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European Biopharmaceutical Review

Challenges for Small Businesses in the Global Pharma Market

The pharmaceutical industry was considered a relatively ‘safe’ environment in which to be employed in the early 1990s. It was seen by many to be a recession-proof business where intellectual property (IP) and patents in particular were critical to profitability.

The business was global and powered by huge researchbased companies: Big Pharma, who took drugs all the way from preclinical research, through clinical development, to commercialisation. Companies like Glaxo, Merck, Pfizer, Eli Lilly, Bayer, and, in Sweden, the likes of Astra and Pharmacia, were multinational R&D-based powerhouses that dominated the life sciences landscape. In 1995, Astra had the biggest selling drug in the world: the proton pump inhibitor Losec® (omeprazole) and employed thousands of people in R&D. To its employees (which included the author at the time), the company seemed invincible.

The Changing Landscape

Drugs commanded high prices in the developed world, which represented almost the entire market in terms of value, with the US market being by far the most lucrative. Although the Hatch- Waxman Act – a US federal law designed to encourage generic drug manufacture and sale with a view to lowering prices – had been around for just a few years, generics companies were still somewhat smaller and often local organisations that tended not to enter the market until at least the basic patent covering a drug expired.

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Stephen McNeeney PhD is an experienced UK and European Patent Attorney at Potter Clarkson, where he is a partner and Head of Chemistry and Pharma. Stephen completed his degree in chemistry and obtained a master’s degree in organic chemistry, before further achieving a PhD in the subject. He joined Potter Clarkson in 1996, specialising in pharmaceutical industry-related inventions. Today, Stephen acts for a variety of clients, ranging from Big Pharma, through SME drug discovery and drug development companies, to start-ups and university spin-outs, many of which are based outside the UK, particularly in Scandinavia.
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Stephen McNeeny PhD
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