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Alnylam, Max Planck Settle Suit Over Tuschl IP

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By Doug Macron

Alnylam Pharmaceuticals said this week it has settled its protracted legal row over the so-called Tuschl-I and -II patent families with the Whitehead Institute for Biomedical Research, the Massachusetts Institute of Technology, and the University of Massachusetts.

Alnylam said that as part of the agreement, it would allow Merck, the parent company of one-time rival Sirna Therapeutics, to sub-license a portion of the disputed IP to which it previously did not have access. Additionally, Max Planck, Whitehead, UMass, and MIT have agreed that future US prosecution of the patent estates will be “coordinated and led by ... Max Planck.”

Max Planck will also remain in charge of Tuschl-II's prosecution outside the US, while UMass will lead future prosecution of the Tuschl-I family internationally.

Additional terms of the settlement were not disclosed.

"Today's settlement provides for a favorable resolution of this dispute for all parties and significantly optimizes the successful prosecution of both the Tuschl-I and Tuschl-II patent families, which together represent critical innovations for the advancement of RNAi therapeutics as breakthrough medicines,” Alnylam CEO John Maraganore said in a statement.

"We are very pleased that the settlement provides for coordinated prosecution of the Tuschl-I and Tuschl-II patent families in the United States that will encourage further development of RNAi therapeutics," Whitehead Director David Page added.

Both of the Tuschl patent estates generally relate to the use of siRNAs, 21 to 23 nucleotides in length, to target specific mRNA degradation in mammals, although Tuschl-II also includes claims related to 2- to 3-nucleotide-long 3' overhangs.

The Tuschl-I IP was invented by one-time Max Planck researcher Tom Tuschl, Whitehead's Phillip Zamore and Phillip Sharp, and MIT's David Bartel, each of whom are Alnylam co-founders. Tuschl has since moved on to Rockefeller University, while Sharp now works at MIT and Zamore at the University of Massachusetts Medical School.

Tuschl performed the work that gave rise to the IP at both Whitehead and Max Planck, and assigned his interest in the inventions to both institutes. Sharp and Bartel, meanwhile, assigned their interests to Whitehead and MIT, while Zamore transferred his to UMass. Independently, Tuschl and colleagues developed additional inventions that were incorporated into the Tuschl-II family and assigned to Max Planck.

In 2001, Max Planck, Whitehead, MIT, and UMass signed an agreement essentially making Whitehead responsible for securing patent protection on the inventions covered by Tuschl-I and authorizing MIT to out-license the Tuschl-I and Tuschl-II IP for research purposes, according to the lawsuit, which was originally filed in mid-2009.

About two years later, Max Planck, MIT, and Whitehead forged a new deal under which Whitehead would once again take charge of filing patent applications for the Tuschl-I IP, but giving Max Planck the responsibility of granting two non-exclusive licenses to the Tuschl-I and Tuschl-II IP for therapeutic applications. Alnylam took one of those licenses and later acquired the other licensee, Germany's Ribopharma.

Although Alnylam had thereby secured exclusive access to Tuschl-II, UMass did not join Whitehead, MIT, and Max Planck in their second agreement, and instead chose to license its ownership in Tuschl-I to Sirna and, to a limited degree, RXi Pharmaceuticals' one-time parent firm CytRx.

So Alnylam and Max Planck sued Whitehead, MIT, and UMass, charging that the three institutions had misappropriated certain Tuschl-II inventions into Tuschl-I patent application filings, specifically 3' overhang data. In doing so, they claimed, UMass' licensees had unfairly gained access to the Tuschl-II property without paying for a license.”

Licenses to its patent estate have been a major revenue driver for Alnylam, which states that it has raised roughly $725 million by granting access to its IP for therapeutic and research purposes.

According to court filings, the plaintiffs maintained that overhang data were allowed to be incorporated into Tuschl-I filings to support the applications, but only on the condition that they “not be used to claim nor provide support for claims to RNAi agents having 3' overhangs and their use,” which were to be inventions reserved for Max Planck's own Tuschl-II patent applications.

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Additional filings show that Sirna, for one, did not agree. According to a court document, in 2004 Maraganore met with then-Sirna CEO Howard Robin to discuss each companies' rights to the Tuschl patent estates.

Shortly thereafter, Maraganore sent Robin a letter in which he claimed the 3' overhang technology as exclusive to the Tuschl-II family and solely licensed to Alnylam. Disagreeing, Robin responded with his own letter to Maraganore weeks later, claiming the Tuschl-I applications "clearly contemplate and cover all forms of short interfering RNAs, including those with 3'-nucleotide overhangs.”

In the months since Alnylam and Max Planck originally filed their suit, the wrangling had grown increasingly heated. The defendants lodged counterclaims and suggested that after UMass licensed Tuschl-I to Alnylam's biggest competitor, the RNAi shop began “a campaign to harm the Tuschl-I applications and seek advantage for the Tuschl-II applications,” according to a court filing.

According to the defendants, Maraganore summed up the company's approach to the issue “succinctly in an e-mail: 'SCREW THEM!!!'”

The plaintiffs, meantime, told the court that the defendants had “implemented a secret strategy” to persuade the US Patent and Trademark Office to issue a Tuschl-I patent containing the overhang data in order to undercut the Tuschl-II IP.

During the course of the suit, Alnylam and Max Planck successfully blocked prosecution of Tuschl-I applications in the US by asking the US Patent and Trademark Office to pull the power of attorney it gave Whitehead in order to oversee the IP.

Each side claimed it had suffered harm by the actions of the other, and the case was set to go to trial this month. However, with the settlement, the matter has been resolved.

In addition to UMass being permitted to provide Merck with access to Tuschl-II in exchange for “a share of certain future sub-license income,” Max Planck, Whitehead, UMass, and MIT have now agreed that future prosecution of the two Tuschl patent families in the US will be “coordinated and led by ... Max Planck,” Alnylam said this week. Max Planck will also remain in charge of Tuschl-II's prosecution outside the US, while UMass will lead future prosecution of the Tuschl-I family internationally.

Additional terms of the settlement were not disclosed.

"Today's settlement provides for a favorable resolution of this dispute for all parties and significantly optimizes the successful prosecution of both the Tuschl-I and Tuschl-II patent families, which together represent critical innovations for the advancement of RNAi therapeutics as breakthrough medicines,” Maraganore said in a statement.

"We are very pleased that the settlement provides for coordinated prosecution of the Tuschl-I and Tuschl-II patent families in the United States that will encourage further development of RNAi therapeutics," Whitehead Director David Page added.


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