Personalised medicine — patenting new drugs from old?

By Paul England

A combination of high research costs and dwindling opportunities for small molecule targets have diminished the number of candidates entering and progressing through the product pipelines of some leading originator pharmaceutical companies. At the other end of the pharmaceutical product lifecycle, patents on the active ingredients of many ‘blockbuster’ drugs are expiring. This allows generic challenges to what are often perceived to be weaker secondary patents and thus increased competition in the marketplace.

A further pressure on pharmaceutical pipelines is the need for each new drug candidate to pass a rigorous approvals process before it can be authorised for public use. Add to this the need to secure a favourable price and reimbursement from public funds where the emphasis is on the need to show that a drug has clear benefits over and above those already on the market.

In fact, it has been estimated that only one out of 10,000 compounds at the start of development actually make it through to a marketed drug: a ratio that only works commercially if that one drug is a blockbuster…

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