The limitations of the European Patent Office—in the view of the English appeal court

01-01-2010

Jacqueline Needle

Recent decisions have seen the English Appeal Court criticise the decision-making process of the European Patent Office. Jacqueline Needle looks at the implications.

Recent decisions have seen the English Appeal Court criticise the decision-making process of the European Patent Office. Jacqueline Needle looks at the implications.

Introduction

Practitioners in the UK had generally been led to believe that the English courts would defer to the European Patent Office (EPO) wherever possible. However, in recent cases, the English Appeal Court has found itself, and the lower courts, to be better equipped than the EPO to deal with cases requiring an evaluation of facts. The Appeal Court has therefore declared that it will give no deference to the findings of the Technical Boards of Appeal of the EPO for cases that are ‘fact-sensitive’.

Furthermore, the English Court of Appeal has also suggested that the ‘problem and solution’ approach, much used by the EPO when considering obviousness, should be considered to be an ‘administrative tool’ only—one that does not necessarily lead to the ‘correct’ answer.

English trials versus the EPO

In Eli Lilly v. Human Genome, the Court of Appeal considered the validity of Human Genome’s European patent (UK) No. 0939804. The court held the patent, which sought to protect a gene sequence, to be invalid, not capable of industrial application and insufficient. By contrast, the Technical Board of Appeal (TBA) of the EPO had upheld the European patent, after opposition, on the basis of more restricted claims.

In giving the judgment of the Court of Appeal, Jacob LJ considered the decision-making process in the English courts and at the EPO, and explained why the English court had felt able to come to a decision at variance with that of the TBA.

English trials

As noted by Jacob LJ, first instance trials in England involve intensive investigation and testing of evidence, with resultant high costs. There is disclosure of the parties’ documents and evidence from expert witnesses, and the evidence is tested by the process of cross-examination. The judge not only has expertise in patent law but considerable general technical expertise.

Furthermore, independent technical experts can be involved. For example, in this particular case, the Court of Appeal used a scientific advisor from King’s College, London.

At the EPO

By contrast, the opposition procedure at the EPO is purely ‘administrative’. There is no crossexamination and no compulsory disclosure of documents. There is also much more latitude for the admission of fresh material on appeal. So, in the English courts, the Court of Appeal generally concerns itself with determining whether the judge at first instance made errors in coming to the decision.

There is no rehearing of the case. However, at the TBA, there can be a complete rehearing. In this particular case, the TBA permitted 700 pages of new evidence to be admitted just three weeks before the oral hearing.

Jacob LJ therefore concluded that whilst decisions of the TBAs on questions of law were of immense importance, where a case was fact-based, the courts were far better placed to assess the facts. He said:

“In the UK the key importance of the TBAs’ case law is well settled. We follow any principle of law clearly laid down by them, only reserving the right to differ if we are sure that the commodore is steering the fleet on to the rocks.

“I do not see why the English court’s intense fact finding and evaluation process should give deference to the findings of evaluations of fact by the TBA in other cases.”

Susceptible of industrial application

The European patent disclosed the nucleotide and amino acid sequence of a novel member of the TNF ligand superfamily, which it called Neutrokine-a. The patent identified the polypeptide as a member of the TNF ligand superfamily and included a long description of its activities and uses. The description, however, was not supported by any data obtained from in vitro or in vivo studies.

The English courts thought the patent was essentially a prediction based upon what was known about other members of the TNF superfamily.

In determining that the invention in this case was not susceptible of industrial application, and hence that the patent was invalid, Jacob LJ commented:

“The upshot, stated broadly, is that you can patent an isolated gene sequence but only if you disclose the industrial application of the protein for which it encodes. However clever and inventive you may have been in discovering a gene sequence, you cannot have a patent for it or for the protein which it encodes if you do not disclose how it can be used.”

The Court of Appeal reviewed the decision of the TBA in great detail. The court decided that the board’s decision depended on its assessment of the facts, and not on any principle of law, and hence that the court was entitled to come to a conclusion opposite to that of the EPO.

Obviousness in the courts and at the EPO

Actavis v. Novartis is another decision from the English Appeal Court in which the decision-making processes of the EPO were considered. In this case, the English courts concluded that the claims of Novartis’s European patent (UK) No. 0948320 were obvious. In upholding the judgment of the lower court, the Court of Appeal considered the proper test for obviousness, and concluded that the problem and solution approach used by the EPO had its own problems.

“In the English courts, the Court of Appeal generally concerns itself with determining whether the judge at first instance made errors in coming to the decision. There is no rehearing of the case.”

The claims of the patent related to sustained-release pharmaceutical compositions comprising a water-soluble salt of fluvastatin as an active ingredient. The claims required that the active ingredient be released from the sustained formulation over more than three hours. The prior art showed that fluvastatin was a known statin. Fluvastatin sodium was also known, and the concept of sustained release was well known and well understood.

Deciding obviousness in the English courts

In giving judgment, Jacob LJ considered the law of obviousness and explained the structured approach that is generally to be used. This was set out in the earlier case, Pozzoli v. BDMO, which provides four steps, as follows:

  1. (a) Identify the notional ‘person skilled in the art’
    (b) Identify the relevant common general knowledge of that person
     
  2. Identify the inventive concept of the claim in question or if that cannot readily be done, construe it
     
  3. Identify what, if any, differences exist between the matter cited as forming part of the ‘state of the art’ and the inventive concept of the claim or the claim as construed
     
  4. Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps that would have been obvious to the person skilled in the art or do they require any degree of invention?

The problem and solution approach to obviousness at the EPO

At the EPO, and as set out in its guidelines, an examiner should normally apply the problem and solution approach, which has three main stages, as follows:

  1. Determine the ‘closest prior art’ 
     
  2. Establish the ‘objective technical problem’ to be solved, and
     
  3. Consider whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to the skilled person.

Jacob LJ had comments on the problem and solution approach. He noted that it is not the only way to consider obviousness although, for this case, he thought the approach was useful.

He thought stage 1 of the approach was simply a tool for assisting the EPO. At the EPO, an opposition attack may involve a very large number of pieces of prior art. In practice, it is extremely useful to identify, and focus on, just a single prior art document.

However, as that single prior art document may not have been known to the inventor at the outset, establishing the ‘objective technical problem’ may require some reformulation of the problem. The European guidelines acknowledge that the problem may not appear in the patent and may have to be reformulated.

Jacob LJ commented:

“For myself, I think the reformulation—which really means retrospective construction—of a problem is perhaps the weakest part of the PSA [problem and solution approach]. It will be noted that with the Pozzoli/Windsurfing approach, once one has finished the orienting step 3, the question is simply left open: is the invention obvious? There is no attempt to force the question into a problem/solution.

“Another aspect of obviousness which is not readily answered by the PSA is illustrated by the 5¼ inch plate paradox. This runs like this. Suppose the patent claim is for a plate of diameter 5¼ inches. And suppose no one can find a plate of that particular diameter in the prior art. Then (a) it is novel and (b) it is non-obvious for there is no particular reason to choose that diameter. The conclusion, that the plate is patentable, is so absurd that it cannot be so.

“What then is the answer to the paradox? It is this: the 5¼ inch limitation is purely arbitrary and non-technical. It solves no problem and advances the art not at all. It is not inventive.”

Jacqueline Needle is a partner with London firm Beck Greener. She can be contacted at: jneedle@beckgreener.com

EPO, English appeal court, gene patents, invention, biotechnology

WIPR