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Max Planck, Alnylam Sue Whitehead, MIT, UMass for Breach of Contract in RNAi Patent Filings

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This article was originally published on June 29.

The Max Planck Society, Max Plank Innovation, and Alnylam Pharmaceuticals are suing a trio of Massachusetts research institutions for allegedly breaching their contractual and fiduciary duties in prosecuting patents surrounding RNA interference technology.

The complaint, filed late last week in Suffolk County Superior Court in Boston, names as defendants the Whitehead Institute for Biomedical Research, the Massachusetts Institute of Technology, and the University of Massachusetts.

The suit charges the defendants with misappropriating and misrepresenting as their own a number of inventions that Max Planck claims are solely its own, and that it has exclusively licensed to Alnylam.

According to the plaintiffs, this situation has arisen due to the defendants' negligence in properly filing a family of patent applications based on inventions that predated the Max Planck inventions.

Max Planck argues that the defendants' actions will prevent it from owning patents related to its own inventions — assuming they are granted — and will deprive Alnylam of its financial interest in the patents. As such, the plaintiffs have asked the court to prevent the defendants from seeking any further patents that might compromise the patentability of the Max Planck inventions, according to the complaint.

The case revolves around two families of inventions known as Tuschl I and Tuschl II, named after Tom Tuschl, a scientist at Max Planck, co-founder of Alnylam, and the only individual to have contributed to both sets of inventions, according to the complaint.

The Tuschl I inventions refer to a series of RNAi technologies that Tuschl and colleagues at Whitehead and MIT developed in the early 1990s. Tuschl performed part of his work while employed at Whitehead and part of it while employed by Max Planck. One co-inventor also contributed to the inventions while employed at Whitehead; however, he later joined UMass and assigned his interest in the technology to that school, an event that would become a central feature in the suit.

The Tuschl II family, meantime, comprises a separate set of RNAi-related inventions developed by Tuschl and colleagues exclusively at Max Planck. As such, Max Planck is the sole owner of those inventions, according to the complaint.

The suit rests on two joint invention and marketing agreements signed by various players. The first agreement, signed by all parties in September 2001, gave MIT primary responsibility for marketing and licensing the Tuschl I and Tuschl II inventions as research reagents and for internal research use. As part of this agreement, the Whitehead, an MIT affiliate, was given responsibility for securing patent protection for the Tuschl I inventions, the complaint states.

The second agreement, penned in July 2003 between Max Planck, Whitehead, and MIT, but not UMass, was designed to guide how both invention families would be licensed for therapeutic purposes.

Under that pact, the Whitehead assumed primary responsibility for filing patent applications based on the Tuschl I inventions; while Whitehead and MIT authorized Max Planck Innovation, the tech-transfer arm of Max Planck, to grant two non-exclusive licenses to their ownership interests in the Tuschl I and Tuschl II inventions for therapeutic purposes, the suit claims.

UMass opted to license its ownership in the Tuschl I inventions for therapeutic purposes to companies other than Alnylam, according to the complaint.

In December 2002 and July 2003, Max Planck co-exclusively licensed the Tuschl I and II inventions to Alnylam and Ribopharma, respectively. Alnylam acquired Ribopharma in 2003, making it the exclusive licensee of the Tuschl II inventions for therapeutic purposes, according to the suit.

In last week's suit, Max Planck and Alnylam point out that Whitehead and MIT, by signing the second joint therapeutic-use agreement, had agreed to be bound by Max Planck's licensing agreement with Alnylam.

Financial details of the licensing agreements referenced in the suit have not been disclosed. In a statement, Max Planck and Alnylam said that they will not provide specific details on the suit while in active litigation.

According to the suit, Max Planck and Alnylam have taken issue with the Whitehead over what they claim was a failure to properly prosecute patents related to the Tuschl I inventions as laid out in the research-use-only joint agreement.

According to this part of the complaint, the Whitehead "assumed a duty" to act on behalf of Max Planck and Alnylam to secure patent protection for the co-owners' IP. In addition, Max Planck, through payment from Alnylam, paid Whitehead to apply for patent protection of its ownership interest in the Tuschl I inventions.

However, Whitehead "continues to seek, to plaintiffs' detriment, patent protection for aspects of the Tuschl II inventions for benefit of the co-owners of the Tuschl I invention;" and "is seeking to misappropriate the inventions that were invented by the Tuschl II inventors by including in Tuschl I patent applications … material regarding those inventions," the complaint states.

Max Planck and Alnylam claim in their suit that they have repeatedly informed Whitehead of its alleged wrongdoing and that the institute has "failed, and affirmatively refused, to remove the Tuschl II inventions from the Tuschl I patent applications, and has failed to offer any justification … for failing and refusing to direct prosecution counsel to delete the Tuschl II inventions from the Tuschl I applications."

They are also alleging breach of contract, breach of fiduciary duty, interference with advantageous business relations, unjust enrichment, and negligence, among other complaints.

According to Alnylam, the Tuschl I family of inventions, whose prosecution is controlled by the Whitehead, has so far only resulted in patents in New Zealand and Australia — and an intent-to-grant motion from European patent regulations. Meantime, "numerous" patents in the Tuschl II family, whose prosecution is controlled by Max Planck, have been issued or granted in the US, Japan, and more than 30 other countries, including in Europe, Alnylam said.

"Despite our exhaustive efforts, the Whitehead Institute … has failed in their business obligations to Max Planck and Alnylam regarding the proper and successful prosecution of the Tuschl I applications," Alnylam CEO John Maraganore said in a statement regarding the suit.

"It is unfortunate that we need to take this action, but we are convinced that it is necessary to correct improper and negligent prosecution of the Tuschl I patent applications," Maraganore added.

Whitehead and MIT declined to comment on the litigation as per institution policy.

Further, in their complaint the plaintiffs bemoan the potential consequences of UMass' decision not to participate in the therapeutic-use joint agreement.

"Unlike the other co-owners, UMass instead chose to license its property rights in the Tuschl I inventions to companies other than Alnylam," the complaint states. "If a Tuschl I patent issues that incorporates the usurped Tuschl II invention, then UMass' licensees will unfairly gain access to the Tuschl II property without paying any consideration for a license to the Tuschl II property."

As a result, the complaint states, "Alnylam will no longer be able to reap the benefit of its license agreement with Max Planck. Hence, Alnylam has a substantial and immediate interest in preventing defendant's misappropriation of the Tuschl II inventions."

The plaintiffs are seeking a temporary restraining order to prevent the defendants from further prosecuting any Tuschl I patent applications. They are also seeking monetary damages, punitive damages, and related costs and attorney fees.

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