District Court Issues Ruling Finding Adderall XR® Patents Infringed
Cambridge, Mass., USA - March 23, 2018 - Shire (LSE: SHP, NASDAQ: SHPG) announces that its subsidiary, Shire Development LLC, welcomes yesterday's favorable ruling against Abhai LLC in connection with their Abbreviated New Drug Application (ANDA) for a generic version of Shire 's ADDERALL XR. ADDERALL XR is indicated for the treatment of attention deficit hyperactivity disorder in children and adults.
Following a bench trial in the U.S. District Court of the District of Massachusetts, the judge issued a ruling holding that the proposed ANDA formulation infringes the claims of patents RE42,096 (a reissue of US 6,322,819) and RE41,148 (a reissue of US 6,605,300). Accordingly, Abhai is prohibited from marketing its ANDA product until the expiration of the patents.
In addition, the court sanctioned Abhai for its litigation misconduct and directed that a certified copy of the court's opinion be sent to FDA's attention in light of what the court described as Abhai's "pervasive corporate unwillingness to play by the rules." The amount of monetary sanctions to be paid to Shire will be determined at a later date.
Shire is pleased with the decision and will continue to vigorously defend its patents to protect the innovation and value Shire products bring to patients.
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NOTES TO EDITORS
Shire is the global leader in serving patients with rare diseases. We strive to develop best-in-class therapies across a core of rare disease areas including hematology, immunology, genetic diseases, neuroscience, and internal medicine with growing therapeutic areas in ophthalmics and oncology. Our diversified capabilities enable us to reach patients in more than 100 countries who are struggling to live their lives to the fullest.
We feel a strong sense of urgency to address unmet medical needs and work tirelessly to improve people's lives with medicines that have a meaningful impact on patients and all who support them on their journey.
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a further list and description of risks, uncertainties and other matters can be found in Shire 's most recent Annual Report on Form 10-K and in Shire 's subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in "ITEM1A: Risk Factors", and in Shire 's subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire 's website.
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