Patents are critical to a small company based on knowledge. If you make an invention and it is not patented, anyone with suitable resources is free to come along and copy it. For a small company, many of your competitors will have far greater resources than you do and so can simply take your ideas and use them themselves. For this reason, investors and professional management are very eager to protect your intellectual property (IP) with suitable legal walls, and ideally with patents. The process of patenting in the UK is beyond this seminar. In summary, the scientist, advised by someone who knows the language and law of patenting, has to submit ('file') a description of the invention to the patent office. The office's own examiners then check that the patent fulfils the three critical criteria:
- Novelty--no-one has done it before, or even talked about it in a realistic way.
- Utility--it must be useful for something. This means that the gene you discovered is not patentable in its own right but must be related to a product.
- Enablement--you must describe how someone else could do it (whatever it is).
If it passes, then the patent is granted. The process takes a long time, and costs a lot of money. In a novel field like biotechnology there is also a lot of debate (much of it carried out in the law courts) about just what 'an invention' is.
The critical part of the patent is the exact wording of the claims. The claims are a set of statements, usually at the end of the patent, which define exactly what it is you are patenting. If your claims are very 'broad' (i.e. general), you can succeed in getting a patent on a number of potential applications of your idea, not only one. The wording here is critical. Thus 'a nucleic acid' is broader than 'DNA' or 'a gene'; 'a molecule' is broader than 'an alcohol' which is broader than '2-methyl-butan-l-ol' and so on. Of course, if your claim is too broad then the patent office will not allow it because it will not be novel: use of 2-methylbutan-l-ol as a cure for cancer may be novel but use of 'a molecule' certainly is not.
Your role in patenting is therefore to make sure that you have described your invention in terms of a final product--in the case of a gene sequence, may be a diagnostic test for a genetic defect or a drug that blocks the action of that gene's protein product--and in terms that meet the criteria above. A good patent agent can be very helpful in this process and their help should be encouraged.
Conclusion: jumping the fence
This seminar has not been about 'entrepreneurship'. An entrepreneur is someone who can see a way to make all the things we describe in this learning experience actually happen, and does it. The former needs knowledge, breadth of experience and contacts, but the latter is the most important, and really can be summed up in three words--Just Do It. Three words do not a seminar make, so we have focused on what an entrepreneur or business person should do to create a successful biotechnology business rather than the personal characteristics that make a scientist into an entrepreneur. But without the will to make it happen, none of this is relevant. This is why we have returned many times to the nature of the people involved rather than a formal process that will lead them gently and inevitably to success.
This is an extremely favourable time in history for new, fast-moving companies in high technology. Investors, regulators and governments all want to see your small company succeed. It is also a time of unprecedented technological change in the life sciences, and so the environment has never been better to build a life-science based company. For all its commercial failings and public misconception, the biotechnology industry will continue to be as dynamic and exciting a business sector as any in the next decade. It is a superb environment for a scientist to enter, for good science, the potential of substantial reward, and just plain fun.
