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May 23 2023
8:30 AM - 3:00 PM

Linda Pissott Reig, shareholder in the firm's FDA/Biotech and Life Sciences practice groups, was the Director of the first-ever New Jersey Buchanan Life Sciences Summit on May 23, 2023. Linda was a speaker in the following presentations:  

“Principles to Practice, Small Table Workshop: Real World Scenarios,” with Lloyd Smith, shareholder and IP Litigation Practice Group Leader, and Trisha Klan, associate in the firm’s Litigation section.                

This workshop began with a brief overview of Lanham Act claims, and other tactics for addressing competitor advertising and promotion tactics.  Attendees were then asked to work through a variety of questions and plot twists relating to the following scenario:

  • A drug manufacturer reaps significant financial benefits from an on-line pharmacy/telemedicine’s advertising campaign promoting a drug for off-label uses. 
  • This campaign is diverting significant market share from another drug manufacturer that is marketing its product for on-label uses. 

Each attendee assumed a role (CEO, Legal or Sales) at their individual tables for one of the two drug manufacturers or the on-line pharmacy/telemedicine provider. Questions posed included:  What recourse exists for the on-label drug manufacturer who is losing significant market share?  What legal options exist if the online pharmacy/telemedicine provider does not respond to a demand to end its off-label promotion of an independent drug manufacturer’s product? If the drug manufacturer reaping significant benefits did not create the advertising campaign, is that company permitted to reap the financial rewards and avoid responsibility/liability?  What options exist – e.g.  “cease and desist” demand, Lanham Act actions and recourse to FDA and what are the benefits/limitations of each?  What about the option of advertising that directly attacks the online pharmacy/telemedicine’s advertising campaign? 

“Ethical Insights for In-House Success” addressed:

  • the in-house attorney’s obligation of confidentiality;
  • ensuring employees understand that an in-house lawyer represents the company;
  • sensitivity in corporate communications;
  • ethical expectations for attorneys serving in supervisory roles; and
  • managing damaging information implicating senior management and when action may be warranted to protect the public health, well-being and society as a whole.

Other presenters were: Amy Todd Klug, Executive Associate General Counsel, Litigation, Corporate Functions & Legal Operations Legal Affairs at Daiichi Sankyo; Sarina Rivera, Associate General Counsel at Genentech; Genevieve Spires, Senior Legal Counsel at Melinta Therapeutics; and Christopher Warren, counsel in the firm’s Litigation section.