ALKS Alkermes PLC

Item 8.01               Other Events.

On June 3, 2016, the U.S. Patent and Trademark Office (the “U.S. PTO”) accepted two separate petitions for inter partes review (“IPR”) filed by Luye Pharma Group Ltd., Luye Pharma (USA) Ltd., Shandong Luye Pharmaceutical Co., Ltd., and Nanjing Luye Pharmaceutical Co., Ltd. (collectively, “Luye”) challenging U.S. Patent Number 6,667,061 (the “‘061 Patent”), which is an Orange Book-listed patent for each of Bydureon®, Risperdal Consta® and Vivitrol®. Alkermes plc, together with its affiliates (the “Company”), has a three-month period to respond, following which the U.S. PTO has a further three-month period to decide whether or not to institute a review of the challenged claims of the ‘061 Patent. If such review is instituted, a decision on the matter would be expected, pursuant to the statutory time frame, within one year of the U.S. PTO’s decision to institute such review.

The Company will oppose Luye’s requests to institute the challenge of the ‘061 Patent , and, if the U.S. PTO institutes such challenge, the Company will oppose the full proceedings and vigorously defend the ‘061 Patent.

Note Regarding Forward-Looking Statements

Certain statements set forth in Item 8.01 above constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including if the U.S. PTO institutes the challenge of the ‘061 Patent, the timing of the U.S. PTO’s decision if such challenge is instituted, the Company’s ability to oppose the institution of the ‘061 Patent IPR and, if instituted, the Company’s ability to defend the ‘061 Patent. Although Alkermes believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include those risks described in the Alkermes plc Annual Report on Form 10-K for the fiscal year ended Dec. 31, 2015 and in any other subsequent filings made by the Company with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. The information contained in Item 8.01 above is provided by the Company as of the date hereof, and, except as required by law, the Company disclaims any intention or responsibility for updating or revising any forward-looking information contained therein.

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