SPCs
A step too far? At
first sight, the opinion of the Advocate-
General seems to represent excellent news for the innovative pharmaceutical industry. This is because it offers the first possibility of suitable rewards and incentives for those companies that develop important medical innovations using old active ingredients.
However, the opinion could have hidden dangers as, inadvertently,
it breaks an
important link in the legislation that is key to producing a balanced and sustainable system of rewards and incentives.
The authors of the original SPC legislation were careful to stipulate that not all new patents and new marketing authorisations would lead to the reward of an SPC. For example, a relevant section of the Explanatory Memorandum for the original legislation (Point 36 of “Proposal for a Council Regulation [EEC] concerning the creation of a supplementary protection certificate for medicinal products”; COM[90] 101 final – SYN 255) states that:
be the subject of several patents and several authorisations ... the SPC will only be granted for that product on the basis of a single patent and a single authorisation to be placed on the market, namely the first chronologically given in the state concerned.”
The same section also states that:
the active ingredient itself, a new certificate may not be granted for one and the same active ingredient whatever minor changes may have been made regarding other features of the medicinal product (use of a different salt, different excipients, different pharmaceutical presentation, etc).”
product is often judged upon criteria that are completely unrelated to regulatory concerns.
“IN THIS RESPECT, THE ADVOCATE-GENERAL’S INTERPRETATION OF THE LEGISLATION DOES NOT APPEAR TO DISTINGUISH BETWEEN THOSE APPLICANTS WHO HAVE CONDUCTED FULL CLINICAL TRIALS AND THOSE WHO HAVE NOT.”
The purpose of this stipulation appears
to have been to link the availability and duration of SPC protection to only those authorisations requiring submission of a complete package of (pre-)clinical data for the active ingredient(s) concerned. Unlike later marketing authorisations for the same active ingredient(s), the first marketing authorisation is guaranteed to have required the submission of such a complete package of clinical data.
Before the Advocate-General's opinion, this link had been relatively firm. That is, it had been weakened only by Recital (14) of a later piece of
legislation (Regulation 1610/96,
creating SPCs for plant protection products and amending the earlier legislation). However, the practical effects of that recital are essentially limited to SPCs for new salt forms of active ingredients. On the other hand, the opinion of the Advocate-General now appears effectively to sever this important link almost completely. This is because it is common for a new marketing authorisation for an old active ingredient to be the first to fall within the scope of a particular patent. More importantly, the interpretation of the legislation proposed by the Advocate-General does not appear to prevent (either directly or indirectly) the authorisation and patent pertaining to the kind of changes to a medicinal product that were expressly mentioned in the Explanatory Memorandum as not qualifying for fresh SPC protection.
In
Dr Mike Snodin specialises in handling pharmaceutical and chemical patent
expertise on
matters. He has particular SPCs and has authored
various influential articles, including one proposing the concept of negative term SPCs, which has now been accepted by the CJEU in case C-125/10.
28 this respect, the Advocate-General’s
interpretation of the legislation does not appear to distinguish between those applicants who have conducted full clinical trials and those who have not. This could make SPC protection available to applicants whose marketing authorisations rely either in whole or in part upon clinical data submitted by others (including even authorisations for generic medicinal products), as the patentability of modifications
to Life Sciences Intellectual Property Review 2012 an authorised medicinal
www.worldipreview.com
Dr Michael Pears handles a wide range of biotechnological patent matters. In recent years he has developed experience in SPCs and has been involved in coordinating the prosecution of high profile SPC portfolios throughout Europe, and in taking a case to the CJEU (Georgetown University et al, C-422/10).
Mike Snodin is a chartered and European patent attorney, and partner at Potter Clarkson LLP. He can be contacted at:
mike.snodin@
potterclarkson.com
Michael Pears is a chartered and European patent attorney, and associate at Potter Clarkson LLP. He can be contacted at:
michael.pears@
potterclarkson.com
Many observers will believe that because
Neurim has been obliged to supply a complete package of clinical data, it should not count against it that there was an earlier authorisation for the same active ingredient. Indeed, were it to count against the company, a majority of observers would probably concur with the UK Court of Appeal’s comment that “the Regulation will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose”.
Te ‘fix’ proposed by the Advocate-General that would allow Neurim to be awarded an SPC is therefore appealing in many ways. However, that fix appears likely to throw the SPC system inadvertently out of balance in a way that, through enabling a proliferation of SPCs based upon almost any kind of marketing authorisation (including even an authorisation for a generic medicinal product), could be detrimental to the long-term interests of the innovative industry. In this regard it is possible that, when delivering its final judgment, the CJEU might ultimately settle upon an alternative solution that grants Neurim an SPC but does not produce such undesired side-effects.
Te views expressed in this article are the personal views of the authors and are not intended to reflect the views of Potter Clarkson LLP or its clients.
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