PTAB Life Sciences Report - July 2017

by McDonnell Boehnen Hulbert & Berghoff LLP
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About the PTAB Life Sciences Report:  Each month we will report on developments at the PTAB involving life sciences patents.

Myriad Genetics, Inc. v. Johns Hopkins University

PTAB Petition:  IPR2017-01102; filed March 16, 2017.

Patent at Issue:  U.S. Patent No. 6,440,706 ("Digital amplification," issued August 27, 2002) claims a method for determining the ratio of a selected genetic sequence in a population of genetic sequences.

Petitioners Myriad Genetics, Inc.; Myriad Genetic Laboratories, Inc.; Bio-Rad Laboratories, Inc.; and RainDance Technologies, Inc. are challenging the '706 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1 and 4) or obvious under 35 U.S.C. § 103(a) (grounds 2, 3, 5, and 6).  View the petition here.

Related Matters:  According to the petition, the '706 patent is presently the subject of the following patent infringement lawsuits:  Esoterix Genetic Laboratories, LLC and Johns Hopkins University v. Myriad Genetics, Inc. and Myriad Genetics Laboratories, Inc., 1:16-cv-1112 (M.D.N.C.); and Esoterix Genetic Laboratories, LLC and John Hopkins University v. Ambry Genetics Corp., 16-cv-1111-WO-JEP (M.D.N.C.).  Petitioners concurrently filed petitions for inter partes review of related U.S. Patent Nos. 7,824,889 (IPR2017-01106; filed 03/17/2017; pending); 7,915,015 (IPR2017-01107; filed 03/17/2017; pending); and 8,859,206 (IPR2017-01105; filed 03/16/2017; pending).

Myriad Genetics, Inc. v. Johns Hopkins University

PTAB Petition:  IPR2017-01105; filed March 16, 2017.

Patent at Issue:  U.S. Patent No. 8,859,206 ("Digital amplification," issued October 14, 2014) claims a method for detecting quantity of a genetic sequence in a mixed population of human genomic nucleic acid sequences comprising at least a first and a second human genomic sequence, wherein the first sequence is a sequence of a wild-type allele of a locus and a second sequence is a sequence of a mutant allele of the locus.

Petitioners Myriad Genetics, Inc.; Myriad Genetic Laboratories, Inc.; Bio-Rad Laboratories, Inc.; and RainDance Technologies, Inc. are challenging the '206 patent on four grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obvious under 35 U.S.C. § 103(a) (grounds 2-4).  View the petition here.

Related Matters:  According to the petition, the '206 patent is presently the subject of the following patent infringement lawsuits:  Esoterix Genetic Laboratories, LLC and Johns Hopkins University v. Myriad Genetics, Inc. and Myriad Genetics Laboratories, Inc., 1:16-cv-1112 (M.D.N.C.); and Esoterix Genetic Laboratories, LLC and John Hopkins University v. Ambry Genetics Corp., 16-cv-1111-WO-JEP (M.D.N.C.).  Petitioners concurrently filed petitions for inter partes review of related U.S. Patent Nos. 7,824,889 (IPR2017-01106; filed 03/17/2017; pending); 7,915,015 (IPR2017-01107; filed 03/17/2017; pending); and 6,440,706 (IPR2017-01102; filed 03/16/2017; pending).

Hospira, Inc. v. Genentech, Inc.

PTAB Petition:  IPR2016-01771; filed September 9, 2016.

PTAB Trial Instituted; entered March 16, 2017.

Patent at Issue:  U.S. Patent No. 7,622,115 ("Treatment with anti-VEGF antibodies," issued November 24, 2009) claims a method for treating cancer in a patient comprising administering an effective amount of bevacizumab and assessing the patient for gastrointestinal perforation during treatment with bevacizumab.

Petitioner Hospira, Inc. is challenging the '115 patent on eleven grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1-4) or obvious under 35 U.S.C. § 103(a) (grounds 5-11).  View the petition here.  Administrative Patent Judges Sheridan K. Snedden (author), Zhenyu Yang, and Rober A. Pollock issued a decision instituting inter partes review of whether claims 1–5 of the '115 patent are anticipated under 35 U.S.C. § 102(b) by Kabbinavar; whether claims 1–5 of the '115 patent are obvious under 35 U.S.C. § 103(a) in view of Kabbinavar; and whether claims 1–5 of the '115 patent are obvious under 35 U.S.C. § 103(a) in view of 2000 Press Release.

