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

ABS Global, Inc. v. XY, LLC

PTAB Petition:  IPR2018-01224; filed June 08, 2018.  View Petition here.

Patent at Issue:  U.S. Patent No. 9,365,822, entitled ″System and method for sorting cells,″ describes an improved flow cytometer system particularly adapted to use for sex-selected sperm sorting including enhanced sheath fluid and other strategies which minimize stress on the sperm cells.  Improved collection systems and techniques for the process are described so that commercial applications of sperm samples as well as the resulting animals may be achieved.

Background:  U.S. Patent No. 5,135,759 describes and claims the practice of collecting, processing and using processed bovine sperm to inseminate cows utilizing advances in flow cytometry systems.  This allows breeders to preferentially breed one sex of animal.  Petitioner contends that claim 11 of the ′822 patent differs from the examples in the ′759 patent in a single respect -- it recites that the "sheath" and "collector" fluids "include[] a citric acid."  Petitioner also contends that adapting the scheme to use citric-acid containing sheath and collection would have been obvious well before 1997.  Petitioner therefore contends that claim 11 should be cancelled.

Related Matters:
• The ′822 patent is the subject of litigation in the U.S. District Court for the District of Wisconsin (17-cv-00466).
• The ′822 patent is also the subject of pending litigation in the U.S. District Court for the District of Colorado, XY, LLC v. Trans Ova Genetics, LC (1:17-cv-00944).

Merck Sharp & Dohme Corp. v. GlaxoSmithKline Biologicals SA

PTAB Petition:  IPR2018-01229; filed June 11, 2018.  View Petition here.

Patent at Issue:  U.S. Patent No. 8,753,645, entitled "Conjugation process of bacterial polysaccharides to carrier proteins," describes a process of conjugation of bacterial saccharides including Streptococcus pneumoniae and Haemophilus influenzae saccharides by reductive amination.  Merck Sharp & Dohme Corp. requested inter partes review of independent claim 1 and dependent claims 2-11 of the ′645 patent as anticipated and/or obvious under 35 U.S.C. §§ 102 or 103.

Background:  Conjugates of bacterial saccharides to proteins are commonly-used components of vaccines.  The challenged claims are directed to processes for making conjugates of a particular S. pneumoniae bacterial saccharide, 23F.  Petitioner noted that the very same 23F "glycoconjugates" were well-known long before the alleged invention of the ′645 patent and featured in Pfizer's commercial Prevnar® vaccine.  Specifically, Petitioner notes that persons of ordinary skill in the art used reductive animnation to attach S. pneumoniae bacterial saccharides -- including 23F -- to proteins for decades before the ′645 patent.  Petitioner further contends that the claimed range of periodate in the ′645 patent does not produce unexpected results when compared to periodate outside of the range.

Related Matters:
• Petitioner concurrently filed IPR2018-01234 against U.S. Patent No. 9,265,839, entitled ″Conjugation process of bacterial polysaccharides to carrier proteins,″ which describes a process for conjugation of bacterial saccharides including Streptococcus pneumoniae and Haemophilus influenzae saccharides by reductive amination.  Petitioner challenges that independent claim 1 and dependent claims 2-10 are anticipated and/or obvious under 35 U.S.C. §§ 102 or 103.  View Petition here.
• Petitioner concurrently filed IPR2018-01236 against independent claim 1 and dependent claims 2-11 of the ′645 patent as obvious under 35 U.S.C. § 103.  View Petition here.
• Petitioner concurrently filed IPR2018-01237 against independent claim 1 and dependent claims 2-10 of the ′839 patent as obvious under 35 U.S.C. § 103.  View Petition here.

Alnylam Pharmaceuticals, Inc. v. Silence Therapeutics GmbH

PTAB Petition:  PGR2018-00067; filed June 11, 2018.  View Petition here.

Patent at Issue:  U.S. Patent No. 9,758,784, entitled "Interfering RNA molecules," describes a ribonucleic acid comprising a double stranded structure whereby the double-stranded structure comprises a first strand and a second strand, whereby the first strand comprises a first stretch of contiguous nucleotides and whereby said first stretch is at least partially complementary to a target nucleic acid, and the second strand comprises a second stretch of contiguous nucleotides whereby said second stretch is at least partially identical to a target nucleic acid, and whereby the double stranded structure is blunt ended.

Background:  Petitioners assert that the ′784 patent purports to cover an enormous, potentially unlimited, genus of structurally diverse small interfering RNA molecules, and therefore contend that the scope of the ′784 patent claims is far broader than any invention described in or enabled by the patent.  Petitioners also contend that the '784 patent claims are so broad that they cover modifications and genetic targets that have yet to be discovered.

Pfizer Inc. v. Hoffmann-La Roche Inc.

PTAB Petition:  IPR2018-01219; filed June 14, 2018.  View Petition here.

