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`Inter Partes Review
`United States Patent No. 9,815,827
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`SLAYBACK PHARMA LLC
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`Petitioner
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` v.
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`SUMITOMO DAINIPPON PHARMA CO., LTD
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`Patent Owner
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`
`
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`Patent No. 9,815,827
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`
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`Inter Partes Review No. Unassigned
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`
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`DECLARATION OF DR. THOMAS R. KOSTEN, M.D.
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`Inter Partes Review
`United States Patent No. 9,815,827
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`1.
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`I, Thomas R. Kosten, M.D., have been retained by counsel for
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`Petitioner Slayback Pharma LLC (Petitioner or Slayback). I understand that
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`Petitioner seeks inter partes review (“IPR”) of U.S. Patent 9,815,827 (EX-1001,
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`‘827 Patent), assigned to Sumitomo Dainippon Pharma Co., Ltd. (Patent Owner) to
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`request that the United States Patent and Trademark Office cancel claims 1-75 of the
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`‘827 patent as unpatentable. I submit this expert declaration in support of Petitioner’s
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`IPR Petition for the ‘827 patent.
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`I.
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`QUALIFICATIONS AND BACKGROUND
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`A.
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`Education and Experience
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`2. My education and experience includes training as a medical doctor with
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`board certification in Psychiatry from the American Board of Psychiatry and
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`Neurology.
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`3.
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`I am presently a professor in the Departments of Psychiatry,
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`Pharmacology and Neuroscience at Baylor College of Medicine, Vice-Chair of
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`Psychiatry and founding Director of the Division of Addictive Disorders and
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`Alcoholism. I have directed psychiatric treatment programs for over 25 years
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`including the Yale University and Veterans Administration (VA) programs in
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`Connecticut and now in Houston, Texas. I am also the past national Director for the
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`VA substance use disorders Quality Enhancement Research Initiative Center, which
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`monitors and sets standards for the quality of VA substance abuse care.
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`4.
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`In my practice, I have had numerous opportunities to determine when
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`individuals are treated appropriately with a full range of psychotropic medications
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`including antipsychotics such as Latuda® (lurasidone HCl) and complications of
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`these treatments. Because of my education, training and experience, I can provide
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`an expert opinion on this class of antipsychotic medications, their development and
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`their application to a range of psychiatric disorders including, but not limited to,
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`schizophrenia and non-schizophrenic disorders such as and including bipolar
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`disorders.
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`5.
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`I have treated hundreds of patients with antipsychotic medications such
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`as lurasidone.
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`6.
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`Since 2001, based on an annual ranking by U.S. News & World Report,
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`I have retained the distinction of “Top Doc” in the field of psychiatry; rated in the
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`top 10% of Addictions Medicine, and top 1%, of United States physicians
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`nationwide. I am an editor for the American Journal on Addictions and was on the
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`editorial boards of the American Journal of Psychiatry and major journals in the field
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`of psychiatry.
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`7.
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`I am a Distinguished Life Fellow in the American Psychiatric
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`Association and the American College of Neuropsychopharmacology (ACNP), the
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`organization responsible for the journal Neuropsychopharmacology.
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`8.
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`I received a Bachelor of Science in Biophysics from Rensselaer
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`Polytechnic Institute/Troy, NY in 1973 and a Medical Degree from Cornell
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`University Medical College/New York, NY in 1977.
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`9.
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`A copy of my curriculum vitae is attached as Exhibit A and provides
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`all 750 of my publications. In it are detailed my internationally recognized
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`credentials as an expert in psychiatric disorders including schizophrenic, substance
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`use, anxiety and affective disorders, which includes bipolar disorders.
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`B. Materials Considered
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`10.
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`In forming my opinions set forth in this declaration, I considered and
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`relied upon my education, background, and years of experience in the practice of
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`medicine in the field of psychiatry, as well as the materials identified in this
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`Declaration. The materials considered are listed in Exhibit C.
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`C.
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`11.
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`Scope of Work, Compensation, Other Matters
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`I have been retained by counsel for Petitioner in connection with this
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`matter. I am being compensated for my consulting work at the rate of $450 per hour.
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`My compensation in this case is in no way dependent on the outcome of this matter.
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`A list of the cases since 2014 where I have testified as an expert is attached as
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`Exhibit B.
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`II.
