Patent protection in the pharmaceutical industry

Patent Protection in the Pharmaceutical Industry


3 ways to extend patent protection

Patent cliff refers to a sharp decline in revenue or profitability when a firm’s patents expire, opening them up to competition. Prevention strategy is one of the ways to tackle this.

The prevention strategy aims to prevent competition primarily by extending the length of the exclusive period. This enables profits to be maintained past the expiry of the initial patent and is done mostly by means of legal measures.

1. Strategic patenting

1.Secondary patents can be utilised to create ‘patent clusters’ (e.g. patent on improved manufacturing methods or different forms of the original compound). This leads to ambiguity as to when LOE occurs, discouraging the launch of competitors.

2. Supplementary protection certificates (SPCs)

SPCs are additional protective mechanism which can serve as an extension to the patent right, however SPC protection can be legally challenged.

3. Orphan drug status and paediatric clinical trials

An orphan drug status and/or undertaking paediatric trials can lead to patent extensions. Off-label prescribing may still enable generic competition in some markets

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