Patisiran - USA

Decision on PGR: Nov 20, 2018

AIA Review	Filing Date	Institution Date	Petitioner	US Patent	Respondent	Status
PGR2018-00075	07/09/2018	--	Alnylam Pharmaceuticals, Inc.	9,783,802	Silence Therapeutics GMBH	Terminated-Settled
PGR2018-00088	07/17/2018	--	Alnylam Pharmaceuticals, Inc.	9,790,505	Silence Therapeutics GMBH	Terminated-Settled
PGR2018-00089	07/17/2018	--	Alnylam Pharmaceuticals, Inc.	9,790,501	Silence Therapeutics GMBH	Terminated-Settled

US 9,783,802 (Silence Therapeutics GMBH; Exp: Aug 05, 2023*TD):

1. A double stranded siRNA molecule against a target nucleic acid, wherein the double stranded siRNA molecule comprises a first strand and a second strand, wherein the first strand comprises a first stretch that is complementary to the target nucleic acid, wherein the second strand comprises a second stretch that has the same length as the first stretch and is complementary to the first stretch, wherein the first strand and the second strand form a double-stranded structure comprising the first stretch and the second stretch, wherein the first stretch and the second stretch each has the length of 18-19 nucleotides, wherein the first stretch and the second stretch each comprises unmodified ribonucleotides and 2'-O-methyl ribonucleotides, wherein at least one of the two strands has an overhang of at least one nucleotide, and wherein the overhang comprises at least one deoxyribonucleotide.

US 9,790,505 (Silence Therapeutics GMBH; Exp: Aug 05, 2023*TD):

1. A double stranded siRNA molecule against a target nucleic acid, wherein the double stranded siRNA molecule comprises a first strand and a second strand, wherein the first strand comprises a first stretch that is complementary to the target nucleic acid, wherein the second strand comprises a second stretch that has the same length as the first stretch and is complementary to the first stretch, wherein the first strand and the second strand form a double-stranded structure comprising the first stretch and the second stretch, wherein the first stretch and the second stretch each has the length of 17-21 nucleotides, wherein the first stretch and the second stretch each comprises a plurality of groups of 2'-O-methyl ribonucleotides flanked on one or both sides by a flanking group of unmodified ribonucleotides or modified ribonucleotides different from 2'-O-methyl ribonucleotides, and wherein at least one of the two strands has an overhang of at least one nucleotide at the 3'-end.

US 9,790,501 (Silence Therapeutics GMBH; Exp: Aug 05, 2023*TD):

1. A double-stranded siRNA molecule against a target nucleic acid, wherein the double-stranded siRNA molecule comprises a first strand and a second strand, wherein the first strand comprises a first stretch that is complementary to the target nucleic acid, wherein the second strand comprises a second stretch that is the same length as the first stretch and is complementary to the first stretch, wherein the first strand and the second strand form a double-stranded structure comprising the first stretch and the second stretch, wherein the first stretch and the second stretch each comprises contiguous alternating 2'-O-alkyl ribonucleotides, wherein the 2'-O-alkyl ribonucleotides alternate with unmodified or differently modified ribonucleotides, wherein the 2'-O-alkyl ribonucleotides of the first strand are shifted by one ribonucleotide relative to the 2'-O-alkyl ribonucleotides of the second strand, and wherein each of the first stretch and the second stretch consists of at least 17 and fewer than 30 ribonucleotides.

Both the parties have also settled their dispute in EU & worldwide. See below press release for more information.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 10, 2018-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it has resolved all litigation worldwide with Silence Therapeutics. The settlement allows Alnylam to avoid the costs and distraction associated with continued litigation in multiple countries. Under terms of the global settlement, Silence will receive a low royalty on annual net sales of ONPATTRO in the EU only, with tiered royalties of 0.33 percent to 1.0 percent through 2023.

http://investors.alnylam.com/news-releases/news-release-details/alnylam-announces-settlement-litigation-silence-therapeutics