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`SUMMARY OF OPINIONS
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`12. As discussed in this Declaration:
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`a)
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`It is my opinion that the methods of treatment claimed in the manic
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`depressive claims of the ‘827 Patent are disclosed in Latuda® Information
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`(EX-1007), and therefore, each manic depressive claim of the ‘827 Patent is
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`anticipated by Latuda® Information.
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`b)
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`It is my opinion that the manic depressive claims were obvious to a
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`POSA when Latuda® Information (EX-1007) and Loebel (EX-1008) are viewed in
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`light of the state of the art prior to August 27, 2013.
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`c)
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`It is my opinion that claims 1-75 of the ‘827 Patent are invalid for
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`obviousness over the Saji Patent (EX-1009) in light of the prior art.
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`13. The claims of the ‘827 Patent (EX-1001) relate to methods of using
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`lurasidone or its salts to treat psychiatric disorders. Some issued claims of the ‘827
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`Patent are limited to treating schizophrenia. Other issued claims of the ‘827 Patent,
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`referred to herein as the “manic depressive claims” comprise treating “manic
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`depressive psychosis.”
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`14. The manic depressive claims of the ‘827 Patent all require:
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`a)
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`b)
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`c)
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`treating manic depressive psychosis;
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`by administering lurasidone or its salts;
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`orally;
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`d)
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`e)
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`at specific daily amounts;
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`without a clinically significant weight gain.
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`15. The Priority Application (EX-1004), U.S. Patent Application
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`10/525,021, does not show a person of skill in the art (POSA, defined later) that the
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`inventors of the Priority Application possessed the method of using lurasidone or its
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`salts to treat “manic depressive psychosis” as required by the manic depressive
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`claims of the ‘827 Patent.
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`16. The term “manic depressive psychosis” is old and vague and is not used
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`in modern psychiatric practice. Nevertheless, a POSA understood that the Examiner
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`and inventors of the ‘827 Patent referred to “manic depressive psychosis” as either
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`“bipolar illness” or “bipolar disorder.” During 2001-2014, and through 2017 if
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`relevant, a POSA understood “Bipolar Disorders” to include Bipolar I Disorder,
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`Bipolar II Disorder, Cyclothymia and Bipolar Disorder Not Otherwise Specified.
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`17. A POSA understood that a disclosure of treating major depressive
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`episodes associated with bipolar I disorder disclosed treating manic depressive
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`psychosis.
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`18. Before August 21, 2001 a POSA expected that the administration of
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`lurasidone HCl as an antipsychotic to at least some patients with schizophrenia or
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`bipolar I disorder would not lead to weight gain.
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`19. Before August 21, 2001 it was routine to develop appropriate dosing
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`regimens in the ordinary course of drug development.
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`III. LEGAL STANDARDS
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`20.
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`I have been informed of certain legal standards and I have applied these
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`standards in rendering my opinions.
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`21. My understanding of written description is in Paragraph 57, below.
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`22.
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`I understand that a Person of Ordinary Skill, a POSA, is a hypothetical
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`person possessing the education, training, experience, skill and knowledge of the
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`ordinary practitioner in the field of an alleged invention, is presumed to know the
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`relevant art at the time of an invention, and can rely on the knowledge and skill of
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`others if it was ordinary to do so. A POSA is not an automaton and would employ
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`the inferences and creative steps of a person in the relevant field. My definition of
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`a POSA with respect to the ‘827 Patent is in Paragraph 30, below.
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`23.
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`I understand that to prove anticipation or obviousness, it is a
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`Petitioner’s ultimate burden to prove anticipation or obviousness by a preponderance
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`of the evidence.
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`24.
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`I understand that the question of whether the claims of a patent are
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`anticipated or obvious is considered from the perspective of a person of ordinary
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`skill in the art (a POSA). Whether a claim would have been anticipated or obvious
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`is ascertained at the relevant time period.
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`25.
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`I understand that an obviousness analysis involves ascertaining the
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`scope and content of the prior art, the level of the person of ordinary skill in the
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`pertinent art, the differences between the claimed invention and the prior art and
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`whether there are additional factors present that may nevertheless weigh against
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`obviousness such as unexpected results attributable to the actually claimed.
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`26.
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`I understand that under the existing law, in assessing obviousness when
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`there is a design need or market pressure to solve a problem, a POSA has good reason
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`to pursue the known options within his or her technical grasp. If this would lead to
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`the claimed invention with a reasonable expectation of success, it is likely the
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`product not of innovation but of ordinary skill and common sense. The fact a
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`combination of elements was obvious to try can show that it was obvious.
