Legal Issues

KEI has worked on legal issues relating to access to medical technologies and access to knowledge, including analyzing court cases and submission of amicus briefs.

DNA and diagnostic patents


Patent Exhaustion

Copyright Exhaustion

  • KEI Comments to USPTO on Genetic Diagnostic Testing
  • BRCA gene case: James D. Watson, co-founder of double helix structure, rejects patentability of DNA and other amici filings
  • Federal Appellate Court: Pay-for-Delay is “prima facie evidence of an unreasonable restraint of trade.”
  • Federal Circuit Oral Arguments in BRCA Gene Patent Case (Round 2)
  • Federal Circuit decision again results in three-way split in reasoning in AMP v. USPTO; 2-1 ruling upholds DNA patents
  • Federal Circuit decision in AMP v. USPTO results in three-way split in reasoning; 2-1 decision finds isolated DNA patentable
  • Federal Circuit hears oral arguments on patent eligibility of DNA claims
  • Federal judge in Myriad patent case says invalidation of gene patents does not violate TRIPS
  • KEI and UAEM file brief as amici curiae in BRCA gene patent case
  • KEI files amicus brief in BRCA gene patent case
  • KEI files amicus brief in case on international patent exhaustion
  • KEI files amicus brief in pay-for-delay case; SCOTUS to resolve circuit split on legality of reverse payment settlements
  • KEI files amicus brief to Supreme Court in BRCA gene patent case
  • Pay-for-Delay Circuit Split Continues; 31 States File Amicus Brief Arguing Pay-For-Delay is Presumptively Unlawful
  • SCOTUS Oral Arguments in AMP v. Myriad Genetics; Court to Determine Answer to Question: Are Human Genes Patentable?
  • SCOTUS Oral Arguments in FTC v. Actavis; Court to Decide Legality of Pay-For-Delay (Reverse Payment) Settlement Agreements
  • Unanimous Supreme Court decision invalidates Prometheus diagnostic test patents and reverses Federal Circuit decision
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