PTAB Life Sciences Report - February 2020

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

Abbott Laboratories v. Edwards Lifesciences Corp.

PTAB Petition:  IPR2020-00480; filed January 28, 2020.  View Petition here.

Patent at Issue:  U.S. Patent No. 6,719,767, ″Device and a method for treatment of atrioventricular regurgitation," describes a less invasive based mitral-valve clip method for treating "mitral insufficiency" instead of traditional open-heart surgery.  Petitioner requests institution of IPR, seeking cancellation of claims 1-3, 5, and 14 of the ′767 patent as unpatentable under 35 U.S.C. §§ 102 and 103.

Background:  Petitioner alleges that the challenged claims recite a clip that can be delivered with a catheter passing through a patient's blood vessels and used to repair the mitral valve in the heart, rather than via open-heart surgery.  Petitioner notes that Abbott's subsidiary, Evalve, had already developed and patented several such clips.  Specifically, Abbott's prior art U.S. Patent No. 6,629,534 describes clips for catheter-based mitral valve repair.  Petitioner alleges that the clips in the prior art and the '767 patent are nearly identical, other than the position of the crossbars.

Glaxosmithkline Consumer Healthcare Holdings (US) LLC v. Cipla Ltd.

PTAB Petition:  IPR2018-0368; filed January 31, 2020.  View Petition here.

Patent at Issue:  U.S. Patent No. 8,163,723, "Combination of azelastine and steroids," is directed at a pharmaceutical product comprising azelastine and a steroid, in a form suitable for nasal or ocular administration.  The '723 patent provides a method of prophylaxis or treatment in a mammal where anti-histamines and/or one or more steroids is indicated.  Petitioner challenges claims 1-218 of the ′723 patent as unpatentable under 35 U.S.C. § 103.

Background:  The claims are directed to methods of using formulations comprising azelastine and fluticasone.  Petitioner alleges that nasal sprays comprising each of these ingredients were known in the prior art and approved by the FDA as safe and effective for allergic rhinitis.  Petitioner also alleges that co-formulation of the two ingredients into a single formulation, and the benefits of such co-formulations, were also known in the prior art, and that combining the teachings of the prior art to arrive at the claimed invention would have been obvious to one of skill in the art.

Mylan Laboratories Ltd. v. Janssen Pharmaceutica NV

PTAB Petition:  IPR2020-00440; filed February 7, 2020.  View Petition here.

Patent at Issue:  U.S. Patent No. 9,439,906, "Dosing regimen associated with long acting injectable paliperidone esters," is directed at a method of treating patients in need of treatment with long acting injectable paliperidone palmitate formulations.  Petitioner challenges claims 1-21 of the '906 patent as unpatentable under 35 U.S.C. § 103.

Background:  The ′906 patent claims a dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment for schizophrenia, schizoaffective disorder, or schizophreniform disorder.  Petitioner alleges that the claims of the '906 patent are the result of routine optimization of dosing amounts of paliperidone palmitate reported in the prior art.  More specifically, Petitioner alleges that dosing regimens and dosages can be found in the prior art.  Petitioner also alleges that the dosage on each day would have been guided by well-known principle involving injectable depot formulations.

NanoCellect Biomedical, Inc. v. Cytonome/ST, LLC

PTAB Petition:  IPR2020-00549; filed February 11, 2020.  View Petition here.

Patent at Issue:  U.S. Patent No. 10,029,263, "Method and apparatus for sorting particles," is directed at a method and apparatus for the sorting of particles in a suspension, where the input flow path of a sorting module can be split into several output channels.  The claims are further directed at a particle sorting system in which a plurality of sorting modules are interconnected to increase particle throughput.  NanoCellect challenges claims 1, 5-6, 8, 15, and 16 as obvious under 35 U.S.C. § 103.

Background:  The '263 patent claims a microfludic system for sorting particles.  Petitioner alleges that the claimed combination of elements was already disclosed in a prior art reference.  Further, Petitioner alleges that by the priority date cytometers, including sorters using heater electrodes and piezoelectric actuators for cell sorting, were widely available, and functioning microfluidic devices were also known.

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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