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`27.
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`I understand that a prior art reference anticipates a patent claim if the
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`prior art reference discloses subject matter within the scope of the claim, with all of
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`the claim limitations.
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`28.
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`I understand that claim elements can be disclosed in the prior art either
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`expressly or inherently. In assessing anticipation, a claim element is inherent in a
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`reference if that element, or characteristic, is the natural result that flows from the
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`reference’s disclosure.
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`29.
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`In assessing obviousness, a claim element is inherent when it is the
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`natural result that flows from what is otherwise obvious.
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`IV. PERSON OF ORDINARY SKILL IN THE ART
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`30. The claims of the ‘827 Patent (EX-1001) relate to using lurasidone or
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`its salts as an antipsychotic to treat psychiatric disorders. A POSA had the education
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`and experience of a medical doctor trained in psychiatry who spent several years
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`using psychiatric medications to treat patients with schizophrenia and bipolar
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`disorders and had several years experience developing or investigating psychiatric
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`medications, and was familiar with the literature on drugs for schizophrenia and
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`bipolar disorders.
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`31.
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`In rendering my opinions, I understand that the knowledge and
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`literature available to a POSA depends on the particular timeframe being considered.
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`V. BACKGROUND OF PSYCHIATRIC DISORDERS
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`32. Many persons who suffer from psychiatric disorders can benefit from
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`medical intervention, which can include the administration of psychiatric
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`medications.
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`33. The Diagnostic and Statistical Manual of Mental Disorders (“DSM”) is
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`a widely used tool and reference for persons treating psychiatric disorders. During
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`the time period 2001-2014, the editions of the included DSM-IV (1994) (EX-1022),
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`DSM-IV-TR (2000) (EX-1023) and DSM-5 (2013) (EX-1024).1
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`34. At all points in time during the period 2001-2017, as reflected in the
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`1 EX-1022, -1023 and -1024 contain relevant portions from the respective DSM’s.
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`DSM, a POSA considered schizophrenia and bipolar disorders to be different
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`psychiatric conditions. See EX-1022, -1023 and -1024.
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`VI. U.S. PATENT NO. 9,815,827 (EX-1001)
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`35.
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`I have read the ‘827 Patent (EX-1001). I understand that the ‘827
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`Patent issued from the ‘827 Patent Application (EX-1003), filed in the U.S. Patent
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`Office August 28, 2014. I have reviewed EX-1046, which I understand to be the file
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`history of the ‘827 Patent Application at the U.S. Patent Office, beginning with the
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`August 28, 2014 filing of the ‘827 Patent Application (EX-1003).
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`36. The ‘827 Patent (EX-1001) lists 75 claims at columns 10-14. When I
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`cite to a patent, “X:Y-Z” means column “X”, lines “Y” to “Z”.
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`37. The claims of the ‘827 Patent (EX-1001) divide into two groups:
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`Claims comprising treating
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`Claims 8-18, 25-28, 30-31, 33-44, 46, 48-60, 62, 64,
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`manic depressive psychosis
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`66, 67, 69, 71, 73 and 75 (manic depressive claims)
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`Claims limited to treating
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`Claims 1-7, 19-24, 29, 32, 45, 47, 61, 63, 65, 68, 70,
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`schizophrenia
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`72 and 74 (schizophrenia claims)
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`
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`38. Claims 8-18, 25-28, 30-31, 33-44, 46, 48-60, 62, 64, 66, 67, 69, 71, 73
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`and 75 comprise treating “manic depressive psychosis” and are referred to as the
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`“manic depressive claims.”
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`39. Claims 1-7, 19-24, 29, 32, 45, 47, 61, 63, 65, 68, 70, 72 and 74 are
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`restricted to treating “schizophrenia” and are referred to as the “schizophrenia
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`claims.”
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`40. The ‘827 Patent (EX-1001) repeatedly states the “present invention” is
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`a method of using a specific chemical or its salts to treat “schizophrenia.” See EX-
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`1001, Abstract, Technical Field (1:14-17), Disclosure of the Invention (2:45-46),
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`Detailed Description of the Invention (3:42-53) and Industrial Applicability (10:29-
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`41) (emphasis added).
