Drivers such as the expiration of pharmaceutical patents, legal and regulatory reforms, and social and cost pressures have increased the value of intellectual property (IP). At the same time, new collaborative ways of working and the externalization of certain workflows and processes have created IP opportunities and threats; while a shift in emphasis to so-called ‘soft’ IP rights or non-patent IP has changed the way in which companies understand and value IP.
Redefining IP protection
Patents are essential and allow innovative companies to recoup increasing R&D costs by charging higher prices for patented products. But an IP strategy focused solely on securing and defending patents runs the risk of falling foul of patent expiration. Whether the process is gradual or en masse, the only certainty is that patents have a shelf life. This strategy also ignores IP that isn’t patentable, such as trade secrets, processes and other company expertise. These aspects of IP either do not fall under the protection of patents or would be undesirable to be made public – disclosure being a necessary part of patent prosecution.
Another major driver of change in the pharma sector comes in the form of the rise of personalized medicine, which requires an entirely new approach to IP compared with the traditional model. It relies far more on the identification of biomarkers and the process of diagnosis and treatment itself rather than the molecule used in treatment, which are harder to patent.
The upshot is that large R&D organizations are moving from a focus on IP for end products to a greater emphasis on end-to-end IP rights processes, spanning the business from marketing and finance to R&D and even competitive intelligence groups who are looking at business justification for new ideas. The costs and risks involved also mean that there is greater willingness to collaborate with third parties, as shown in the established culture of outsourcing in pharma.
The role of ELN technology
With IP matters becoming ever more complex and evolving so quickly, we’re witnessing a shift in the way the industry uses technology to manage and protect IP. Electronic data management platforms can provide both secure and searchable repositories for IP and also facilitate its sharing and communication. They are also perfectly suited to matching the shift in focus from IP end points (e.g. patents), to a greater emphasis on an end-to-end IP management strategy and defined process. This involves recognizing the value in all the paid-for knowledge and structured data that an R&D organization accumulates over time. It means going beyond documents and patentable information to evaluating processes and methodology and the structured data that is used to make decisions and drive the organization.
Although we never know what’s around the corner, the fact remains that IP in all its guises is set to become an ever more valuable asset to R&D-led companies. This is not only true in the life sciences but also in industrial sciences such as the oil & gas and food & beverage sectors. It’s likely that ELNs will adapt in their flexibility and responsiveness as the enterprise software industry strives to balance the R&D sector’s requirements linked to collaborative ways of working, new R&D revenue streams and the need to record and protect IP.