SPCs -- Current Litigation Issues

This blog is one of the sponsors of C5's forthcoming conference on Pharma & Bio Patent Litigation, 17-18 February 2009 in Amsterdam (full details and booking form available here). One of the speakers is Duncan Curley (Innovate Legal), who will be reviewing current litigation issues involving SPCs. Guesting for the blog this morning, Duncan gives a foretaste of his talk:

"As readers of this blog will know, the active pharmaceutical ingredient (API) in many blockbuster drug products will usually have been discovered and patented a long time before the highly profitable years of peak sales. SPCs can prolong these “golden years” with a period of extra legal exclusivity, based upon the extension of a patent monopoly that must be designated in the application for a SPC.

Most small molecule APIs that are now being targeted for generic competition in Europe will have been subject to protection by a SPC at some point. When an API is protected by a claim in the basic patent to the chemical compound itself, the criteria for the grant of a SPC are often easy to fulfil and there will usually be little scope for an attack on the validity of a certificate.

Drug discovery programmes have changed considerably since 1993, when SPCs first became available. In recent years, pharmaceutical companies have focused more on the development of new forms of drug administration to the patient population, including reformulations of existing drugs, combination therapies (including co-administration of two or more drugs), optimised dosage regimes and novel drug delivery systems. Companies have sought patent protection for these innovations. In some cases they have applied for SPCs, but these applications may not always be as straightforward as SPCs based on patent claims covering simple, small molecule APIs. For example, the Gilead Sciences case (here) earlier this year concerned an appeal from the rejection by the UK IPO of a certificate for the combination product Truvada®. In the Yissum case (here), the patent claims were for a new use of an old API, calcitriol – and the application for a certificate was rejected.

Generic drug producers recognise the weaknesses in the existing system for the grant of certificates and SPCs are now becoming an increasing focus of litigation in the pharma and biotech sectors. We have just seen another legal challenge to the validity of a certificate in the levofloxacin decision of the Patents Court - and there are other cases in the pipeline. The growing trend of generic industry attacks on SPCs and many other burning legal issues will be explored in detail at the C5 Pharma & Bio Patent Litigation conference - sponsored by The SPC Blog - in Amsterdam, next February".