BENG2007 Notes

Notes for Intellectual Property Rights and their Application to the Life Science Industries

Known questions to consider: * ‘A life scientist in a top university in the UK is working on a research which she thinks she can patent. If you were to give her some basic advice, what questions would you ask her in order to establish the likelihood of patentability of her work?’ X2 (25) * Explain the different stages of patenting and associated timescales and estimated associated costs X4 * Which biological materials are NOT patentable and why? X1 * What is meant by Intellectual Property? X2 * Describe the different types of IP available X1 * What are the salient features of patents (10) X1

What is Intellectual Property? * The ownership of ideas. Unlike tangible assets to your business such as computers, intellectual property is a collection of ideas and concepts.

Types of Intellectual Property (source www.ipo.gov.uk) * Patents * Designs * Trade Marks * Copyright

Confidentiality * For the law of confidence to apply: * The information must be secret * Must have control over who can see/use it * Damaging unauthorized use * Practical advice: * Record how you came to possess the information * Adopt a procedure for retention and destruction of documents * Make clear what is confidential and what is not * Stamp/ mark ‘Confidential’ on all relevant documents if so * Keep a record of the people allowed to see the confidential documents * Keep numbered copies for named recipients and keep a record of delivery * Recover confidential copies after named recipients have no further use for them * Ensure all employees know which information is confidential so they can treat it as such * Use confidentiality agreements/undertakings

Patents * Maximise investment by protecting your research * Getting patents of value * Controlling costs. Renewal fees are paid, and if there is no reason to keep the patent, then let it go * Know what you have and prune * Patent contents: * Title * Background – what your invention solves, what it does * Invention - definition * Invention – description * Illustrations – black and white, Figure 1, Figure 2, etc, use reference numbers * Claims – a statement detailing the invention you want to protect * Patentable inventions – requirements. The invention must: * Be new * Inventive step – not a routine development (square wheels eg p29) * Industrial application * Can it be made and sold? * Still only speculative? * Not excluded

Excluded categories: * Discoveries, scientific theories and mathematical methods * Software/business methods/games * Literary, dramatic, musical or artistic works, methods of playing games * Presentation of information * Methods of treatment of human/animal bodies by surgery/therapy (does not apply in the US) * Methods of diagnosis practiced on human or animal bodies * Contrary to public morality

Patents for Biological Material/Processes
No automatic bar to patentability for: * A product consisting of or containing biological material * A process by which biological material is produced, processed or used
NOT Patentable: * Any variety of animal or plant, or any essentially biological process for the production of animals or plants which is not a micro-biological, or other technical process or the product of such a process * The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene * Processes for cloning