http://ipkitten.blogspot.com/2022/03/back-to-life-sciences-in-amsterdam.html
On 14-16 March, this GuestKat had the opportunity to attend the “Pharma & Biotech Patent Litigation” conference in Amsterdam, which, as many readers will know, not only hosts the Kattenkabinet museum (here below a sample of the oeuvres of the museum…), but it’s also an important IP and Life Sciences hub.
Although this Kat is not usually a fan of sponsored conferences, he found this conference to be instructive. The speakers were well prepared and the organization was good, but what probably rendered it so pleasant was the possibility to meet so many colleagues at an international level in person. The conference lasted almost three days and with a large number of topics having been discussed. The original conference program (which was only slightly amended due to some covid-related absences). The IPKat reports on some of the trends and topics from the conference below.
On the first day, during a workshop, reference was made to the expectation that Germany will file its instrument of ratification for the UPC on 1st July 2022, which would then trigger the 3-months sunrise period for opt-outs and alike. In fact, it is expected that the Unified Patent Court shall be operative starting from 1 October 2022. It is therefore important that companies with IP portfolios of European patents soon finally decide to opt-out their crown jewels patents by those dates! [spoiler: Life Sciences companies will initially highly likely opt-out, whilst certain telecoms giants and licensing assertion entities might be more oriented to test the UPC system by participating in the system.]. Also, still on the matter of UPC, it was disclosed that The Hague’s municipality representatives supported by the Dutch government intend to file a request to host the Life Science’s division, therefore being the only competitor to Milan so far (Dublin is not yet in on the race).
The second day was opened by an ‘interview’ with Sir Robin Jacob who highlighted how the UK is responding to the Unitary Patent Court, highlighting in particular how the “creativeness” of decisions from the UK courts such as Arrow declarations, shall remain attractive to companies in the Life Sciences sector, allowing the UK to remain a focal hub for patent litigation.
After that, it was discussed how Dutch Courts would be keen on issuing cross-border injunctions, as demonstrated by the Novartis/Mylan case from 2020 (discussed also here), especially when there is a serious threat that a Dutch company will exercise control, facilitate or incite subsidiaries to infringe, whether or not by making the central marketing authorization available.
Another very interesting and debated aspect has been that of divisional patents. A panel composed mainly of representatives of the generics industry, together with a case handler of the European Commission, highlighted how the use of divisional has become increasingly scrutinized and discussed from the perspective of competition law. Many examples were raised (among which include Apixaban, Bortezomib, Everolimus, Naloxon). There was a clear sense that the Commission intends to verify whether divisionals are used as an illicit evergreening tool. In this regard, it has been pointed out that possible remedies to unfair use of divisional patents could be: time limitation for divisionals’ applications, limitation for filing additional data, stopping the incentive of withdrawing of appeals; consideration of the whole case in examination/opposition.
On the other hand, members of the ‘originators’ side have highlighted the importance of protecting second medical use patentsand highlighted the difficulties of the enforcement of those patents given the need to provide predictable remedies, including at an administrative level, in order to avoid off-label uses of products which have lost patent protection on the active principle. In particular it’s been discussed how the mere adoption of “skinny labels” is not sufficient on the originators’ side to avoid such a risk and that further actions should be implemented, as suggested in particular by some UK decisions (see also here).
An interesting panel highlighted the differences between the doctrine of equivalence in UK and US, letting the audience understand that on that specific aspect the US leads somehow the way, since their FWR test is now adopted by many European jurisdictions, but the level of sophistication of the test is really much higher in the US than in Europe. Also, the US Courts have also somehow been abandoning this test in favour of a more suitable “insubstantial differences” test, to be applied on an element-by-element basis.
The conference held a discussion on how a future litigation trend in Life Sciences will be related to trade secrets and in particular in relation to manufacturing-related issues. In fact, manufacturing is key in the biosimilars/biologics/antibodies area, even more than it was in the field of small molecules. It will be of utmost importance for companies operating in the biologics field to address the issue of protection of confidential information in a consistent way, both to avoid the risk of leakages and to be able to resist possible fishing expeditions by competitors.
On the third day the importance of AI was highlighted in Life Sciences, with possible consequences on the threshold for inventiveness (and plausibility) and a comprehensive review of the current trends on SPCs was performed by a distinguished panel, including another GuestKat – Frantzeska Papadopolu.
So, a lot of food for thought for practitioners and clients attending the Conference. Only negative remark, for an event that in this Kat’s opinion covered many interesting topics in a decent manner: there was a consistent presence of UK and Dutch speakers but limited participation from the other European Countries, including Germany. Considering the incoming UPC, broader participation would have rendered the discussion more interactive and complete. In this relation this Kat notes that having visited the Rijksmuseum the Saturday just preceding the conference this Kat should have already known that the Dutch and Britons are rather used to fighting their battles also on foreign shores.
| Here above “Battle of Livorno” (Tuscany), by Reinier Nooms, 1653 – 1664, which can be admired in the Rijksmuseum |
.png){kind=link}
Content reproduced from The IPKat as permitted under the Creative Commons Licence (UK).