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 I am certainly not going to explore the potential political ramifications of this (swiftly withdrawn) threat of the EU Commission – twitter commentators have had their say on that – but I am interested in whether this unique situation on the island of Ireland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

5th Aug 2020

UK Intellectual Property Office (UK IPO) introduces temporary fee reductions

The UK Intellectual Property Office (UK IPO) has announced several temporary fee changes in relation to patents, supplementary protection certificates (SPCs), trade marks and registered designs. In an effort to support applicants and proprietors facing disruption due to COVID-19, the temporary fee changes waive or significantly reduce certain late payment fees, fees for obtaining extensions, and fees for reinstating or restoring lost rights. The following temporary fee changes will apply between 30 July 2020 and 31 March 2021:

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.

9th Apr 2020

The slow death of Neurim – will SPCs for new indications soon be a thing of the past?

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.

14th Feb 2020

A Whistlestop Guide to SPCs

Supplementary Protection Certificates (SPCs) are European sui generis rights which provide a form of patent term extension available in Europe for medicinal products or plant protection products. The period of effective patent protection for medicinal products and plant protection products can be significantly less than in other sectors because of the need to obtain a marketing authorisation (MA). Obtaining an MA can take a significant amount of time (typically around 12 years), which can be a large portion of the lifetime of a patent (20 years from its filing date). SPCs are national rights available in individual EU countries (and European Economic Area (EEA) countries: Switzerland and Norway) which are governed by EU regulations. They will also continue to be available in the UK following its exit from the EU. The SPC sphere is a fascinating and extremely active area of intellectual property law. There is a steady stream of decisions from the Court of Justice of the European Union (CJEU) attempting to clarify the SPC Regulations, and there are a number of issues outstanding. This brief guide attempts to give a sense of the current state of play.

24th Jan 2020

Option is a failure with combination SPCs

The recent decision from the Court of Appeal of England & Wales in Teva vs Gilead has given us a first glimpse at how a national appellant court interprets the CJEU’s latest guidance on the meaning of Article 3(a) – what is a “product is protected by a basic patent in force”? Unfortunately, I found the judgement rather disappointing. Whilst we can now say with reasonable confidence that a claim covering the optional combination of a known, specified, active ingredient with a non-specified active ingredient would not be considered to protect a combination product within the meaning of Article 3(a) [hopefully this will become clearer later!], the decision is so limited that I struggle to see how it will significantly help patent drafters, prosecutors and litigators in the future. This is all a bit of an anti-climax after the flurry of decisions and opinions from the CJEU on referrals relating to Article 3(a) including this Truvada case (C-121/17), as well as the cases relating to Prezista (C-114/18) and Januvia (C-650/17).

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