Recommendations for Statutory Reform of the Patent Term Extension System to Increase Public Accountability and Fight Soaring Drug Prices

The first period is the time the drug spends in clinical development15 after being given permission under the FDA’s Investigational New Drug program (the IND period).16 The second period is the New Drug Application period,17 which is the time the FDA reviews the drug sponsor’s request for marketing approval (the NDA period).18 The amount of extension for which the patent is eligible is calculated. [...] § 156(d)(4) (permitting the Director of the PTO to define disclosure requirements), § 156(e) (“If the Director determines that a patent is eligible for extension under subsection (a) and that the requirements of paragraphs (1) through (4) of subsection (d) have been complied with, the Director shall issue to the applicant for the extension of the term of the patent a certificate of extension…”). [...] Whether the patent holder derives commercial benefit from the right of exclusion of others to use the patent is a matter apart from the patent system, and commercial success depends on many factors external to the patent system, such as the “commercial practicality of the invention, the state of development, the existence of market and the existence of other federal and state laws which regulate t. [...] It states, “An application for the extension of the term of a patent is subject to the disclosure requirements prescribed by the Director.” This provision both imposes a requirement on the PTE applicant to disclose information to the PTO, and delegates authority to the PTO to define what information, exactly, must be disclosed. [...] This is the only sentence in the provision mentioning disclosure requirements: “An application for the extension of the term of a patent is subject to the disclosure requirements prescribed by the Director [of the PTO].”54 The vague provision affords the PTO very broad latitude to decide what information must be disclosed by the PTE applicant.