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ADVERTORIAL POTTER CLARKSON house”, without condu
cting extremely rigorous due diligence. A pharmaceutical company is thus more likely to show interest in a project that has been taken at least some way into clinical development. Although it is tempting to conclude that pipelines will dry up unless smaller innovative companies are supported by large drug development companies in a less risk-averse way, I repeat that these companies are increasingly being squeezed on all sides in markets such as the US. It is no longer the case that products can necessarily be sold at a premium and pharmaceutical companies often pay rebates to health insurance companies, which can mean that, for some products, the net price can be lower than it is in Europe. In my view, Big Pharma applying such a high level of scrutiny is not them wanting to have it both ways. urthermore, although the Hatch-Waxman Act was intended to level the playing field as between large multinational pharmaceutical concerns and smaller, US generics businesses, the tables have turned. Generic drug companies have seized the initiative created by the new law, which allows them to challenge patents without the risk of having to put a product on the market. The realization that they have so much to gain and relatively little to lose has empowered them to become more aggressive in their approach. Generics have themselves become multinational pharmaceutical companies, and often originator companies are not the big organizations they once were. If Big Pharma is unwilling to invest in early stage companies, it may therefore be necessary to sell a project´s potential to sophisticated private investors, or to secure funding via an IPO. Inevitably though, such investment comes at a price. It can be very hard to secure given that such investors will themselves naturally be looking for a lucrative exit when a Big Pharma player eventually does come on board. Such investors will thus often conduct their own rigorous due diligence, asking the same questions that a Big Pharma company would do. At some point, often early on, in a small company´s life, its patent estate will be scrutinized with a view to ascertaining whether effective protection for a product has been, or in all likelihood will be, obtained. THEY WILL ASK: 01. How easy would it be for a competitor, such as generics company, to circumvent by designing around what is covered by a patent? 02. Is the patent likely to stand up to scrutiny if challenged by a competitor? 03. Does the technology infringe any third party’s legal rights? n view of this, it is critically important for small innovative companies to ensure that appropriate measures are taken to properly protect products at the outset. Ensuring that the protection afforded to a product has real commercial value is a balance between staking out what a company is legally entitled to versus what will stand up to legal scrutiny, either at a patent office or in court. This process cannot happen by itself and requires dialogue between inventors and their patent attorney. A clear overview of the prior art landscape is essential, as is a good patent attorney who, despite not necessarily having all the answers, will know what to ask to secure those answers. innovations coming out of small biopharmaceutical organizations across Scandinavia, it is vital that these enterprises “think big“ and behave like a Big Pharma company would when it comes to protecting their valuable ideas. A good invention is a good start but, in order to stand any chance of successfully bringing an idea to market, it is only the start. NLS Stephen McNeeney ABOUT THE AUTHOR Stephen McNeeney PhD is an experienced UK and European Patent Attorney at Potter Clarkson, where he is a partner. 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 industryrelated 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. NORDICLIFESCIENCE.ORG 45