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HGS v Lilly: Day 2

HGS’s patent for Neutrokine-a contains a “lot of guff” according to Lord Justice Neuberger – but should that invalidate the patent?

That was the key question discussed during the second day of the UK Supreme Court's hearing in HGS v Lilly.

While the judge described the language relating to industrial application as “guff”, HGS’s barrister, Simon Thorley QC preferred to call it “scientific hopes for the future”.

HGS’s Neutrokine-α patent includes many projections of what the uses of the invention could be. Lilly, which challenges the patent's validity, argues that these are too numerous and too far-fetched and that it is unclear to the reader what the actual industrial applications are.

“They frankly threw everything in,” Andrew Waugh QC, who represents Lilly, told the Court today. “They wanted to keep their options open,” he added.

Waugh argued that equal measure and conviction had been given in the patent to all the unproven activities of Neutrokine-α as well as the activities expected from the general knowledge, so the reader could not easily identify its industrial application.

Neuberger asked whether the EPO Technical Board of Appeal (TBA) was aware of this in its 2009 decision to uphold the patent, to which Waugh replied “I wish they were”, which raised a few chuckles in the courtroom. Waugh added that he was not instructed to point this out to the TBA.

The judge highlighted the difficulties arising from the differences between the European and domestic patent systems. He said this was one of problems with hearing the same case in “different courts with different evidence”, and why there has been a push for a unitary patent system in Europe.

Lord Justice Chance added that there is, however, “the opportunity for more detail in the national courts than the TBA”, which does not allow for witnesses to be called or cross-examination.

There seems to be a divergence in opinion between the judges though, as Lord Justice Clarke remarked earlier, “it’s the same ball game, same players and the same materials”.

This morning, Thorley finished presenting HGS’s case from 10.30am until 12pm. He emphasised that “the facts are the same, though the legal judgment is different”, between the England & Wales courts and the EPO TBA.

He remarked that the rulings of Lord Justice Kitchin and Lord Justice Jacob were either “both right or they are both wrong”.

In closing HGS’s appeal, Thorley described the three levels of protein function, identified from the ZymoGenetics case (T0898/05) that can indicate potential industrial application.

“Any one of these three levels is acceptable” said Thorley. “No,” interrupted Lord Justice Neuberger, saying: “Might be acceptable” a point which Thorley conceded.

Waugh later argued that finding merely one of those three levels does not give industrial application. “It might and it might not, depending on the facts”, he said.

“Are you saying that you have to have found the application?” asked Hope.

“No, you have to set the reader on their way,” said Waugh.

When HGS filed its patent “it did not know the function on any of the three levels” he argued.

Thorley and the judges discussed what level of proof is necessary to describe potential therapeutic effects in a gene patent. Thorley said: “If you have to prove in vivo … patenting becomes the exclusive colony of the rich” and that “identifying a cellular function is enough”.

Previous rulings in the lower courts had borrowed the phrase “immediate concrete benefit” as the test for industrial applicability from the ZymoGenetics case.

Both Hope and Clarke agreed that the phrase was an odd use of the word “immediate” to which Neuberger added that it was the sort of case where there was a “weakness or slipperiness with words”.

Thorley argued that immediate does not mean that future research is unnecessary to envisage the industrial application.

“Anybody could read a patent and say, that is concrete, that is plausible and that is a hope for the future.” The TBA took this approach, whereas the England and Wales courts have not, he said.

Neuberger asked to what extent a patent should have predictions for uses. Waugh said that they need to be “derivable in a straightforward manner and should not require a research project to elicit the function”.

Hope said that “the fact the patent claims something which ultimately doesn’t work, doesn’t matter”.

Waugh explained that the patent teaches an activity on T & B cells, which are cells of the immune system, so an immune function is expected. However, the potential industrial application of the patent “does not confine itself to immune system disorders”.

It is not in the public interest to grant a monopoly on the wide claims for antibodies to Neutrokine-α relevant to many diseases, said Waugh, who was pressed extensively by the judges today.

The hearing continues at 10.30am and is expected to conclude tomorrow.

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