About the PTAB Life Sciences Report:  We will periodically report on developments at the PTAB involving life sciences patents.

Eli Lilly and Company v. Teva Pharmaceuticals International GmbH

PTAB Petition:  IPR2018-01710; filed September 28, 2018.  View Petition here.

Patent at Issue:  U.S. Patent No. 8,586,045, ″Methods of using anti-CGRP antagonist antibodies″ describes methods for preventing or treating CGRP associated disorders including headaches and hot flashes by administering an anti-CGRP antagonist antibody.  Antagonist antibody G1 and antibodies derived from G1 directed to CGRP are also described in the patent.

Background:  Petitioner claims that by the time Teva filed its first application in November 2005, the CGRP pathway was a clinically validated target for treating migraines.  Further, Petitioner asserts that a published, double-blind, placebo-controlled clinical trial by Olesen et al. that associated CGRP blockade with migraine relief was not before the USPTO during examination of the '045 patent.  Petitioner asserts that the ′045 patent is available for IPR based on Teva's assertions to the USPTO that it is entitled to a pre-AIA filing date of November 14, 2005.

Related Matters:
• On October 24, 2017, Teva filed declaratory judgment action, that Lilly's investigational drug galcanezumab infringed U.S. Patent Nos. 8,586,045; 8,597,649; 9,266,951; 9,340,614; and 9,346,881.
• On February 6, 2018, Teva filed another declaratory action, seeking a declaration that Lilly's product will infringe U.S. Patent Nos. 9,884,907 and 9,884,908.  A week later, Teva amended its complaint in the second-filed action to incorporate U.S. Patent Nos. 9,890,210 and 9,890,211.
• On September 27, 2018, the District Court dismissed Teva's Amended Complaints in both declaratory judgment actions.  Later that day, Teva filed a third action for patent infringement for the same patents.  The patents in the litigations purport to claim priority to the same U.S. provisional application as the '045 patent.
• On August 8, 2018, Lilly filed petitions for inter partes review against U.S. Patent Nos. 9,340,614; 9,266,951; 9,346,881; 9,890,210; 9,890,211; and 8,597,649.  These petitions are pending before the Board as IPR2018-01422, IPR2018-01423, IPR2018-01424, IPR2018-01425, IPR2018-01426, and IPR2018-01427, respectively.
• Lilly filed PGR2018-01711 against Teva Pharmaceuticals on October 1, 2018, against U.S. Patent No. 9,884,907, ″Methods for treating headache using antagonist antibodies directed against calcitonin gene-related peptide″.  View Petition here.

Hubei Grand Life Science and Technology Co. v. Vitaworks IP, LLC

PTAB Petition:  IPR2018-01766; filed September 28, 2018.  View Petition here.

Patent at Issue:  U.S. Patent No. 9,428,450, ″Process for producing taurine from alkali taurinates″ is directed at a process for producing taurine from alkali ditaurinate or alkali tritaurinate, or their mixture, comprising the conversion of alkali ditaurinate to dialkali ditaurinate or alkali tritaurinate to trialkali tritaurinate, or their mixture, the ammonolysis reaction of ammonia added to a solution of dialkali ditaurinate or trialkali tritaurinate, or their mixture, to yield alkali taurinate, removing excess ammonia from the foregoing and neutralizing alkali taurinates with an acid to form a crystalline suspension of taurine, and recovering taurine by means of solid-liquid separation.

Background:  Petitioner challenges claims 1 and 3-7 of the ′450 patent.  Petitioner claims that patent claims are directed to a method of industrial taurine synthesis that is neither innovative nor novel.  Rather, Petitioner claims that the synthesis of taurine through ammonolysis of an isethionate salt has been known for at least 80-plus years.  Further, the Petitioner claims that the identity of the byproducts has also been known for decades and, that it is known that the byproducts, can convert to and from alkali taurinate through an equilibrium reaction.  The Petitioner also asserts that the other claim limitations are simply recitations of basic organic synthesis techniques that are known in the art.

Related Matters:
The ′450 patent is subject to pending U.S. District Court litigations in the District of New Jersey:
• Vitaworks IP, LLC v. Qianjiang Yongan Pharmaceutical Co., No. 2:17-cv-06849-CCC-MF; filed Sept. 6, 2017; and
• Vitaworks, LLC v. Qianjiang Yongan Pharmaceutical Co., No. 2:16-cv-05321-CCC-MF; filed Aug. 31, 2016.
• Petitioner filed IPR2018-01767 on September 28, 2108 against U.S. Patent No. 9,428,451, ″Cyclic process for the production of taurine from alkali isethionate".
• Petitioner filed IPR2018-01768 on September 28, 2018 against U.S. Patent No. 9,573,890, ″Process for producing taurine″.

Adello Biologics, LLC v. Amgen Inc.

