8th Feb 2021
Just over one month into the “real Brexit” we have already seen two very high profile consequences of its impact on the pharmaceutical industry.Firstly, the UK’s medicine agency (the MHRA) approved the BioNTech/Pfizer and Oxford University/Astra Zeneca Covid-19 vaccines faster than the European Medicines Agency (EMA). Then, at the end of January, the European Commission threatened to prevent Covid-19 vaccines passing into Northern Ireland from Ireland. I am certainly not going to explore the potential political ramifications of this (swiftly withdrawn) threat of the EU Commission – twitter commentators have had their say on that – but I am interested in whether this unique situation on the island of Ireland could have future consequences for supplementary protection certificates (SPCs) in the UK and Europe.
30th Oct 2020
On 17th October 2020, China approved the fourth amendment to the China Patent Law, which will come into effect on 1st June 2021. This amendment introduces a number of changes to Chinese patent law, with the introduction of patent term extensions (PTEs), patent term adjustments (PTAs) and a patent linkage system being of particular interest to both originator and generic pharmaceutical companies operating in China
19th Oct 2020
The United Kingdom (UK) left the European Union (EU) on 31 January 2020. It’s been business as usual during the current transition period, but all that will change from 1 January 2021 when “post-Brexit” reality dawns. We still do not know how the issue of the border between Ireland (part of the EU) and Northern Ireland (part of the UK) will be resolved post-Brexit.
13th Jul 2020
In his recent article, Robin Ellis summarised the key take-home messages from the UK Supreme Court judgement in Regeneron v Kymab.In this article Andrew Carridge takes a more in-depth look into the concept of a ‘principle capable of general application’, exploring when broad claims may be justified and when claims may legitimately cover as yet undiscovered embodiments.
10th Jul 2020
On 9th July 2020, the Court of Justice of the European Union (CJEU) handed down their emphatic judgement concerning Supplementary Protection Certificates (SPCs) in Santen v INPI (C‑673/18). For those interested in the details and history of the case they can be found in my earlier blog, published in January, where I discussed the Advocate General’s preliminary and non-binding opinion. As far as this judgement is concerned the conclusion is clear: “a marketing authorisation (MA) cannot be considered to be the first MA … where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of an MA for a different therapeutic application” – emphasis added Put another way, the CJEU has decided that the literal wording of Articles 1(a), (b) and 3(d) of the SPC Regulation mean what they say. The previous CJEU decision in Neurim is consigned to the scrapheap.
8th Jul 2020
On 24th June 2020 the UK Supreme Court handed down their judgement addressing the question of breadth of claim and sufficiency. Although the decision is well written, its background is in biotechnology which is likely to dissuade a lot of people from reading it and/or understanding its broader implications. So with this in mind, here’s my attempt to explain Regeneron v Kymab sufficiency using … TELEPORTATION.
24th Jun 2020
Because of the disruption caused by the Covid 19 pandemic, since 24 March 2020 the UK IPO has treated every day as an “interrupted day” as far as deadlines are concerned. This applies to UK applications and registrations for: patents, supplementary protection certificates, trade marks, designs. It also applies to deadlines in proceedings relating to these rights, such as oppositions and invalidity actions.
9th Apr 2020
In January 2020, the Advocate General (AG) provided his opinion in Santen v INPI relating to how Article 3(d) of the SPC regulation should be interpreted. This opinion from the AG is interesting and important for two reasons. Firstly, it is trying to clear up almost 10 years of confusion that was caused by the Neurim judgement, and secondly the recommendation provided is very clear.