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Alnylam Awaits USPTO Issuance; Challenges Remain

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Alnylam Pharmaceuticals came one step closer to winning issuance of a patent within its Tuschl-2 family recently after the US Patent and Trademark Office issued the company a notice of allowance for the IP. The company expects the patent to be issued before April.

With the allowance, Alnylam is on track to secure patent protection over an even greater portion of the RNAi field. But ongoing opposition proceedings against other of its RNAi patents overseas, as well as an unrelated patent dispute in the US, raise questions as to whether other players in the RNAi field will let the Tuschl-2 patent stand unchallenged.

The patent application on track for USPTO issuance is entitled “RNA Interference Mediating Small RNA Molecules,”
No. 20040229266. According to Alnylam, it describes the use of siRNAs, between 19 and 25 nucleotides long, to mediate RNAi, as well as the use of overhangs on the 3’ ends of dsRNAs to mediate target RNA cleavage.

Alnylam says that the patent

application also covers siRNAs, regardless of their target, with these features that incorporate various chemical modifications, including the use of phosphorothioates, 2’-O-methyl, and/or 2’-fluoro modifications.

Alnylam has long made IP primacy a key component of its corporate image. At the JP Morgan Healthcare Conference in San Francisco earlier this year, Alnylam President and CEO John Maraganore told the investment community that “when all is told as it relates to the prosecution and issuance of claims of [our] patents, we believe that we have built … the strongest IP position in the RNAi field.”

But despite Alnylam’s apparent willingness to make its IP available — albeit for a fee — it is unclear whether its rivals in the RNAi drugs arena will go along or choose instead to call for a re-examination of the patent.

— Doug Macron

PATENT WATCH
US patent application 20060008907. Control of gene expression via light-activated RNA interference. Inventors: Simon Friedman and Samit Shah. Assignee: University of Missouri. Filed: June 9, 2005.

This patent application provides for a modified siRNA and a method for controlling the spacing, timing, and degree of gene expression that includes: selecting a target mRNA, obtaining siRNA corresponding to the target mRNA, modifying the siRNA with a photo-labile group to inhibit RNA interference, introducing the modified siRNA into a cell, and selectively irradiating the cell with light having a predetermined wavelength, according to the abstract.  


US patent application 20060008822. Single-stranded and double-stranded oligonucleotides comprising a 2-arylpropyl moiety. Inventors: Muthiah Manoharan, Kallanthottathil Rajeev, and Vekitasamy Kesavan. Assignee: Alnylam Pharmaceuticals. Filed: April 27, 2005.

This invention describes aralkyl-ligand-conjugated oligonucleotide compounds — which feature improved pharmacokinetic properties — and methods for their preparation. The oligonucleotides covered are both single-stranded and double-stranded. Conjugated oligonucleotide agents can modify gene expression, either inhibiting or up-regulating, by targeting and binding to a nucleic acid or to a protein.


Dharmacon and the Massachusetts Institute of Technology have settled their licensing dispute out of court, with each party agreeing to drop all charges against the other while bearing its own costs. This marks the end of a nearly year-old row, in which MIT sued Dharmacon for allegedly failing to meet its royalty obligations under a previous licensing deal for a portfolio of siRNA-related IP.

Ambion announced its expectations that Asuragen, a cancer diagnostics start-up created out of Ambion’s diagnostics and services divisions, will be ramped up by mid-year. Several executives and research scientists from Ambion are also joining the new company, which itself will maintain its parent company’s ties with Rosetta Genomics.

Alnylam Pharmaceuticals released details about its product-development and business goals for 2006, announcing, among other things, that it will add an additional RNAi-based drug to its formal pipeline and release non-human primate data from its systemic RNAi program.

Sirna Therapeutics CEO Howard Robin provided an update about the company’s pipeline, disclosing details on the firm’s age-related macular degeneration program recently out-licensed to Allergan, as well as non-human primate data from its hepatitis C program. Robin said that the company remains on track to sign one major partnership with a big pharma in 2006.

Datapoint
2006
An Israeli newspaper reported that Rosetta Genomics was planning an IPO for June 2006, but CEO Isaac Bentwich called that “misleading and inaccurate.” Earlier Bentwich had indicated the possibility of an IPO in 2007.

 

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