Top 10 Tips for Inventive Step (Obviousness) Arguments for Biotech Cases at the European Patent Office (EPO)

To assist those having to argue inventive step at the EPO.

1. Is There A Reasonable Expectation Of Success?

Biotech is complicated and unpredictable.  Many suggestions in the prior art are not going to work, and Examiners are very open to persuasion on this point.  This is a powerful and established way of arguing in support of inventive step.

2. Surprising And Unexpected Advantages

Examiners are very receptive to surprising and unexpected advantages.  Such advantages will go a long way to persuading an Examiner even in cases where carrying out the invention might seem pretty obvious from the prior art.

3. Teaching Away and Prejudice

Documents do not only disclose features.  They also teach in a particular direction, which may be away from the invention.  When Examiners collate features from different documents as part of an inventive step objection, point out the documents which teach away from the invention.

It is difficult to overcome inventive step objections using arguments showing there was a prejudice in art. However where a prejudice does exist it can be used to argue inventive step.

4. Lack Of Supporting Data In The Prior Art Document

If a cited prior art document lacks data, then this should be pointed out.  The credibility of a purely theoretical teaching must be questionable, particularly if it is of a speculative nature.

5. Declarations Are Persuasive

Certain arguments can be difficult to support using published documents.  Negative results and the expectations that scientists in the art might have had will often not be published, but are clearly very relevant to inventive step.  Declarations are an effective way of providing this to the Examiner.  In addition complex scientific analysis of prior art documents can sometimes be better presented in a declaration, keeping it separate from the legal arguments.

6. Post Filing Data

This is very effective in helping to persuade Examiners.  It can consist of one’s own published or unpublished data or even other party’s publications.

7. The Documents Have Been Found With Hindsight

The Examiner locates prior art documents with knowledge of the claims, and so his/her search is carried out with hindsight.  However there will be situations where the skilled person in the art would not have chosen to look at certain documents when faced with the problem that is solved.

8.Consider All Of The Technical Problems That Are Solved

Biotech inventions often solve more than one problem.  The invention may be cheaper, easier to make, more stable, less toxic or have higher activity.  It must be remembered that apparently minor features can still give rise to inventive step.

9. The Power of Amendment

Amendment of the claims is often very helpful to progress of a case.  It can change the perspective which the Examiner has of the problem being solved and the contribution being made.  It is seen as a sign of cooperation and compromise from the applicant, particularly given the prevailing notion that biotech cases have claims which are too broad.

10. Stamina And Belief In The Invention

One must not get tired or lose hope if the Examiner does not agree with you.  Oral proceedings can be a good forum to iron out the differences and arrive at acceptable claims.  Failing that Appeal Proceedings provide an opportunity for a different set of people to look at the case.  Success comes with persistence in believing in the invention whilst also being able to appreciate and respond to the Examiner’s concerns.

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