November 27, 2018
`
`Sumitomo Dainippon Pharma Co., Ltd.
`
`Sumitomo Dainippon Pharma Announces Resolution of Disputes
`under Consolidated Patent Infringement Lawsuit Regarding ANDAs
`for LATUDA® in the U.S.
`
`Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director,
`President and CEO: Hiroshi Nomura) announced today that, as a result of settlements (the
`“Settlements”) with remaining defendants of the consolidated patent infringement lawsuit (the
`“Lawsuit”), jointly filed with its U.S. subsidiary, Sunovion Pharmaceuticals Inc. (“Sunovion”), before
`the U.S. District Court for the District of New Jersey (the “Court”) in February 2018 against a total
`of 16 generic companies seeking to market a generic version of their proprietary atypical
`antipsychotic agent, LATUDA® (lurasidone HCI), based on U.S. Patent No. 9,815,827 (the “827
`Patent”) and U.S. Patent No. 9,907,794 (the “794 Patent”), all disputes underlying the Lawsuit have
`been resolved.
`
`After filing the Lawsuit, Sumitomo Dainippon Pharma and Sunovion had, while pursuing the Lawsuit,
`engaged in negotiation with defendants for settlements, following the Court’s order, and the number
`of defendants of the Lawsuit had reduced through withdrawal and settlement agreements. As a
`result of the Settlements, all disputes underlying the Lawsuit have been resolved and the Lawsuit
`will conclude with respect to all the defendants thereof, following confirmatory procedure of the
`Court.
`
`Pursuant to the Settlements and other settlement agreements entered with some of the defendants
`of this Lawsuit, certain number of generic companies that were parties to the Lawsuit will be
`permitted to distribute their generic versions of lurasidone HCL starting on February 21, 2023. Other
`terms and conditions of the settlement agreements will not be disclosed.
`
`The impact of resolving the Lawsuit on Sumitomo Dainippon Pharma’s consolidated financial results
`of the fiscal year ending March 31, 2019 is not expected to be material. We are currently evaluating
`the potential impact on Sumitomo Dainippon Pharma’s consolidated financial results of the fiscal
`year ending March 31, 2020 and thereafter.
`
`Separately, three patent infringement lawsuits remain pending in the U.S. District Court for the
`District of New Jersey against three generic companies, also based on the 827 Patent and the 794
`Patent, which also submitted Abbreviated New Drug Applications seeking approval of a generic
`lurasidone HCL.
`
`1
`
`Exhibit 2012
`Slayback v. Sumitomo
`IPR2020-01053
`
`

`

`
`
`Disclaimer Regarding Forward-looking Statements
`The statements made in this press release contain forward-looking statements based on
`management's assumptions and beliefs in light of information available as of the day of this release,
`which involve both known and unknown risks and uncertainties. Actual results of those matters
`covered in the forward-looking statements including financial forecast may differ materially from
`those contained in this release, due to a number of factors.
`
`Contact:
`Public & Investor Relations Group, Corporate Governance
`Sumitomo Dainippon Pharma Co., Ltd.
`TEL: +81-6-6203-1407 (Osaka); +81-3-5159-3300 (Tokyo)
`
`
`
`2
`
`