Top 10 Tips On Getting Difficult Biotech Cases Through The European Patent Office (EPO)

  1. Look for a good amendment if that is possible.  Amendments which retain an acceptable claim scope are a very powerful way of making progress on a case.  Ideally an amendment should be identified which corresponds to the strongest arguments available.
  2. Sometimes the cited prior art gives a very inaccurate or misleading picture of the state of the art at the priority date.  A declaration by an inventor or independent expert can be used to show the Examiner the real life situation that faced the skilled person at that time.
  3. European Examiners are very open to looking at data and other evidence filed during examination. Data in support of inventive step or sufficiency can be very helpful.
  4. On biotech cases it is often possible to argue inventive step based on both why the skilled person would not have got to the invention and the special advantages which the invention provides.  One should aim to do so whenever possible.
  5. Be awake to situations where the Examiner is making judgments based on hindsight.  In particular look out for situations where the documents cited in the search could only have been identified by knowledge of the invention, and therefore do not represent what the skilled person would realistically have looked at when faced with the problem.
  6. Often it is necessary to point out what is reasonable under European practice, for example extrapolation being allowed from animal or in vitro studies.  The Guidelines and case law do not always address every issue, but EPO Examiners will be responsive to an argument based on what is normally accepted under European practice.
  7. Be selective in choosing how much to argue and where to comply as best as possible.  There may be no point in arguing a clarity objection if it can be easily fixed by amendment.
  8. Try to make progress at each examination report, accepting the reality of what the Examiner will be prepared to allow.  Some complex cases do require several examination reports as amendments raise new issues.
  9. Be realistic as to what is not going to be possible.  Certain objections, once raised, can be close to impossible to overcome, such as objections against a reference to a functionally defined compound.
  10. Sometimes it is worthwhile thinking of examination as a negotiation, rather than the simple applying of several tests for patentability.  Essentially the Examiner will be assessing the quality of the contribution made and whether it is deserving of a patent.  Thus is may be worthwhile separately stressing the contribution as well as demonstrating patentability according to required criteria.
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