Workshops

Hosted by Mark Worsman, Senior Associate, DLA Phillips Fox

Mark Worsman is a senior associate in the Sydney office of DLA Phillips Fox where he specialises in commercial transactions and regulatory issues affecting the life sciences, intellectual property and information technology sectors.

Mark has worked in-house at a global originator pharmaceutical company and routinely advises on regulatory matters affecting Australian industry participants.

He has been involved in product launches in Australia and England and he is experienced at reviewing and advising on promotional materials and activities, including applicable Codes in Australia and England. He has delivered compliance workshops to sales and general staff.

Hosted by John McCann, Principal and Gavin Adkins, Patent Scientist, Chemical/Life Science team, Spruson & Ferguson

• Infringing and non-Infringing activities following patent grant and en route to obtaining PBS listing before and after the grant of a patent extension of term
• Possible patent infringement ramifications after application by a section 26B certificate applicant for a PBS listing including a review of relevant case law
• Registration Case study – Covering hypothetical steps to be taken by an applicant relying on the safety and efficacy data of an earlier registration or listing of a therapeutic good for the registration or listing of that good prior to providing a section 26B certificate under the Therapeutic Goods Act 1989. The workshop will include an examination of the factors that such an applicant should take into account
• Infringement/Interlocutory Injunction Case Study – Covering hypothetical steps to be taken by a patentee or exclusive licensee and the factors to be taken into account prior to providing a 26C certificate under the Therapeutic Goods Act 1989 and commencing infringement proceedings or filing an application for an interlocutory injunction against a 26B certificate applicant for registration or listing of a therapeutic good
• The workshop will also cover:
  • legislative patent certification requirements for applicants for registration or listing of a therapeutic good on the ARTG under the Therapeutic Goods Act 1989;
  • legislative patent certification requirements prior to commencement of patent infringement proceedings by a patentee or an exclusive licensee of a pharmaceutical patent against a 26B certificate applicant for registration or listing of a therapeutic good on the ARTG;
  • penalties for false or misleading patent certificates or breaches of undertaking in the patent certificates;
  • legislative notification requirements prior to commencement of proceedings for an interlocutory injuction by a patentee or an exclusive licensee of a pharmaceutical patent against a 26B certificate applicant for registration or listing of a therapeutic good on the ARTG; and
  • potential penalties against patentees who commence interlocutory injunction proceedings in respect of pharmaceutical patents against a 26B certificate applicant for registration or listing of a therapeutic good on the ARTG.