What seems to be going on with RNAi related patents in the US

Reciting Table 1 from Ref 1 and Table 3 from Ref 2:

Fire and Mello US 6,506,55: RNAi with siRNA >24 nucleotidesr
Tuschl et al. US 108,923 (Tuschl I, pending): synthetic or in vitro produced siRNA 21-23 bps
Tuschl et al US 7,056,704 and 7,078,196 (Tuschl II): synthetic siRNA 19-23, with 3′ overhangs;
Kreutzer-Limmer EP 1,144,623: siRNA 15-21 bps;
Benitec, DNA-driven RNAi DNA driven: granted in 2003, then became under re-examination.

By the end Nov 2008 it appears that Allele’s patent (US 7,294,504 and 7,422,896) are the only currently granted DNA based RNAi patents. The focus of Allele’s technology is siRNA of 21-23, either in separate sense and antisense strands, or shRNA or miRNA format, thus not covered by the Fire patent or the Kreutzer-Limmer patent. Since these RNAi inducers are not synthesized by chemical reactions, or produced with enzymes or cell lysate in vitro, they do not relate to Tuschl I or II patent groups. Allele Biotech can not guarantee that its interpretation is correct or final by any means; commercial user of any of the related technologies should perform own due diligence.

[1] Charlie Schmidt. March 2007 “Negotiating the RNAi patent thicket” Nature Biotechnology 25 (3): 273-275

[2] Dirk Haussecker. May 2008 “The Business of RNAi Therapeutics” Human Gene Therapy 19: 451-462

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Thursday, December 4th, 2008 RNAi patent landscape

4 Comments to What seems to be going on with RNAi related patents in the US

January 8, 2009

The two reviews provide the best summaries in this topic, which you would think should be over-reviewed by now. It is not. It is actually difficult to find much writing about this subject, probably due to the ongoing uncertainty and intrinsic complexity.

December 10, 2009

Allele’s 3rd US patent, 7,625,750, was issued on Dec 1st, 2009. It focuses on high throughput use of polIII driven shRNA in cell-based assays.

February 8, 2010

The iPS patent landscape started to look like the RNAi one.

btw, Allele has been granted a patent covering DNA-encoded RNAi with 174 claims, the broadest in any major market. It covers DNA templates encoding RNAi inducing siRNA intermediates, shRNA, the process of introducing such molecules, and cells and animal models created using the DNA cassettes. Formal news release to follow.

February 9, 2010

According to Genomeweb, USPTO Maintains Rejection on Claims in Benitec’s US Patent (January 21, 2010), which also concerns DNA-expressed RNAi. The news states “The IP fell under USPTO scrutiny as part of a protracted patent-infringement battle Benitec waged with now-defunct expressed RNAi shop Nucleonics.” The case was actually sent all the way up the US supreme court, but was declined for review.

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