`
`
`
`
`
`IPR2020-01053
`United States Patent No. 9,815,827
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`SLAYBACK PHARMA LLC
`
`Petitioner
`
` v.
`
`SUMITOMO DAINIPPON PHARMA CO., LTD
`
`Patent Owner
`
`
`
`
`Patent No. 9,815,827
`
`
`
`Inter Partes Review No. IPR2020-01053
`
`
`
`SUPPLEMENTAL DECLARATION OF DR. THOMAS R. KOSTEN, M.D.
`
`
`
`
`{80267460:1}
`
`
`PAGE 1
`
`
`
`
`
`
`SLAYBACK EXHIBIT 1051
`
`
`
`
`IPR2020-01053
`United States Patent No. 9,815,827
`
`1.
`
`In this proceeding, I, Thomas R. Kosten, M.D., submitted my
`
`Declaration (EX-1002) dated March 26, 2020.
`
`2. My deposition was taken in this proceeding on February 17, 2021.
`
`3.
`
`I have reviewed the part of my deposition transcript (EX-2134) from
`
`page 88, line 8 to page 90, line 14 (using the page numbers at the bottom right of the
`
`page). I understand from counsel that Patent Owner cites from this part of my
`
`deposition transcript to assert I recanted (i.e. “took back”) part of my opinion. I did
`
`not recant.
`
`4.
`
`Rather, when I testified in that part of my deposition that I did not have
`
`an “objection” to the “schizophrenia claims” of U.S. Patent No. 9,815,827 (EX-1001
`
`“the ‘827 Patent”) I meant that the clinical data in the ‘827 Patent (EX-1001 5:1-
`
`10:25) demonstrated the safety and efficacy of using lurasidone to treat
`
`schizophrenia.
`
`5.
`
`I also understand from counsel that Patent Owner cites to Wong (EX-
`
`2032) to argue that Wong taught it was necessary to co-administer a second active
`
`agent with a number of antipsychotic drugs in a single formulation to minimize
`
`weight gain. I reviewed Wong and I disagree. Although Wong does state that the
`
`two active components “can be given as a single combined dose,” Wong goes on to
`
`state that the two active ingredients can be “given separately” and at “different
`
`times” as long as both drugs are given “over a 24-hour period.” EX-2032 9:25-28.
`
`{80267460:1}
`
`PAGE 2
`
`
`
`
`
`
`SLAYBACK EXHIBIT 1051
`
`
`
`
`IPR2020-01053
`United States Patent No. 9,815,827
`
`Teaching that a second drug can be given separately and within 24 hours of a first
`
`drug is the exact opposite of teaching that it was necessary to co-administer a second
`
`drug with the antipsychotic in a single formulation.
`
`6. Moreover, Wong emphasizes that the second drug is preferably a
`
`selective norepinephrine reuptake inhibitor such as reboxetine. Id. 1:16-19.
`
`However, putting a second drug such as reboxetine in a fixed combination with an
`
`atypical antipsychotic (e.g. olanzapine) would remove important flexibility from the
`
`prescribing psychiatrist. This is because olanzapine is typically dosed before
`
`bedtime and reboxetine is typically dosed in the morning due to the fact that dosing
`
`reboxetine at bedtime can make it difficult for the patient to sleep. This is another
`
`reason that Wong does not teach that it was necessary to co-administer a second drug
`
`with the antipsychotic in a single formulation.
`
`7.
`
`I also understand from counsel that Patent Owner does not argue that
`
`the second drug would have to be a second antipsychotic. This makes perfect sense
`
`because, although second drugs are often prescribed to help ameliorate the weight
`
`gain associated with certain atypical antipsychotic drugs, the paradigm second drug
`
`is metformin. Metformin, a drug often used in the treatment of diabetes, is not an
`
`anti-psychotic. The successful use of metformin as a treatment for weight gain in
`
`children taking olanzapine, risperidone, quetiapine or valproate was reported in the
`
`American Journal of Psychiatry in April 2002. EX-1056 (“Morrison”). Although
`
`{80267460:1}
`
`PAGE 3
`
`
`
`
`
`
`SLAYBACK EXHIBIT 1051
`
`
`
`IPR2020-01053
`United States Patent No. 9,815,827
`
`metformin is the paradigm second drug, I am not aware of a fixed combination drug
`
`marketed in the United States where metformin in combined with an antipsychotic
`
`drug in a single formulation.
`
`I declare under penalty of perjury that the foregoing is true and correct.
`
`Dated: June 09, 2021
`
`
`
`
`
`
`
`
`
`
`
`By:
` Thomas R. Kosten, M.D.
`
`
`
`{80267460:1}
`
`PAGE 4
`
`
`
`
`
`
`SLAYBACK EXHIBIT 1051
`
`