About the PTAB Life Sciences Report:  Each month we will report on developments at the PTAB involving life sciences patents.

Sawai USA, Inc. v. Astellas Pharma Inc.

PTAB Petition:  IPR2018-00079; filed October 16, 2017.

Patent at Issue:  U.S. Patent No. 6,346,532 ("Amide derivatives or salts thereof," issued February 12, 2002) claims amide derivatives represented by a general formula or salts thereof which are useful in the treatment of diabetes mellitus and obesity.

Petitioners Sawai USA Inc. and Sawai Pharmaceutical Co. Ltd are challenging the '532 patent on two grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, the '532 patent is the subject of the following patent infringement lawsuits:  Astellas Pharma Inc., et al. v. Sawai USA, Inc., et al., No. 16-cv-954-SLR (D. Del. 2016) as consolidated with Astellas Pharma Inc., et al. v. Actavis Elizabeth LLC, et al., No. 16-cv-905- SLR (D. Del. 2016).

ThermiGen, LLC v. Viveve, Inc.

PTAB Petition:  IPR2018-00088; filed October 20, 2017.

Patent at Issue:  U.S. Patent No. 8,961,511 ("Vaginal remodeling device and methods," issued February 24, 2015) claims a method for remodeling a therapeutic zone within a target tissue, the target tissue comprising tissue underlying an epithelium of female genital tissue comprising at least one of vulva, introitus and vagina tissue, the method comprising: heating the target tissue, and remodeling the therapeutic zone of target tissue, wherein the heating includes heating a portion of the vagina extending from the introitus inwardly to a location from 1 cm to 3.5 cm in from the introitus.

Petitioners ThermiGen, LLC and ThermiAesthetics, LLC are challenging the '511 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (ground 2).  View the petition here.

Related Matters:  According to the petition, the '511 patent is presently the subject of patent infringement lawsuit:  Viveve Inc. v. ThermiGen, LLC, ThermiAesthetics, LLC, and Red Alinsod, M.D., Case No. 16-cv-1189 (E.D. Tex.).  Petitioner concurrently filed a second petition for inter partes review of claims 43-58 of the '511 patent (IPR2018-00089; filed 10/20/2017; pending).

ThermiGen, LLC v. Viveve, Inc.

PTAB Petition:  IPR2018-00089; filed October 20, 2017.

Patent at Issue:  U.S. Patent No. 8,961,511 ("Vaginal remodeling device and methods," issued February 24, 2015) claims a method for remodeling a therapeutic zone within a target tissue, the target tissue comprising tissue underlying an epithelium of female genital tissue comprising at least one of vulva, introitus and vagina tissue, the method comprising: heating the target tissue, and remodeling the therapeutic zone of target tissue, wherein the heating includes heating a portion of the vagina extending from the introitus inwardly to a location from 1 cm to 3.5 cm in from the introitus.

Petitioners ThermiGen, LLC and ThermiAesthetics, LLC are challenging the '511 patent on two grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, the '511 patent is presently the subject of the following patent infringement lawsuit:  Viveve Inc. v. ThermiGen, LLC, ThermiAesthetics, LLC, and Red Alinsod, M.D., Case No. 16-cv-1189 (E.D. Tex.).  Petitioner concurrently filed a second petition for inter partes review of claims 1-42 of the '511 patent (IPR2018-00088; filed 10/20/2017; pending).

Initiative for Medicines, Access & Knowledge, Inc.  v. Gilead Pharmasset, Inc.

PTAB Petition:  IPR2018-00103; filed October 25, 2017.

Patent at Issue:  U.S. Patent No. 7,429,572 ("Modified fluorinated nucleoside analogues," issued September 30, 2008) claims a ((2'R)-2'-deoxy-2'-fluoro-2'-C-methyl nucleoside (β-D or β-L) or its pharmaceutically acceptable salt of the structure.

Petitioner Initiative for Medicines, Access & Knowledge, Inc. (I-MAK) is challenging the '572 patent on three grounds as being being anticipated under 35 U.S.C. § 102(b) (grounds 1 and 2) or as obvious under 35 U.S.C. § 103(a) (ground 3).  View the petition here.

Related Matters:  According to the petition, the '572 patent is not involved in any ongoing matters.

Initiative for Medicines, Access & Knowledge, Inc.  v. Gilead Pharmasset, Inc.

