The Legal Consequences of Research Misconduct: False Investigators and Grant Proposals.

In a survey on research misconduct, roughly 20% of the respondents admitted that they have submitted federal grant proposals that include scholars as research participants even though those scholars were not expected to contribute to the research effort. This manuscript argues that adding such false investigators is illegal, violating multiple federal statutes including the False Statements Act (18 U.S.C. §1001), the False Claims Act (31 U.S.C. §3729), and False, Fictitious, or Fraudulent Claims (18 U.S.C. §287). Moreover, it is not only the offending academics and the false investigators that face civil and criminal penalties because administrators may also be liable if they sign off on proposals and are in a position to know that false investigators might be included. Policy recommendations that should reduce the use of false investigators include changing institutional cultures, better training and oversight of the responsible conduct of research, and, most importantly, making all grant reviews double blind.

Patent lifecycle management strategies in open innovation projects.

Proper implementation of lifecycle management strategies is important for profit maximization in the pharmaceutical industry. This article investigates the ownership of follow-on patents for approved drugs in the USA. We discover that a considerable number of follow-on patents are originally developed by, and issued to, external partners and not drug sponsors. We also find that the use of follow-on patents is more common in some therapeutic areas than in others. Based on these findings, we develop lifecycle strategies to effectively manage and use external patents in open innovation projects. These strategies include proper license contract design, post-FDA-approval acquisition and open innovation.