PTE & Regulatory

Patenting drug products as early as possible in the development cycle and securing a patent term extension are key to protecting long term value.

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Pharmaceutical and life science companies developing new therapeutics including biologic and small molecules can benefit from obtaining extended patent terms for their products.

Competition in the market often requires innovators to patent their drug products as early as possible in the development process in order to protect their value and revenue.  However, because drugs must undergo a lengthy review process prior to commercial use or launch, related patents are usually filed long before regulatory approval is secured.

Patent holders typically benefit most after a drug is commercially launched and whilst competition is excluded. Thus, patent term extensions (PTEs) are designed to compensate patent owners for the time it takes to obtain regulatory and marketing approval for new drugs.  PTEs in Australia last for up to 5 years beyond the normal 20-year patent term. 

PTEs optimize protection and ensure that companies are fairly rewarded for the development of new pharmaceuticals.  PTEs are only available for certain patents relating to pharmaceutical substances and only if number of requirements are satisfied. 

The specific rules and regulations governing PTEs are complex but Shelston IP is highly experienced and we are experts in both developing PTE strategies and attaining PTEs.

Shelston IP also have experts who are able to provide advice on the interpretation of regulatory legislation or assist with the regulatory approval process through the Therapeutic Goods Administration in Australia and other regulatory bodies around the world.