Expert Review Of Drug Patent Applications: Improving Health In The Developing World

Abstract

Many developing countries have enacted intellectual property laws allowing patents on pharmaceutical products. These countries now must figure out how to provide legitimate protection of innovative discoveries while avoiding drug patents that do not conform to their laws. Using case-study examples, including the antiretroviral tenofovir disoproxil fumarate (TDF, or Viread), we demonstrate the importance of having outside experts participate in the review of drug patents. Vibrant patent review systems require sharing information among developing countries and active consultation with local public health authorities.

Secondary Patenting Of Branded Pharmaceuticals: A Case Study Of How Patents On Two HIV Drugs Could Be Extended For Decades

“…For example, if the US Patent and Trademark Office permitted outside experts to provide opinions about individual patents during the pharmaceutical patent evaluation process, the introduction of duplicative or otherwise invalid patents might be reduced. 33 As a first step in this direction, the Patent Reform Act of 2011 established a postpatent Settlements between brand-name and generic manufacturers keep potentially invalid patents in force in exchange for payments to a generic challenger.…”

The Patent Policy Trilemma

“…neither the applicant nor the state) can provide input. Opposition systems vary according to multiple dimensions, including who has the right to provide input, and the timing of procedures relative to the publication of application for or granting of the patent (Amin et al 2009). A robust pre-grant opposition system, as India has now (and as Japan had in the 1960s-1980s), may allow a wide range of actors from civil society to provide information that becomes part of the legal examination process.…”