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Patenting in the Immunotherapy Space: Post-filing in Australia, Europe, and the US

In our article series for patenting antibodies in Australia, the US and in Europe, one of the issues raised during our general discussions surrounded the criteria for support and enablement, as well as for inventive step in applications within this space. The main concern was what would happen if these objections were raised during prosecution in Australia, the US and in Europe, could there be a way to supplement data already contained within the patent application, through post-filing, to address these objections.  The present article discusses this topic in further detail.

  • US

It is possible to add further material to a patent application that has already been filed in the US. For example, this may be done to address non-obviousness and/or enablement objections, by providing further working examples, further evidence of unexpected technical effects or similar. In some cases, submission of such further data is inevitable, particularly if the data was not available or generated on time at the time of filing the patent application. However, to do so, it must be demonstrated that the new material is relevant to the subject matter of the claimed invention. Furthermore, an accompanying declaration must be submitted by the inventor or a qualified person in the relevant technical area.  

Post-filing data has been discussed in the case of Amgen Inc. v Hoechst Marion Roussel, Inc. 314 F.3d 1313 (Fed Cir. 2003), wherein the Federal Circuit Court considered the further data filed after the filing of the patent application, in determining the scope of the claims in question, to assess whether there was enablement in the claims.

  • Europe

In Europe, it is generally more challenging to seek inclusion of post-filing data, as its admissibility depends on whether or not the further data is directly relevant to the application as filed, and its addition should confirm what is already disclosed in the specification as filed. In other words, any new data that is not already disclosed in the specification as filed is not permitted.

In the context of patent applications related to antibody inventions, post-filing data may be admitted if the specification contains preliminary data, for example on the therapeutic effects of the antibody. This may be the case where the claims of the application are directed to treatment of a disease, but the specification only contains in vitro or in vivo data, or even a speculative discussion on the anticipated effects. The further data to be included in the application should confirm the effectiveness of the antibody treatment, in for example, human clinical trials, or other in vivo data.

In Europe, it is also possible to also file further comparative data to provide support that the claimed antibody offers an improvement over a reference antibody that has been cited as prior art by the EPO.

Therefore, whilst post-filing data is permitted in Europe, generally there are strict guidelines as to what material is permitted for inclusion into the specification as filed.

  • Australia

Similar to the US, Australia accepts post-filed data for addressing objections in relation to inventive step and support and enablement, and typically involves the filing of expert declarations or a declaration from the inventor, to support the submission of extra data. Admissibility of post-filing data was discussed in the case of BASF Corp [2019] APO 34 (U.K), wherein the Delegate emphasized that the admissibility of data is “strictly limited” to confirm data already contained within the patent application or to refute an opponent’s contention that the invention does not work. In other words, post-filing data is not to be considered as a “substitute for sufficient disclosure in the specification.”

Therefore, filing additional data is a possibility before the Patent Offices in Australia, the US and in Europe. However, given that there is no guarantee such data may be accepted by the Patent Office, we do not advise Applicants to rely on post-filing data as the primary means to overcome objections raised during prosecution of their patent applications. To avoid such scenarios, it is advisable to formulate a solid strategy with your Patent Attorney from the outset, particularly for antibody inventions.  Our team at Michael Buck IP will be pleased to assist clients with their commercial goals in this niche area of Life Sciences. Please do not hesitate to contact us.