Last year was notable in the field of patent litigation in that the House of Lords, who normally hand down patent decisions at the rate of one every five or so years, took the opportunity of clarifying the law on construction and insufficiency in Kirin-Amgen v TKT (21 October 2004) and the patentability of collocations in Sabaf v Meneghetti (14 October 2004). Indeed, there is even one more case in the pipeline for later this year concerning anticipation (Synthon v GSK). Important though these decisions obviously are to both practitioners and industry alike, as important is the way in which litigation is being conducted at the “coalface” in the lower courts. This article considers some important developments in the way patent litigation is being conducted in the UK in the light of the first and second instance cases decided in 2004 and apparent.
Summaries of the decided first and second instance cases themselves are set out in tables 1 and 2 below respectively.
Some general comments
Under Fysh HH’s control, the Patents County Court (PCC) is now well and truly rehabilitated. Two of the first instance decisions are from the PCC and the first appeal from one of Fysh HH’s PCC decisions (Unilin v Berry) was heard by the Court of Appeal last July – his decision that the patent was valid and infringed was upheld (albeit on a narrower construction of the main claim).
Four pharmaceutical patents were litigated in the High Court – in CIPLA v Glaxo (salmeterol/ fluticasone propionate) the patent held invalid for obviousness; in Sandoz v Roche (EPO formulation), the patent was held valid; in Mayne v Pharmacia (epiribicin), the patent was held not to be infringed; and in Abbott v APS et al (clarithromycin), the patent was held invalid on the basis of added matter and lack of priority and an intervening anticipation. The last two decisions are the subject of pending appeals. In CIPLA, both the Judge and the Court of Appeal refused permission to appeal, a matter discussed in more detail below.
Each of the three new judges who have been assigned to hear patent cases (Patten J, Mann J and Lewison J) heard a trial and the feedback on all three of them is very positive.
Jacob LJ has only had the opportunity of hearing three patent cases since his elevation to the Court of Appeal in the summer of 2003, but the early signs are encouraging, at least for patentees – all three patents in suit under appeal were held to be valid and, in two of the cases, he overruled the first instance judges’ findings of invalidity.
Some important developments
Interim Injunctions remain a threat to market entry, at least in the pharmaceutical field: In SKB v Generics (2003 FSR 31), the Court of Appeal endorsed the first instance court’s approach that it was incumbent on new entrants to a particular market to “clear the path” of any patent obstacles ahead of time or face the prospect of an interim injunction.
The decision of Pumfrey J in Abbott v APS illustrates the difficulty faced by generic entrants to the pharmaceutical market, even in the absence of a need to clear the path ahead of time - in the Abbott case, the patent in suit had only been granted 4 or so months prior to the date on which the regulatory data exclusivity period expired. Fortunately for the defendants in this case, the Judge held, on an application for summary judgment, that the patent in suit was invalid on the ground of an intervening disclosure (the claim to priority having been lost) and added matter. The cautionary note for future aspiring market entrants in this field, however, is the comment from the Judge that had he not held the patent invalid, then even though the patent was weak, he would still have granted the injunction. In other words, the weakness of the patent was not sufficient to shift the balance of convenience in the defendants’ favour. In the pharmaceutical sector, or indeed any industry sectors, where competition is likely to lead to price depression, the weakness of the patent in suit cannot therefore necessarily be relied upon to assist a defendant in resisting the grant of an interim injunction.
Trials become quicker: In April 2003, the Practice Direction governing the conduct of actions in the Patents Court and the Patents County Court was amended so as to introduce a so called “streamlined procedure” for patent actions. The Practice Direction states that:
“A streamlined procedure is one in which save and to the extent that it is otherwise ordered:
- all factual and expert evidence is in writing
- there is no requirement to give disclosure of documents
- there are no experiments
- cross-examination is only permitted on any topic or topics where it is necessary and is confined to those topics
- the total duration of the trial fixed and will normally be not more than one day
- the date for trail will be fixed when the Order for a streamlined procedure is made and will normally be about six months thereafter.”
A streamlined procedure also includes minor variants of the above (eg, disclosure confined to a limited extent)”
A streamlined procedure can be ordered either by agreement between the parties or by the court where the application of the so called overriding objective indicates that it is appropriate. There is also a duty placed on the legal advisors to the parties to a patent action to draw the availability of a streamlined procedure to their client’s attention. This duty was emphasised recently in Generics v Merck (2004 RPC 607).
The importance of the streamlined procedure, however, is that it is providing a reference or starting point for the parties and the judge at the first Case Management Conference. Whereas in the past, it tended to be taken for granted that parties would be given the benefit of disclosure, the opportunity to carry out experiments and involve several experts, nowadays in the light of the streamlined procedure, there is a tendency for the Court to ask the parties why they should be given the benefit of disclosure, experiments or more than 1 expert. The result in practice is less disclosure, fewer experiments and speedier and shorter trials in the majority of cases.
Thus, Sandoz v Roche (a pharmaceutical patent revocation action) came to trial six months after the CMC, both Mayne v Pharmacia (a pharmaceutical patent non-infringement action) and Saint-Gobain v Fusion (a chemical patent non-infringement action) came to trial within five months of the Claim Form being issued, and Agilent v Waters (a mechanical patent infringement action) came to trial within nine months of the Claim Form being issued.
