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HGS v Eli Lilly: day 1 report

At 10.30 am today the doors to Court 1 at the UK Supreme Court were opened to hear the Court’s first patent case, Human Genome Sciences v Eli Lilly

Today saw HGS’s case put forward by barrister Simon Thorley QC. He began by stating that the crux of the hearing was to determine whether the subject of the disputed patent is capable of industrial application under Articles 52 and 57 of the European Patent Convention (EPC).

Thorley said that domestic application of the EPC is “supposed to have the same effect” as its application at the EPO.

Lord Justice Hope, one of five judges hearing the case, led the questioning. He began proceedings at 11.00 am by introducing the Court's Assessor, Dr Murphy, who will advise the judges on technical scientific points.

The judge stressed that Murphy will play no part in the decision-making process. The advisor was also present in the same function at the Court of Appeal hearing in 2010.

One of the five judges is Lord Justice Neuberger who is not a member of the Supreme Court but has considerable experience of patent cases.

The Court is hearing the case because of a perceived diversion in the interpretation of the EPC. In this case, the Court of Appeal (England & Wales) in 2010 found HGS's patent for the protein Neutrokine-α invalid for lack of industrial application while the EPO Technical Board of Appeal (TBA) in 2009 upheld its validity.

HGS, represented by Thorley, is asking the court to overturn the Court of Appeal decision.

Thorley first went through public policy relating to Articles 52 and 57 and then the drafting history of the EPC relating to industrial applicability, explaining that there were “people who wanted to exclude the biological”.

Regarding the agreed wording of the EPC, he stated that the phrase “susceptible of industrial applicability” was “intended to be an inclusive definition” and not an “immediate high standard”.

On this point Thorley argued that in the Court of Appeal hearing, Lord Justice Jacob’s interpretation of the word “susceptible” had been that of “capable” – which Thorley suggested is a higher requirement that that applied in the EPO.

The QC for HGS presented some background exemplary cases on the EPO’s approach to industrial applicability citing TBA decisions on Max-Planck (T0870/04), ZymoGenetics (T0898/05) and Genentech (T0604/04).

In these decisions, the Max-Planck appeal was dismissed because no uses for the invention were given whereas the patents were upheld in the other cases.

Thorley then discussed Mr Justice Kitchin’s interpretation of the law in his 2008 High Court judgment, which led to the patent being revoked in England & Wales.

He stated, on industrial applicability, that “the Judge is being influenced by American law, which undoubtedly sets a higher standard”. US law states that the utility of the patent must be “specific, credible, and substantial”.

For industrial applicability under the EPC, “if is it plausible then that is good enough”, said Thorley. The judge had set “too high a test”, he added.

One of the final points Thorley made today concerned the previous ruling of Lord Justice Jacob in the Court of Appeal. He said that Jacob had a “harsh approach to Article 57” and that he “aligns himself with Kitchin and Kitchin with US law”.

“Many patents include statements with scientific hopes for the future,” said Thorley. The TBA could see what was plausible and what was “scientific hopes for the future” – which expert witness Professor Jeremy Saklatvala had previously referred to as a “wish list” in Lilly’s 2006 claim for revocation.

He argued that because Neutrokine-α is a member of the TNF family and affects T & B cells at the cellular level, that was enough for both the plausible applications and the “wish list” and that “whether is it actually of use for the diseases in the wish list is an entirely different matter”.

To end the day’s proceedings Thorley took the court though the TBA’s decision in the case (T18/09) saying that the TBA “drew a distinction between the claims of the product and the use of the product” and that “the patent may go beyond the necessary” regarding potential uses, but that does not invalidate the patent.

He added that the skilled person is used to this “going beyond the necessary” in the description.

Lord Justice Clarke asked whether the UK court should see the EPO TBA ruling as “irrelevant”. Thorley responded: “There has to be good reason to substitute your own judgment for that of the EPO on the same facts.”

The hearing continues tomorrow with a further 1hr 30 mins from the appellants after which Lilly will respond.

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