On December 14, 2017, Shire filed a motion for preliminary injunction against Roche subsidiaries Genentech Inc. and Chugai Pharmaceutical Co., Ltd., as part of our ongoing U.S. patent infringement lawsuit to protect our ‘590 patent from infringement by Roche’s emicizumab, currently being marketed as HEMLIBRA.®
Shire remains steadfastly committed to the hemophilia community and cares deeply that patients are treated appropriately. The filing of the preliminary injunction is not a decision we made lightly, and we carefully considered the impact this filing may have on hemophilia patients. Our motion requests the court to prevent the infringement of our intellectual property while the litigation proceeds, which is a customary request within the pharmaceutical/biotech industry. Shire’s motion is not seeking a blanket prohibition of emicizumab sales, but rather the request proposes a carve-out to enable those patients with the greatest need continue to have access to the treatment.
Until the court‘s decision on the motion for the preliminary injunction is made, expected summer 2018, there will be no patient impact. Although Shire has proactively proposed a carve-out in its request for a preliminary injunction, the scope of the injunction and any carve-out provision is ultimately a matter for the court to decide.
Intellectual property protection laws afford Shire, and other companies in the pharmaceutical industry, the ability to reinvest, innovate and provide value to the patient communities they serve. It is for this reason we believe we have a responsibility to rigorously protect our intellectual property.
Shire has a long track record of successfully resolving U.S. patent issues, and after over two years of discussions with Roche, we are optimistic and confident that this intellectual property matter will now have an accelerated resolution.
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