Appealing becomes harder: The scope for an unsuccessful litigant in a patent action to appeal against an unfavourable first instance judgment is becoming ever more difficult. It used to be the case that the unsuccessful litigant had a right of appeal to the Court of Appeal against a final judgment and although deference was accorded to the Judge’s findings of primary fact, in practice, the appeal was by way of a de novo rehearing on the transcripts of the evidence rather than a judicial type review.
In May 2000, following a review of the civil appeal system, the procedural rules were amended in two important respects. First, appeals against final judgments could no longer be brought as of right, but required the permission either of the first instance court itself or failing that the Court of Appeal. Second, other than in exceptional circumstances, appeals were to be limited to a judicial type review of the first instance court decision. The impact of these changes has now started to be felt in practice in patent cases.
The fact that virtually all appeals are now limited to a review of the first instance decision means that for a decision which “involves the application of a not altogether precise legal standard to a combination of features of varying importance, …an appellate court should not reverse a judge’s decision unless he has erred in principle” (per Lord Hoffmann in Designers Guild v Russell Williams  1 WLR 2416). Thus, reversing a first instance finding on obviousness (which “involves the application of a not altogether precise legal standard to a combination of features of varying importance”) requires the appellant to establish that the first instance judge has made an error of principle. In many cases, this is going to be a difficult hurdle to overcome. In fact it was overcome in both Rockwater v Technip and SKB v Apotex – in both cases Jacob LJ overturned first instance findings of invalidity based on obviousness. In Unilin v Berry, the appellants (defendants) did not even raise the issue of obviousness at the appeal hearing itself, presumably because they realised that, on the basis of the first instance judgment, they would be an insurmountable hurdle to overcome.
When the requirement for permission to appeal against a final judgment was first introduced, it was generally thought that permission in patent cases would (should) be given by the trial judge as a matter of course. The Court of Appeal decision in Teva v Merck (CITATION) at the end of 2002 started to change all that. The Court of Appeal in that case strongly criticised the appellant (patentee) for not clearly identifying in its Grounds of Appeal the points of principle on which the judge was alleged to have erred. Indeed, the Court advised that this should in future be done at the permission stage. Just under a year later, in Generics v Merck (a case concerning construction and infringement) permission was refused for the first time by both the first instance Judge (Laddie J) and the Court of Appeal. Then, earlier last year in CIPLA v GSK (a case concerning obviousness) permission was again refused by both the first instance Judge (Pumfrey J) and also the Court of Appeal.
The efforts being made by the first instance judges to “streamline” actions which involve fewer legal issues and/ or require less or no disclosure or experiments and bring them to a conclusion within a six to nine month time frame is to be applauded. Indeed, in the majority of cases, parties are obtaining a result more quickly (and therefore in most cases, more cheaply) than was previously the case. For the more legally complicated, fact intensive cases then the parties will normally be able to agree on or, failing that, persuade the Judge of the need for disclosure, experiments and possibly more than two experts.
At the same as trials are speeding up, however, appealing is becoming more difficult – for many issues the judicial review hurdle means that unless the appellant can show that the judge has gone wrong in principle, the appeal should be dismissed (assuming that permission to appeal is granted in the first place). Again, the result is that parties are obtaining a final appellate decision more quickly (and therefore cheaply) than was previously the case.
The consequence of these twin developments, however, is that, as never before, the key to successful litigation before the English Courts is preparation in terms of lawyers, experts, arguments and evidence (especially experiments) well in advance of the action starting and certainly well in advance of the first case management conference.
Table 1: Patents Court and Patents County Court judgments on validity and infringement for 2004
|17 March 04 ||Russell Finex v Telsonic||Filtering device||Laddie J||No||Not Applicable (N/A)|
|19 March||CIPLA v Glaxo||Salmeterol/ Fluticasone propionate||Pumfrey J||N/A||No - obvious|
|12 May||Machinery Developments v St Merryn Meat||Packaging device||Fysh HH||Yes||Yes|
|17 June||Sec of State for Education v Frontline||Radio link attendance system||D Young QC||N/A||Yes (partial)|
|22 July||Ultraframe v Eurocell||Conservatories||Lewison J||No||Yes|
|29 July||Sandoz v Roche||EPO formulation||Patten J||N/A||Yes|
|15 September||Burnden v Ultraframe||Conservatories||Fysh HH||N/A||No – Anticipated & Obvious|
|15 September||Ultraframe v Burnden||Conservatories||Fysh HH||N/A||No - obvious|
|08 October||Nikken v Pioneer||High Speed Tool Chuck||Mann J||N/A||No|
|01 November||Mayne v Pharmacia||Epiribicin||Wyand QC||No||N/A|
|03 November||Saint Gobain v Electrosteel||Corrosion resistant iron pipe||Pumfrey J||N/A||Yes|
|19 November||Abbott v APS||Clarithromycin||Pumfrey J||N/A||No – added matter and lack of priority|
|21 December||Agilent v Waters||HPLC pumps||Pumfrey J||No||N/A|
Table 2: Court of Appeal Judgments on validity and infringement for 2004
|01 April||Rockwater v Coflexip||No||Yes (reversing)||Yes (reversing)|
|30 July||Unilin v Berry||Yes||Yes||Yes|
|20 November||SKB v Apotex||No||No||Yes (reversing)|
First published in the March 2005 issue of Patent World.