A case for the streamlined procedure - Lyophilization Articles & Reports

A case for the streamlined procedure
Julian Hitchcock
21 March 2005
Mills & Reeve
A recent swift conclusion to a patent claim in the Court of Appeal could herald more patent litigation in the UK, say Lino Di Lorenzo and Julian Hitchcock of Mills & Reeve.
On 17 February 2005, the Court of Appeal held that a ready-to-use anti-cancer drug manufactured by Mayne Pharma infringed a patent held by Pharmacia Italia SPA.
Pharmacia Italia SPA owned the UK patent for an injectable, ready-to-use anthracycline glycoside solution 'which has not been reconstituted from a lyophilizate'. Lyophilization is essentially freeze-drying. Mayne Pharma produced an injectable, ready-to-use anthracycline glycoside solution. However, the anthracycline glycoside salt from which they reconstituted the solution had previously been freeze-dried in bulk. Mayne added water and put the resulting solution in vials.
Mayne Pharma applied to the High Court for a declaration of non-infringement under s. 71 Patent Act 1977, arguing that as their product was reconstituted from a lyophilizate, it fell outside the scope of Pharmacia's patent. The High Court agreed. It found that the patent was not intended to cover solutions prepared where lyophilization was any step in the process. The whole teaching of the patent was about avoiding the need for a lypohilizate altogether.
Pharmacia Italia SPA appealed. The Court of Appeal had to determine what 'which had not been reconstituted from a lyophilizate' actually meant. In doing so, the Court of Appeal applied the Kirin-Amgen judgement (see Construing patents after Amgen v TKT, the Biolines article of 24 January 2005), holding that claims should be read in their context, and that, in the case of any ambiguity, the description and any drawing should be used to determine the inventor's purpose. However, if the patent contained an obvious and deliberate limitation, then that limitation 'must have a meaning'. But what?
The court considered that the notional 'person skilled in the art' was a pharmaceutical manufacturer who had the knowledge of how to make the end product. He would be aware that lyophilisized anthracycline glycoside hydrochloride is very toxic. He would see that the real point of the teaching in the patent was the provision of a stable, ready-to-use solution.
Such a highly desirable product was not available before the patent filing date. In order to fall outside the claim of the patent, it was this ready-to-use solution which must not be reconstituted from a lyophilizate. It made no difference if the raw material itself was a lyophilizate as in this case. Mayne's injectable solution therefore did infringe Pharmacia's patent.
What was remarkable about this case was that not only was it the first Court of Appeal decision to apply the Kirin-Amgen principles, but that it took just nine months from the start of the claim for the case to run through both the High Court and the Court of Appeal.
The Judge commended this use of the streamlined procedure, and the parties in this case had taken full advantage of it. Despite the rapid progress through the courts, however, the Court of Appeal deplored the extraordinary number of files of paper produced. Only two pages were referred to in the appeal and Lord Justice Jacob said that this would be taken into account in making an award for costs.
The streamlined procedure was formally introduced in April 2003 to make the best use of court resources and to make patent litigation quicker and cheaper. This followed a growing concern that patent litigation would drift to more 'efficient' European courts, such as in Germany.
A case is made subject to the streamline procedure by court order, with or without the agreement of the parties. Whether this is appropriate is up to the court and will depend on a number of factors, including the complexity of the case and the financial position of both parties.
Streamlined cases will be limited to written evidence, and there is no need to disclose vast quantities of documents. There will also be no experiments. Trial will usually be set down within six months and will not normally last longer than a day.
The fact that this appeal was heard only three months after the High Court decision is a clear indication of the success of the streamlined procedure. In non-streamlined cases, appeals tend to be heard in about a four to nine-month window unless there are grounds for expediting it.
Given the greatly reduced timescales and costs, the streamlined procedure should be considered by both parties at the outset of a claim such as this. This decision shows that patent claims can be dealt with quickly and efficiently in the English courts. We could see a growth in patent cases being determined in the UK as a result.