News & Comment

You are a biotech company that has just been granted a patent connected with drug discovery. What do you do with it? The costs of drug discovery and development are so prohibitive that only large companies have sufficient resources to proceed with such an undertaking. Therefore most biotech companies will need to involve a larger third party at some stage in order to develop the product and get it to market. When should your average biotech company try to tie the knot with a big pharma partner?

If you believe that a European patent has been wrongly granted, you can challenge the validity of the patent using the European Patent Office's Opposition procedure. This can result in a limitation of the scope of the patent or even its complete revocation. Oppositions are filed against about 5–6% of granted European patents.

The specification of a United States patent must “contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art ... to make and use the same”. This statutory language has been construed to embrace two overlapping but distinct disclosure mandates: a 'written description' requirement and an 'enablement' requirement.

As technology develops, experimental boundaries are being pushed further and further. Discoveries that were considered ground-breaking as little as five years ago are today considered routine. In this article, we examine the ever-more stringent inventive step/obviousness requirements of the European and US patent offices.