Pharmaceutical Practice

Phillips Ormonde Fitzpatrick pharmaceutical and agricultural practice integrates experienced litigators, patent attorneys and analysts in life sciences with technical depth and patent knowledge to provide our clients with strategic patent and non-patent protection including market/data exclusivity and litigation support to de-risk their development phase and exposure on launch of pharmaceuticals and biological agricultural products.

Selecting the right counsel in an IP related matter is critical because of the inherent complexity of the subject matter.  In today’s competitive and often crowded market, it can be difficult to clear a path to market while navigating regulatory approval.

We coordinate and execute local and multi-jurisdictional IP strategies to support regional and global market entry, exclusivity, enforcement and licensing negotiations for:

• Pharmaceuticals
  • Small molecule drugs and generics
  • Biologics (e.g., antibodies, CAR-T cells) and follow-on biologics including interchangeables and biosimilars
  • Vaccines
• Agricultural products
  • biological chemicals (e.g., pheromones, hormones, growth regulators, enzymes and vitamins).
  • plant and other extracts (e.g., plant extracts, oils).
  • microbial agents (e.g., bacteria, fungi, viruses, protozoa).
  • other living organisms (e.g., microscopic insects, plants and animals plus some organisms that have been genetically modified).

Our practice includes:

• Prepare and file patent term extension applications in Australia.
• Prepare and file plant breeders rights (PBR) applications in Australia.
• Patent landscape searching
• Freedom to Operate searching
• Patent validity and infringement analyses including searching
• Exclusivity strategies (including data and market exclusivity)
• IP analysis for inclusion in prospectus for initial public offering
• Support for preparation of patent certifications for Hatch-Waxman/Abbreviated New Drug Applications (ANDAs) and 505(b)(2) applications
• Support for ANDA and 505(b)(2) related litigation
• Support for Abbreviated Biologics License Application (ABLA) and Biologics Price Competition and Innovation Act (BPCIA) related litigation
• Litigation support for Patent Trial and Appeal Board (PTAB), Inter Partes Review (IPR), Post-Grant Review (PGR) proceedings in the United States; and oppositions in Europe useful for clearing a path to market