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Court Denies Alnylam, Max Planck’s Request to Block Tuschl-I IP Prosecution in US

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By Doug Macron

A court has denied a request by Alnylam Pharmaceuticals and the Max Planck Institute to block efforts by the University of Massachusetts, the Massachusetts Institute of Technology, and the Whitehead Institute for Biomedical Research to prosecute intellectual property at the heart of an ongoing legal battle, according to a court document released this week.

Specifically, the court rejected Alnylam and Max Planck’s request after determining that they have “not shown a substantial likelihood of success” on the merits of their case.

The row began in June when Alnylam and Max Planck sued UMass, Whitehead, and MIT in a Massachusetts State Court 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).

Alnylam holds the exclusive rights to the Tuschl-II estate through a license from the IP's sole owner, Max Planck. However, the company 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, CytRx spinout RXi Pharmaceuticals.

The plaintiffs charged 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,” and said that the US Patent and Trademark Office was poised to grant a Tuschl-I patent.

As such, they asked the court in July for a preliminary injunction barring 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).

But this week, the US District Court for the District of Massachusetts, which is now hearing the case, denied that request, stating that Alnylam and Max Planck have failed to demonstrate “a likelihood of success on their core claim that [the] defendants misappropriated their invention by putting the overhang and [related] mammalian data in the Tuschl-I applications, and refusing to take it out because the plaintiffs specifically authorized [the] defendants to do so.”

According to the court document, in 2001, the patent attorney representing Max Planck agreed to a request by an attorney representing Whitehead to include the data in Tuschl-I patent applications. At the same time, Max Planck included the data in its own Tuschl-II applications.

Despite awareness of the potential for the IP to “overlap,” Whitehead and Max Planck decided not to combine the applications but instead agreed to prosecute their IP separately, while claiming priority to each other’s applications, the court said.

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“In March 2001, Whitehead sent a copy of the Tuschl-I applications to Max Planck,” which did not “protest … the inclusion of the mammalian data or any other information in the Tuschl-I applications” until 2003, when UMass licensed its rights to the Tuschl-I IP to Sirna and CytRx, according to the court.

In 2007, the USPTO told all owners of the Tuschl-I and Tuschl-II IP that it would not grant more than one patent on the same invention, and rejected applications from both families on obviousness-type double-patenting grounds, the court said. Despite subsequent meetings between the defendants and plaintiffs, a resolution could not be reached, and Whitehead refused to remove the data at issue from Tuschl-I applications.

Further, in June this year, Whitehead, without consulting Max Planck, asked the USPTO to allow a Tuschl-I application because it was filed before any Tuschl-II application, prompting the lawsuit, the document notes.

In explaining its decision to deny the plaintiffs’ request for a preliminary injunction, the court said that Alnylam and Max Planck’s argument that the 3’ overhang data was misappropriated “will not fly as Max Planck’s lawyer … unconditionally authorized Whitehead in writing to include the information and data” in Tuschl-I applications.

Although the attorney now contends that Whitehead did not act in good faith because it did not “fully explain the origins of the data, there is no evidence of fraudulent misrepresentation or bad faith,” the court noted. “Moreover, even if there had been a misunderstanding … the full patent application with the disputed information was sent to Max Planck before it was filed, and Max Planck did not protest the inclusion of the data for two years.”

In handing down its decision, the court also took into account a letter MIT Technology Licensing Office Director Lita Nelsen sent to Chester Bisbee, director of the University of Massachusetts Medical School Technology Transfer Office, stating 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.

According to the court filing, Whitehead argued that it only agreed not to assert “species” claims, which are limited to a single disclosed embodiment of an invention, to the 3’ overhangs, but “never committed” to not prosecute broader genus claims.

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“No doubt, this is a complicated, arcane area of patent law fraught with landmines,” the court wrote in its decision. “Both sides have experienced patent counsel and realized that both [Tuschl-I and Tuschl-II] applications have broad initial claims [that] might overlap in ways troubling to the USPTO.”

Still, “both sides knowingly took the risk based on genus/species law and rolled the dice, rather than combining the patents, the safer bet,” the court added.

Perhaps more importantly, Max Planck has known since at least 2001 about the claims contained in Tuschl-I filings, and, by its own admission, did not complain until late 2003, the court said.

“Trying to swat away the lapse in years, [the] plaintiffs state without persuasive facts that after the USPTO indicated for the first time in 2007 that it would reject both applications on … double-patenting grounds,” they expected the defendants to remove the disputed data from Tuschl-I applications, the court noted. And while Alnylam and Max Planck claim that a 2008 meeting with the defendants “gave them reason to hope for a resolution … [they] waited for over a year … to file this lawsuit.”

Additionally, the court said, Alnylam and Max Planck chose to seek an emergency injunction in a suit filed in a state court “with little or no patent expertise” just before the Fourth of July weekend.

“A party cannot delay the initiation of litigation and then use an emergency created by its own decisions concerning timing to support a motion for a preliminary injunction,” the court stated.

Whitehead has also claimed that it would suffer by deleting information in a patent filling at such a late date in the patent office proceedings, and the court agreed.

In light of these findings, the court denied Alnylam and Max Planck’s motion for a preliminary injunction.

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