Amgen, one of the world’s leading biotechnology companies, recently filed a complaint for patent infringement under the Biologics Price Competition and Innovation Act (BPCIA) against Mylan. According to Big Molecule Watch, the litigation claims that “certain actions by Mylan during the patent dance exchanges prejudiced Amgen and/or violated the BPCIA.”
Amgen alleges that Mylan “materially prejudiced and impeded Amgen’s ability to review the Mylan aBLA” by only allowing access to the aBLA through a virtual data room that (a) prohibited Amgen from “saving, copying, annotating, or printing any documents or data,” (b) “was also slow and cumbersome, and lacks fully working hyperlinks,” (c) left Amgen “unable to view many of the documents and data …, including many of the xml, xsl, sas, xpt, jpeg, and txt files,” and (d) “suffered periodic technological failures, preventing Amgen from accessing or viewing the documents and data.”
The new BPCIA litigation highlights the important role of specialized virtual data rooms in the patent dance information exchanges between biotech firms. For biotech and pharma companies, whose revenues depend on their ability to develop, protect and license innovations, protecting intellectual property is everything. Virtual data rooms are designed to enable the secure, cloud-based sharing of sensitive documents between third parties in support of complex, structured processes, and are frequently used by biotech firms for raising capital to fund clinical trials, in-licensing and out-licensing IP, IPOs, mergers and acquisitions.
This new complaint illustrates that choosing a virtual data room is not a decision that biotech and pharma companies should take lightly. Investing in a file sharing solution that is unwieldy or difficult to use may not only cause friction, delays and frustration for everyone involved, it could even lead to a costly lawsuit.
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