Representing Lilly, which is challenging the validity of HGS's patent for Neutrokine-α, Andrew Waugh QC told the court that the EPO Technical Board of Appeal (TBA), doesn’t investigate matters as profoundly as the domestic courts.
“Judgments are delivered after only a short adjournment and following what is normally only a day and a half ”, he said. The boards also have a “lax approach to late admissions [of documents]”, and very rarely call expert witnesses, he added.
Referring to the EPO’s decision to uphold HGS’s patent for Neutrokine-α, Waugh said: “We are not appealing the TBA.”
One of the five judges, Lord Justice Neuberger, interjected: “So what you are saying is that a) the evidence is different and b) the evaluation of the evidence is different”.
Lord Justice Clarke asked whether the case was put differently by HGS at the TBA. Waugh simply stated: “There was different evidence.”
In reply, Simon Thorley QC representing HGS said that he had read though the TBA submission from Lilly and there was substantially “no difference in submissions”. He added that the TBA had Mr Justice Kitchin’s 2008 judgment and supporting documents and even referred to them in the written decision (T18/09).
Waugh had yesterday retorted that he wished evidence of the kind within Kitchin’s judgment were presented at the 2009 TBA hearing.
From the previous day’s proceedings an analogy of wheat and chaff was used to describe what the patent was actually getting at and what was just “guff”, as referred to by Neuberger.
Thorley remarked that in Kitchin’s 2008 ruling, the judge could see what was obscured by the chaff. “He did see wheat,” said Thorley, “but he regarded the quality of the wheat as too poor.”
“The question is: was the standard right or wrong?” stated Thorley – to which Neuberger nodded.
The key question for the Court is whether the patent meets the industrial applicability requirement. Thorley asked the court to consider why HGS was looking for a member of the TNF family in the first instance. He said it was because they “hope and expect” it will have a therapeutic benefit and “that is enough [to satisfy Article 57]”.
Isn’t “maybe” a better word than “is”, suggested Lord Justice Hope. “It is susceptible [of industrial application]”, responded Thorley.
Neuberger retorted that speculation on industrial activity does not count, while an “educated guess” does. Thorley agued that “one man’s speculation is another man’s educated guess”, and that it was certainly a low-level test.
In the morning session, Waugh explained to the court that HGS’s approach was to find a gene, file a patent as soon as possible and then spend one to two years researching the activities of the protein encoded by the gene.
This post-filing research led to a paper in Science from HGS, which indicated only B-cell activity and not T & B cells.
The paper had 22 authors and essentially took 44 man-years to research, said Waugh, in an effort to convince the judges that this does not equate to an immediatelyobvious industrial application at the time of filing.
“If ever there was a clear example of a vague patent, this is it,” he said. “Computational bioinformatics allowed them to clone these genes without any indication as to what it does”.
“This is what Biogen, Lilly and ZymoGenetics were doing at the time anyway,” he said, adding that HGS simply tried to file first.
Hope pointed out that it was “curious” why Lord Justice Jacob’s opinion at the Court of Appeal (2010) did not mention the three levels of protein function, which may indicate industrial application. “This is important”, the judge said.
However, Waugh said it didn’t matter, because the patent fails on all three levels.
In Monday’s hearing, Thorley had remarked that the lower courts’ judges had aligned themselves with US law on industrial applicability, which “undoubtedly sets a higher standard”.
In response, Waugh today tried to highlight the similarities between the the US Section 101 and EPC Article 57 rules on industrial applicability saying that both conform to the TRIPS agreement. He was interrupted by Clarke though, who said “what’s the purpose of this, why don’t we just apply the EPO?”
During the closing arguments, Waugh stated that Kitchin’s original 2008 judgment was “entirely correct and fair”, to which Hope added “and the Court of Appeal endorse what he said”.
Thorley said that for the patent to meet the EPO criteria on industrial applicability: “What more is required?”
The judges’ decision in the case is expected some time before the end of this year.
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