Patent at Issue:  U.S. Patent No. 8,314,225, entitled ″Heavy chain mutant leading to improved immunoglobulin production,″ describes methods and nucleic acids useful in the production of immunoglobulins in mammalian cells.

Background:  Petioner requested inter partes review of claims 1-5, 10-12, and 20 the ′225 patent.  Petitioner asserts the claims are unpatentable as anticipated and/or rendered obvious by U.S. Patent Application Publication No. 2002/0160006, International Publication No. WO 2007/068429, and U.S. Patent Application Publication No. 2006/0292152.

Related Matters:
• Genentech, Inc. and City of Hope v. Sandoz, Inc., No. 17-13507 (D. N.J.)
• Genentech, Inc. and City of Hope v. Pfizer Inc., No. 17-1672 (D. Del.)
• Re-examination Control No. 90/014,063

Mylan Technologies Inc. v. Noven Pharmaceuticals, Inc.

PTAB Petition:  IPR2018-00173; filed December 4, 2017.  View Petition here.

Institution of inter partes review; entered June 12, 2018.  View Decision here.
Panel:  Administrative Patent Judges Susan L. C. Mitchell, James T. Moore, and Kristi L.R. Sawert

Patent at Issue:  U.S. Patent 9,724,310, entitled ″Transdermal estrogen device and delivery,″ claims a transdermal drug delivery systems for the transdermal administration of estrogen, comprising a polymer matrix and estrogen.  Methods of making and using such systems also are described.

Background:  Mylan Technologies, Inc. requested inter partes review of claims 1–15 of the ′310 patent.  Noven Pharmaceuticals, Inc. filed a Preliminary Response.  Petitioner failed to show sufficiently for purposes of institution that cited art teaches a transdermal therapeutic system having an estradiolflux within the range recited in claim 1.  Further, because claims 2, 8, and 10–15 depend from claim 1 and require an estradiol flux within the range of about 0.0125 to about 0.05 mg/cm2/day, Petitioner also failed to show sufficiently for purposes of institution that it would prevail in its assertion that the prior art anticipates those claims.  Applying the precedent of SAS Inst., Inc. v. Iancu, (138 S. Ct. 1348, 1355–56 (2018)), and upon consideration of the information presented in the Petition and the Preliminary Response, the Petition was denied and the IPR not instituted.

Related Matters:
• Noven Pharmaceuticals, Inc. v. Alvogen PineBrook LLC, No. 1:17-cv-01429-LPS (D. Del.).
• Petitioner also petitioned for inter partes review of U.S. Patent 9,730,900, IPR2018-00174.  The Petition was denied.  View Decision here.
• Petitioner stated that the '310 and the '900 patents both claim the benefit of U.S. Patent No. 8,231,906.
• Petioner identified both pending and terminated litigations involving the ′906 patent:
    • Noven Pharmaceuticals Inc. v. Mylan Technologies Inc., No. 1:15-cv-00328 (D. Del.) (terminated);
    • Noven Pharmaceuticals Inc. v. Mylan Technologies Inc., 1:15-cv-00069 (N.D. W.V.) (terminated);
    • Noven Pharmaceuticals Inc. v. Actavis Laboratories UT, Inc., Nos. 1:15-cv-00249-LPS and 1:16-cv-00465-LPS (D. Del.) (pending);
    • Alvogen Pine Brook LLC v. Noven Pharmaceuticals, Inc., No. 1:16-cv-00395-LPS (D. Del.) (pending).

Initiative for Medicines, Access & Knowledge (I-MAK), Inc. v. Gilead Pharmasset LLC

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

Institution of inter partes review; entered June 13, 2018.  View Decision here.
Panel:  Administrative Patent Judges Erica A. Franklin, Lora M. Green, and Richard J. Smith

Patent at Issue:  U.S. Patent No. 7,429,572, entitled "Modified fluorinated nucleoside analogues," describes and claims compositions and methods of treating a Flaviviridae infection, including hepatitis C virus, West Nile Virus, yellow fever virus, and a rhinovirus infection in a host, including animals, and especially humans, using a (2'R)-2'-deoxy-2'-fluoro-2'-C-methyl nucleosides, or a pharmaceutically acceptable salt or prodrug thereof.

Background:  Initiative for Medicines, Access & Knowledge, Inc. filed a Petition requesting inter partes review of claims 1‒19 of the ′572 patent.  Gilead Pharmasset LLC filed a Preliminary Response to the Petition.  Petitioner asserted that the ′572 patent claims pharmaceutical compounds that were already published by the United States Government years before Patent Owner applied for the ′572 patent.  In addition, Petitioner contended that other scientists also publicly identified the pharmaceutical compounds claimed by the ′572 before Patent Owner applied for the ′572 patent. Upon considering the Petition and the Preliminary Response, the panel held that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of any of the challenged claims.  Institution of inter partes review for any challenged claim of the ′572 patent was denied.