Related Matters:  According to the petition, the '115 patent is not involved in any judicial proceedings.

Fisher & Paykel Healthcare Ltd. v. Resmed Ltd.

PTAB Petition:  IPR2017-00059; filed October 11, 2016.

PTAB Trial Instituted; entered March 16, 2017.

Patent at Issue:  U.S. Patent No. 8,960,196 ("Mask system with interchangeable headgear connectors," issued February 24, 2015) claims a mask for delivering breathable gas to a patient at positive pressure to treat sleep disordered breathing, the mask comprising: a mask frame having a central bore, said mask frame having no built-in or integral headgear attachment points; a sealing cushion provided to the mask frame and adapted to form a seal with the patient's face; and a headgear connector adapted to engage the mask frame, said headgear connector including a pair of lower headgear clip anchors adapted to be engaged with respective ones of a pair of lower headgear clips, said headgear connector including a forehead support connected to the headgear connector by an upper support member, said forehead support including a pair of openings adapted to attach to respective ones of a pair of upper side straps, wherein the mask frame is adapted to removably connect to more than one headgear connector, each headgear connector being different in at least one aspect.

Petitioner Fisher & Paykel Healthcare Ltd. is challenging the '196 patent on two grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Richard E. Rice, Barry L. Grossman, and James J. Mayberry (author) issued a decision instituting inter partes review of whether claims 23–78, 80–82, and 84–86 are obvious under 35 U.S.C. § 103(a) over Ogden, Lovell, and Gunaratnam; and whether claims 79 and 83 are obvious under 35 U.S.C. § 103(a) over Ogden, Lovell, Gunaratnam, and Geist.

Related Matters:  According to the petition, the '196 patent is involved in U.S. International Trade Commission Investigation No. 337–TA–1022.  The '196 patent is also the subject of the following litigation:  Fisher & Paykel Healthcare Ltd. v. ResMed Corp., Case No. 3:16-cv- 02068 (S.D. Cal.).  Petitioner also concurrently filed a second petition seeking inter partes review of the '196 patent (IPR2017-00057; Fisher & Paykel Healthcare Ltd.; filed 10/11/2016; Institution denied 03/16/2017).

Myriad Genetics, Inc. v. Johns Hopkins University

PTAB Petition:  IPR2017-01106; filed March 17, 2017.

Patent at Issue:  U.S. Patent No. 7,824,889 ("Digital amplification," issued November 2, 2010) claims a method for determining an allelic imbalance in a biological sample, comprising the steps of: amplifying template molecules within a set comprising a plurality of assay samples to form a population of amplified molecules in each of the assay samples of the set, wherein the template molecules are obtained from a biological sample; analyzing the amplified molecules in the assay samples of the set to determine a first number of assay samples which contain a selected genetic sequence on a first chromosome and a second number of assay samples which contain a reference genetic sequence on a second chromosome, wherein between 0.1 and 0.9 of the assay samples yield an amplification product; comparing the first number of assay samples to the second number of assay samples to ascertain an allelic imbalance in the biological sample.

Petitioners Myriad Genetics, Inc.; Myriad Genetic Laboratories, Inc.; Bio-Rad Laboratories, Inc.; and RainDance Technologies, Inc. are challenging the '889 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1 and 4) or obvious under 35 U.S.C. § 103(a) (grounds 2, 3, 5, and 6).  View the petition here.

Related Matters:  According to the petition, the '889 patent is presently the subject of the following patent infringement lawsuits:  Esoterix Genetic Laboratories, LLC and Johns Hopkins University v. Myriad Genetics, Inc. and Myriad Genetics Laboratories, Inc., 1:16-cv-1112 (M.D.N.C.); and Esoterix Genetic Laboratories, LLC and John Hopkins University v. Ambry Genetics Corp., 16-cv-1111-WO-JEP (M.D.N.C.).  Petitioners concurrently filed petitions for inter partes review of related U.S. Patent Nos. 6,440,706 (IPR2017-01102; filed 03/16/2017; pending); 7,915,015 (IPR2017-01107; filed 03/17/2017; pending); and 8,859,206 (IPR2017-01105; filed 03/16/2017; pending).

