Biosimilars – the fight over Humira continues

AbbVie’s blockbuster drug Humira (adalimumab) generated worldwide sales of around $14bn in 2015, some two thirds of the company’s revenues. Understandably, other producers would like a piece of the action. As we've discussed previously, AbbVie is doing all it can to defend Humira’s position, with its international portfolio of secondary patents a key part of that strategy. 

In the UK, the basic patent on adalimumab together with its SPC will last until October 2018. Fujifilm Kyowa Biologics (FKB), Samsung Bioepis and Biogen Idec have applied to the court to enable them to access the UK market once the basic patent expires. To do this they will need to show that their own products would be obvious or not novel by the priority dates of the secondary patents, with the result that those patents could not be used to stop marketing of their products.

Two recent decisions have gone against AbbVie. We will look at the first of these here, and follow up with a report on the second in our next blog.

Summary judgment or striking-out – is the case worth the candle?

At the very end of 2016, patents judge Carr J ruled against AbbVie’s application for summary judgment on FKB and SB/Biogen’s applications, or to strike them out, in the light of recent events. AbbVie had taken steps to remove the UK from its EP 2,940,044 patent, and to inform the European Patent Office that it no longer approved the text of its EP 1,944,322 patent. It said that it would submit to UK revocation of EP 1,737,491. As a result, AbbVie argued, there was no point in continuing with the declarations, because they could serve no useful purpose.

FKB and SB/Biogen argued that this was part of a long course of conduct. AbbVie, they said, had dragged out proceedings for as long as possible whilst threatening to sue for infringement. It had then abandoned its patent rights at the last moment, whilst filing further divisionals with very similar claims. They presented a series of reasons why the requested declarations would serve a useful purpose. These included the potential to influence other European jurisdictions – the “spin-off value” of a judgment in courts elsewhere, and the protection of the biosimilar producers’ international supply chain.

The judge concluded that it was not appropriate to kill off FKB’s and SB/Biogen’s applications at this stage and allowed them go forward to trial. Commenting on the value of the market for these drugs, he said:

“This is not a case where it can be said that the game is not worth the candle. On the contrary, it is worth a great many candles.”

We will look at the second of these recent judgments in another blog.

MHRA consulting on standards for biologicals

Interesting to note too that UK drugs regulator the MHRA is consulting on quality standards for biological medicines. That consultation, recognising the importance of biological medicines to healthcare globally, is due to run until 10 April.

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