Updates

SUPPLEMENTARY PROTECTION MAY NOW BE AVAILABLE FOR PREVIOUSLY AUTHORISED ACTIVE INGREDIENTS

23 July 2012

SPCs

SPCs are national rights in Europe that protect authorised uses of a "product" (an active ingredient or combination of actives) that was the subject of patent protection. The patent may protect the Product as such, a process for obtaining the Product, or an application of the Product. The protection provided by SPCs is particularly valuable, since it can effectively block generic competition for up to five (or even five and a half) years beyond patent expiry.

Neurim's Case and the CJEU's Judgement

Our IP Update 169 outlines the background to the Neurim case. In essence, the UK Court of Appeal asked the CJEU to clarify whether the existence of earlier (veterinary) authorisations for the active ingredient melatonin precluded the grant of (or determined the duration of) an SPC application based upon Neurim's authorisation for the first human medicinal product containing melatonin.

In response to the questions, the CJEU has ruled that the existence of earlier (veterinary) marketing authorisations should not prevent the grant of an SPC to Neurim. The Court concluded that a patent and new authorisation for a "different application" of an "old" active ingredient should lead to the grant of a new SPC.

The CJEU also decided that the term of Neurim's SPC should be set by "the marketing authorisation of a product that comes within the limits of protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate".

Commentary

The judgement appears to be good news for the innovative pharmaceutical industry as, for the first time, companies that provide valuable new treatments by finding new uses for "old" active ingredients could become entitled to an extended monopoly period for those treatments.

It may be some time before the full impact of the new judgement becomes clear. This is because the wording of the judgement is open to several different interpretations. The next months (and perhaps even years) will therefore see the various national patent offices and courts working out the interpretations that are correct.

For example, it is not entirely clear what is meant by "different application". It may mean just a different therapeutic indication (or new use of an agrochemical), or it may be construed more broadly, for example to encompass reformulations.

Further, it is uncertain whether an applicant who is the owner of an earlier SPC to an active ingredient would be prevented from obtaining the grant of a further SPC based upon a new "application" of that active. This is because the Court's ruling may not have changed the interpretation of an existing provision that prevents multiple SPCs being awarded to the same person for the same active ingredient or combination of actives.

It could be argued that the Court intended the authorisation that sets the term of an SPC to be the one that first places the product on the market for the newly patented "application". However, this is not what the judgement actually says. Thus, it is possible that the Court instead intended a more restrictive interpretation in which it is the earliest authorisation for the active ingredient that sets the SPC term (which would lead to SPCs for a new "application" generally having either little or no term).

The Court did not comment on one point on which the Advocate-General (but not the UK Court of Appeal) had sought clarification, namely whether it is possible to obtain more than one SPC for each basic patent. However, the CJEU may be asked to rule on this point soon, in connection with a case that our firm is handling.

Possible action

Despite possible uncertainty as explained above, clearly the SPC system is now open to those companies that obtain both patents and marketing authorisations for new therapeutic indications of previously authorised active ingredients. Further, the judgement may in future be applied to many other medicinal products containing "old" actives (e.g. reformulations).

Therefore, we recommend that you seek the advice of our SPC experts if you have an interest in a patent (or patent application) in Europe that protects an innovative aspect of a medicinal product for which marketing approval will be, or has been, sought in Europe (by you or a third party).

In view of the liberalisation of the SPC system, it will be particularly important to contact us if your medicinal product contains an old active agent and had previously seemed unlikely to qualify for SPC protection.

If you require any further information, please contact John Miles, Mike Snodin or Michael Pears of our SPC & Regulatory group. If you are interested in receiving further information on SPCs in addition to our news updates, please email Kerry Meadwell (kerry.meadwell@potterclarkson.com).

 

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