This is written from the perspective of a UK-based patent attorney practising in the biotech/pharma sector. The patenting process has many uncertainties, which makes it difficult to predict the claims which will be granted and how much the process will cost. Here are our top 10 uncertainties:
1. Case Law and What is Patentable
Case law does evolve, and that can mean huge changes in what is patentable. In past years transgenic plants and computer programs have become patentable. Presently software, diagnostic methods and stem cell case law is continuing to evolve.
2. Inventive Step
How an Examiner views inventive step will often determine the scope of claims which will be granted. However it is frequently very difficult to predict the inventive step objection which will be raised and how easy it will be to persuade the Examiner to change his/her mind. Increasingly though Examiners are becoming stricter on inventive step in biotech.
3. Documents Identified in the Search
There is always the possibility of a surprise document being found in the search which makes patentability a lot more difficult than expected.
4. Search Problems
It can be difficult to predict whether there will be problems with the search at the European Patent Office (EPO), either in terms of lack of unity or lack of clarity. Incomplete searches will impact tremendously on the scope of claims that will be granted.
5. Which Terms Will be Deemed Unclear in a Claim
One never knows which terms will be deemed unclear in claims. This varies tremendously from territory to territory, with Canada being one of the strictest places on clarity.
6. Whether an Amendment Will Add Matter
Sometimes it is difficult to predict whether an amendment will be deemed to add matter. That is particularly true if the amendment concerns combining two independent features or concerns deletion of a feature. Strictness on added matter varies tremendously from territory to territory, with the EPO being one of the strictest.
7. Whether Functional Features Will Be Accepted in the Claims
The EPO can be very strict on whether functional features can be allowed in claims, particularly when they are used to define compounds or disease conditions.
There is uncertainty in the cost of a patent application through to grant because it is difficult to predict how complex examination will be. Lengthy responses with substantial amendments may be needed, and several examination reports may issue. In addition paying additional search fees and filing divisionals is expensive if required. If appeal or opposition proceedings occur that will also increase costs.
9. Oral Proceedings at the EPO
Many surprising things happen at Oral Proceedings. Certain documents or arguments may suddenly become more relevant. How the different parties will perform and whether justice will be done seems to vary markedly.
10. How Much A Patent Case is Worth
How to evaluate the worth of a patent case remains a very uncertain art. However what it is clear is that investors at getting much better at evaluating biotech patent cases.