Patisiran – USA

Patisiran – USA

Decision on PGR: Nov 19, 2018

AIA Review
Filing Date
Institution Date
Petitioner
US Patent
Respondent
Status
PGR2018-00059
04/02/2018
10/10/2018
Alnylam Pharmaceuticals, Inc.
9,695,423
Silence Therapeutics GMBH
Terminated-Settled
PGR2018-00067
06/11/2018
Alnylam Pharmaceuticals, Inc.
9,758,784
Silence Therapeutics GMBH
Terminated-Settled
US 9,695,423 (Silence Therapeutics GMBH; Exp: Aug 05, 2023*TD):

1. A double-stranded siRNA molecule wherein: (i) at least one strand of the double-stranded siRNA molecule comprises one or more groups of modified nucleotides and one or more groups of flanking nucleotides, the flanking nucleotides being on one or both sides of the modified nucleotides, wherein: the one or more groups of modified nucleotides have an amino, fluoro, alkoxy, or alkyl modification at the 2′-position; and the one or more groups of flanking nucleotides have an amino, fluoro, alkoxy, or alkyl modification at the 2′-position, the modification at the 2′-position of the flanking nucleotide being different from the modification at the 2′-position of the modified nucleotide, (ii) the number of nucleotides in the one or more groups of modified nucleotides is 1-10 and the number of nucleotides in the one or more groups of flanking nucleotides is 1-10; (iii) the double-stranded siRNA molecule has a double-stranded region of 17-21 nucleotides in length; and (iv) the double-stranded siRNA molecule is capable of RNA interference.
12. A double-stranded siRNA molecule wherein: (i) each strand of the double-stranded siRNA molecule comprises one or more groups of modified nucleotides and one or more groups of flanking nucleotides, the flanking nucleotides being on one or both sides of the modified nucleotides, wherein the one or more groups of modified nucleotides have an amino, fluoro, alkoxy, or alkyl modification at the 2′-position; and the one or more groups of flanking nucleotides have an amino, fluoro, alkoxy, or alkyl modification at the 2′-position, the modification at the 2′-position of the flanking nucleotide being different from the modification at the 2′-position of the modified nucleotide, (ii) the number of nucleotides in the one or more groups of modified nucleotides is 1-10 and the number of nucleotides in the one or more groups of flanking nucleotides is 1-10; (iii) the double-stranded siRNA molecule has a double-stranded region of 17-21 nucleotides in length; and (iv) the double-stranded siRNA molecule is capable of RNA interference.
US 9,758,784 (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 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 double-stranded siRNA molecule is blunt ended on at least one end, and wherein each stretch consists of at least 15 and fewer than 30 ribonucleotides and wherein the first stretch and the second stretch each comprises contiguous alternating modified ribonucleotides, wherein the alternating modified ribonucleotides alternate with unmodified or differently modified 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.

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