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Whitehead Moves to Block Alnylam, Max Planck Motion to Halt Tuschl-I Patent Prosecution


By Doug Macron

The Whitehead Institute for Biomedical Research this week fired its latest salvo in its ongoing legal battle over the Tuschl-I patent family, asking the court to deny a motion by plaintiffs Alnylam Pharmaceuticals and the Max Planck Institute for a court order to block the prosecution of patents from the intellectual property estate.

According to Whitehead, Alnylam and Max Planck's request represents an "eleventh hour … rush into court to seek emergency relief from a situation of their own making," and therefore should be denied.

In late June, Alnylam and Max Planck sued Whitehead, the Massachusetts Institute of Technology, and the University of Massachusetts for allegedly misappropriating certain RNAi-related technology for inclusion into Tuschl-I patent applications (see RNAi News, 7/9/2009).

Specifically, the plaintiffs charged that the defendants co-opted certain inventions, such as the 3' overhang feature, from the Tuschl-II patent family, which is owned by Max Planck and exclusively licensed to Alnylam, and have attempted to include it in patent applications from the Tuschl-I family, to which Alnylam, RXi Pharmaceuticals, and Merck subsidiary Sirna Therapeutics all hold licenses.

Earlier this month, Alnylam and Max Planck told the court that the US Patent and Trademark Office may "very shortly" give notice that it will award a patent on a Tuschl-I application, and that such an event would give Sirna and RXi unfair access to the Tuschl-II property. "As a result, Alnylam will no longer be able to reap the benefit of its license agreement with Max Planck," they noted.

To remedy the situation while the lawsuit plays out, Alnylam and Max Planck 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 (see RNAi News, 7/16/2009). Such an order would effectively allow Max Planck to halt the prosecution of Tuschl-I patents in the US.

Soon thereafter, the defendants argued in court filings that there is no concrete evidence that the USPTO was poised to issue a Tuschl-I patent, and that the court order would be unnecessary and potentially damaging (see RNAi News, 7/16/2009).

This week, Whitehead further argued that Alnylam and Max Planck "have known for years that the data at issue is in the Tuschl-I application" and that it would be included in a Tuschl-I patent application even before the application was filed.

The charge that Whitehead has misappropriated Tuschl-II data is "ludicrous" since Max Planck had given permission for its inclusion in Tuschl-I applications, Whitehead said in its latest court filing.

"Any notion that … permission was not knowingly given is completely specious," in part because Max Planck and former Max Planck researcher and Alnylam co-founder Thomas Tuschl, for whom the IP at issue is named, "indisputably received the final version of the Tuschl-I application shortly after it was filed and made no complaint that data had been improperly included," Whitehead added. "Tuschl in particular was specifically advised to review the application carefully, and he swore under oath on May 2001 that he did so."

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The plaintiffs acknowledge that Max Planck "confirmed" its consent to the application in 2003, and "the notion that [it] did not knowingly consent to the inclusion of [the data at issue] in Tuschl-I is squarely refuted by these facts," Whitehead charged this week.

For these and other reasons, Whitehead said that the court should deny the plaintiffs' motions for the court order.

One of Many

Threatening to break Alnylam's lock on what has been characterized as some of the RNAi field's most fundamental IP, the dispute over the Tuschl-I and -II patent estates may very well be the most significant litigation the space has seen thus far. But it is just one legal battle of many that have been waged in the short history of the gene-silencing technology.

Perhaps the earliest occurred in 2002, when Isis Pharmaceuticals sued privately held reagent shop Sequitur for allegedly infringing four US patents covering the use of antisense molecules to inhibit specific gene targets.

Sequitur, which is perhaps best known for developing the Stealth line of modified siRNAs, denied the infringement charges, and the companies settled their dispute less than five months later through a licensing agreement, the terms of which were not disclosed.

About two years later, Australian expressed RNAi shop Benitec sued three companies for allegedly infringing its core US patent, No. 6,573,099, which claims gene-expression inhibition using DNA that transcribes double-stranded RNA (see RNAi News, 4/2/2004).

Although two of the companies, Ambion and GenScript, took licenses to the patent to end the litigation, the third defendant, Nucleonics, chose to fight, seeking a court ruling that Benitec’s intellectual property was invalid and opposing or requesting re-examination of certain Benitec patents in the US and abroad.

Although Nucleonics ultimately shut its doors due to an unrelated issue (see RNAi News, 11/6/2008), over the course of the dispute, the US Patent and Trademark Office rejected all the claims within the ‘099 patent. Benitec, which has restructured as a much smaller company after closing its US operations, continues to fight to maintain certain claims within the patent (see RNAi News, 5/7/2009).

Patent infringement was also at issue when Sigma-Aldrich and partner Oxford BioMedica sued Open Biosystems in 2006 for allegedly infringing patents claiming lentiviral vectors that can be used to introduce RNA into slowly dividing and non-dividing cells (see RNAi News, 6/15/2006).

After nearly two years, the companies settled their dispute, with Open Biosystems taking a license to IP held by Sigma-Aldrich and Oxford BioMedica for use in research activities (see RNAi News, 3/13/2008).

Open Biosystems has since been acquired by Thermo Fisher Scientific (see RNAi News, 7/3/2008).

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But IP hasn't always been the source of contention between players in the RNAi space.

In 2005, MIT sued Thermo Fisher Scientific unit Dharmacon for failing to pay sufficient royalties on RNAi products pursuant to a 2001 agreement under which the RNAi shop obtained co-exclusive access to certain siRNA technology for internal research or for the sale of research products (see RNAi News, 2/11/2005).

The next year, the parties settled their dispute out of court (see RNAi News, 1/5/2006). While the details of the settlement were not disclosed, a Dharmacon official confirmed that the company's rights to the IP were not affected.

Contractual obligations were also at the heart of legal wrangling between Sirna and Protiva Biotherapeutics (now known as Tekmira Pharmaceuticals) over a license to a drug-delivery technology. In its 2006 suit, Sirna alleged that the deal was void because Protiva didn't actually own the rights to the technology.

According to Sirna, those rights remained with former Protiva parent company Inex Pharmaceuticals, which became involved in separate but related litigation with Protiva.

After Merck acquired Sirna, it took a non-exclusive license to the SNALP technology in order to settle the litigation (see RNAi News, 10/18/2007). But the war between Protiva and Inex, which later restructured into Tekmira, continued until last year when the companies agreed to merge and drop all charges against each other (see RNAi News, 4/3/2008).

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