EPO publishes decision on Sprycel patent invalidation

A European Patent Office (EPO) Board of Appeal has published its decision that invalidated a patent owned by Bristol-Myers Squibb (BMS) which covered a blockbuster anti-cancer drug.

Published on Monday, July 24, the decision invalidated European Patent number 1169038, a composition-of-matter patent covering dasatinib.

Dasatinib is a targeted therapy used to treat leukaemia sold under the brand name Sprycel. In 2016, the drug obtained worldwide revenues of $1.8 billion.

The decision was made in February this year and, at the time, BMS announced that it didn’t impact the company’s patents outside of Europe or other Sprycel-related patents.

BMS had appealed against a decision of the EPO’s opposition division which revoked the patent, but the Board of Appeal upheld the ruling.

According to the EPO, the application was directed to an “extremely broadly defined group of compounds of a generic formula”.

The application included a statement that said “compounds tested in the following examples have been tested in one or more of these assays and have shown activity”.

There was no range of values or values for specific compounds, and the assays were to identify protein tyrosine kinase (PTK) inhibitors.

However, there was no evidence in BMS’s application showing that any of the compounds falling within the scope of the formula were active as an inhibitor for any of the specific PTKs, said the EPO.

After the patent was revoked, BMS amended the patent to cover a single compound (dasatinib) and relied on post-application evidence to show its efficacy.

But the EPO’s appeal board held that post-published evidence can only be used if it’s plausible from the original application that the problem [it purports to solve] has been solved, explained Jason Rutt, patent attorney at Boult Wade Tennant.

The EPO also held that the assessment of inventive step was to be made at the filing date of the patent.

Rutt said: “Revocation of this patent is commercially a big deal. With this patent gone, it’s likely there is no protection for the product across Europe, a significant and valuable market.”

He added that with a patent expiry of 2020 and possible supplementary protection certificates extending to 2025, BMS could have lost up to eight years of monopoly over a blockbuster drug.

For BMS, “it’s the end of the road” in Europe, he added.

“It’s a reminder that the new patents court [Unified Patent Court] will be pan-EU and something for proprietors to consider as they mull over opting their patents in or out.”

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