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28 August 2018Big Pharma

Chugai victorious in patent royalties dispute at English High Court

Late last week, Chugai Pharmaceutical emerged victorious after the English High Court found that the Japan-based company doesn’t owe royalties under a patent licence with UCB.

Mr Justice Birss handed down the decision on Friday, August 24, concluding that Chugai’s tocilizumab product (a humanised antibody used to treat rheumatoid arthritis) doesn’t infringe US patent 7,566,771.

The patent is part of a portfolio that was licensed to Chugai by UCB in December 2007. Since January 2016, all of the patents in the portfolio have expired, except for the ‘771 patent.

According to the licence, royalties are paid on the sales of the product if it falls within the scope of one of the patent’s claims.

However, Chugai argued that its tocilizumab product, which is marketed under the brand name Actemra in the US and RoActemra in Europe, falls outside the scope of claim 2 of the ‘771 patent, so no royalties are due.

In May last year, UCB requested summary judgment, claiming that although the proceedings were framed as a claim for a declaration relating to a contract, part of the proceedings concerned not only the scope but also the validity of the ‘771 patent.

Because the patent is US-based, the English court doesn’t have the power to determine its validity, UCB claimed. However, the court refused to decline jurisdiction.

Last week, Birss sided with Chugai and held that no royalties are due for tocilizumab under the patent licence for products manufactured after January 2016.

In coming to this conclusion, Birss construed claim 2 of the patent under US law.

Chugai argued that on UCB’s construction of the claim, the claim would be invalid because it would cover a prior art antibody called anti-Tac described in a reference called “Queen”.

In response, UCB admitted that anti-Tac would fall within the claim and, for the purposes of these proceedings only, that this would make the claim invalid.

But UCB added that this consequence is irrelevant to the issues the court has to decide and that Chugai’s remedy always has been to bring proceedings in the US court to invalidate the relevant claims.

“If those proceedings were to be commenced, one of the things UCB has made clear is that it would defend such an invalidity attack on the basis that it can ‘swear behind’ ‘Queen’,” said Birss.

Under US law, the act of swearing behind is where, if a patentee can establish the necessary facts, a “putative item of prior art is not prior art”, according to the court.

“The facts to be established would essentially be that although the putative prior art dates from before the earliest effective filing date of the patentee’s patent, the patentee’s invention was actually made before the prior art,” said Birss.

Following deliberation, Birss noted that the claims could be read in either Chugai’s or UCB’s favour.

He concluded: “I am satisfied that, approached purely as a matter of construction, I should not find in favour of UCB’s construction. That is because overall, the case in support of UCB is not better than the case for Chugai’s construction.”

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More on this story

Big Pharma
31 May 2017   The English High Court has dismissed UCB Pharma’s request for summary judgment in a case against Chugai Pharmaceutical.

More on this story

Big Pharma
31 May 2017   The English High Court has dismissed UCB Pharma’s request for summary judgment in a case against Chugai Pharmaceutical.