PTAB Petition:  IPR2018-00119; filed October 25, 2017.

Patent at Issue:  U.S. Patent No. 7,964,580 ("Nucleoside phosphoramidate prodrugs," issued June 21, 2011) claims (S)-2-{[(2R,3R,4R,5R)-5-(2,4-Dioxo-3,4-dihydro-2H-pyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydro-furan-2-ylmethoxy]-phenoxy-phosphorylam- ino}-propionic acid isopropyl ester or a stereoisomer thereof and method for treating subject infected by a virus by administering an effective amount of the compound or a stereoisomer thereof as claimed in claim 1.

Petitioner Initiative for Medicines, Access & Knowledge, Inc (I-MAK) is challenging the '580 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 and 3).  View the petition here.

Related Matters:  According to the petition, the Petitioner concurrently filed another petition for inter partes review of the '580 patent (IPR2018-00120; filed 10/25/2017; pending).

Initiative for Medicines, Access & Knowledge, Inc.  v. Gilead Pharmasset, Inc.

PTAB Petition:  IPR2018-00120; filed October 25, 2017.

Patent at Issue:  U.S. Patent No. 7,964,580 ("Nucleoside phosphoramidate prodrugs," issued June 21, 2011) claims (S)-2-{[(2R,3R,4R,5R)-5-(2,4-Dioxo-3,4-dihydro-2H-pyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydro-furan-2-ylmethoxy]-phenoxy-phosphorylam- ino}-propionic acid isopropyl ester or a stereoisomer thereof and method for treating subject infected by a virus by administering an effective amount of the compound or a stereoisomer thereof as claimed in claim 1.

Petitioner Initiative for Medicines, Access & Knowledge, Inc (I-MAK) is challenging the '580 patent on two grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, the Petitioner concurrently filed another petition for inter partes review of the '580 patent (IPR2018-00119; filed 10/25/2017; pending).

Edwards Lifesciences Corp. v.  Boston Scientific Scimed, Inc.

PTAB Petition:  IPR2017-01295; filed April 19, 2017.

Institution of Inter Partes Review; entered October 25, 2017.

Patent at Issue:  U.S. Patent No. 8,709,062 ("Stent delivery system having stent securement apparatus," issued April 29, 2014) claims a medical device and a system for delivering a medical device.

Petitioner Edwards Lifesciences Corp. is challenging the '062 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges James A. Tartal, Robert L. Kinder, and Amanda F. Wieker (author) issued a decision instituting inter partes review of whether claims 1–7, 9–15, 17–21, and 23–26 are obvious under 35 U.S.C. § 103(a) over Rupp, Sugiyama, Jendersee, and the knowledge of a person of ordinary skill in the art.

Related Matters:  According to the petition, the '062 patent is the subject of the following civil litigation:  Boston Scientific Corp. & Boston Scientific SciMed Inc. v. Edwards Lifesciences Corp., No. 16-cv-730 (C.D. Cal.).

Initiative for Medicines, Access & Knowledge, Inc.  v. Gilead Pharmasset, Inc.

PTAB Petition:  IPR2018-00121; filed October 26, 2017.

Patent at Issue:  U.S. Patent No. 8,334,270 ("Nucleoside phosphoramidate prodrugs," issued December 18, 2012) claims a compound and method for treating subject infected by a virus by administering an effective amount of the compound or a stereoisomer thereof as claimed in claim 1.

Petitioner Initiative for Medicines, Access & Knowledge, Inc (I-MAK) is challenging the '270 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 and 3).  View the petition decision.

Related Matters:  According to the petition, the Petitioner concurrently filed another petition for inter partes review of the '270 patent (IPR2018-00122; filed 10/26/2017; pending).

Initiative for Medicines, Access & Knowledge, Inc.  v. Gilead Pharmasset, Inc.

PTAB Petition:  IPR2018-00122; filed October 26, 2017.

Patent at Issue:  U.S. Patent No. 8,334,270 ("Nucleoside phosphoramidate prodrugs," issued December 18, 2012) claims a compound and method for treating subject infected by a virus by administering an effective amount of the compound or a stereoisomer thereof as claimed in claim 1.

Petitioner Initiative for Medicines, Access & Knowledge, Inc (I-MAK) is challenging the '270 patent on two grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, the Petitioner concurrently filed another petition for inter partes review of the '270 patent (IPR2018-00121; filed 10/26/2017; pending).