Thursday 16 December 2010

When can a third party gain access to documents from discontinued litigation?

In Pfizer Health AB & another v Schwarz Pharma AG & others [2010] EWHC 3236 (Pat), a Patents Court for England and Wales decision of Mr Justice Floyd, the court had to consider whether a third party -- which was commercially active in a technical field relating to that of certain patents which had been the subject of discontinued litigation -- was entitled to obtain copies of documents from the court file relating to the patents' validity, where the third party maintained it had a legitimate interest in seeing the grounds on which those patents had been attacked.

In this case a law firm, Strickland, sought permission to obtain copies of documents from the court file in both a patent action and counterclaim in an action between Pfizer and Schwarz. The main proceedings, being a claim for infringement of two patents relating to a medicinal compound for treating urinary incontinence, had been stayed and then discontinued with the exception of an application to amend the specification of one of the patents; the amendment proceedings were also discontinued.  Strickland, who represented a client who wished to know of documents having a bearing on the validity of those patents in order to determine its freedom to act in that technical area, sought disclosure of the pleadings (defence, counterclaim and amended counterclaim for invalidity and the grounds and amended grounds of invalidity), applications for directions and documents relating to "experiments".

Floyd J granted the application.  While there was no unfettered right to gain access to documents on the court file in situations not provided for by the Civil Procedure Rules, the function of the requirement to seek permission was a "safety valve" to allow access to documents which should in all the circumstances be provided.  In his view the principle of open justice was a powerful reason for allowing access to documents where the purpose was to enable it to be seen that justice was done.  However, where that was not the purpose but the documents had nevertheless been read by the court as part of the decision-making process, the court should lean in favour of disclosure if a legitimate interest could still be shown for obtaining the documents.

A party who was commercially active in a technical field to which a patent related had a legitimate interest in seeing the grounds on which a patent was attacked, since sight of the documents would help the third party make sensible commercial decisions and might deter him from taking legal action or save him considerable time, effort and money in locating relevant prior art.  The re-amended grounds of invalidity were relevant to this, so Strickland would be permitted to copy them from the court file.

The application for directions had included witness statements from a solicitor acting for the patent proprietor and an expert employed by it.  Since it could be assumed that those statements had been read by or to the court on the application, Strickland would be permitted copies of them too as they had a bearing on the validity of the patent in question and Strickland had established a legitimate interest in having such copies.

There was no reason why Strickland should be permitted to obtain any of the publicly available material exhibited in relation to those statements -- they could be obtained from public sources. While the statement of grounds in the amendment proceedings was likely to be available from the UKIPO, the court was prepared to order disclosure of that too.

The judge summarised the principle of allowing access to the documents in this case as follows.
"28. This is not a case where the third party can contend that it is interested in seeing whether justice was done in the main proceedings, far less monitoring that process while it is taking place. I would, however, accept straightaway that a party who is commercially active in a technical field to which a patent relates has a legitimate interest in seeing the grounds on which a patent is attacked. Sight of these documents will help the third party to take sensible commercial decisions. It may in some cases deter him from taking legal action. In other cases it may save him considerable time and effort and money in locating relevant prior art"

1 comment:

Norman said...

A very similar issue has been raised in Canada. We have a system in which, prior to receiving regulatory approval to market a particular drug, a generic drug manufacturer must address all patents listed against that drug by alleging either invalidity of the listed patent or non-infringement. (This is based on the US Orange Book system.) This amounts to a mini-trial of the patent validity. The initiating document specifying the allegations of invalidity, is called a “Notice of Allegation” (NOA). In Pfizer Canada Inc. v. Novopharm Ltd. / pregabalin (NOC), 2010 FCA 258 affm’g 2010 FC 668 affm’g 2010 FC 409, Novopharm moved to have its NOA declared confidential, arguing that otherwise other generics would be able to free ride on the investment made by Novopharm in preparing the NOA. There is an obvious irony in this argument coming from a generic. The confidentially motion was denied at all levels.

A couple of quotes give the flavour:

FC [4] Novopharm submits that it has made a substantial investment in the preparation of its NOA and that it has consistently treated and maintained that NOA as confidential. The evidence indicates that Novopharm incurred approximately $200,000.00 in costs to prepare its NOA. That investment was made to assist Novopharm “to be a very close second, if not the first, generic [drug manufacture] to obtain an NOC for its pregabalin product.”

FCA[4] Novopharm alleges that its competitive position as potentially the first or second generic pharmaceutical company on the market with pregabalin would be prejudiced by the disclosure of its NOA to its competitors, who could copy Novopharm’s NOA when applying for their own NOC for pregabalin. In this way, competitors would obtain for free the benefit of the considerable effort and resources that Novopharm has devoted to producing its pregabalin NOA.