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`41. The ‘827 Patent identifies the compound of the “present invention” by
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`its chemical name and structural formula:
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`Chemical name (EX-1001, 2:51-54):
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`(1R,2S,3R,4S)-N-[(1R,2R)-2-[4-(l,2-benzoisothiazol-3-yl)-l-
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`piperazinylmethyl]-1-cyclohexylmethyl]-2,3-bicyclo[2.2.1]heptane-
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`dicarboximide;
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`
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`Structural formula (id., 2:55-67):
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`42. This compound is lurasidone (see e.g. EX-1047, p. 4). The
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`hydrochloride salt of this compound is lurasidone hydrochloride, a/k/a lurasidone
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`HCl, and lurasidone HCL is identified in the ‘827 Patent as “SM-13496.” EX-1001,
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`4:47-50.
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`43. The ‘827 Patent reports a “First Stage Phase II Clinical Trial,” wherein
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`“patients with schizophrenia” were administered placebo or SM-13496” (i.e.
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`lurasidone HCl), but it does not report giving any drug to any patient with “manic
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`depressive psychoses.” See EX-1001, 5:1-12.
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`44.
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`I understand that the priority chain leading to the ‘827 Patent starts with
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`Provisional Application, EX-1005, filed at the U.S. Patent Office August 22, 2002.
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`45.
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`I have read Provisional Application, EX-1005. The term “manic
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`depressive psychoses” appears in the Provisional Application exactly once, under
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`the heading “Background Art.” Id., p. 2, ln. 25. The Provisional Application
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`contains no mention of using lurasidone to treat anything besides schizophrenia and
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`there is no association in the Provisional Application of lurasidone or its salts with
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`“manic depressive psychoses.” EX-1005.
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`46.
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`I understand that the priority chain leading to the ‘827 Patent continues
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`with Priority Application, EX-1004, filed at the U.S. Patent Office August 20, 2003.
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`47.
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`I have read the Priority Application, EX-1004. The claims of the
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`Priority Application were limited to: a method for “treatment of schizophrenia”
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`(claims 1-13); an “agent for treatment of schizophrenia” (claims 14-16); and the
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`“preparation of an agent for treatment of schizophrenia” (claims 17-19). EX-1004.
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`48. The term “manic depressive psychoses” appears in the Priority
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`Application exactly once, under the heading “Background Art.” EX-1004, p. 2, ln.
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`30. The Priority Application contains no mention of using lurasidone or its salts to
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`treat anything besides schizophrenia and there is no association in the Priority
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`Application of lurasidone with “manic depressive psychoses.” EX-1004.
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`49.
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`I understand that the chain of applications leading to the ‘827 Patent
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`continues with the ‘827 Patent Application, EX-1003, filed at the U.S. Patent Office
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`August 28, 2014.
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`VII. CLAIM CONSTRUCTION
`50.
`I have been asked to give my opinions on what a POSA would
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`understand certain claim terms of the ‘827 Patent to mean. My opinions remain the
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`same for the entire period 2001-2017.
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`51. The claims of the ‘827 Patent include the terms “a patient” and “the
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`patient.” In the context of the ‘827 Patent, a POSA would read “a patient” and “the
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`patient” according to their plain meaning, i.e. singular, and would not understand “a
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`patient” and “the patient” to mean a patient population.
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`52. Claim 6 of the ‘827 Patent uses the term “said patient has a BPRS score
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`of at least 42.” In discussing the selection criteria of a subject for the clinical trial,
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`the ‘827 Patent (EX-1001) lists as criterion “2” “Patients having 42 or more of
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`Extracted-BPRS Score.” EX-1001, 5:26. The BPRS score recited in claim 6 is
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`clearly a characteristic of an individual, and construing “a patient” or “the patient”
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`to mean “patient population” would cause claim 6 to not make sense.
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`53. Three claims of the ‘827 Patent (EX-1001, claims 25, 40 and 56) recite
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`“treating a patient with an antipsychotic.” A POSA would read this language to
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`comprise “treating a patient for schizophrenia with an antipsychotic” and “treating
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`a patient for manic depressive psychosis with an antipsychotic.” In particular, each
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`of claims 25, 40 and 56 has a dependent claim which recites that “the method treats
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`schizophrenia in the patient,” and another dependent claim reciting “the method
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`treats manic depressive psychosis in the patient.” EX-1001: claims 25, 29 and 30;
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`claims 40, 45 and 46; and claims 56, 61 and 62. For these pairings to make sense,
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`“treating a patient with an antipsychotic” must comprise “treating a patient for
`
`schizophrenia with an antipsychotic” and “treating a patient for manic depressive
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`psychosis with an antipsychotic.”
