Simon Strothers, new business development di­rector at ITCM, explains how the effective crea­tion and management of intellectual property can strengthen and expand a company’s posi­tion within its market. Indeed, by creating USPs and differentiation, increased market share can be both established and maintained. A bespoke approach to both design and production proces­ses can set the wheels in motion, something best approached with an entirely fresh pair of eyes.

The pharmaceutical market is an expensive place to be. Huge re­search and de­v e l o pme n t expenditure and extremely onerous va­lidation processes both play their part in adding time and costs to any new product development process. Indeed, many drug companies have to make sure that they recover these costs and generate healthy profit levels before patents and exclusivity rights run their course.

Means of recovering costs

The primary means of recovering these costs throughout the life of a product is selling price, with minor manufacturing efficiency gains and economies of scale also contributing to some extent. The problem is that once a patent has expired, many manufacturers lose out to lower-cost competitors who can afford to sell the drugs at lower margins – with very low initial set up costs. The question is, how can pharmaceutical companies maintain a level of product-specific profitability not only throughout the product’s patented lifecycle, but also afterwards, beyond its patented term? Many look to new or modi­fied products to keep profit levels high, in lieu of revenue lost to competition, but this is a self-repeating cycle – the same issues will be faced at the end of the life of the new product.

A holistic view of the whole process

Technical and engineering managers within pharmaceutical companies need to take a ho­listic view of the whole process and identify areas where additional savings can be made. Once a broader view is established, it becomes obvious that manufacturing and packaging pro­cesses can be primary targets where economies and efficiencies can be gained. But the manu­facturing discipline within the pharmaceutical sector lags some way behind other industries in the adoption of new and improved processes. If technical personnel were to study procedu­res adopted, say by the automotive industry, they would instantly recognise areas that could transpose easily into their industry, delivering the same economies many of the large automo­tive companies and their suppliers see.

The creation of Intellectual Property (IP) should not only rest on the shoulders of those that de­velop the formulations for the drugs. Instead – taking the holistic approach again – ma­nufacturing and packaging disciplines can also develop and introduce significant levels of IP into the whole project. In many cases, IP introdu­ced into the manufacturing process by savvy technical personnel can also add a new level of “protection” to the brand or drug – creating ad­ditional barriers that the competition will find harder to breach if they want to develop “me too” products.