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Articles by Garreth Duncan
SPCs For Combination Products – Will CJEU Need To Look Again?
Garreth Duncan’s articles from HGF Ltd are most popular: within Intellectual Property topic(s) in United Kingdom with readers working within the Insurance and Healthcare industries HGF Ltd are most popular: within International Law and Energy and Natural Resources topic(s) National courts have diverged on the interpretation of the EU Court of Justice’s latest decisions on SPCs for combination products – in particular on whether data in the application as filed are required for a combination...
Playing Loose – CJEU Asked To Decide On Combination SPCs
Garreth Duncan’s articles from HGF Ltd are most popular: within Intellectual Property topic(s) with Inhouse Counsel in United States with readers working within the Pharmaceuticals & BioTech industries In a new referral (C-262/26), the EU’s Court of Justice has been asked to decide whether a medicine which receives a marketing authorisation (MA) as a monotherapy, but labelled with instructions to take it in combination with another medicine (a so-called “loose combination”) is eligible for...
Pro = Active? CJEU Asked To Decide
Garreth Duncan’s articles from HGF Ltd are most popular: within Intellectual Property topic(s) with Inhouse Counsel in Ireland with readers working within the Business & Consumer Services and Pharmaceuticals & BioTech industries In a new referral to the EU’s Court of Justice (C-794/25), the CJEU has been asked to rule on the question whether an approved pro-drug of a previously approved active pharmaceutical ingredient is eligible for SPC protection in the EU independently of the originally...
Santen Revisited – CJEU Asked To Think Again On “first Authorisation” For SPCs
HGF Ltd are most popular: within International Law topic(s) with readers working within the Retail & Leisure industries A new referral to the Court of Justice of the EU will once again consider what is meant by the “first marketing authorisation” requirement of Article 3(d) of the EU medicines SPC Regulation.
SPCs post-Brexit: UK Court of Appeal sticks with the CJEU in Merck decision
SPCs extend the term of patents for medicinal and plant protection products in Europe which have been granted a marketing authorisation (MA). However, Article 3(d) of Regulation (EC) 469/2009 (the SPC Regulation) requires that the MA is the “first authorisation to place the product on the market as a medicinal product”.
SPCs in Europe: what’s round the corner?
The European Union is planning sweeping changes to supplementary protection certificates (SPCs), the most significant reform to the SPC system since it was introduced in the early 1990s. SPCs extend the term of patents for medicines and plant protection products which require a marketing authorisation (regulatory approval) before they can be put on the market. The term extension conferred by an SPC is up to five years, making SPCs hugely valuable to the pharmaceutical and agricultural sectors.
Can We Finally Advance? CJEU Asked Once Again To Consider SPC Eligibility Of Patents For Combination Products
The Irish Supreme Court has referred a number of questions to the Court of Justice of the European Union (CJEU) on issues relating to the eligibility of combination medicinal products for protection by supplementary protection certificates (SPCs). The referral has the potential to decide Europe-wide litigation on a combination product and provide some much-needed clarity to a matter which has vexed courts in the EU for over a decade.
Special report: patents and SPCs post-Brexit - pharma’s big opportunity? | Lexology
The United Kingdom has left the European Union and following lengthy negotiations, a UK-EU trade and cooperation agreement was eventually signed on Christmas Eve 2020. As with all Christmas gifts there is a lot to be thankful for, but there are also some clear omissions. It is undoubtedly positive that the UK has managed to agree a quota and tariff-free trade agreement with the EU.
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