31 July 2012

Europe Allows Extended Protection For Second Medical Uses (via SPCs)

Just this month, a decision by the Court of Justice of the European Union (CJEU) has again brought into focus the significant role played by Supplementary Protection Certificates (SPC’s) in the pharmaceutical industry. There have recently been a number of CJEU decisions clarifying the circumstances in which an SPC may be granted and those in which one may not. The most recent is Case C-130/11 Neurim Pharmaceuticals relating to the protection of second/further medical uses of known active ingredients.

As way of background, an SPC is a form of intellectual property that provides extended protection after the expiry of a patent. Products (medicinal, veterinary, plant) that require authorisation before being placed on the market may qualify.  The extended protection is limited to the authorised product itself and has a maximum lifetime of 5 years.

The fundamental objective of the SPC Regulation (from a public policy perspective) is “to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health”.  The reason given for the adoption of the SPC Regulation is that the period of effective protection under the patent is sometimes insufficient to cover the investment put into pharmaceutical research and the regulation therefore sought to make up for that insufficiency by creating an SPC for medicinal products.  In particular, since it can take a long time to obtain the necessary authorisation to place a product on the market and thus reduce the length of time during which an innovator may commercially benefit from the monopoly that a patent provides, the extended protection provided by the SPC Regulation is intended in some way to compensate for this.  The duration of an SPC (up to a maximum of 5 years) is in fact calculated partly based on the date of the first market authorisation.

Until this recent decision, it was previously thought that SPC protection for second or further medical uses of known active ingredients was not allowed.  Nevertheless, this always appeared to be contrary to the fundamental objectives of the SPC Regulation referred to above, namely to “ensure sufficient protection to encourage pharmaceutical research” by compensating innovators accordingly.  Research into as yet unknown properties of known active ingredients plays an increasing role in the search for new therapies.

The opportunity to challenge this long held perception arose from a dispute in the UK involving an application by Neurim Pharmaceuticals for an SPC relating to melatonin (a naturally occurring hormone).  Neurim discovered that appropriate formulations of melatonin could be used for treating insomnia (in humans).  Neurim subsequently obtained a patent directed to such use and in 2007 the European Commission issued Neurim with a market authorisation enabling it to market that formulation (Circadin®).  Based on the patent and the market authorisation, Neurim applied for an SPC at the UK Intellectual Property Office.  However, melatonin had previously been the subject of an earlier market authorisation: for use in controlling the reproduction of sheep.  The SPC Regulation requires that an SPC may only be granted based on a first marketing authorisation.  The question therefore arose: does the earlier marketing authorisation relating to reproduction in sheep prevent the granting to Neurim of an SPC based on the later marketing authorisation for treating insomnia in humans?

Neurim’s application was refused and the UK High Court agreed with the decision to refuse it.  However, the UK Court of Appeal, bearing in mind the objectives of the SPC Regulation, seriously questioned the value of such a decision, stating:

“if Neurim are wrong, then the [SPC] Regulation will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose.”

The UK Court of Appeal therefore submitted the case to the CJEU for clarification of the law.

In what was good news for innovators, in particular those involved in the search for new uses of known active ingredients, the CJEU decided that Neurim should be allowed an SPC based on their discovery of a new use (treating insomnia in humans) for melatonin.  The existence of an earlier marketing authorisation relating to the use of melatonin for regulating sheep reproduction did not prohibit the granting of this later SPC application.  In more general terms, the decision stated:

“…the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient, as protected by the new patent, may enable its proprietor to obtain an SPC…”

The SPC would of course provide a monopoly covering, not the active ingredient, but only the new use of that product.

Although this decision will clearly have a liberalising effect on the granting of SPC’s, some issues do remain.  For example, before the decision many commentators raised concerns that such a decision would lead to an inevitable increase in “ever-greening” practices; e.g. the decision now potentially permits the same proprietor to obtain multiple SPC’s for the same active ingredient.  How effective such practices would be given the precise wording of the judgement and whether they would be allowed remain to be seen.  To what extent the “new” therapeutic use must be different from the therapeutic use referred to in the first marketing authorisation is also unclear. Further case law will probably be required in order to clarify these issues.

If you have any specific queries regarding SPC’s or how to protect research relating to new uses of known active ingredients, do not hesitate to contact Tim Russell (patent attorney) at Venner Shipley LLP.