How plausible may be a conference on IP (and regulatory) exclusivity? Sufficiently

Last October this GuestKat attended an interesting conference in Munich (program here) named "Life Sciences Strategy: Summit on IP and exclusivity".

It is obviously not easy to summarise three full days of very intensive work (and many coffee breaks) and the reports of dozens of experts who effectively shared their knowledge with the participants, in an atmosphere open to debate and discussion. However the two recent posts of this very same blog, one on the preliminary opinion of EBA on plausibility (G2/21, here), the other on the requisite of sufficiency of disclosure for a first medical use patent (T0424/21, here) have removed any doubt on whether or not to try and cover it.

In this sense, perhaps, this Kat also wants to trigger dialogue like that started by fellow Kat colleague Hayleigh Bosher regarding her posts on the function of academic conferences (here and here).  In this Kat's opinion the corporate conferences (when well organised) are still well alive such that interest in both learning and networking that can justify the stamina and effort of the trip (while agreeing with Hayleigh that no one should exaggerate with her/his carbon footprint).

(a wise cat that care about environment kindly provided in CC0 Public Domain license by Pixhere.com)

Having to make a selection among the many topics covered, this GuestKat finds it interesting to note that during the conference the EPO case G2/21 on 'plausibility', was repeatedly discussed from different angles.  The discussion highlighted the difficult relationship between regulatory departments and IP departments in pharmaceutical companies, in relation to what must/should not be published prior to patent filing and in relation to the level of detail of clinical studies, whether at a more or less advanced stage, required to support valid patent applications. In particular, when asked to provide a concluding sentence regarding patents for second medical use, the departments may respectively state: "patenting is not the right means of protection, rather turn to marketing and data exclusivity" as opposed to a lapidary "protect innovation, but ask your scientists for some data to support patent applications".

In this last regard, it seems to this GuestKat that the coupling of a possible decision in the G2/21 proceedings in line with the prior opinion issued by EPO, together with the recent decision T0424/21 seem to mark a real boxing one-two recognized in favour of originators by the EPO. In this context, it may be interesting to see the approach that the UPC (and the English Courts, in some instances) will take with respect to these complicated and interesting issues in the near future. Indeed, in the context of more complex actions where the infringement aspect (and in some cases also the regulatory aspect) will have to be taken into account, it might be possible to strike a better balance between the originators' interest in fair remuneration for their pharmaceutical research activities and the public interest in full and complete disclosure of truly innovative technical solutions, in the particular area of second medical use of medicines.

(a cat punch kindly released by Takashi(aes256) on Flickr under cc-by-sa-2.0)

Another very interesting presentation was made by two panelists in relation to Regulation (EU) NO 536/2014 on clinical trials. The latter, contrary to what it might appear from its date of adoption (2014), is a regulation that is certainly topical, having started to take effect as of 31 July 2022, with a transitional period that will last until 31 January 2025, but which will see a first and fundamental provision entering into force on 31 January 2023. In particular, what is of interest to patent practitioners is that from the beginning of next year, all applications submitted to the EMA for the conduct of clinical trials will be published in a publicly available portal as soon as the application is allowed by the EMA. The system will allow the applicant to apply for keeping confidential some of the information provided, but it is clear that the public interest in disclosure will highly likely prevail and it is not really clear if there will be a possible appeal on the decision denying confidentiality.

For those working in the pharmaceutical sector, it is clear that this is a small revolution, since the publicity given to clinical protocols, including criteria for selecting candidates, will be immediately visible, and this could have quite a few consequences on the evaluation of the information that any purported ‘person skilled in the art’ will have to take into consideration. It should be noted, in this regard, that this puts the European Union in a different situation from that of the UK, where the same disclosure obligations apparently do not exist and which could therefore become a more interesting territory for clinical trials, and even the USA, where the disclosure obligation is triggered only after the so-called phase 1 of clinical trials has been carried out.

(a perplexed travelling Kat from Sheila Sund on Pixhare)

A further aspect that this Kat found remarkably interesting was brought to the attention of the audience during a presentation on Data and Market Exclusivity in the EU. After an overview of the regulation of market and data exclusivity and the regulation of orphan drugs, the speaker brought to the attention of the participants the very recent Opinion of Advocate General Medina in the joined cases C-438/21 P and C-440/21 P, delivered on 6 October 2022.  The case (very complicated but also well summarised here) revolves around the question whether or not an authorised fixed combination medicinal product, on the one hand, and a mono-substance medicinal product based on a component of that fixed combination, on the other, may be considered to belong to the same global marketing authorisation (within the meaning of the second subparagraph of Article 6(1) of Directive 2001/83). If that is the case, in fact, the second medicinal product would not enjoy the data and market exclusivity as provided for by the Directive.

The General Court expressed a restrictive view, stating that the first authorisation of a medicinal product containing a certain active ingredient used in combination for a certain disease prevents the enjoyment of market and data exclusivity on a second medicinal product using the same mono-substance for a different use. Advocate General Medina, however, took a contrary view, suggesting that the Court should overturn this assessment and deny generic applications based on the second medicine before the end of the market and data exclusivity period.

An issue, it seems to this GuestKat, that in some ways seems to echo the discussions that have arisen in recent years around the definition of what may constitute a valid 'basic patent' capable of supporting an SPC application, and which always revolves around the concept of reward for investment and research for worthy originators.

Finally, the comparative approach given to the entire conference certainly deserves a mention, where some American lawyers provided the audience with a number of interesting insights, both with regard to regulatory differences and by promoting interesting discussions on damages for inducement and skinny labelling, discussing in detail the most recent US case law (in particular the recent developments of the famous GSK v TEVA case, well covered – this GuestKat then discovered – also by the IP Watchdog blog here).

In short, the thought with which this GuestKat attended the conference and assesses the outcome could be summarised as: interesting times ahead and hopefully new interesting conferences as well.