Top 10 Problematic Things for a Patent Attorney to Advise On

The following list is very much based on my personal experience of practising as a European biotech patent attorney, with tech transfer offices and research companies as clients, and a lot of healthcare cases. The aim is to produce an informative list of things we might find it difficult to advise on, where clients might assume that we should be able to.

1.       Inventive Step (Obviousness). Inventive step is perhaps the most well-known unknown.  When deciding to file patent attorneys can propose reasonable-sounding arguments in support of inventive step, but how applicable they remain after the Patent Office search and the specific objections that are raised is an open question.

2.       The Value of a Patent Case.  ‘How much is my patent application worth?’ is often close to unanswerable. It depends on how you decide to measure it, and there are complex and different ways to do that. It’s a little like deciding on the value of a stock, but without a central stock market where buyers and sellers will determine the price.

3.       Which Claims Will be Granted Where? Patent Offices are similar but different.  Some are strict (EPO, US, Japan), and others are lenient (Australia, Canada).  Some are tough on data to support therapy, and others are not. This should not be the case, but it is.

4.       Who Are The Inventors? Unpublished contributions which were of some assistance to forming the inventive concept, at least for some embodiments can be difficult to assess. It must be remembered that inventorship is an absolute concept, and should not depend on how nice you want to be.

5.       Do We Have Freedom To Operate?  Given the number of pending unexamined applications out there, the fact that claim scope can be broadened post-filing and before grant, and that you do not yet know what dosages, carriers and patient groups you wish you treat, perhaps.

6.       Will The Amendment Be Allowed (Added Matter)? I find added matter to be surprisingly difficult to predict sometimes at the EPO.  It can depend on the mindset/personality of the Examiner.  Some will allow little ‘leeway/extrapolation’ from the language of the application, but as compensation will be the same with prior art based objections (so inventive step will be easier).

7.       Which Auxiliary Request Will Be Allowed? I find this one difficult to predict too. Sometimes one assumes that the reasoning which knocks out requests 2 and 3, will also cause request 4 to fall.  However, don’t assume that, and so be careful in the requests that you withdraw.

8.       Which Claim Construction Will Be Used? Entire cases can hinge on the ascribed meaning of a word.  To complicate matters the UK has ‘purpose construction’ and Article 2 of the Protocol on the Interpretation of Article 69 EPC refers to equivalents of elements in the claims.

9.       How Much Data Is Needed To Support A Medical Use Claim?  For the EPO clinical data should not be needed, but for the US it seems close to necessary sometimes. How much data is needed for variant compounds or similar conditions to those exemplified can be difficult to judge as Patent Offices seem to be becoming stricter on this.

10.   Cost? Things always seem to cost more than expected.  In biotech there are more complications than we cater for as Examiners become stricter and more creative, and the European patent that cost a fortune to validate in so many designated states is unexpectedly opposed.