The law of patents and SPCs has yet to be tested in the context of medicines which can be used to treat specific groups of patients, as Paul England explains.
An industry under pressure
A combination of high research costs and dwindling opportunities for small molecule targets has diminished the number of candidates entering 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. Added to this is 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.
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personalised medicine, SPCs, generics, Dr Reddy's, Agrevo