European IP Bulletin - Issue 79, April 2011

PATENTS

Gedeon Richter plc v Bayer Schering Pharma AG: "Obvious to Try" and "Fair Expectation of Success"

In Gedeon Richter plc v Bayer Schering Pharma AG [2011] EWHC 583 (Pat), Gedeon Richter plc applied to have two divisional patents belonging to Bayer Schering Pharma AG revoked for invalidity (the '301 and '069 patents). One of the grounds of invalidity was that the patents were obvious in respect of four items of prior art.

The patents were for the combination of two steroidal hormones, ethinylestradiol (EE) and drospirenone (DSP), both of which regulate the female menstrual cycle and are used as a contraceptive. Both patents under examination were aimed at finding an effective and safe formulation of the hormones in the development of an oral contraceptive pill. They were directed towards a skilled formulation team working specifically in the area of the development of oral contraceptives.

Both sides in this case were agreed that there was nothing inventive per se in embarking on in vitro pre-formulation testing to determine the physico-chemical characteristics of the ingredients concerned. Such tests would be performed in ignorance of the results of the testing and in ignorance of whether any particular formulation strategy would have a fair expectation of success. But they would nevertheless be an obvious thing to do. They were said to be obvious because the evidence showed that the skilled person would do them anyway, as part of his routine work. The question was, however, how would the skilled person proceed after having undertaken such obvious tests? This question would, Floyd J said, involve more in the way of a value judgment. Further, he said, the mere fact that such further steps could be characterised as being performed in order to make an informed decision did not prevent those steps necessarily from contributing to a finding of inventiveness.

Floyd J summarised the case law on obviousness and looked also at the "obvious to try" test.

"Where, therefore, the evidence reveals that to arrive at the invention, the skilled person has to embark on an experiment or series of experiments where there was no fair expectation of success, the conclusion will generally be that the invention was not obvious. Mr Thorley submitted that one had to distinguish between experiments which were conducted in order to make an informed decision as to what to do, and experiments which are conducted only because it is believed that they will produce the desired end result. The former type could be obvious experiments to do, notwithstanding that they were performed without any prior knowledge of the result, or whether the result would predict a successful outcome of the whole project. There was an independent motive for driving the project forward, namely to find out whether a solution to the problem was possible."

Further, in Floyd J's view, there was no general rule: the guiding principle must be that one has to look at each putative step that the skilled person is required to take and decide whether it is obvious. Even then, he said, one has to step back and ask an overall question as to whether the step by step analysis, performed after the event, may not in fact prove to be unrealistic or driven by hindsight.

The expert witnesses differed in their analysis of what steps the skilled person would take after having undertaken the in vitro tests to determine the rate of dissolution in an acidic environment. The expert witness for the Defendant said that he would take the results of dissolution to mean that an enteric coat (a layer added to oral medications to allow the active ingredient to pass through the stomach and be absorbed in the intestine) needed to be adopted and that he would not take an immediate release formulation (i.e., an uncoated ingredient) into animal trials. The expert witness for the Claimant said, however, that he thought it would be prudent to proceed to an animal model to assess the relative merits of both an uncoated and a coated formulation.

Floyd J was not able to conclude that it would be routine to do animal tests on an uncoated formulation. It would, he said, be a matter for the skilled judgment of the formulator. Therefore, it was not, in Floyd J's view, obvious on the basis of the information acquired by in vitro testing. Further, it would not be a step that the skilled person would be able to take with the necessary "fair expectation of success". The skilled formulator would have well in mind, he said, that success in this field included near certainty of efficacy in all patients. The difficulties likely to be encountered if the drug were allowed to pass unprotected into and through the stomach would not, therefore, be productive of confidence.

However, while claim 1 of the '301 patent and claim 6 of the '069 patents were not found to be obvious, Floyd J found that the two claims that set out the steps taken to improve the rate of dissolution by surface coating inert particles with DSP or by spraying were obvious. Floyd J found that it would be obvious to a skilled person to surface coat inert particles in order to achieve a better dissolution rate. As for spraying, this was found to be part of the common general knowledge for achieving rapid dissolution of a poorly soluble ingredient. Therefore, these claims were both found to lack inventive step.