Myriad Genetics, Inc. v. Johns Hopkins University

PTAB Petition:  IPR2017-01107; filed March 17, 2017.

Patent at Issue:  U.S. Patent No. 7,915,015 ("Digital amplification," issued March 29, 2011) claims a method for determining an allelic imbalance in a biological sample, comprising the steps of: amplifying template molecules within a set comprising a plurality of assay samples to form a population of amplified molecules in each of the assay samples of the set, wherein the template molecules are obtained from the biological sample; analyzing the amplified molecules in the assay samples of the set to determine a first number of assay samples which contain a first allelic form of a marker and a second number of assay samples which contain a second allelic form of the marker, wherein between 0.1 and 0.9 of the assay samples yield an amplification product; comparing the first number to the second number to ascertain an allelic imbalance in the biological sample; and identifying an allelic imbalance in the biological sample.

Petitioners Myriad Genetics, Inc.; Myriad Genetic Laboratories, Inc.; Bio-Rad Laboratories, Inc.; and RainDance Technologies, Inc. are challenging the '015 patent on four grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obvious under 35 U.S.C. § 103(a) (grounds 2-4).  View the petition here.

Related Matters:  According to the petition, the '015 patent is presently the subject of the following patent infringement lawsuits:  Esoterix Genetic Laboratories, LLC and Johns Hopkins University v. Myriad Genetics, Inc. and Myriad Genetics Laboratories, Inc., 1:16-cv-1112 (M.D.N.C.); and Esoterix Genetic Laboratories, LLC The John Hopkins University v. Ambry Genetics Corp., 16-cv-1111-WO-JEP (M.D.N.C.).  Petitioners concurrently filed petitions for inter partes review of related U.S. Patent Nos. 7,824,889 (IPR2017-01106; filed 03/17/2017; pending); 8,859,206 (IPR2017-01105; filed 03/16/2017; pending); and 6,440,706 (IPR2017-01102; filed 03/16/2017; pending).

Thermo Fisher Scientific Inc. v. Bio-Rad Laboratories, Inc.

PTAB Petition:  IPR2017-00054; filed October 14, 2016.

PTAB Trial Instituted; entered March 17, 2017.

Patent at Issue:  U.S. Patent No. 8,236,504 ("Systems and methods for fluorescence detection with a movable detection module," issued August 7, 2012) claims a fluorescence detection apparatus for analyzing samples located in a plurality of wells in a thermal cycler, the apparatus comprising: a support structure attachable to the thermal cycler; a shuttle movably mounted on the support structure; and a detection module attached to the shuttle, the detection module including: a housing having an opening oriented toward the plurality of wells; an excitation light generator disposed within the housing; and an emission light detector disposed within the housing, wherein, when the support structure is attached to the thermal cycler, a heating element is disposed between the detection module and the sample wells and the shuttle is movable to position the detection module in optical communication with different wells of the plurality of wells through a plurality of openings extending through the heating element.

Petitioner Thermo Fisher Scientific, Inc. is challenging the '504 patent on five grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obvious under 35 U.S.C. § 103(a) (grounds 2-5).  View the petition here.  Administrative Patent Judges Sheridan K. Snedden, Zhenyu Yang (author), and Christopher G. Paulraj issued a decision instituting inter partes review of whether claims 23–78, 80–82, and 84–86 are obvious under 35 U.S.C. § 103(a) over Ogden, Lovell, and Gunaratnam; and whether claims 79 and 83 are obvious under 35 U.S.C. § 103(a) over Ogden, Lovell, Gunaratnam, and Geist.

Related Matters:  According to the petition, the '504 patent is the subject of the following litigation:  Bio-Rad Labs, Inc. v. Thermo Fisher Scientific Inc., Case No. 16-358 (D. Del.).  Petitioner also concurrently filed a second petition seeking inter partes review of the '504 patent (IPR2017-00055; Thermo Fisher Scientific Inc.; filed 10/14/2016; Instituted 04/03/2017).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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