This article has been corrected from a previous version, which mistakenly named the Whitehead Institute as the sole owner of the Tuschl-2 IP, rather than the Max-Planck Institute. RNAi News deeply regrets the error.
Less than three weeks after receiving the exclusive rights to UMass’ shares of the seminal Tuschl IP with a promise to broadly sublicense the technology, Sirna is already entertaining offers and expects to have at least one deal signed by the end of the year, according to Bharat Chowrira, vice president of legal affairs and patent counsel at Sirna.
Chowrira said that interest in sublicenses has been “quite significant,” especially from companies interesting in developing RNAi for therapeutic applications. As a result (and in line with UMass’ desire to see the technology in the hands of as many researchers as possible), Sirna will sell non-exclusive access to the technology, in any capacity, to anyone willing to pay a “commercially reasonable” fee.
That fee, he said, would depend on the extent of the rights being sought. “Depending on whether they want non-exclusive, across the board [rights] on all fields, or non-exclusive [rights] in certain therapeutic areas, we have structured the deal terms accordingly.”
He also said that this fee for licensing the IP in a particular field would be the same for all licensees. “We certainly don’t want to treat different partners differently,” Chowrira said.
He noted, however, that Sirna understands that some smaller companies and research institutions might not have the wherewithal to pay the fee upfront. So, the company is willing to negotiate on the structure of the payment arrangement, he said.
Chowrira declined to specify exactly how much Sirna is asking, or plans on asking, for various sublicenses to the IP, but said that the company would work with UMass on determining what is “commercially reasonable.”
Sirna Breaks Alnylam’s Hold
It was mid-September when Sirna announced that it had picked up from UMass the exclusive rights to the so-called “Tuschl-1” patent application (which covers the use of short interfering RNAs, 21 to 23 nucleotides in length, to induce RNAi in mammalian cells) after agreeing to the university’s demand that it widely sell sublicenses to the IP, an apparent sticking point in earlier negotiations with other interested companies.
Prior to this deal, Alnylam was the only other company with access to the Tuschl-1 IP, having exclusively licensed it from its three other owners: the Max-Planck Institute, the Whitehead Institute and MIT. Alnylam also took an exclusive license to the Tuschl-2 patent application, which describes the two-to-three nucleotide 3’ overhanging ends on the end of certain siRNAs, from its sole owner, the Max-Planck Institute.
When Alnylam announced in February that it had acquired the rights to these patent applications, it made no mention of any intention to sublicense — although the company did stress that it had the “strongest intellectual property estate in the burgeoning field of RNA interference” — and it appeared to many that the company had little intention of letting up on its stranglehold on the technology.
This, in fact, may very well have been the case; it wasn’t until Sirna said that it would be outlicensing the Tuschl-1 IP that Alnylam CEO John Maraganore stated publicly that his company intended to do the same; on the day the Sirna deal was announced, Maraganore told RNAi News that Alnylam had long-intended to out-license the IP in areas outside of its focus.
Regardless of how it happened, the two companies with the rights to arguably the most important IP in the field of RNAi after the widely available Fire-Mello patent have stated they are taking offers on sublicenses to the Tuschl technology.
But while Sirna has gotten right into it, Alnylam has yet to make a move.
Barbara Yates, an independent public relations consultant for Alnylam, told RNAi News that the company has yet to grant any sublicenses to the Tuschl IP it controls. She also declined to comment on whether deals were in the works. “If that were the case,” she said, “we wouldn’t want to tip our hand to a competitor.”
Mirus has received a patent for a process used to non-virally deliver nucleic acids into mammalian cells.
The patent — number 6,627,616 — covers a process of designing a naked polynucleotide and inserting it into a “mammalian vessel such as a tail vein or artery,” according to the patent’s abstract.
“Prior to insertion, subsequent to insertion, or concurrent with insertion the permeability of the vessel is increased thereby the genetic material is delivered to the parenchymal cell altering endogenous properties of the cell,” the abstract reads.
“A method covered by this patent, the tail vein delivery procedure, has become a worldwide method of choice for delivering nucleic acids into liver cells and other organs in mice,” Jim Hagstrom, Mirus vp of scientific operations, said in a statement. “In addition, we have found that this intravascular methodology is useful for delivering polynucleotides to targeted tissues.”