Speedier patent trials in the UK – the "new" streamlined procedure

01-Oct-2005  |  Life Sciences & Healthcare

A recent decision of the UK patents court is likely to make the streamlined procedure even more common in patent cases.

Lawyers Nigel Stoate

 

Here we look at the procedure and recent case law.

What is the streamlined procedure?

The streamlined procedure is a procedure available for patent litigation in the UK patents courts.  The rationale behind the procedure is to enable appropriate cases to be brought to trial more quickly and cost effectively than under the standard procedure.

Cases under the streamlined procedure start in the normal way.  Once the case has started, any party may apply at any time for an order that the procedure be streamlined.  This will normally mean the following procedural directions will apply to the case:

  • All factual and expert evidence is in writing
  • There is no requirement to give disclosure of documents
  • There are no experiments
  • Cross-examination is permitted only on topics where it is necessary
  • The total duration of the trial will not normally be more than one day
  • The trial will be fixed for a date within 6 months of when the order for the streamlined procedure is made 

The party requesting a streamlined procedure prepares a draft order with the proposed directions, along the lines set out above, and ask the other parties to agree the order.  The procedure is designed to be flexible, consistent with the Patents Court's desire to provide a "menu" of options tailored to the individual case, and minor variants to the above directions will be allowed provided they do not compromise the overall speed and efficiency of the proceedings.

If there is agreement, the Court will usually make the order on a written application.  If there is no agreement, there will be a hearing. Although it can be heard at any time, the application for a streamlined procedure will normally be heard at the case management conference, which is required by the Court rules to be within 14 days of service of the defence.

The Court will take the following factors into account in deciding whether a streamlined procedure is appropriate:

  • Proportionality
  • The financial position of each of the parties
  • The complexity of the case
  • The importance of the case

Mayne Pharma v Pharmacia

On 17 February 2005 the Court of Appeal gave judgment in Mayne Pharma v Pharmacia, one of the first cases to be heard under the streamlined procedure in the UK Patents Court.

Mayne wished to sell an injectable solution of epirubicin hydrochloride, a cancer drug typically used to treat breast cancer, and started proceedings for a declaration of non-infringement of the patents owned by Pharmacia in the area.  The only issue in the case was the proper construction of claim 1 of Pharmacia's UK patent no. 2 178 311 and, when properly construed, whether Mayne's product satisfied one particular feature.

Claim 1 of the patent claims "an injectable, ready-to-use, sterile, pyrogen-free, [epirubicin hydrochloride] solution … which has not been reconstituted from a lyophilisate".

Lyophilisation means freeze-drying.  Mayne used freeze-dried epirubicin hydrochloride to manufacture their solution product and so the only issue to be decided was whether this meant Mayne's product was excluded, because of the disclaimer in the claim, or not.

The principles of claim construction are well established in the UK, having been the subject of a recent appeal to the House of Lords (Kirin-Amgen [2004] UKHL 46).  In short, to decide on the meaning of the claim it is necessary to construe it in the context of the rest of the patent specification, when read by the relevant skilled addressee and in light of the common general knowledge in the art. 

At trial, the Judge found in Mayne's favour, holding that the skilled addressee would understand that the patentee saw lyophilisation as an undesirable process step and intended to exclude a solution made by the use of lyophilisation; it did not matter if the lyophilisation was followed by other steps in the process. 

The Court of Appeal, however, overturned the trial Judge's decision on the basis that the patent was concerned with the formulation of a ready-to-use solution, and so it was only the previously necessary lyophilisation in the vial which was excluded from the claim.

How long did it take?

Mayne issued proceedings on 18 May 2004.  The trial was heard in October 2004 and the trial Judge gave his decision within a week of the trial.  The decision was appealed. The appeal was heard on 9 February and the Court of Appeal gave judgment, again in little more than a week, on 17 February.  The whole proceedings took less than 9 months from start to finish, including the appeal.

Conclusion

Following the decision of Mr Justice Jacob (now Lord Justice Jacob) in SmithKline v Generics [2002] 25(1) IPD 25005 it is generally accepted that, prior to launch of a generic pharmaceutical, it is necessary to take some action to "clear the way" where there are patents which might be infringed.  For the right cases, the streamlined procedure offers a fast and cost effective way of having patent issues determined before launch.

While the right to appeal a first instance decision of the UK Patents Court is no longer automatic, the case also highlights that the UK court of Appeal recognises the need to dispose of any appeal proceedings quickly as well as the trial in order to have certainty.

The Research in Motion v Inpro decision

The recent decision of Mr Justice Laddie in Research in Motion v Inpro [2005] EWCA Civ 137 is likely to make the streamlined procedure even more common in patent cases.  In this case, Research in Motion had requested the streamlined procedure in the UK in an attempt to stay infringement proceedings in Germany.  Each party accused the other "forum shopping" to get the best commercial results. 

Mr Justice Laddie stated that it is not improper for parties to "forum shop" in this way.  Also, he stated that once a party has requested a streamlined procedure the court should proceed on the basis that such a procedure is appropriate, unless there are convincing reasons why the streamlined procedure should not be used, such as the complexity of the technology involved. 

This approach, if followed, may mean the courts are more likely to view the streamlined procedure as the default position in UK patent litigation.  This will make patent litigation faster and cheaper in the UK and is likely to make the UK an increasingly attractive forum for patent litigation in Europe.

So what cases might be suitable for the streamlined procedure?

Any case, which can be dealt with simply and using the procedural directions outlined above will be suitable for the streamlined procedure, but examples could include:

  • Construction of a claim, perhaps having simple written or numerical limits
  • Infringement: clear cases of infringement (or non-infringement)
  • Revocation: anticipation by written description; or clear case of added matter.

Nigel Stoate and Matthew Jones

Taylor Wessing London

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