[
please note the changes below after I discovered that I missed the last claim amendments, as correctly pointed out by a commenter]
Alnylam announced today that the US patent office had issued 3
Notices of Allowance in recent weeks pertaining to the Tuschl patent
estate. Before your eyes glace over, read on, it's actually one of the few important patent news.
The granted composition-of-matter
claims cover very broadly 19-25bp RNAi triggers, independent of structure. This is a stark departure from the trend that
had materialized in the Tuschl patent applications where Tuschl I seemed to get
relegated to treating diseases of fly lysates and Tuschl II suffering from double-patenting
issues over Tuschl I.
Claim 1 of allowed patent application 12/537602:
1.
Isolated double-stranded RNA molecule, wherein each RNA strand has a length
from 19-25 nucleotides, wherein said RNA molecule is capable of target-specific
nucleic acid modifications.
1. An isolated
double-stranded RNA molecule, which is a non-enzymatically processed RNA
molecule, wherein: (i) each RNA strand independently consists of 19-25
nucleotides in length, and (ii) at least one RNA strand forms a single-stranded
3'-overhang from 1 to 5 nucleotides, wherein said RNA molecule is capable of
target-specific RNA interference.
The reason why such a comeback was possible can be traced back to the
settlement over the Tuschl patents 'with Merck' in early 2011. This allowed the Tuschl I and II prosecutions
to be aligned such that the double-patenting issue for the 3' overhang claim could be overcome such that the broadness of the Tuschl I RNAi triggers could be rescued
into the valuable human therapeutic uses.
Among those without RNAi trigger licenses from Alnylam, Silence
Therapeutics (and its partners, especially Quark) should be hit particularly hard by the
latest development: 19bp RNAi triggers are no place to hide any more.
There are thus two monsters of RNAi trigger patents that consequently co-exist
in the commercially very important US market: Baulcombe for almost all types of therapeutically useful double-strand RNA lengths (20-24/30bp; see here) and Tuschl for the desirable 3' overhang feature of RNAi triggers.
It is unclear to me how two patents can essentially claim the same. Either the patent office is aware of this and
is satisfied with ultra-fine semantics distinguishing the two, or this is an issue
worth reconsidering.
Another indication that the last word might not have been spoken may be the multiple requests by Alnylam (i.e. their
law firm) to expunge certain materials that were rendered during the Tuschl patent prosecutions (possibly relating to timing and nature of the claimed invention), but are deemed trade
secrets by Alnylam (can’t help but smile, here). Has Utah taken notes in time?