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`54. Some claims of ‘827 Patent recite treating “manic depressive
`
`psychosis.” “Manic depressive psychosis” is an old and vague term not used in
`
`modern psychiatric practice. “Manic depressive psychosis” was not listed in DSM
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`during 2001-2017. EX-1022, DSM-IV (1994); EX-1023, DSM-IV-TR (2000); and
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`EX-1024, DSM-5 (2013).
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`55. Although “manic depressive psychosis” is a vague and ill-defined term,
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`a (POSA) reading the prosecution of the ‘827 Patent Application (EX-1046)
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`appreciates that the Examiner and the inventors understood “manic depressive
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`psychosis” to mean “bipolar illness” or “bipolar disorder”. EX-1033, p. 4 (Examiner
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`stating: “manic depressive psychosis is typically referred to as bipolar illness.”); EX-
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`1034, p. 14 (applicants stating: “present application relates to a method of treating a
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`patient with schizophrenia or manic depressive psychosis (bipolar disorder)”).
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`56. During 2001-2017 a POSA understood that “Bipolar Disorders”
`
`included Bipolar I Disorder, Bipolar II Disorder, Cyclothymia and Bipolar Disorder
`
`Not Otherwise Specified. DSM-IV (1994) (EX-1022), DSM-IV-TR (2000) (EX-
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`1023) and DSM-5 (2013) (EX-1024). A POSA understood patients with Bipolar I
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`Disorder experience manic episodes, major depressive episodes and mixed episodes.
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`Id. Although “manic depressive psychosis” is not well-defined, a POSA would
`
`understand “manic depressive psychosis” to comprise “Bipolar Disorders.”
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`VIII. THE MANIC DEPRESSIVE CLAIMS LACK WRITTEN
`DESCRIPTION IN THE PRIORITY APPLICATION
`57.
` I understand that to satisfy written description a patent application must
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`convey with reasonable clarity to a POSA that the inventor was in possession of the
`
`claimed invention. The application must clearly allow a POSA to recognize that the
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`inventor actually invented and set forth in the specification what is claimed. I
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`understand that disclosure of a species does not describe a genus and that the mere
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`inclusion in the application of words recited in the claims is not written
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`description. I understand that assessing written description requires an objective
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`analysis of what is actually disclosed in the application itself, sometimes called “an
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`inquiry into the four corners of the specification.” Finally, I understand that even if
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`the disclosure in an application renders a claimed invention obvious, that is not in
`
`and of itself satisfaction of the written description requirement.
`
`58. Claim 8 of the ‘827 Patent (EX-1001) reads as follows:
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`8. A method for treating manic depressive psychosis in a
`patient without a clinically significant weight gain,
`comprising:
`administering orally
`to
`the patient
`(1R,2S,3R,4S)-N-[(1R, 2R)-2-[4-(l,2-benzoisothiazol-3-
`yl)-l-piperazinylmethyl]-l-cyclohexylmethyl]-2,3-
`a
`bicyclo[2.2.1]heptanedicarboximide
`or
`pharmaceutically acceptable salt thereof at a dose of from
`20 to 120mg/day such that the patient does not experience
`a clinically significant weight gain.
`
`Reduced to its elements, claim 8 requires:
`
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`a)
`
`b)
`
`c)
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`d)
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`e)
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`“treating manic depressive psychosis in a patient”
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`by “administering orally”;
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`“[lurasidone] or a pharmaceutically acceptable salt thereof”;
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`“at a dose of from 20 to 120 mg/day”, and;
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`“the patient does not experience a clinically significant weight
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`gain. EX-1001, claim 8.
`
`59. The Priority Application (EX-1004) recites a clinical trial of lurasidone
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`HCl for treating schizophrenia, but a POSA knows that schizophrenia and manic
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`depressive psychosis are different psychiatric illnesses. DSM-IV (1994) (EX-1022),
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`DSM-IV-TR (2000) (EX-1023) and DSM-5 (2013) (EX-1024). There is no
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`disclosure in the Priority Application (EX-1004) of using lurasidone or its salts to
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`treat manic depressive psychoses with any dosing regimen, let alone the specific
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`regimens recited in representative claim 8 and the other manic depressive claims.
