- Adoption
- Restraining OrderAmgen v. Sandoz, the purpose is to ensure that, starting from when the applicant’s product, uses, and processes are fixed by the FDA license, the necessary decision-making regarding further patent litigation is not conducted under time pressure that will impair its fairness and accuracy. At a minimum, the reference product sponsor needs time to make a decision about seeking relief based on yet-to-be-litigated patents, and a district court needs time for parties to prepare for complex litigation. The 180-day period gives the reference product sponsor time to assess its infringement position for the final FDA-approved product as related to yet-to-be-litigated patents. And if further infringement litigation ensues, the 180-day window affords the parties and the district court the time for adjudicating such matters without the rush attending requests for emergent relief against immediate market entry. The Court noted that “the Act’s legislative history confirms the aim to avoid the uncertainties and deficiencies associated with a process in which requests for temporary restraining orders and preliminary injunctions are presented and adjudicated on short notice.”
- Business TransactionsThe last thing a business needs is to invest heavily in obtaining a patent on a product, only to see the patent invalidated when they attempt to enforce it against an infringer. Because of a statutory provision commonly known as the “on sale bar”, this can happen if a business is not extremely careful about engaging in commercial transactions involving their new product prior to filing a patent application. And the task of avoiding the on sale bar has become even more problematic since the advent of the Leahy-Smith America Invents Act (AIA), which added language to the provision that is yet to be definitively interpreted by the courts.
- Intellectual PropertyIn order to get a provisional patent, a provisional patent application must be filled out following a comprehensive USPTO patentability search guaranteeing your invention has not already been patented. An experienced patent attorney can assess the specifics of your invention and fill out a provisional patent application to highlight the uniqueness and patentability of your idea, while continuing to guarantee you intellectual property protection.