The traditional business model for a new drug relies on a substantial period of market exclusivity to recoup extensive research and development costs.
It is important to understand the likelihood of obtaining the required degree of exclusivity, whether through strong patent protection, data exclusivity or orphan designation. Richard Korn and Stephanie Pilkington look at how patent exclusivity can be enhanced as development progresses.
Since patent applications are often filed at an early stage in the development of a drug, long before clinical trials are contemplated, there is a danger that the clinical and regulatory teams dealing with the trials may take the patent situation for granted.
Conversely, patent attorneys are typically handed responsibility for obtaining valid patents, assessing third-party rights and clearing the way to market, but have no professional role in the clinical trials. This separation of patent and clinical/regulatory teams can easily lead to potentially patentable and highly valuable new inventions being overlooked.
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dosage, clinical trials, pharmaceuticals, stratified medicine, patent applications