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`60. A POSA reading within the four corners of the Priority Application
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`would see that the inventor’s did not possess the invention of claim 8 and the other
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`manic depressive claims because:
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`
`
`a)
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`The Priority Application (EX-1004) mentions “manic depressive
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`psychoses” only once, and only in the context of generally stating that an enormous
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`genus of compounds “may be useful as an antipsychotic…for treatment of
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`schizophrenia, senile
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`insanity, manic depressive psychoses, and nervous
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`breakdown….” EX-1004, p. 2, ln. 26-p. 3, ln. 7. The genus is described in the
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`Priority Application as follows:
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`
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`b)
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`The Priority Application never refers to using lurasidone to treat
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`manic depressive psychosis;
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`c)
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`The Priority Application
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`includes a single clinical
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`trial
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`“Experiment 1” of treating “patients with schizophrenia” (EX-1004, p. 8);
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`
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`d)
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`The Priority Application repeatedly states that the “present
`
`invention” is the use of lurasidone and its salts to treat schizophrenia (EX-1004, pp.
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`1, 4, 5, 6, 17, and 22);
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`
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`e)
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`The claims of the Priority Application are all limited to treatment
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`of “schizophrenia” (id., claims 1-19, beginning at p. 19);
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`
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`f)
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`A POSA knew in 2002 and 2003 (when the Provisional and
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`Priority Applications were filed) that if administering a drug according to a certain
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`regimen was shown to treat schizophrenia, that did not mean that administering that
`
`drug in the same way was useful for treating other psychiatric conditions;
`
`
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`g)
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`The Priority Application’s Title is “Agent for The Treatment of
`
`Schizophrenia” (id. p. 1); and
`
`
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`h)
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`The Priority Application (EX-1004) contains no association
`
`between lurasidone or its salts and the treatment of manic depressive psychosis.
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`61. Simply put, a POSA reading the Priority Application would understand
`
`that in the inventors’ minds the Priority Application was only about the use of
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`lurasidone to treat schizophrenia.
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`62. The Provisional Application (EX-1005) adds nothing with respect to
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`the treatment of manic depressive psychosis compared to Priority Application (EX-
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`1004) itself.
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`VII.
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`INVALIDITY ANALYSIS
`A.
`Latuda® Information Discloses the Manic Depressive Claims
`63.
`I understand that if Latuda® Information (EX-1007) qualifies under the
`
`law as prior art to a manic depressive claim of the ‘827 Patent and Latuda®
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`Information discloses the alleged invention of that claim, that claim is invalid
`
`because it is “anticipated” by Latuda® Information.
`
`64.
`
`It is my opinion that Latuda® Information (EX-1007) discloses the
`
`alleged invention of each manic depressive claim because Latuda® Information
`
`discloses each element of the manic depressive claims in a method of using
`
`lurasidone HCl to treat major depressive episodes associated with bipolar I disorder.
`
`65. Therefore, assuming Latuda® Information is prior art to the manic
`
`depressive claims of the ‘827 Patent, it is my opinion that each manic depressive
`
`claim is invalid because it is anticipated by Latuda® Information.
`
`1. treating manic depressive psychosis in a patient
`66. Latuda® Information (EX-1007) is a detailed announcement in the
`
`American Journal of Psychiatry telling psychiatrists and other psychiatric care
`
`givers that “Latuda® (lurasidone HCl)” was “Now Approved” for “Adult Patients”
`
`with “Bipolar Depression” and it specifically states under “Indications” that
`
`“LATUDA is indicated for • Treatment of major depressive episodes associated with
`
`bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy
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`with lithium or valproate in adults.” Treating major depressive episodes associated
`
`with bipolar I disorder discloses “treating manic depressive psychosis in a patient.”
`
`Thus, Latuda® Information discloses “treating manic depressive psychosis in a
`
`patient.”
`
`2. administering orally
`67. Latuda® Information discloses Latuda® as “(lurasidone HCl) tablets.”
`
`Oral administration is the preferred route for administering drugs and a POSA
`
`reading “tablets” in Latuda® Information immediately knew and envisaged that
`
`Latuda® was in the form of tablets for oral use. See also EX-1037, Latuda Label
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`2012, Sec. 11. Description (“LATUDA tablets are intended for oral administration
`
`only”); EX-1035, June 2013 Press Release (“taken with food”). Thus, Latuda®
`
`Information discloses oral administration.
