Business Context and Reporting Period
Company: Alkermes Plc.
Filing Type: Form 8-K (Current Report)
Date of Report: November 7, 2018
Subject: Item 8.01 Other Events regarding a Patent Trial and Appeal Board (PTAB) proceeding.
Key Financial Metrics
This filing is a current report regarding a legal event and does not contain financial statements. The filing text does not provide values for revenue, profit, cash flow, margins, debt, or liquidity.
Material Changes and Legal Proceedings
- Event: On November 7, 2018, the PTAB issued an order instituting an inter partes review (IPR) of claims 1-13 of U.S. Patent Number 7,919,499 (the "'499 Patent").
- Context: The '499 Patent is an Orange Book-listed patent for the product VIVITROL®.
- Opposing Party: The IPR was initiated following a petition filed on April 20, 2018, by Amneal Pharmaceuticals LLC challenging the validity of the patent.
- Timeline: A decision on the matter is expected by November 7, 2019.
Guidance, Outlook, and Risks
The filing includes a standard caution regarding forward-looking statements, specifically noting that the expected timing of the PTAB's decision is subject to uncertainty. The Company disclaims any responsibility for updating these statements except as required by law. Investors are directed to the Company's Annual Report on Form 10-K for the year ended December 31, 2017, for a comprehensive description of risks and uncertainties.
Key Facts for Investor Verification
- Verify the status of the IPR proceeding for U.S. Patent Number 7,919,499 and its potential impact on VIVITROL® exclusivity.
- Review the Company's Form 10-K for the year ended December 31, 2017, for detailed risk factors related to intellectual property litigation.
- Monitor future filings for updates on the PTAB decision expected by November 7, 2019.