Life Sciences stakeholders in Europe and abroad are voicing their concerns about the European Patent Offices’ initiative to shorten the time for the examination of patents from up to 56 months to 12 months.
Gavin Recchia, Principal at Australia’s large IP attorney firm Davies Collison & Cave told European Biotechnology that the so-called Early Certainty on Examination “may well have the unintended consequence of reducing the filing of life sciences patent applications in Europe”.
He outlined that, in most countries of the world, life sciences patents are filed in very early stage by academic research institutes and start-up companies, which only have small budgets. “Filing a European phase application is already more expensive than filing in any other major jurisdiction,” he said, “and there will be a significant disincentive to file if prosecution is going to advance too quickly and costs are going to be incurred earlier than they currently are.” Recchia concludes that early certainty means the likelihood of higher costs earlier on, not only in terms of prosecution but also the filing of divisional applications, before a commercialisation partner or investor has been found. “It not only means larger costs are incurred earlier, but also that the applicant needs to make a decision on subject matter to pursue in the primary European application versus a divisional one earlier in the life of the European case, and potentially before it is clear what the most valuable commercial embodiment will be.” This could make an European patent less attractive to file as typically investors decide on the best embodiment of an invention after having licensed a patent. As patents must be filed in very early stage of development, after 12 months of examination there will be not yet all data available to select the best drug candidate or the best embodiment.
European experts had carefully criticised the Early Examination plans earlier. Now, sources told European Biotechnology that the German biotech association BIO Deutschland will come up with a position paper this week. According to leaked information, the lobby group will propose to the EPO to establish an option to de-pace the accelerated examination on request in order to grant early legal certainty on one hand but also to prevent potential downsides of the new rules to the life sciences sector.
French biotech association France Biotech told European Biotechnology that once a patent has been granted, it is no longer possible to broaden the scope of the claims or to file divisional applications on another aspect of the invention, what biotechnology companies usually do very often. “Therefore, our biotech companies may prefer to delay the procedure allowing them to modify or refine the scope of protection according to the evolution of the invention as exploited,” France Biotech Chairman Maryvonne Hiance said. According to the EPO, 15% of all European filings are for life sciences inventions. Typically, drug development takes 10-15 years from the idea to the market. As 90% of drug candidates fail to reach the market, companies are keen to balance risk and potentials.
In mid-February, the European pharma industry association gave some input: "EFPIA welcomed EPO's Early Certainty from Search initiative, which aims at providing an examination report within six month from application and welcomes the overall effort underpinning the Early Certainty Initiative", the association wrote to European Biotechnology. "However, in view of the long development timelines for pharmaceutical products and the early stage in product development at which patent applications are filed, the time pressure is less than for sectors with much shorter development timelines and which indeed rely on their patents being rapidly granted. In any case, speed should not come at the expense of quality of the examination, which is critical especially in our sector where a small number of patents, and sometimes only one, can cover investments of over a billion euros. Sectoral differences should be taken into consideration by the EPO in the implementation of their "Early Certainty Initiative". German pharma VFA underlined that quality is critical. According to the EPO the higher workload due to the shortened timelines for examination will be complemented by hiring young patent attorneys. Patent experts , however, said that examination of the complex life sciences patents would require a lot of experience and that it would be highly probable that more patents will be rejected for formal reasons when unexperienced staff will dilute the EPO's highly renown expertise.