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UMass, Whitehead Fire New Salvo in Tuschl IP Suit, Claim Max Planck Meddled with Power of Attorney

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By Doug Macron

The University of Massachusetts and the Whitehead Institute for Biomedical Research this week returned fire against the Max Planck Institute and Alnylam Pharmaceuticals in their ongoing legal battle, counterclaiming that, among other things, Max Planck inappropriately sought to replace the Whitehead-appointed law firm overseeing prosecution of the intellectual property at issue in the case.

UMass further argued in its counterclaim that a key aspect of the disputed RNAi technology — the 3’ overhangs commonly incorporated into siRNAs — was an inherent feature of the RNAi molecules described in a patent application filed prior to another patent application from Max Planck that specifically claims the overhangs.

The litigation began in June when Alnylam and Max Planck sued UMass, Whitehead, and the Massachusetts Institute of Technology for allegedly misappropriating certain RNAi inventions, most notably the use of 3’ overhangs on siRNAs, from the Tuschl-II patent family and included them in patent applications from the Tuschl-I IP estate (see RNAi News, 7/9/2009).

Both Tuschl-I and Tuschl-II generally relate to the use of siRNAs, 21 to 23 nucleotides in length, to target specific mRNA degradation in mammals. However, Tuschl-II includes claims on two-to-three nucleotide-long 3’ overhangs. Both are named after former Max Planck researcher Thomas Tuschl, an Alnylam co-founder who is now a researcher at Rockefeller University.

Alnylam acquired the exclusive therapeutic rights to the Tuschl-II family from the IP's sole owner, Max Planck, but shares therapeutic rights to the Tuschl-I estate — invented at Max Planck, Whitehead, MIT, and UMass — with Merck subsidiary Sirna Therapeutics (see RNAi News, 9/13/2003) and, to a limited degree, RXi Pharmaceuticals.

Alnylam and Max Planck maintained in their lawsuit, which was filed in the Suffolk County Superior Court in Boston, that if any Tuschl-II inventions are included in Tuschl-I patents, Sirna, RXi, and any other companies sublicensing Tuschl-I will "unfairly gain access to the Tuschl-II property without paying consideration for a license."

In an effort to prevent the issuance of any Tuschl-I patents in the US, the plaintiffs asked the court to temporarily block the payment of issuance fees on any Tuschl-I application unless all the IP's co-assignees, including Max Planck, agree that the fee shall be paid, which would effectively halt the prosecution of Tuschl-I IP in the US (see RNAi News, 7/16/2009).

According to this week’s counterclaims, it appears that Max Planck has also taken steps to switch out Whitehead’s patent attorney overseeing the Tuschl-I patent applications with one more sympathetic to its cause.

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In 2001, Max Planck, Whitehead, MIT, and UMass agreed to put Whitehead in charge of managing the prosecution of Tuschl-I applications. But according to UMass and Whitehead, last month Max Planck unilaterally filed a petition with the US Patent and Trademark Office to revoke the power of attorney it had given to Whitehead under that 2001 deal for each pending Tuschl-I patent application.

“If these petitions are granted, Whitehead’s chosen patent attorneys for the Tuschl-I patent prosecutions … would no longer be able to manage the patent filing, prosecution, and maintenance of these applications,” Whitehead said in its counterclaim.

The move by Max Planck violates its obligation “to allow Whitehead to manage the … Tuschl-I applications and to cooperate with Whitehead” in such endeavors, it added. “Rejecting Whitehead’s choice of patent attorneys is a complete repudiation of Max Planck’s duty of cooperation.”

“By filing the petition to revoke, Max Planck intended unilaterally to stop the ongoing prosecution of the jointly owned applications,” UMass added in its own countersuit.

As such, both UMass and Whitehead have asked the court to order Max Planck to cooperate with Whitehead’s prosecution of the Tuschl-I patent applications and to withdraw its petition to revoke power of attorney.

‘Known in the Field’

In an effort to bolster their case, Alnylam and Max Planck recently argued to the court that a 2004 letter sent by officials at Whitehead and MIT to UMass indicates that the 3’ overhang technology belongs to Max Planck and should not be included in Tuschl-I applications (see RNAi News, 8/6/2009).

Specifically, MIT Technology Licensing Office Director Lita Nelsen sent a letter to University of Massachusetts Medical School Technology Transfer Office Director Chester Bisbee in which she stated that the overhang technology "originated" at Max Planck. John Pratt, associate director of Whitehead, also signed the letter to Bisbee.

"Claims containing the inventive subject matter of the 3' overhangs were to be reserved for [Max Planck's] own patent,” Nelsen wrote, adding that she sent the letter to Bisbee at Max Planck's request in order to "confirm our understanding" of the overhang data.

While court documents indicate that attorneys for UMass questioned whether the so-called Nelsen-Pratt letter "was simply a private communication that did not involve [the] plaintiffs and did not reflect any agreement,” the university went one step further this week, telling the court that the siRNAs described in Tuschl-I filings “inherently comprised molecules with 3’ overhangs.”

As of 2000, “it was known in the field of RNA research that the ends of dsRNA molecules could be aligned exactly or could have an overhang of one or more nucleotides on … the 3’ end or … the 5’ end,” UMass stated in its court filing.

That year, a few weeks after the inventors of the Tuschl-I IP — Tuschl, UMMS’ Phillip Zamore, Whitehead’s David Bartel, and MIT’s Phillip Sharp — published in Cell the findings that laid the groundwork for the patent family, University of Utah School of Medicine researcher Brenda Bass published a review in the same journal in which she suggested that “the dsRNA fragments isolated by the inventors … likely had 3’ overhangs, based upon the known biology of RNase III enzymes,” UMass noted.

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Later that same year, “Tuschl sequenced the dsRNA fragments obtained using the Drosophila lysate system used by the inventors in their research and confirmed that the structure of these fragments comprised 3’ overhangs, as … Bass had hypothesized,” it added.

In 2001, it was discovered that the RNase III enzyme dubbed Dicer cleaves long dsRNA into siRNA with two-nucleotide-long 3’ overhangs of during the RNAi process, UMass stated. “It is now known that it was the Dicer enzyme present in the Drosophila lysate system … that catalyzed the cleavage of long dsRNA to generate the target-specific short … RNA fragments that the inventors recognized as the mediators of RNAi.”

As a result, the siRNAs described in Tuschl-I “inherently” comprise molecules with 3’ overhangs, UMass claimed.

Nonetheless, in late 2000, Max Planck filed on its own a European patent application that “included broad claims overlapping” with the claims in the pending Tuschl-I US applications filed by UMass, MIT, Whitehead, and Max Planck, it stated.

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