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Adding to Its Royalty Case, MIT Sues Dharmacon for Patent Infringement

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Having had its sights set on the development of an RNAi-based reverse-transfection platform for years, Dharmacon wasn't going to let the demise of partner Akceli last year stop its progress.

But while Dharmacon seems to be achieving this goal with the release of its siArray reverse transfection format line of products, the company isn't out of the woods yet.

Last week, the Massachusetts Institute of Technology expanded a lawsuit it had filed against Dharmacon three months ago over a licensing arrangement to include the infringement of a patent covering reverse-transfection technology that had at one time been exclusively licensed to Akceli.

In January, MIT sued Dharmacon in the US District Court for the District of Massachusetts for allegedly failing to pay sufficient royalties on the sale of RNAi products pursuant to a licensing deal (see RNAi News, 2/11/2005).

Dharmacon, along with Ambion, Qiagen, and Proligo, is co-exclusive licensee of an intellectual property portfolio related to the use of short pieces of double-stranded RNA to mediate RNAi. That IP portfolio — which includes US patent application no. 09/821,832; US patent application no. 10/255,568; and PCT application no. US01/10188 — is jointly owned by MIT, the Whitehead Institute, the Max-Planck Institute, and the University of Massachusetts. MIT is authorized to act as licensing agent on behalf of all the institutes.

According to MIT's lawsuit, Dharmacon has reinterpreted its license and has not met its financial obligations. As part of the deal, Dharmacon is required to pay MIT a 7-percent royalty on any products that include siRNAs, "regardless of how the siRNA product is selected, purified, or treated, and including kits that contain any siRNA component."

Dharmacon has yet to file with the court an official response to the original MIT suit. However, this has not stopped MIT from taking its case one step further. In an amended version of its complaint, the institute alleges that Dharmacon has infringed US patent 6,544,790, entitled "Reverse-Transfection Method." According to its abstract, the patent covers "a reverse-transfection method of introducing DNA of interest into cells and arrays, including microarrays, of reverse-transfected cells."

The reverse-transfection technology covered by the patent was invented by Whitehead Institute researcher David Sabatini. According to MIT, it is the exclusive licensing agent for the Whitehead Institute and has the exclusive right to enforce the patent.

Akceli had licensed the technology in a bid to commercialize it, and had signed an agreement with Dharmacon in late 2003 to develop it for RNAi applications. Unable to raise sufficient capital, however, Akceli ceased operations shortly thereafter (see RNAi News, 3/19/2004).

Specifically, the patent covers "a method of introducing nucleic acid molecules into mammalian cells [involving] depositing a plurality of nucleic acid molecule-containing mixtures onto a surface in discrete, defined locations, wherein each of the nucleic acid molecule-containing mixtures comprises a nucleic acid molecule to be introduced into mammalian cells and a gelatin; [and] allowing the nucleic acid molecule-containing mixtures to dry on the surface, thereby producing a surface having the nucleic acid molecule-containing mixtures affixed thereon in discrete, defined locations."

The method further involves "plating the mammalian cells onto the surface at a [certain] density … under appropriate conditions for entry of the nucleic acid molecules in the nucleic acid molecule-containing mixtures into mammalian cells … whereby the nucleic acid molecules are introduced into the mammalian cells in the location in which each of the nucleic acid molecule-containing mixtures was deposited," the patent states.

The patented method also involves "covering the surface bearing the nucleic acid molecule-containing mixtures with an appropriate amount of a lipid-based transfection reagent and maintaining the resulting product under conditions appropriate for complex formation between the nucleic acid molecules in the nucleic acid molecule-containing mixture and the transfection reagent; and removing the non-complexed transfection reagent."

While Akceli's end effectively killed its partnership with Dharmacon, Dharmacon forged ahead with its reverse-transfection efforts. Last October, William Marshall, executive vice president of research and operations and site manager at Dharmacon, told RNAi News that his company was planning to introduce a reverse-transfection platform and reagent (see RNAi News, 10/22/2004).

Marshall said at the time that differences exist between Akceli's technology and what Dharmacon had ultimately developed, stating that Akceli was doing reverse transfection in a microarray format "with … plasmid-expressed siRNAs in the bottom of microtiter plates," while Dharmacon is using siRNAs. Dharmacon's platform uses one siRNA per well, compared with Akceli's microarray design, he added.

Apparently, MIT fails to see the difference. According to its amended lawsuit, filed on April 5, Dharmacon uses "one or more of the methods claimed in the '790 patent in the ordinary course of business, and [makes, uses, sells and/or offers] for sale products that infringe the '790 patent.

"For example, Dharmacon employs reverse-transfection methods that infringe the '790 patent," the suit states. "Dharmacon also sells kits that include both reagents used for reverse transfection as well as reverse-transfection libraries."

In addition to asking Dharmacon and its parent company Fisher Scientific to "account for its sales of all siRNA products, … to pay as damages the full amount of royalties due on those products," and for a ruling that Dharmacon is obliged to pay the 7-percent royalty on its siRNA products, MIT has now asked the court to find that Dharmacon has infringed the '790 patent.

MIT is further seeking an enjoinder against further infringement, monetary damages, and costs and attorney's fees.

In regards to MIT's suit over the royalty payments, Marshall told RNAi News this week that "Dharmacon has developed novel and innovative siRNA products [and] a dispute has emerged … about how the license [to the IP portfolio] applies to those products. The two parties have differing views, and a resolution to the dispute is necessary to calculate proper royalty payments under the license."

As for the amended claim regarding the reverse-transfection technology, Marshall said that "Dharmacon believes … we have a unique siRNA transfection technology that is not covered by any patents anywhere. We have, in fact, filed a patent application on the technology underlying those Dharmacon products." He declined to provide additional details on how the company's technology differs from that covered under the '790 patent, but said that the company plans to issue a statement about its technology in the near future.

Marshall added that Dharmacon is focused on resolving the situation with MIT, but declined to comment on whether his company is engaged in out-of-court negotiations with MIT to settle the dispute. "We are attempting all channels to resolve the issue appropriately," he said.

MIT spokeswoman Denise Brehm declined to comment on "continuing legal action."

— DM

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