Committee Co-Chair Mike Visconti, Senior Patent Counsel at Johnson & Johnson, kicked off the event by welcoming the audience and introducing the panelists. Co-Chair Tim Fisher, Patent Counsel at Pierce Atwood, presented a primer on the legal background of willful infringement and enhanced damages as they relate to opinions-of-counsel. The primer covered evolution of the law of enhanced damages culminating in the current law under statute and the Supreme Court’s 2015 Halo decision.

Co-Chair Lisa Adams, Member at Mintz, moderated a discussion among panelists Angie Verrecchio, Senior Counsel, Patent Litigation at Johnson & Johnson; Rick Musgrave, General Counsel & Secretary at Husky Injection Molding System; and Jeremy Bond, Senior Counsel, Digital and Device Patents at Sanofi. The panelists discussed issues related to FTO studies such as when and how they begin the clearance process, who is involved, how to ensure that product changes are cleared, and what records they prepare and maintain. With regard to written opinions, the panelists discussed the decision to get an opinion, when to obtain the opinion, how the opinion is delivered, how the opinion is documented and tracked, and whether any policies have changed in light of Halo. The panelists also discussed the scope of an opinion as it relates to the scope of potential waiver of attorney-client privilege at trial.

The audience spurred further discussion with pointed questions on issues such as how often FTO studies result in engineering changes, whether to share FTO results with engineers, what kind of training of non-legal employees may help avoid a finding of willfulness, when to adjust strategy based on level of risk of infringement damages, and when or when not to rely on an opinion based on an analysis that differs from what is at issue in litigation (e.g., a different claim construction or different references).

The Medical Devices Committee extends its thanks to the panelists, attendees, and everyone who helped produce this event behind the scenes.