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Defendants in Tuschl-I IP Suit Cast Doubt on Claims of Pending Patent Issuance

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By Doug Macron

Although Alnylam Pharmaceuticals and the Max Planck Institute contend in a lawsuit that the US Patent and Trademark Office is poised to issue a patent from the Tuschl-I intellectual property portfolio, the defendants in the case argued this week that this expectation is mere speculation.

For this and other reasons, the defendants told the court, Alnylam and Max Planck's request for a court order essentially blocking any kind of Tuschl-I patent issuance is unnecessary and potentially damaging.

The legal battle began late last month when Alnylam and Max Planck sued the Whitehead Institute for Biomedical Research, the Massachusetts Institute of Technology, and the University of Massachusetts for allegedly misappropriating certain RNAi-related technology in patent applications (see RNAi News, 7/9/2009).

Specifically, the suit charged that the defendants have misappropriated technology, including the use of 3' overhangs in siRNA design, from the Tuschl-II patent family for inclusion in Tuschl-I patent applications.

While the Tuschl-II IP is solely owned by Max Planck and exclusively licensed for therapeutic use to Alnylam, the Tuschl-I family is jointly owned by Max Planck, Whitehead, MIT, and UMass. The first three institutes licensed their Tuschl-I ownership interests to Alnylam, but UMass chose to license its share to Sirna Therapeutics, which is required to make the IP widely available for sub-licensing (see RNAi News, 9/13/2003).

UMass also licensed certain limited therapeutic rights to the Tuschl-I IP to CytRx, which later passed along those rights to spinout RXi Pharmaceuticals.

As reported by RNAi News (see related story, this issue), earlier this month Alnylam and Max Planck told the court overseeing their lawsuit that the USPTO would "very shortly" give notice that it plans to issue a Tuschl-I patent claiming technology derived from Tuschl-II inventions.

Such a development, the plaintiffs alleged in a memorandum, would eliminate all of Max Planck's property rights in the Tuschl-II inventions "because once an invention is disclosed in one patent, the USPTO will not allow the same invention or obvious variants thereof to be protected by a second patent."

At the same time, companies that had licensed the Tuschl-I IP through UMass would "unfairly gain access to the Tuschl-II property without paying consideration for a license … [and] Alnylam will no longer be able to reap the benefit of its license agreement with Max Planck," according to the lawsuit.

In order "to preserve the status quo" while the litigation proceeds so that the court can rule on the case before the USPTO issues a Tuschl-I patent, Alnylam and Max Planck asked the court in the memorandum to issue an injunction preventing the payment of an issuance fee on any Tuschl-I application unless all the IP's co-assignees, including Max Planck, agree that the fee shall be paid.

This week, the defendants in the case fired back, charging in separate opposition filings that there is no evidence that the USPTO intends to issue a patent on a Tuschl-I application and that the court has no authority to stop IP-related payments to the patent office.

The plaintiffs "speculate as to the imminent issuances of a Tuschl-I patent and assert that that event will bar pending Tuschl-II patents from issuance, but have presented no evidence in support of these assertions," UMass said in its opposition.

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"Even if a Tuschl-I patent were to issue, Tuschl-II applications claiming separate and distinct inventions could also issue," the university added. "If the patent office finally concluded that the Tuschl-II claims are not patentable in view of the Tuschl-I claimed invention, ample additional avenues exist for [the plaintiffs] to seek relief, including appeals to the patent board of appeals, a United States District Court, and the Federal Circuit.

"There is no justification for the court to enter the fray at this point in time after the patent office has been examining and evaluating these applications over the course of the past eight years," UMass added.

Furthermore, "an injunction … preventing [payment of] the issuance fee on Tuschl-I could cause the [USPTO] to declare the patent abandoned … [causing] irreparable harm," Whitehead stated in its own opposition filing.

For its part, MIT argued that it is not even really relevant to the situation, noting that Alnylam and Max Planck's request for injunctive relief is "directed only at Whitehead, [which is] the party authorized to manage the prosecution of the Tuschl-I patent" applications.

Still, MIT said that it agrees with Whitehead that the "prosecution of the Tuschl-I patents has been proper, including the inclusion of the claim for priority and data that [the] plaintiffs now seek to have removed."

MIT further pointed out that Max Planck first raised its concerns over the Tuschl-I and -II IP over five years ago, but waited until last month to bring the matter to court.

Alnylam and Max Planck "now assert that immediate relief is required during the pendency of [the lawsuit] to avoid irreparable harm," MIT stated in its opposition. "But … a party cannot delay the initiation of litigation until an 'emergency' is created, and then rely upon the 'emergency' created by its own decision concerning timing to support a motion for preliminary injunction."

In its opposition to the requested injunction, Whitehead argued that more than eight years ago, it and Max Planck agreed to "prosecute the Tuschl-I and Tuschl-II patent applications on parallel tracks," and that Max Planck specifically agreed that Whitehead's Tuschl-I applications could contain "the very information [the] plaintiff's now contend was misappropriated."

It was only after UMass struck its deals in 2003 with Sirna and CytRx that Max Planck "began to complain about the content of Tuschl-I applications and the possible impact on Tuschl-II."

And because of the multiple licenses to the Tuschl-I IP, the co-owners of the patent estate "have different incentives regarding prosecution of the Tuschl-I applications," Whitehead noted.

Max Planck owns the largest shares of licensing revenue from Alnylam, as well as a significant slice of the company's equity. "It therefore has an incentive to broaden Tuschl-II at the expense of Tuschl-I in order to place Alnylam at a competitive advantage over Merck," which acquired Sirna in 2006, Whitehead stated. "On the other hand, UMass, which receives no royalties from Alnylam … but does receive license fees and royalties from Merck and RXi, has the opposite incentive.

"The net result is that, since late 2003, there has been nearly continuous disagreement among the co-owners of Tuschl-I … [and] Whitehead is thus caught in the middle between [Max] Planck and UMass," it added.

Whitehead maintained in its opposition filing that it is committed to its obligation to "maximize the lawful patent protection for Tuschl-I for the benefit of all [the IP's] co-owners. … It has done so without regard for any impact, positive or negative, that its actions might have on patent protection for the Tuschl-II applications."

It is for this reason, Whitehead noted, that it has rejected Max Planck's earlier requests to remove certain data from Tuschl-I applications.

All three defendants asked the court to deny Alnylam and Max Planck's injunction request.

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