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Max Planck, Alnylam Attorneys Argue UMass Letter Shows Max Planck Owns Tuschl-II Inventions

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By Doug Macron

A letter sent in 2004 by officials at the Whitehead Institute for Biomedical Research and the Massachusetts Institute of Technology to the University of Massachusetts indicates that RNAi intellectual property at the heart of an ongoing legal battle belongs to the Max Planck Institute and therefore should be viewed as a confirmation of the ownership of the disputed IP, attorneys for plaintiffs Max Planck and Alnylam Pharmaceuticals argued this week.

The letter "was never intended to be a private communication," the attorneys said in a court filing. "Rather, it was intended to confirm the parties' understanding of the limits on the use of data [at issue] and inventions owned exclusively by Max Planck and reserved" for its own patent applications.

In the filing, the plaintiffs' counsel also provided some background on the dispute, including details of a meeting in early 2004 between the chief executives of Alnylam and rival Sirna Therapeutics that led up to the litigation.

In June this year, Alnylam and Max Planck announced that they had sued Whitehead, MIT, and UMass for allegedly misappropriating certain siRNA-related inventions, including the use of 3' overhangs, from the so-called Tuschl-II patent family for inclusion in patent applications from the Tuschl-I estate (see RNAi News, 7/9/2009).

Alnylam holds the exclusive therapeutic rights to the Tuschl-II family, which were licensed 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.

As such, the plaintiffs allege in their lawsuit, filed in the Suffolk County Superior Court in Boston, that if Tuschl-II inventions are incorporated into Tuschl-I patent applications, Sirna, RXi, and any other company sublicensing the IP "will unfairly gain access to the Tuschl-II property without paying consideration for a license."

One of the plaintiffs' key pieces of evidence supporting their claims is the 2004 letter sent from MIT Technology Licensing Office Director Lita Nelsen to University of Massachusetts Medical School Technology Transfer Office Director Chester Bisbee confirming that data related to the overhang technology "originated" at Max Planck.

"The data was given to us contingent upon our not using it to claim nor provide support for claims to RNAi agents having 3' overhangs and their use," the letter states. "Claims containing the inventive subject matter of the 3' overhangs were to be reserved for [Max Planck's] own patent."

Nelsen notes that she sent the letter to Bisbee at Max Planck's request in order to "confirm our understanding" of the overhang data.

John Pratt, associate director of Whitehead, also signed the letter to Bisbee.

In a letter submitted at the request of the court this week, Max Planck and Alnylam's counsel noted that during a late July hearing conducted to consider their motion for a court order temporarily blocking the issuance of any Tuschl-I patent (see RNAi News, 7/16/2009 & 7/16/2009), an attorney 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."

In fact, the letter was sent not only to UMass but also Alnylam "in response to Max Planck's request that the co-assignees of the Tuschl-I applications confirm that the information relating to 3' overhangs 'originated at' Max Planck," which only allowed the defendants to include the data in Tuschl-I applications as long as they did not use it to "claim nor provide support for claims to RNAi agents having 3' overhangs and their use," Alnylam and Max Planck's attorneys claimed.

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"In other words, the Nelsen-Pratt letter was sent to [the] plaintiffs to reassure them that Whitehead and MIT agreed with [Max Planck and Alnylam's] understanding of the ownership of the material in the two families of patent applications and to notify UMass that it was not permitted to license the Tuschl-II inventions," they added.

'Quite Frankly, Surprised'

In support of its contention that the Nelsen-Pratt letter confirms Max Planck's ownership of the 3' technology, the plaintiffs' attorneys included in their court filing background information on the dispute, including details of a meeting and disagreement between Alnylam President and CEO John Maraganore and Sirna CEO Howard Robin.

According to the attorneys, Maraganore and Robin spoke during a lunch meeting in January 2004 about each company's rights to the Tuschl-I and Tuschl-II IP. 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.

"Although this information is included in the Tuschl-I application, the inventorship and priority of this data was first established in an … application in the Tuschl-II series and cannot be claimed in the Tuschl-I series," Maraganore's letter to Robin reads.

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.

"Sirna has rights to all such molecules under [the Tuschl-I] family of application," Robin added. "We believe it is incorrect and inappropriate to suggest to anyone in the marketplace that the rights to double-stranded siRNAs having 3' overhangs reside anywhere other than the joint owners" of the Tuschl-I family.

Because Sirna's rights to the Tuschl-I family stem from a 2003 licensing deal with UMass, "Max Planck confronted UMass about the broad therapeutic licensing rights that Sirna was claiming" and requested confirmation that the 3' overhang data did not belong in Tuschl-I applications, Max Planck and Alnylam's attorneys wrote the court this week.

The result was the Nelsen-Pratt letter.

In addition, in July 2005, Whitehead filed an information disclosure statement with the US Patent and Trademark Office, based on the plaintiffs' request, "affirmatively representing that the Tuschl-I applicants 'do not rely' on the Tuschl-II information 'for … any of the currently pending claims' in the Tuschl-I applications," the attorneys noted.

In light of the Nelsen-Pratt letter and the IDS, the plaintiffs expected the defendants to withdraw Tuschl-II material from Tuschl-I filings when the USPTO first indicated in 2007 that it would reject applications from both patent families on the grounds that more than one patent cannot be issued for a single invention, they wrote to the court.

The plaintiffs "were, quite frankly, surprised at Whitehead's refusal to take steps to implement compliance with its understanding of the proper allocation of rights between the Tuschl-I and Tuschl-II patent families."

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