Myles Jelf (Bristows LLP) talks about the difficulty with software patents. The difficulty arises from a need to identify the dividing line between the pure algorithm which should not be patentable and a technical invention which happens to use a computer. There are three different definitions between the UK, EPO and theUS.
The EPC Article 52 sets out the exclusions, including for programs for computers ’as such’. In the UK the test has stabilised to:
The second and third questions are most difficult. Useful signposts are questions abou [...]
John Richards (Ladas & Parry LLP, New York) identifies the problem that filing a patent involves a prior art search which is probably not as focussed as searched that occur in litigation and therefore the patent might require later amendment. The Patent Trial and Appeal Board (PTAB) takes a very strict approach to amendment in the USA. Most jurisdictions do not allow broadening of scope after grant except for the USA and Canada in specific circumstances and under strict time limit.
Penny Gilbert from Powell Gilbert LLP explains the position of biosimilars in the pharmaceutical industry. Biosimilars are essentially generic versions of biologics. Traditional generic compounds are chemical reproductions of the patented compound which makes regulatory approval more straightforward. Biological compounds (proteins or antibodies which are produced from genes) are not identical with one another and have higher hurdles in terms of achieving regulatory approval. The cost of bringing it to market is significant. Doctors may be less willing to prescribe biosimilars as compared to generic chemical compounds when considering the alternatives to the originator’s product. Undertakin [...]
Adam Mossoff (Professor of Law, George Mason University) states that much of the focus in the USA is around litigation, but patents are not simply tools for litigation, they are commercial assets. Litigation is more public than confidential private transactions and therefore has disproportionate focus. He remarked that the ‘sewing machine wars’ of the 1850s in the USA introduced a ‘patent pool’ as a solution.
At the time of any work toward innovation, a prediction of value has to be made and is a driver for innovation. How should the innovation be defined and what are the knock-on commercial factors? These are questions for business and transactional lawyers. Litigation is a backstop and the [...]
Justin Watts (Freshfields) asked whether the strict test for priority fails to appreciate the early stage at which the inventor will be enunciating the invention (often in multiple jurisdictions). He refers particularly to the decision of G2/98 which is that one has to understand the application as a whole through the eyes of the skilled person and therefore takes into account implicit factors as well as explicit. However, a number of hard line approaches have been taken, not least in T213/05 where a gene sequence was later corrected, but still had over 97% homology and yet was denied priority. Mr Watts referred to the ‘Goldilocks’ approach being neither too narrow nor too broad, but ‘just r [...]
Marleen H J van den Hors (BarentsKrans in the Netherlands) dealt with the interesting question of enforcement of second medical use patents and suggested that regulatory changes might be required to facilitate enforcement. She pointed out that there has been different interpretations of Swiss-style claims in the Netherlands and the UK leading to a different basis for enforcing, for example in relation to direct and indirect infringement.
Generics can carve out the patented indication from their marketing authorisation and should avoid promoting the product for that indication. The generics could also send warning letters to health authorities, prescribers, pharmacies and end-users. It is d [...]