James Cook University Laboratory

Inventive step considerations in the immunotherapy space

Following on from our previous article, which discussed some considerations for support and enablement of antibody inventions, our present article discusses the assessment of inventive step across the jurisdictions of Australia, Europe and the US, which relates closely to the criteria for support and enablement.

Inventive step objections typically arise as a result of insufficient evidence of what is being claimed.

In Australia and also in Europe, mere structural non-obviousness whereby an antibody exhibits a unique sequence, is usually insufficient in itself to justify a finding of inventive step. This is because the generation of antibodies using known methods is considered obvious to a skilled person. Instead, to satisfy the requirements of inventive step, there must be shown a surprising or unexpected technical effect, such as the antibody having reduced toxicity, improved pharmacokinetics or even an improved binding affinity.

When describing these unexpected technical effects, care should be taken to include supporting data in the specification (T 735/00 ‘Anti-CRP antibodies/IATRON LABORATORIES, INC.’; see also T 645/02 of 16 July 2003), to ensure that the claims are at least supported and enabled across the full scope of the claims.

In Europe, the “problem-solution approach” is the preferred method for assessing inventive step. In considering the problem-solution approach, antibody patent protection can still be obtained from the European Patent Office (EPO) even if the antibody was known previously and the problem sought to be addressed is not new. In other words, an alternative solution to a known problem could satisfy the inventive step requirements, as long as the technical solution is not obvious (T 0092/92 ‘Glide-shoe arrangement for a variable-crown roll’). This holds true even if there is no ‘improvement’ over the technical solution as provided in the prior art (T 588/93 ‘A porous adsorbent for adsorbing low density lipoproteins’).

Contrary to the position in Europe and in Australia, the “structural non-obvious approach” for the assessment of inventive step is permitted before the US Patent Office (USPTO), which means that the USPTO considers the sequence of an antibody does not accurately predict the structure and function of the antibody. Thus, an antibody having a unique sequence is likely patentable before the USPTO, even if it performs the same function as an antibody that is already known.

Whilst there are clear differences between the examination criteria between the US, Europe and Australia, there are also similarities between for example, the EPO and USPTO approach to inventive step, which include the fact that both jurisdictions permit patent protection for specific antibodies even if said antibody was known in the prior art. 

Similar to our previous article for support and enablement, it may be possible to post-file additional data to support a finding of inventive step. This option is especially useful in cases whereby arguments alone may not suffice to overcome an Examiner’s inventive step objections.

If you have any questions in relation to any of the above, please do not hesitate to reach out to our Life Sciences team. In the meantime, look out for our next article in this series, which will explore the different types of claim formats that are conventionally used by Applicants when seeking to obtain a patent for antibody inventions.