The SPC Regulation: Fit for purpose?
hjkgh On 3 May 2012, Advocate General Trstenjak delivered her Opinion on the Neurim CJEU referral(1) concerning whether Neurim Pharmaceutical (1991) Limited was entitled to obtain a supplementary protection certificate (SPC) for melatonin for human use in circumstances where melatonin had previously been authorised to other parties for veterinary use.
If the Opinion is followed by the CJEU it may lead to a significant increase in applications for SPCs based on further medical uses for known products whether such uses are to treat humans or for veterinary use.
An SPC extends the period of protection initially conferred by a patent once that patent has expired. This extension relates only to the product or use of the product covered by a marketing authorisation (MA). This case relates to the interpretation of Article 3(d) of the SPC Regulation(2).
Melatonin is a natural hormone that was discovered in 1958. In April 1992, Neurim filed a European patent application concerning pharmaceutical formulations of melatonin to treat insomnia. It then took Neurim over 15 years to obtain an MA, which it sells under the name CIRCADIN. Neurim relied on its CIRCADIN MA to apply for an SPC at the UK IPO. The application named the product as 'melatonin' and Neurim’s MA was identified as the first MA to place the product on the market in the UK as a medicinal product (as required by Article 3(d)).
The UK IPO rejected the application on the grounds that Neurim’s MA was not the first MA and, hence, did not comply with Article 3(d). The UK IPO identified an earlier MA relating to the veterinary medicinal product REGULIN whose active ingredient is melatonin for improving reproductive performance in ewes.
Neurim unsuccessfully appealed to the High Court. The Court of Appeal, however, sided with Neurim and LJ Jacob provided quite a strongly worded opinion as to why Neurim’s arguments justifying the granting of an SPC were not only tenable but right leading to a referral to the CJEU. He concluded by stating that if the CJEU did not find in favour of Neurim, it would show that the SPC Regulation was "not fit for purpose".
The AG in her Opinion rejects a purely literal interpretation of the SPC Regulation and supplements this with a teleological or purposive approach, to agree with LJ Jacob and the Court of Appeal, and concludes that the fact there may be a previous MA for the same product for human or veterinary use does not preclude the grant of an SPC based on a later MA as a new medicinal product, provided the first-authorised medicinal product is not within the scope of protection conferred by the patent designated by the applicant as the basic patent. In calculating the term of the SPC, the relevant MA is to be understood as the first MA which is within the scope of protection conferred by the basic patent designated by the applicant.
The AG concedes that on a purely literal interpretation of the SPC Regulation no SPC could be granted for CIRCADIN. This is not, however, compatible with the overall objective of the SPC Regulation which seeks to provide a balanced considering the interests of all parties (the pharmaceutical and generics industry, as well as public health authorities and patients). The AG recognises that further medical uses of known substances can be patented and research into therapeutic effects of known substances has considerable health and economic importance.
If the CJEU follows the conclusions of the AG, this will be a good result for Neurim and, in our opinion, the correct result given the facts of the case. The fact that melatonin was previously authorised would not prevent the grant of an SPC as the previous authorisation (relating to treatment of ewes) is not within the scope of protection of the latter patent for human use. The duration of the SPC would be calculated in terms of the MA for CIRCADIN thereby affording Neurim a 5 year SPC.
The generics industry will not consider it a balanced solution as they fear it will open the floodgates to SPC applications for further medical uses when arguably the contribution may be minor. For originators, the grant of further medical use patents per se is evidence that the contribution is not minor and justified.
Even though the AG has agreed with LJ Jacob, we would question whether the SPC Regulation is 'fit for purpose' given that it is clearly poorly drafted resulting in numerous referrals on its interpretation and ambiguous CJEU decisions.
One final point which could have significant repercussions to the pharmaceutical industry is the AG's strongly expressed view that only one SPC may be granted per basic patent. Indeed, since the recent Medeva decision, there has been much debate as to whether the CJEU changed the law as previously stated in Biogen(3) by holding that only one certificate may be granted per basic patent. So far, the UK IPO's position is that SPCs may be granted on the basis of the same patent as long as they are for different products. Ideally the Neurim CJEU decision should provide some clarification on this point but we suspect that the issue will be dodged as it is not relevant to the questions referred.
In-house Counsel 'to do' list
- Consider submitting SPC applications for any further medical use patents granted in the last 6 months (whether these are granted will ultimately depend on the Neurim CJEU decision).
- Assuming the CJEU follows the AG's Opinion, exclude mere product claims from further medical use patents to avoid the risk that an earlier MA may be within the scope of protection of that patent.
- Consider divisional applications to ensure that have one patent per product though this could be a costly exercise.
Mark Hodgson is a partner in the IP & Technology Dispute Resolution Group at Field Fisher Waterhouse LLP. He specialises in patent litigation before the UK courts and courts in Europe particularly on behalf of life sciences companies.