At the time of writing, over one hundred and eighteen thousand cases of novel coronavirus (Covid-19) have been confirmed worldwide and this number is expected to rise significantly. In response to the outbreak, pharmaceutical companies and research organisations are racing to develop new vaccines and repurposing existing anti-viral drugs.
Insights: Biotechnology & Pharmaceuticals
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.
It may only be the opinion of the Advocate General but after almost a decade of fog surrounding Article 3(d) of the SPC Regulation this latest offering in Santen v INPI suggests that clarity may be about to prevail.In the past the decisions and opinions of the CJEU & Advocate General have often been criticised for their lack of clarity and applicability but this is not a criticism that can be levelled at Giovanni Pitruzzella. If the CJEU choose to follow his guidance then Neurim will be scrubbed from the record books and Article 3(d) will, once again, mean what is says.As a quick reminder, Article 3(d) of the SPC regulation states that a certificate shall be issued if:“the authorization [for the product] is the first authorization to place the product on the market as a medicinal product”The “medicinal product” and “product” are defined in Article 1 of the regulation and essentially relate to “any substance or composition presented as having curative or preventive properties with regard to human or animal diseases” and “the active ingredient or the composition of active ingredients in a drug” respectively.
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).
On Wednesday 15th January 2020, US president Donald Trump and Chinese vice-premier Liu He signed an economic and trade agreement which Mr Trump described as “the biggest deal anybody has even seen”. The deal promises to be the first phase of a larger new trade agreement between the US and China, signifying a de-escalation in their trade war – at least for now. Intellectual property (IP) was one of the main points of contention during the trade talks and thus it is perhaps unsurprising that IP matters are addressed in the first chapter. Of particular interest to those in the pharmaceutical sector will be Sections C and D of Chapter 1, which outline China’s commitment to improving protection and enforcement of pharmaceutical related patent rights. Sceptics will argue that these provisions simply represent a long overdue pledge by China to align its patent system with the US and other Western states, with no guarantee that they will actually implement or enforce the provisions of the agreement. However, in my view the deal appears to represent China’s willingness to do more to protect pharmaceutical patent rights and contains provisions that (if properly implemented and enforced) could significantly increase the value of drug related patents in China.
When it comes to exclusivity in the pharmaceutical and biopharmaceutical fields, patents and supplementary protection certificates (SPCs) are not the only games in town. In Europe, it is important to consider another layer of exclusivity, associated with regulatory data.
At the European Patent Office, protection can be sought for antibodies in a number of ways. This article provides a brief review of how antibodies can be characterised, and when a particular characterisation may be appropriate.