`
`
`
`
`
`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
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