Related Matters
• Patent Owner identified U.S. Patent Application No. 12/878,262, now U.S. Patent No. 8,415,322, as well as U.S. Patent Application No. 11/854,218, which is pending.
• IPR 2018-00123: Initiative for Medicines, Access & Knowledge (I-MAK), Inc. requested inter partes review of claims 1 and 2 of U.S. Patent No. 8,735,372.  Gilead Pharmasset LLC filed a Preliminary Response.  The ′372 patent is directed to a method of treating a human infected by hepatitis C virus comprising administering both an NS5a inhibitor and a prodrug of a nucleoside derivative.  The Petitioner did not show a reasonable likelihood that it would prevail in establishing the unpatentability of any challenged claim.  The panel denied institution of inter partes review.  View the Decision here.

Novartis Pharmaceuticals Corp. v. Plexxikon Inc.

PTAB Petition:  IPR2018-01287; filed June 18, 2018.  View petition here.

Patent at issue:  U.S. Patent No. 9,469,640, entitled ″Compounds and Methods for Kinase Modulation, and Indications Therefor," describes disease indications which are amenable to treatment by modulation of kinase activity by the compounds of the present invention.

Background:  Petitioner challenges claims 1, 2, 4-6, 9, 11 and 12 of the ′640 patent.  The ′640 patent claims priority to U.S. Application No. 12/669,450 (PCT/US2008/070124), filed on July 16, 2008, through a series of three continuation applications (all abandoned), and claims earliest priority to U.S. Provisional Application No. 60/959,907.  Petitioner asserted that the challenged claims are not entitled to the benefit of the July 16, 2008 filing date or the earlier provisional application because U.S. Application No. 12/669,450 does not satisfy the written description and enablement requirements of 35 U.S.C. § 112 (pre-AIA).

Related Matters:
• The ′640 patent is asserted in Plexxikon Inc. v. Novartis Pharmaceuticals Corp., No. 4:17-cv-04405 (N.D. Cal).
• A petition for Post-Grant Review of U.S. Patent No. 9,844,539 ("the '539 patent) is being filed concurrently with the IPR.  The ′539 patent is in the same patent family as the ʼ640 patent and is also asserted in the above referenced district court action.
• U.S. Application No. 15/656,990 is currently pending before the Office and claims priority to the application that issued as the ′640 patent.

Merck Sharp & Dohme Corp. v. Microspherix LLC

PTAB Petition:  IPR2018-01288; filed June 18, 2018.  View Petition here.

Patent at issue:  U.S. Patent No. 6,514,193 claims a method for administering a therapeutically active component including a non-radioactive drug to a target tissue in a subject.

Background:  Petitioners requested inter partes review and cancellation of claims 1-2 of the ′193 patent, asserting that the method is both anticipated and rendered obvious by the prior art.  Petitioners contend the ′193 patent does not purport to improve on prior art implantation devices, and instead, the '193 patent states that its seeds are designed to be implanted "with the needles used in many conventional brachytherapy strand implantation devices."

Related Matters:
• Petitioners have filed IPR petitions 2018-00393, -00402, and -00602 for three related patents.

Samsung Bioepis Co. v. Genentech, Inc.

PTAB Petition:  IPR2018-00192; filed November 30, 2017.  View Petition here.

Denial of inter partes review; entered June 18, 2018.  View decision here.
Panel:  Administrative Patent Judges Christopher G. Paulraj, Robert A. Pollock, and Zhenyu Yang

Patent at Issue:  U.S. Patent No. 7,846,441, entitled "Treatment with Anti-ERBB2 Antibodies," concerns the treatment of disorders characterized by the overexpression of ErbB2.  More specifically, the invention concerns the treatment of human patients susceptible to or diagnosed with cancer overexpressing ErbB2 with a combination of an anti-ErbB2 antibody and a chemotherapeutic agent other than an anthracycline, e.g., doxorubicin or epirubicin.

Background:  Petitioner requested inter partes review of claims 1–14 of the ′441 patent.  Patent Owner, Genentech, Inc., filed a Preliminary Response to the Petition.  Samsung Bioepis Co. argued that claims 1–14 of the ′441 patent would have been obvious over the combination of (1) Lottery in view of Hayes and/or Baselga ′96, and Gelmon, and (2) Baselga ′96 in view of Baselga ′94 and Gelmon.  Patent Owner contended that the Petition should be denied under 35 U.S.C. § 325(d) "in view of the previously-instituted IPRs based upon Baselga ′96, which are at an advanced stage."  Patent Owner's argument was persuasive.  Institution of inter partes review was denied.  The panel cited Harmonic Inc. v. Avid Tech, Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (explaining that under § 314(a), "the PTO is permitted, but never compelled, to institute an IPR proceeding").  Under 35 U.S.C. § 325(d), in determining whether to institute inter partes review, the PTAB "may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office."

