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
Insights: Biotechnology & Pharmaceuticals
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.
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.
Interpreting Article 3(a) of supplementary protection certificates (SPCs) regulation with respect to combination products
At the end of 2019, a decision from the Court of Appeal of England & Wales (EWCoA) in Teva vs Gilead gave us an idea of how national courts will interpret the CJEU’s latest guidance on the meaning of Article 3(a) – what is a “product … protected by a basic patent in force”?
Drug discovery is expensive. Computers are an important tool in combating this, because their computations can reduce the number of time-consuming physical tests needed. The use of computers in drug discovery is the subject of a great deal of research and we saw an example of this in the news last week when it was reported that a powerful new antibiotic had been discovered using artificial intelligence (see J. Stokes et al., “A Deep Learning Approach to Antibiotic Discovery”, Cell, vol. 180, no. 4, pp. 688-702.e13, 2020. Available: 10.1016/j.cell.2020.01.021, widely reported by the media).
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.