What is intellectual property and how does it affect innovation within the life sciences industry?
Intellectual property is a diverse body of national, EU and international laws concerned with the substance, ownership and protection of exclusive rights to works or products of innovative technology and other many other creative endeavours. It is absolutely crucial in the life sciences sector. This is because without exclusive rights to sell an innovative drug for a number of years, pharmaceutical and biotechnology enterprises would never be able to recoup the billions of dollars of investment required to bring those drugs to market. And once the drugs are on the market, trademarks and related rights become essential for protecting consumer confidence in the quality and origin of drugs - vital in the protection of public health against inferior counterfeits.
In view of the rapid advancement of technology in this sphere, what new considerations need to be taken into account when securing and protecting patents for inventions?
Legal developments tend to happen slowly compared to the march of technology and it is adapting patent law to keep up that is one of the things that makes it so interesting! An issue that is particularly live at the moment in a number of jurisdictions is the boundaries of patent protection for biotech inventions. These are being tested by developments in areas such as biologics and bioinformatics. Patent protection is being scrutinised in other areas of technology too, by questions such as whether some innovations – stem cell research is a particular example – are patentable at all. Furthermore, combination products such as vaccines have caused a flurry of references about supplementary protection certificates in the Court of Justice of the European Union, and biosimilars and nutraceuticals are posing challenges for regulatory laws.
How does the globalisation of life science companies present new challenges for IP lawyers?
Despite international agreements seeking to harmonise many IP laws, implementation in national rules is often very different; as are the decisions of judges on equivalent laws and similar facts from one jurisdiction to the next. But many life sciences companies now do business on an international basis. This creates a conflict between global commercial demands and the particularly national nature of IP laws – industry is understandably perplexed when it can do one thing in one country and not in another. This is a real problem because it causes immense complexity, cost and commercial uncertainty. It also means that no IP lawyer can afford to think in purely national terms – frequently, advice about what to do in one country must be integral to a wider international strategy, requiring cooperation with attorneys in multiple countries. For example, I had to reach for this book the other day in order to advise on the application of an EU directive in the United Kingdom, with a view to options that the client had in France and Germany (because of the directive’s different implementation there), and all of which would have an impact on activities taking place in the United States.
The book covers issues of intellectual property in life sciences in 15 different jurisdictions worldwide. At a global level, what are the most significant trends you see occurring?
Undoubtedly the development in the coming decade is of China as a major IP jurisdiction - not just because of the increasing interest of western life sciences companies in the country, but because of the developing home-grown innovation industry and the efforts that China is making to build a sophisticated system of IP laws, procedures and tribunals. In Europe, the biggest development for decades will be without doubt the establishment of a unitary patent and the Unified Patents Court. This has been a long time coming and it is not quite there yet, but when it is it will introduce a single system that transforms European patent litigation as we know it over a period of just a few years.