A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Tuesday, 4 January 2011

What's Brown, Curley and writes about Pandora's Box?

"Reflections on the Erbitux® decision: Combination Products, Combination Therapies and SPCs" is the title of a Case Comment published today in Lawtext's bimonthly Bio-Science Law Review (volume 11, issue 2, at p.54).  The authors are Chartered Patent Attorney and European Patent Attorney Andrew Brown together with Duncan Curley (Solicitor and Director, Innovate Legal).  The BioSLR has kindly allowed The SPC Blog to make this note available to its readers here.  More details of the journal can be found here.

The authors conclude as follows:
"The preamble to the SPC Regulation contains the following recital (10), which states that:

All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should … be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product.

The SPC Regulation thus seems to envisage a narrow scope of protection for SPCs, once they have been granted. But in his Erbitux® judgment, Lewison J seems to have used this reference in the preamble to justify a restrictive interpretation of the SPC Regulation when assessing eligibility, rather than the scope of protection. This is consistent with other judgments by the English courts, which have to date required correspondence between the product claimed in a basic patent as an active ingredient and the same product as an authorised medicinal product, before granting an SPC. Yet some active ingredients (such as cetuximab) are only ever authorised for use in combination therapies. In the field of biological medicines and in particular mAbs, by the time that an SPC can be applied for, there may no longer be a patent directly claiming the product itself, given the long development times of these products. A restrictive interpretation of the SPC Regulation (as seen in the Erbitux® decision) may exclude such valuable medicines from the possibility of supplementary protection in the future. Should then SPCs based upon the way in which a product is used be allowed (assuming that the granted patent protects, directly or indirectly, such use)? Whilst it is still possible for the ‘infringement’ test to prevail (given the Medeva reference), the answer to this question remains an open one. However, if a further development in the law was to allow SPCs to be granted on this basis, it will open up some further difficult questions, such as what happens when the use of the product

is changed after the initial marketing authorisation is granted, and how the issue of infringement of a certificate is to be resolved for any generic/biosimilar version of a product (given that the argument will be entirely about the question of indirect infringement). The SPC Regulation was drafted and introduced in the early 1990s, at a time when vertically integrated pharmaceutical companies relied upon novel chemistry, small molecule blockbuster products and patents to earn their revenues.

Will the ECJ open the box?
Today, the industry landscape has changed with the advent of biologics. Whilst it is interesting to observe that the English Court of Appeal has referred to the Court of Justice what is essentially a question of policy underlying the SPC Regulation (namely, whether there should be a stand-alone test for multi-diseases vaccines, in order to determine whether a product is protected by a basic patent in Article 3(a) of the SPC Regulation), we doubt whether the European Court will want to open Pandora’s box, by carving out exceptions to the SPC Regulation for novel products and treatments such as vaccines, combination therapies and even chemically-modified small molecules with improved pharmaceutical properties.8 For radical change of this kind, we suggest that there will need to be a more fundamental reform of the patent extension legislation for medicinal products in the EU.
See also The SPC Blog here.

1 comment:

Andrew Brown said...

We wrote and submitted the article before the CoA referred the issue to the ECJ on indirect, secondary infringement in the same case, as picked up in teh SPC blog earlier - the question being

"By an order of 8 October 2010 the Court of Appeal seeks further guidance relating to Article 3(a) of Regulation 469/2009. It seeks to ask, in particular:

"If the criteria for deciding whether a product is 'protected by a basic patent in force' under Article 3(a) ... include or consist of an assessment of whether the supply of the product would infringe the basic patent, does it make any difference to the analysis if infringement is by way of indirect or contributory infringement based on Article 26 of the Community Patent Convention, enacted as s.60(2) Patents Act 1077 in the UK, and the corresponding provisions in the laws of other Member States of the Community?"

An additional question might have been

"If the criteria includes indirect infringement shall the SPC be invalid if the basis upon which the secondary infringement is positive, as described in the SmPC and PIL, is later removed by amendment after grant of the SPC"!