see RNAi News, 3/19/2004).

Going It Alone

While Sirna had been one of several parties opposing Alnylam's European Kreutzer-Limmer patent, it has moved against the Australian IP on its own, raising the possibility that it might try to invalidate other Alnylam IP without help from other companies.

Alnylam owns numerous RNAi-related patents and patent applications, but ongoing opposition proceedings would indicate that key targets could be the company's pending US version of the Kreutzer-Limmer patent and the recently granted European patent No. 1352061 • the so-called Kreutzer-Limmer II patent.

According to Alnylam, Kreutzer-Limmer II includes 103 allowed claims on therapeutic compositions, methods, and uses comprising siRNAs that are complementary to all mRNA sequences in over 125 disease target genes, including VEGF and those expressed by influenza.

Officials from neither Sirna nor Alnylam were available for comment.

Garching

Also in Alnylam's SEC filing, which detailed the company's second-quarter financial performance (see RNAi News, 8/5/2005), were additional details about recent amendments made to the drug developer's agreement with the Max Plank Society for certain RNAi-related IP.

In December 2002, Alnylam struck a deal with Garching Innovation • the technology transfer organization of the Max-Planck Society • for the worldwide rights to use and sublicense certain patented technology, namely the Tuschl-1 and Tuschl-2 patent applications. Under the terms of that arrangement, Alnylam gave Garching a number of shares of preferred stock and agreed to pay royalties on net sales of all therapeutic and prophylactic products developed with the technology.

Alnylam also agreed to establish a research and development presence in Germany comparable to its capabilities in the United States. To satisfy this requirement, Alnylam acquired Ribopharma, which is now known as Alnylam Europe.

But as Alnylam noted in its SEC filing, its "rapid and substantial growth … to over 75 full-time employees … and the geographic separation of our [US and German] sites [have] placed a strain on our administrative and operational infrastructure."

According to Alnylam, it issued a report to Garching in January detailing how it was meeting its obligations to maintain comparable operations in Germany and equally split with Alnylam Europe the indications and sub-indications the companies would pursue based on "estimated market size and accessibility by RNAi."

However, Garching responded less than two weeks later with a notice that Alnylam was not meeting either requirement. The companies and Garching then "engaged into further discussions intended to reach [an] amicable agreement," Alnylam said, which resulted in the amended IP deal.

Under the new terms of the deal, Alnylam provided Garching with 270,000 shares of its common stock, currently valued at almost $2.5 million. In exchange, Alnylam is only obligated to maintain 25 full-time employees with doctoral-level degrees at its German subsidiary. These employees must live in Germany and spend at least 75 percent of their working time in that country.

Alnylam is required to provide a report on its compliance with this requirement within 30 days of the end of each quarter.

The amended agreement also releases Alnylam from sharing indications and sub-indications with Alnylam Europe.

- Doug Macron ([email protected])

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