COPYRIGHT AND DATABASE RIGHT

Football Dataco Ltd v Sportradar GmbH: Copyright and Database Right Infringement and Jurisdiction

Allowing Sportradar's appeal in part, the Court of Appeal of England and Wales has ruled that Dataco's copyright claim in relation to a database of football statistics failed because what was allegedly copied was "mere data", not the database itself. Lord Justice Jacob, however, dismissed Sportradar's appeal on jurisdiction over database right infringement claims insofar as they were based on allegations that Sportradar were joint tortfeasors with its UK customers. Further and most significantly, on the question of primary infringement by Sportradar of Dataco's database rights, Jacob LJ has decided to refer the reutilisation issue to the Court of Justice of the European Union (CJEU).

Background

Dataco creates and exploits data relating to football matches in the English and Scottish leagues. Sportradar provides live scores, results and other statistics relating to football and other sports, including UK football matches, to the public via the internet. A number of Sportradar's customers provide betting services for and aimed at the UK market. In Football Dataco Ltd and others v Sportradar GmbH and another [2010] EWHC 2911 (Ch) Dataco argued that Sportradar copies data from Dataco.

Sportradar denied copying and commenced proceedings against Dataco in Germany, seeking declarations that its activities did not infringe Dataco's rights. Sportradar contended that the English proceedings did not disclose a "good arguable case" against the company and so the German court is the court first seised with the dispute.

Decision

Copyright Claim

Jacob LJ accepted Sportradar's submission that the data alleged to have been copied (goals, goal scorers, etc.,) were matters of fact that were precluded from copyright protection as mere "contents" of a database. It followed, therefore, that when the proceedings started, the English court was not seised of a claim in copyright to the necessary standard.

Database Right: Joint Tortfeasorship

The issue here was not subsistence of database rights but whether Dataco's claim identified properly any cause of action justiciable in the English courts.

Jacob LJ agreed with Dataco's submissions, finding that the English courts were first seised of the dispute insofar as Dataco's claim alleged that Sportradar was joint tortfeasor with businesses in the United Kingdom over which the court had jurisdiction. If Dataco was right about copying, it was arguable clearly that Sportradar and its customers were acting in concert to enable access in the United Kingdom to the copied data.

Database Right: Primary Infringement

On the question of primary infringement, Jacob LJ decided to refer to the CJEU questions on the meaning of "reutilisation" under Article 7.2 of the Database Directive (96/9/EC). Dataco's claim of primary infringement by Sportradar turned on the definition of infringement in the Directive, which includes transmission.

Transmission over the internet, in Dataco's submission, involves both the acts of hosting the website and also the act of the user in accessing it. Sportradar's case is that acts of transmission occur only in the place from where the data emanates. Jacob LJ decided that "this very important and difficult question" should be referred to the CJEU.

Comment

Dataco's claim that Sportradar is directly liable for breach of database right is now stayed pending the outcome of the reference to the CJEU, whilst its claim in joint tortfeasorship, which is not dependent on the questions asked, is allowed to proceed. Given the far reaching consequences of a decision that transmission can "occur" where the user accesses the information, the CJEU's view is eagerly anticipated.

TRADE MARKS

Annette Campbell and Bente Zaber v Catherine Hughes (IAN ADAM): Name of Recently Deceased Famous Individual and Bad Faith

Overturning the decision of a hearing officer of the UK Intellectual Property Office, Geoffrey Hobbs QC has held that an application to register the name of the well known deceased voice coach Ian Adam by his former business associate had been made in bad faith (Annette Campbell and Bente Zaber v Catherine Hughes (IAN ADAM) [2011] BL O-094-11).

Background

Catherine Hughes, an assistant to Mr Adam, provided voice training services to clients at his studio, often standing in for Mr Adam. Shortly after Mr Adam's death, Ms Hughes applied to register the name IAN ADAM as a UK trade mark in Class 41 covering, "Education; providing of training, voice training, voice coaching; voice...