`
`3. lurasidone or a pharmaceutically acceptable salt thereof
`68. Latuda® Information discloses Latuda® as “(lurasidone HCl) tablets.”
`
`Lurasidone HCl is a pharmaceutically acceptable salt of lurasidone. Thus, Latuda®
`
`Information discloses lurasidone or a pharmaceutically acceptable salt of lurasidone.
`
`4. at a dose of from 20 to 120 mg/day
`69. Latuda® Information discloses “a short-term, placebo-controlled
`
`premarketing study for bipolar depression in which LATUDA was administered at
`
`daily doses ranging from 20 to 120 mg.” Thus, Latuda® Information discloses “a
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`dose of from 20 to 120 mg/day.”
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`5. patient does not experience a clinically significant weight gain
`70. Latuda® Information discloses: “In the uncontrolled, open-label,
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`longer-term bipolar depression study, patients who received LATUDA as
`
`monotherapy in the short-term and continued in the longer-term study had a mean
`
`change in weight of -0.02 kg at week 24 (n=130).” This discloses “one or more
`
`patients” do not “experience a clinically significant weight gain.” Also, without a
`
`weight gain in one or more patients is an inherent property of administering
`
`lurasidone HCl. Thus, Latuda® Information discloses the patient does not
`
`experience a clinically significant weight gain.
`
`6. lurasidone hydrochloride
`71. Latuda® Information discloses “(lurasidone HCl) tablets.” Lurasidone
`
`HCl is lurasidone hydrochloride. Thus, Latuda® Information discloses lurasidone
`
`hydrochloride.
`
`7. patient does not experience a clinically significant weight gain
`after six weeks of administration.
`72. Latuda® Information discloses “a 6-week monotherapy study in adult
`
`patients with bipolar depression,” a longer “24 week study,” that in the “short-term
`
`study” “[t]he mean weight gain was 0.29 kg for LATUDA-treated patients” and
`
`“[t]he proportion of patients with ≥ 7% increase in body weight (at Endpoint) was
`
`2.4% for LATUDA-treated patients.” This discloses that at least a patient does not
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`experience a clinically significant weight gain after six weeks of administration.
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`Also, without a weight gain in one or more patients is an inherent property of
`
`administering lurasidone HCl. Latuda® Information discloses that at least a patient
`
`does not experience a clinically significant weight gain after six weeks of
`
`administration.
`
`8. detecting a weight gain after six weeks of administration.
`73. Latuda® Information discloses “a 6-week monotherapy study in adult
`
`patients with bipolar depression,” a longer “24 week study,” that in the “short-term
`
`study” “[t]he mean weight gain was 0.29 kg for LATUDA-treated patients” and
`
`“[t]he proportion of patients with ≥ 7% increase in body weight (at Endpoint) was
`
`2.4% for LATUDA-treated patients.” This discloses detecting a weight gain after
`
`six weeks of administration. Thus, Latuda® Information discloses detecting a
`
`weight gain after six weeks of administration.
`
`9. without concurrently administering another antipsychotic
`medication
`74. Latuda® Information discloses administration of Latuda® “as
`
`monotherapy.” This discloses that the drug (lurasidone HCl) is administered
`
`“without concurrently administering another antipsychotic medication.” Thus,
`
`Latuda® Information discloses without concurrently administering another
`
`antipsychotic medication.
`
`10. treating a patient with an antipsychotic
`75. Lurasidone HCl is an antipsychotic, and Latuda® Information
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`discloses: treating bipolar I patients with lurasidone HCl, described therein as an
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`“antipsychotic”; “LATUDA and other antipsychotic drugs”; and “As with other
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`antipsychotic drugs, LATUDA should be used cautiously.” Latuda® Information
`
`discloses treating a patient, with lurasidone HCl, an antipsychotic, for major
`
`depressive episodes associated with bipolar I disorder, which discloses treating a
`
`patient for manic depressive psychosis with an antipsychotic. Thus Latuda®
`
`Information discloses treating a patient for manic depressive psychosis with an
`
`antipsychotic.2
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`11. a composition comprising lurasidone or a pharmaceutically
`acceptable salt thereof as a sole active ingredient
`
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