Better Patent Regulation
The volume of patent applications has increased substantially in the past decade, with a proportion of those apparently aimed at deterring generic competition. A European Commission Sector Inquiry report from 2009 said that applications to the European Patent Office (EPO) nearly doubled between 2000 and 2007 driven in part by defensive commercial strategies aimed at delaying or blocking generic competition.
This included the use of patent clusters or thickets where multiple applications were filed around a single product which can confuse actual current patent status.
Given the volume and unnecessary complexity of some patent clusters - which in certain examples have totalled nearly 1,300 patent applications around a single molecule - it is extremely difficult for generic manufacturers, particularly SMEs, to be confident they would not be in legal breach by launching their product. These practices limit competition and the prospect of lower medicine prices.
We are very concerned that the issue of these type of weak patents - those which don't fully meet accepted criteria - may be aimed at delaying generic competition.
It is crucial that competition authorities ensure that the operation of markets reverts to what was originally intended: that originators receive long periods of market monopoly on their products during the patent term so that they can recoup their research investment, followed by the immediate onset of generic competition to make medicines affordable and to promote true innovation.
We believe that competition law may be breached when an originator makes applications for patents which it knows, or ought reasonably to know, should not be granted; or where it deliberately withholds evidence from the examiner that it knows, or ought reasonably to know, is relevant to the application and may result in it not being granted.
But competition law will not, of itself, resolve all of the problems associated with the granting of weak patents and their proliferation. It has simply been too easy to obtain weak patents through the EPO and national patent agencies. The EPO has taken action to ‘raise the bar’ in terms of quality and thoroughness of the assessment of patent applications and a similar approach should be taken by other authorities. This should not be taken to imply that we necessarily seek a change in the fundamental rules: rather, we seek to avoid poor decisions brought about by the lack of time and information available to the examiner.