Two Upcoming Conferences Discuss Product Lifecycle Management Issues

January 4, 2009

Kurt R. Karst of Hyman, Phelps & McNamara, P.C. (and co-chief blogger of will be speaking at two upcoming conferences on various Hatch-Waxman Act product lifecycle management issues.  The first conference is the Center for Business Intelligence’s Premier Bio/Pharmaceutical Summit on Legal & Regulatory Product Lifecycle Strategies, January 20-21, 2009, at the Hilton Baltimore in Baltimore, Maryland.  Information on the conference is available here.  Conference sessions include: 

  • Advice from the FTC on how to structure a compliant lifecycle strategy;
  • Patent portfolio management in a global environment, including emerging economies;
  • A panel discussion on alternative pathways for exclusivity such as targeted therapeutics, superior molecules, and niche populations;
  • Repurposing “old” drugs;
  • A core workshop on key US laws and regulations pertaining to ANDA patent challenges and PTO patent reform proposals; and 
  • Labeling carve-outs, their impact on generic approvals and affect on therapeutic equivalence ratings (Our favorite!  Mr. Karst will present on this topic.).

For more information or to register for the conference, please contact the Center for Business Intelligence toll-free by phone at 1-800-817-8601 or via e-mail at

The second conference is a Thompson Publishing Group audio conference, titled “New Drug Exclusivity Provisions: How They’ll Impact Your Product Lifecycle Management,” and will take place on January 13, 2009 from 1:00 PM – 2:30 PM.  Information on the audio conference is available here.  This conference will explore the “old” antibiotic and enantiomer exclusivity provisions recently added to the FDC Act, as well as recent issues concerning 180-day generic drug exclusivity and patent term extensions.  Learning points and questions to be answered during the audio conference include:

  • What are “old” antibiotics and what is the new law permitting Hatch-Waxman benefits?
  • Enantiomer exclusivity – what are the new rules permitting 5-year exclusivity? 
  • How is FDA interpreting the 180-day exclusivity forfeiture provisions and when is FDA expected to issue proposed regulations on the forfeiture provisions? 
  • What patents are eligible for a patent term extension? 
  • What if I miss the 60-day patent term extension application period?  What is the status of legislation permitting an extension of the 60-day period? 
  • When are multiple patent term extensions available? 
  • How is the “regulatory review period” calculated for a patent term extension?

For more information or to register for the audio conference, please contact Thompson Publishing Group toll-free by phone at 1-800-925-1878.

Categories: Drug Development