Related Matters:
• IPR2017-00731: Instituted.  Pfizer filed a petition, challenging claims 1–14 of the ′441 patent.  Institution was originally denied, but later granted after Pfizer's request for reconsideration.  View the Decision here.
• IPR2017-02063: Instituted.  Pfizer filed a second petition together with a motion to join Celltrion in IPR2017-01121.  Joinder was granted.  View the Decision here.
• IPR2018-00016: Denied.  A concurrently issued decision and third petition filed by Pfizer, challenging the same claims of the '441 patent.  View the Decision here.
• IPR2017-00737: Instituted.  Pfizer and Celltrion challenged certain claims of U.S. Patent No. 7,892,549, a patent in the same family as the '441 patent.  View the Decision here.
• IPR2017-01960: Instituted.  Filed by Petitioner Bioepis, together with a motion to join Pfizer in IPR2017-00737.  The joinder motion was granted.  View the Decision here.
• The oral hearings for IPR2017-00731, -00737, -01121, -01122, and -01960 were held on May 18, 2018.
• According to the parties, the '441 patent is also the subject of Genentech, Inc. v. Pfizer, Inc., No. 1:17-cv-01672 (D. Del.), Celltrion, Inc. v. Genentech, Inc., No. 3-18-cv-00274 (N.D. Cal.), and Genentech, Inc. v. Celltrion, Inc., No. 1-18-cv-00095 (D. Del.).

Agilent Technologies, Inc. v. Thermo Fisher Scientific Inc.

PTAB Petition:  IPR2018-00297; filed December 13, 2017.  View petition here.

Institution of inter partes review; entered June 18, 2018.  View decision here.
Panel:  Administrative Patent Judges Michael R. Zecher, John F. Horvath, and Daniel J. Galligan

Patent at Issue:  U.S. Patent No. RE54,553, entitled ″Mass Spectrometer and Mass Filters Thereof.″  The ′553 patent generally relates to a method for improving the operational characteristics of mass spectrometers, particularly those with quadrupole mass filter arrangements.  The ′553 patent purportedly addresses an issue where dielectric material is deposited on the rods thereby reducing the mass resolving power or transmission of the mass spectrometer that in some instances renders the mass spectrometer useless.

Background:  Agilent Technologies, Inc. petitioned for for inter partes review of claims 1–66 of the ′553 patent.  Patent Owner filed a Preliminary Response along with a statutory disclaimer pursuant to 35 U.S.C. § 253(a) and 37 C.F.R. § 1.321(a) that disclaims claims 1–31 and 36–61.  Consequently, only claims 32–35 and 62–66 remained for consideration.  Taking into account the arguments presented in Thermo's Preliminary Response, the panel concluded that the information presented in the Petition established that there is a reasonable likelihood that Agilent would prevail in challenging at least one of claims 32–35 and 62–66 of the ′553 patent as unpatentable under 35 U.S.C. §§ 102(b) or 103(a) and an inter partes review as to these claims of the '553 patent was instituted.

Related Matters:
• The parties represent that the ′553 patent is at issue in a district court case Thermo Fisher Scientific Inc. v. Agilent Technologies, Inc. (D. Del.).
• In addition to this Petition, Agilent filed three other petitions challenging the patentability of all the claims in the following two patents owned by Thermo:  (1) U.S. Patent No. 7,230,232 (IPR2018-00299); and (2) U.S. Patent No. RE45,386 E (IPR2018-00298 and IPR2018-00313).
• IPR2018-00299:  Agilent filed a Petition requesting inter partes review of claims 1–34 of the ′232 patent.  Thermo filed a Preliminary Response.  The court instituted an inter partes review as to claims 1–34 of the ′232 patent.  View the Decision here.
• IPR2018-00298:  Agilent filed a Petition requesting an inter partes review of claims 1–8, 10, 12–20, 22, 23, and 25–50 the ′386 patent.  Thermo filed a Preliminary Response.  Petitioner demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ′386 patent.  Accordingly, an inter partes review of all challenged claims on all challenged grounds was instituted.  View the Decision here.
• IPR2018-00313:  Agilent requested inter partes review of claims 1, 5–11, 13–21, 23, 24, 28–35, and 37–50 the ′386 patent.  Thermo disclaimed claims 9, 11, 21, and 24 and filed a Preliminary Response.  Consequently, only claims 1, 5–8, 10, 13–20, 23, 28–35, and 37–50 remained for consideration.  Petitioner demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ′386 patent.  Accordingly, inter partes review of all challenged claims on all challenged grounds was instituted.  View the Decision here.