PTAB Petition:  PGR2019-00001; filed October 01, 2018.  View Petition here.

Patent at Issue:  U.S. Patent No. 9,856,287, ″Refolding proteins using a chemically controlled redox state″ describes a method of refolding proteins expressed in non-mammalian cells present in concentrations of 2.0 g/L or higher.  The method comprises identifying the thiol pair ratio and the redox buffer strength to achieve conditions under which efficient folding at concentrations of 2.0 g/L or higher is achieved and can be employed over a range of volumes, including commercial scale.

Background:  Petitioner asserts that claims 1-30 of the ′287 patent recite methods of refolding proteins expressed in a nonmammalian expression system by a simple two-step process:  (1) contacting the proteins with a buffer having certain characteristics, and (2) incubating the mixture of the proteins and buffer.  Petitioner claims that that it is more likely than not that each of the challenged claims is unpatentable for failing to satisfy the written description and enablement requirements, unpatentable as indefinite, and unpatentable as anticipated and rendered obvious by the prior art.

Related Matters:
• The ′287 patent claims priority to U.S. Patent No. 8,952,138.  Claims 1-17 and 19-24 of the ′138 patent were found unpatentable by the PTAB on February 15, 2018.

Genome & Co. v. University of Chicago

PTAB Petition:  PGR2019-00002; filed October 02, 2018.  View Petition here.

Patent at Issue:  U.S. Patent No. 9,855,302, ″Treatment of cancer by manipulation of commensal microflora″ describes methods of treatment and/or prevention of cancer by manipulation of commensal microflora.  In particular, the amount, identity, presence, and/or ratio of microflora (e.g., gut microflora) in a subject is manipulated to facilitate one or more co-treatments.

Background:  Petitioner seeks PGR and cancellation of claims 1–29 of the ′302 patent.  Petitioner assets that the claims cover methods of treating any and all cancers in a human subject by co-administering the combination of any and all immune checkpoint inhibitors and any and all species of Bifidobacterium.  The Petitioner further asserts that the disclosure of the ′302 patent provides a list of over 165 types of cancer, tens of "immune checkpoint inhibitors," including any protein or protein fragment that binds to an immune checkpoint protein, and 36 different genera of Bifidobacterium, including "Bifidobacterium sp" including any yet to be discovered species of Bifidobacterium.  In contrast, the Petitioner notes that the actual experimental evidence reported in the ′302 patent does not support the claims.

Medtronic, Inc. v. Board of Regents, University of Texas System

PTAB Petition:  IPR2019-00037; filed October 9, 2018.  View Petition here.

Patent at Issue:  U.S. Patent No. 6,596,296, ″Drug releasing biodegradable fiber implant" is directed at tissue engineering compositions and methods wherein three-dimensional matrices for growing cells are prepared for in vitro and in vivo use.  The matrices comprise biodegradable polymer fibers capable of the controlled delivery of therapeutic agents.  The spatial and temporal distribution of released therapeutic agents is controlled by use of defined nonhomogeneous patterns of therapeutic

Background:  Petitioner challenges claims 1-7, 10, 11, 16, 20-23, 25, 26, 31, and 32 of the ′296 patent.  Petitioner asserts that the challenged claims recite a composition of a biodegradable polymer fiber composed of two distinct phases that are immiscible, where one of the phases includes a therapeutic agent.  Petitioner asserts that this type of fiber was known well before the claimed effective filing date of the ′296 patent.  Petitioner cites art from the 1990s using different types of biodegradable polymers for delivering different types of drugs as being well known to those skilled in the art.

Medtronic, Inc. v. Board of Regents, University of Texas System

PTAB Petition:  IPR2019-00038; filed October 9, 2018.  View Petition here.

Patent at Issue:  U.S. Patent No. 7,033,603, ″Drug releasing biodegradable fiber for delivery of therapeutics″ is directed at fiber compositions comprising gels or hydrogels.  The invention further relates to the composition of a gel or hydrogel loaded biodegradable fiber and methods of fabricating such fibers.  The patent further describes tissue engineering and drug-delivery compositions and methods wherein three-dimensional matrices for growing cells for in vitro and in vivo use.  Finally, the patent describes methods of manipulating the rate of therapeutic agent release by changing both the biodegradable polymer properties as well as altering the properties of the incorporated gel or hydrogel.

Background:  Petitioner challenges claims 1, 2, 4–6, 11–13, 15–19, 21, 22, 24–26, and 31–33 of the ′603 patent.  Petitioner challenges that drug-delivery fibers, including those using biodegradable polymers, gels, and hydrogels, were well known before the claimed effective filing date of the '603 patent.  Petitioner asserts that the challenged claims are anticipated under 35 U.S.C. § 102(a), (b), and (e) and rendered obvious under 35 U.S.C. § 103(a).