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Alnylam, Max Planck Say Tuschl-I Patent Issuance Imminent, Ask for Court Order

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By Doug Macron

The US Patent and Trademark Office may "very shortly" give notice that it plans to award the country's first patent on an application from the Tuschl-I intellectual property estate, according to court documents filed earlier this month by the Max Planck Institute and Alnylam Pharmaceuticals.

As a result, they have asked for a court order effectively stopping the issuance of the patent until an ongoing lawsuit over the IP can play out.

The defendants in the case, however, charge in their responses to Alnylam and Max Planck's request that there is no evidence the USPTO intends to issue the patent anytime soon (see related story, this issue).

Late last month, Alnylam and Max Planck announced that they had sued the Whitehead Institute for Biomedical Research, the Massachusetts Institute of Technology, and the University of Massachusetts for allegedly misappropriating certain RNAi-related technology into patent applications (see RNAi News, 7/9/2009).

At the center of the dispute is the so-called Tuschl-I and Tuschl-II IP, named for former Max Planck researcher and Alnylam co-founder Thomas Tuschl. Both patent families relate to the use of siRNAs, 21 to 23 nucleotides in length, to target specific mRNA degradation in mammals, but the latter also includes claims related to two-to-three nucleotide-long 3' overhangs.

According to other court filings by Max Planck and Alnylam, the 3' overhang feature is exclusive to Tuschl-II inventions but has been wrongfully included in Tuschl-I patent applications.

The Tuschl-II IP is owned solely by Max Planck, which exclusively licensed the technology for therapeutic applications to Alnylam.

The Tuschl-I IP, meanwhile, is jointly owned by Max Planck, Whitehead, MIT, and UMass. While the first three institutes licensed their ownership interests in the IP to Alnylam, with Max Planck brokering the deal, UMass chose to license its share to Sirna Therapeutics with the understanding that Sirna would make the IP widely available for sub-licensing (see RNAi News, 9/13/2003).

Before signing its deal with Sirna, which is now a subsidiary of Merck, UMass also licensed certain limited therapeutic rights to the Tuschl-I IP to CytRx, which later passed along those rights to spinout RXi Pharmaceuticals.

In a lawsuit filed on June 26 in the Suffolk County Superior Court in Boston, Alnylam and Max Planck charged Whitehead, MIT, and UMass with "inserting Tuschl-II inventions into the Tuschl-I patent applications … [which] impermissibly broadens the scope of patent protection to embrace the Tuschl-II property that rightfully belongs only to Max Planck.

"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 consideration for a license" to the Tuschl-II IP, the suit adds. "As a result, Alnylam will no longer be able to reap the benefit of its license agreement with Max Planck."

In neither the complaint nor a press release announcing the litigation did the plaintiffs specify what aspect of Tuschl-II had been allegedly misappropriated. But in an affidavit filed with the court on July 1, an attorney for Alnylam and Max Planck stated certain Tuschl-I patent applications include "Tuschl-II proprietary technology referred to as the 3' overhang … [which is] one of the features of the Tuschl-II inventions that render them significantly more effective and desirable as a therapeutic agent than any other previous invention in the field of RNA interference."

The first Tuschl-I patent application — US patent application No. 60/193,594, filed in March 2000 — contains "no reference to or disclosure of the Tuschl-II overhang invention," while the first Tuschl-II patent application — European patent application No. EP00126325, filed in December 2000 — details the technology feature "as part of the very essence of the Tuschl-II invention," the attorney stated.

It wasn't until about four months later in a follow-on patent application — US patent application No. 09/821,832 — that the 3' overhang invention appeared in Tuschl-I filings, she added, noting that the Tuschl-II IP appears to be the source of 3' overhang technology described in the later-filed Tuschl-I application.

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Currently, just two Tuschl-II-related patents have issued in the US: Nos. 7,056,704, awarded June 6, 2006, and 7,078,196, awarded July 18, 2006. Both are entitled RNA Interference-Mediating Small RNA Molecules and were filed on April 27, 2004.

The attorney noted that she also identified "additional incorporations" of Tuschl-II inventions in the Tuschl-I applications, but cited the 3' overhang feature as an example.

In their original complaint, Max Planck and Alnylam asked the court to bar the defendants from "taking any further action in connection with the prosecution of any Tuschl-I patent application.

"An imminent and significant danger exists that [the] defendants will take actions to obtain such a patent, thereafter making it essentially impossible to remove the Tuschl-II inventions from any patent that may issue based upon a Tuschl-I application," they added.

Now, it seems, that danger may have become more immediate. In a memorandum supporting their request for the blocking court order, the plaintiffs claim that "it appears that [the USPTO] will very shortly give notice that it intends to issue a patent based on a Tuschl-I application — a patent that would include a disclosure of Tuschl-II inventions.

"If that happens, [Max Planck] will effectively lose all of its property rights in the Tuschl-II inventions because once an invention is disclosed in one patent, the USPTO will not allow the same invention or obvious variants thereof to be protected by a second patent," the memorandum notes.

"Max Planck has repeatedly requested that [the] defendants simply delete from the Tuschl-I patent applications the Tuschl-II invention information that belongs solely" to Max Planck, which would be a "simple and reasonable solution [to the dispute] given that [the defendants] have admitted that they do not own the Tuschl-II invention," it adds.

Indeed, among the documents filed by the plaintiffs in support of their suit is a 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.

Whitehead, MIT, and UMass have thus far "failed and refused, without offering any meaningful justification, to remove [Max Planck's] Tuschl-II inventions from the Tuschl-I applications," the memorandum states.

Rather, they have continued to take "affirmative steps to gain title to Max Planck's invention," and in light of the USPTO's apparent plan to issue a Tuschl-I patent, Alnylam and Max Planck are seeking "to preserve the status quo" while the litigation proceeds so that the court can rule on the case before the defendants "severely diminish, if not completely destroy, [the] plaintiffs' interest in this [intellectual] property," according to the memorandum.

Specifically, the plaintiffs have asked the court to order that no issuance fee shall be paid on any Tuschl-I application unless all the IP's co-assignees, including Max Planck, agree that the fee shall be paid.

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