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European Biopharmaceutical Review

Freedom to Operate

John Mackle and Clive Lawrence at Clarion Solicitors explain IP management and litigation and how it affects the pharmaceutical industry

The importance of intellectual property (IP) in biological and pharmaceutical industries is clear: in order to operate in these industries, any business needs to know exactly where it stands in relation to the IP rights it needs to conduct its business. The issue is of course both positive and negative: the business needs to be assured of the fact that it holds the rights it requires in order to conduct its business and – from the negative point of view – that it can prevent others from infringing those rights.

MANAGING INTELLECTUAL PROPERTY

IP management is more than simply the creation and maintenance of a patent portfolio. The process of innovation and development creates a multitude of rights in a number of relationships, and solely to concentrate on patent rights is an oversimplification. The purpose of IP management is to ensure the capture, recording, exploitation and (where necessary) the subsequent enforcement of all available rights.

IP management therefore requires those involved to be aware of the entirety of the company’s operations. The IP manager needs to fully understand where and what the company’s current activities are in their entirety and what IP rights are being used for those operations. If patents are being operated, the manager needs to know to whom those patents belong (and if they do not belong to the operating company itself, to ensure that all relevant licences remain up to date and are properly contract managed). They also need to know how long those patents will remain in force and what the company’s plans are, if any, when the expiry point is reached. The manager will also need to be aware of any other rights used, whether they be by way of knowhow, confidential information or even in terms of copyright works (for instance, in relation to the right to reproduce text, photography, diagrammatic materials and so forth) and trademark rights (in relation particularly to brand issues).


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John Mackle joined Clarion Solicitors in 1999, having qualified in April 1997, becoming Senior Associate Solicitor in 2001. He works in the Commercial Dispute Resolution Department and specialises on areas including property dispute resolution. John acts for companies of all sizes, partnerships and sole traders in all manner of disputes, including contractual disputes, building and partnership disputes, commercial property disputes and cases involving surveyors’ and solicitors’ negligence. He is an experienced Court advocate with rights of audience in the Leeds Mercantile Court, and is fluent in Spanish and French.

Clive Lawrence is a Partner in the Corporate and Commercial Department who heads up Clarion Solicitors’ intellectual property (IP) and commercial work. He is an acknowledged expert in IP, sports law and media law, dealing with all IP matters, broadcasting and media rights deals, as well as sponsorship, merchandising and licensing matters. Clive joined Clarion Solicitors as a trainee in 1991 and qualified in 1993. He became a partner in 1996. He is ranked as a leading expert in sport, media and entertainment and corporate work in various publications including Legal 500 and Legal Experts. Clive was voted Young Yorkshire Lawyer of the Year 2001 by the Yorkshire Law Society.

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John Mackle
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Clive Lawrence
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