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28th Apr 2021

Patenting MedTech Simulations

A few weeks ago, the Enlarged Board of Appeal of the European Patent Office (EPO) issued a decision on the extent to which computer-implemented simulations are patentable in Europe (previously reported here). The confirmation that computer-implemented simulations should be considered in the same way as any other computer-implemented process could be significant for the industry that filed more European patents than any other in 2020: Medical Technology.

18th Mar 2021

COVID-19 and the Rapid Rise of Genetic Sequencing

While the United Kingdom’s response to the ongoing COVID-19 pandemic has drawn criticism, there are ways in which the UK has performed well and that perhaps even warrant the accolade “world beating” or, at least, world leading. One of these is the recent success of the vaccine rollout. Another less heralded but equally impressive achievement […]

8th Feb 2021

Supplementary Protection Certificates (SPCs): Could the EU/UK trade deal have an impact on future SPC terms in Europe?

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 I am certainly not going to explore the potential political ramifications of this (swiftly withdrawn) threat of the EU Commission – twitter commentators have had their say on that – but I am interested in whether this unique situation on the island of Ireland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

China’s new patent law – important changes for the pharmaceutical sector

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

Supplementary Protection Certificates (SPCs): How will the border solution between Ireland & Northern Ireland affect SPCs post-Brexit?

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

Regeneron v Kymab – Principles capable of general application

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

Seeing Article 3(d) with 2020 vision – revisited

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.

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