Second Medical Innovation Impact Index Issued by Fairleigh Dickinson University’s Initiative for Patient-Centered Innovation (iPCI)

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MI3 Alert for America Invents Act Inter Partes Review Process from Initiative for Patient Centered Innovation (iPCI)

IPR was implemented to address obstacles to innovation caused by patent trolls, however, several unintended consequences pose severe threats to biopharmaceutical innovation.

The second Medical Innovation Impact Index (MI3) Alert considers inter partes review (IPR), a method of challenging patents under the America Invents Act of 2012. This mechanism for review of patents following their issuance received a MI3 score of -8 (range -10 to +10) for its impact on medical innovation and a score of +6 for its effect on innovation in the technology space by the Initiative for Patient Centered Innovation (iPCI) of Fairleigh Dickinson University’s (FDU) Rothman Institute of Innovation and Entrepreneurship.

IPR was implemented to address obstacles to innovation caused by patent trolls, however, several unintended consequences pose severe threats to biopharmaceutical innovation. Ways in which the IPR can be amended to address the severe adverse effects on medical innovation are also discussed in the MI3 Alert.

The Medical Innovation Impact Index (MI3) is a succinct, real world analysis and scoring system based on interviews with legal and medical experts who interact with government agencies regularly in the review of new products in development. The purported benefits and potential positive impacts on medical innovation are listed and scored zero to +5, based on the likelihood of achieving these objectives; the unintended consequences and potential negative impacts on medical innovation are listed and scored 0 to -5, based on the likelihood of these untoward effects happening. A final composite score (ranging from -10 to +10) is calculated and a recommendation is provided.

Currently, no analysis exists to evaluate rules solely with respect to their impact on the advancement of medical innovation, which is the purpose of the Medical Innovation Impact Index. MI3 alerts will be issued monthly.

About Fairleigh Dickinson University
Devoted to the preparation of world citizens through global education, Fairleigh Dickinson is New Jersey's largest private university and features more than 100 liberal arts and professional degree programs, two international campuses, dozens of partnerships with internationally renowned institutions and special programs and status within the United Nations.

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Dina Schipper
Fairleigh Dickinson University
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