Sacubitril/Valsartan – USA

Sacubitril/Valsartan – USA

In re: Entresto (Sacubitril/Valsartan) patent litigation

Case : 20-md-02930-LPS

Judge:  Judge Leonard P. Stark

Court: District of Delaware

Date: Jul. 08, 2021 – Claim construction

In this multi-district litigation, Novartis sued multiple generic drug manufacturers (Alembic, Alkem, Aurobindo, Biocon, Crystal Pharma, Dr. Reddy’s Lab., Hetero, Laurus Labs, Lupin, Macleods, MSN Pharma, Mylan, Nanjing Noratech Pharma, Novugen Pharma, Teva , Torrent Pharma and Zydus). Novartis asserted that one or more of these Defendants would, if permitted to market their proposed generic drug products, infringe claims of one or more of the following US 8,101,659; US 8,796,331; US 8,877,938; and US 9,388,134.

 

CONSTRUCTION OF DISPUTED TERMS:

 

A. ‘Wherein said (i) … and said (ii)… are administered in combination” / ‘administering… the combination of: (i) …; (ii) …; and wherein said components (i) and (ii) are administered in one unit dose form or in two separate unit dose forms”

Novartis: wherein said (i) … and said (ii) …, are administered in combination / administering … the combination of: (i) …; (ii) …; and wherein said components (i) and (ii) are administered in one unit dose form or in two separate unit dose forms

Defendants: wherein said (i)… and said (ii) … are administered in concert as two separate components / administering … the combination of (i)…; (ii)…; and wherein said components (i) and (ii) are administered in concert in either one unit-dose form or in two separate unit-dose forms, as two separate components

Court: wherein said (i) … and said (ii)…, are administered in combination / administering … the combination of: (i) …; (ii) …; and wherein said components (i) and (ii) are administered in one unit dose form or in two separate unit dose forms

 

B. “trisodium [3-((lS^R)-l-biphenyl-4-ylmethyl-3-ethoxycarbonyH-butylcarbamoyl) propionate-(S)-3 ‘-methyl-2 ‘-(peiitanoyl{2 “-(tetrazol-5-ylate)biphenyl-4 ylmethyi}amino) butyrate] hemipentahydrate in crystalline form” / ”trisodium [3- ((lS,3R)-l-biphenyl-4-ylmethyl-3-ethoxycarbonyl-l-butylcarbamoyl) propionate- (S)-3 ‘-methyl-2 ‘-(pentanoyl{2 “-(tetra2ol-5-ylate)biphenyl-4ylmethyl}amino) butyrate] hemipentahydrate”

Novartis: substantially pure trisodium [sacubitril-valsartan] hemipentahydrate in crystalline form / trisodium [sacubitril-valsartan] hemipentahydrate

Defendants: a substantially pure crystalline supramolecular complex having formula units of trisodium [sacubitril-valsartan] hemipentahydrate, wherein each formula unit in a unit cell of the crystalline complex has 2.5 water molecules and 3 sodium ions / a substantially pure crystalline supramolecular complex having formula units of trisodium [sacubitril-valsartan] hemipentahydrate, wherein each formula unit in a unit cell of the crystalline complex has 2.5 water molecules and 3 sodium ions

Court: substantially pure trisodium [sacubitril-valsartan] hemipentahydrate in crystalline form / trisodium [sacubitril-valsartan] hemipentahydrate (claims 1-4); substantially pure trisodium [sacubitrd-vdsartmj hemipentahydrate in crystalline form (claims 5-15)

 

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