We offer full IP services from early R&D
to commercial launch, and beyond
We assist clients with patent FTO, supporting their product development by circumventing, challenging and creating IP.
R&D, Clinical and Regulatory support
Working with clients’ R&D, clinical and regulatory teams, we provide IP assistance and guidance from the product scoping stage, through early stage development, advanced development and (where necessary) clinicals, and beyond product launch, ensuring that all commercial, regulatory, clinical and IP strategies dove tail. Our regulatory experts also provide regulatory assistance as required, including dealing with the therapeutic goods regulations.
Once our client’s pipeline is settled, we help them to develop global patent strategies to ensure their commercial objectives are met. We provide patent advice and strategic guidance and work with global counsel to obtain pre-launch advices around the world and secure experts in anticipation of litigation.
Our understanding of the global nature of licensing and pharma is second to none. Our work with some of the largest licensing-driven pharmaceutical businesses (both in-house and as external advisors) gives us a level of capability that is rare in the Australian market.
When considering licensing, partnering, entering R&D co-operation projects or any other deal, we work with client’s BD teams to help build and implement their global and regional operations and commercialisation strategies.
Patent office, pre-litigation and litigation strategies
No stone will be left unturned to ensure there are no patent surprises on launch. We work with our clients to find the best IP strategies supporting their commercial objectives, and implement them in Patent Offices and Courts in Australia (and New Zealand), and with agents around the world. We deal with all aspects of patent litigation and prosecution, including:
Revocation “clearing the way” litigation,
Defence of infringement proceedings;
Patent oppositions/amendment oppositions/re-examinations;
Defence of injunctions/launch strategies
Extension of term disputes, oppositions, and applications;
Settlement solutions; and
Patent drafting and prosecution.
Australian patent litigation experience
We have prepared Australian patent litigation strategies for over 100 small molecule generic products, and more than 10 biosimilar products. We have provided hundreds of advices, and have been involved in proceedings in Australia relating to more than 10 pharmaceutical products. We have also conducted additional patent litigation proceedings relating to: over the counter supplements, medical devices, absorbent clays, medical processing technologies, and a range of veterinary pharmaceuticals.
Life cycle management
We work with our clients early as they consider reformulations, additional indications, pediatric studies, and exclusivities in light of expected market dynamics.
Policy/Government affairs support
We work with our clients’ government affairs and policy teams to help craft public messaging regarding pharma/biopharma IP issues.
We work with trade mark attorneys around the world to ensure clients brands are strong, well protected, and compliant with INN naming conventions and policies.
Watching patent, product and industry developments
We help our clients stay current by watching what is happening in the industry, Courts, and patent offices.