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EPO to Hear Mirrx Request for Resumption of Patent Proceedings Covering miRNA Rx Technology


By Doug Macron

The European Patent Office agreed late last month to consider restarting its review of a patent application covering Mirrx Therapeutics' core microRNA antagonist technology roughly six months after it said that it would not do so until litigation surrounding the intellectual property had been decided.

According to an EPO filing, the organization will hear Mirrx's argument for resuming patent proceedings on July 11.

The dispute began in 2009 when Santaris filed suit in a Danish court against Mirrx and its founder, Thorleif Moller, for allegedly using illegally obtained trade secrets to file European patent applications on a miRNA-inhibiting technology for therapeutic applications (GSN 5/6/2010).

The technology comprises so-called Blockmirs, which are steric antisense oligos that bind to specific miRNA target sites, preventing regulation of a particular messenger RNA. According to Mirrx, they "do not recruit any cellular enzymes which mediate degradation of target mRNAs … [so if they do] bind to a non-intended RNA, it will only cause an effect if it prevents binding of a [miRNA] or another cellular factor," thereby reducing the possibility of off-target effects.

In its lawsuit, Santaris charged that Blockmirs were developed using proprietary information that belongs to Santaris and was obtained by Moller when he worked as a consultant specializing in RNA technology for the Danish patent firm and Santaris IP agent Ploughmann & Vingtoft.

"The connection and overlap between Santaris Pharma's [locked nucleic acid] technology and … Moller's applications is so close that there is a presumption against them having been prepared … without knowledge of Santaris Pharma's confidential patent applications and the current research developments at Santaris," Santaris charged.

Further complicating matters is Moller's alleged relationship to a former Santaris staffer who is cited in the lawsuit as Moller's "cohabitating partner." Santaris alleges that the former employee provided Moller with confidential information from a group meeting in September 2007, prior to being dismissed amid general corporate cutbacks.

As part of its legal gambit, Santaris also successfully petitioned the EPO to halt all proceedings related to one of Mirrx's key patent applications, EP 07817970, until the dispute has been settled.

Moller maintains that the Blockmir technology is fundamentally different from Santaris' LNA technology since it prevents a miRNA from binding to a single target, rather than all its targets. In addition, he has alleged that the lawsuit is merely an attempt by Santaris to gain control of a technology that would allow the company to avoid infringing IP held by competitor Regulus Therapeutics.

Both Santaris and Regulus are developing hepatitis C drugs targeting miR-122, but Regulus holds the exclusive rights to US Patent No. 7,307,067, which covers the regulation of the miRNA as an HCV treatment. Regulus has indicated it views the IP as fundamental for developing such a drug. Santaris' drug, called miravirsen, is currently in phase II testing (GSN 9/23/2010).

The intellectual property situation came to a head, Moller contends, when GlaxoSmithKline passed on an option to license miravirsen, instead choosing to partner with Regulus on its preclinical HCV drug (GSN 2/25/2010).

"Thus, apparently GlaxoSmithKline did indeed come to the conclusion that [miravirsen] is dominated by IP held by Regulus," Moller argued.

Mirrx was seemingly handed a defeat when the EPO last year said that it would maintain its stay on its review of EP 07817970, stating that that lawsuit "is an entitlement dispute … and the balance of interests is not clearly in favor of the [intellectual property's] applicant in the sense that proceedings should be resumed" (GSN 8/26/2010).

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"The legal division of the EPO is neither competent nor qualified to decide which party the [patent] application might belong to or which outcome of the … dispute seems more likely," it added.

However, it appears that the EPO is willing to give Moller a chance to plead his case, and in July will hold oral proceedings, not open to the public, to discuss the matter.

In advance of those proceedings, Moller submitted a request to the EPO earlier this month asking for additional information from Santaris regarding its claims to the Blockmir technology.

As stated in earlier filings to the EPO, Santaris "claims to be entitled to … Moller's inventions without identifying any inventors [who] could have provided [the company] with rights to … [the] inventions," Moller's representative wrote to the patent office.

"Since the inventorship … [of the] invention and application is of decisive importance for the entitlement proceedings and the present stay" of the application review process, Santaris is "requested to identify one or more of the inventors that are obliged to assign their rights" to the company, the representative wrote.

If it cannot do so, the representative added, then there is no basis for the entitlement proceedings in the Danish court and the stay must be lifted. If Santaris does not challenge Moller's claim as inventor of the Blockmir technology, then Santaris is asked to confirm its position.

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