9 special IP considerations for Life Sciences

Whatever industry you are in, you need an IP advisor that understands the peculiarities of your industry, so they can advise on strategy and draft IP rights to maximise your opportunities. As an example of how this can work, lets look at Life Sciences.

Life Sciences whether HealthTech or Agri-Tech have peculiarities that affect how we handle their intangible assets and value creation compared to other industries such as electronics and engineering.

1) Development Cycle

Life Science has a long development cycle – often one that goes beyond a typical patent application cycle; which usually requires a complete patent specification with full data to be filed within twelve months of an initial (provisional) patent application. Careful management of patent filings and publication are required.

2) Seasonality

Experimental trials are often seasonal e.g., hay fever, crop production.  Therefore, if data points are missed during a trial, it can be another year or more until additional trials can be run.  Again, that is outside a typical patent cycle.

3) Open/Public Environments

Life Science experiments often need to be conducted in public environments (say hospitals, farms) and therefore are more likely to risk being exposed publicly - potentially destroying novelty for patent purposes or alerting competitors. Security around trials is important here.

4) Variability

Life Science often has more variability, particularly once in vivo studies are undertaken.  Modelling of Life Science innovations is also more complex having more external, less controllable variables. This can cause difficulties in defining an invention and illustrating "reduction to practice”, (a patent drafting requirement).

5) Regulatory Processes

Regulatory processes in the Life Science industries are expensive, time consuming and difficult to navigate – particularly with FDA and similar jurisdictional bodies. There is also risk of premature disclosure during the regulatory process.  Further, regulations differ per country. Surprisingly, clever patent drafting strategies can be employed that take advantage of the barriers to entry given by regulatory processes.

6) Manufacturing Restrictions

Many health products requires Good Manufacturing Practices (GMP) and meeting various protocols (e,g. ISO classification) – sometimes making it difficult to establish or find suitable manufacturing plants. This can affect filing strategies and is another barrier to entry to factor into an IP strategy.

7) Overlaps

There is considerable overlap in applications between the various Life Sciences, for example, horticulture, food technology and health.  This can lead to duplication and working at cross-purposes. It can also lead to greater opportunities - say licensing out the applications the patentees prefer not to focus on.

8) Lack of IP Awareness

Many researchers are in research organisations and hospitals, rather than in commercial entities and often do not recognise the value and protectability of the IP they are generating. IP education is critical in these environments.

9) Money not Important?

IP value is not necessarily monetary and for example  can be a means to control quality delivery - say in public health.

Overall, make sure you are not getting boilerplate IP service, but a tailored approach to your needs.