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Inventive step forward in pharmaceuticals



In delivering its judgment in the case of Actavis Group PTC EHF & Others -v- ICOS Corporation and Another, the Supreme Court has provided useful guidance on whether the required ‘inventive step’ has been met in patent applications. To have an ‘inventive step’ an invention must not be obvious to an expert in the relevant technology.

The invention claimed in the patent was the particular efficacy (akin to that of Viagra) at a certain dosage of the established medical compound, tadafil (sold under the brand name Cialis). One of the lead arguments for revoking the relevant patent application was that the research team’s approach in varying the dosage of tadafil did not involve taking the requisite inventive step to merit patent protection for the drug.

Inventive step patent – factors to be considered

Lord Hodge set out nine relevant, but non-exhaustive, factors that should be considered in such circumstances in making an inventive step patent. These are:

  1. whether the step taken was ‘obvious to try’;
  2. whether the step was ‘routine’;
  3. the burden and cost of the research programme;
  4. necessity for, and nature of, the value judgements;
  5. the existence of alternative or multiple paths of research;
  6. the motive of the skilled person;
  7. whether the results of the research are unexpected or surprising;
  8. whether hindsight or knowledge of the invention had been relied upon; and
  9. if a feature of a claimed invention is an added benefit where the claimed innovation is obvious for another purpose

In giving the Supreme Court’s judgment, and in considering whether a notional skilled team would have carried out the same tests as in the instant case, Lord Hodge stated:

“…the team, having found a therapeutic plateau, would be very likely to test lower doses and so come upon the dosage regime which is the subject matter of the patent.”

The verdict in this case was therefore that the required inventive step had not been taken.

Looking forward to similar cases, the guidance provided by Lord Hodge in this judgment will be of assistance in determining whether an inventive step has been taken. It may also help inventors to assess whether they are likely to be successful in obtaining patent protection.

Clarion’s nine-strong team of dedicated IP specialists can assist with any queries on the wide range of IP rights available in the UK. If you have any queries regarding this article or any questions about IP rights generally, please take a look at the Clarion Intellectual Property Team page for more details or to directly contact the Team.


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