Groundbreaking declaratory relief clears the route to market for Humira biosimilars

Fujifulm Kyowa Kirin Biologics (FKB), a biosimilar pharmaceutical company from Japan, has been granted the first ever arrow declaration by UK courts

The company will be able to launch its biosimilar product with a clear route to market, in the face of a myriad of patent applications from AbbVie Biotechnology.

FKB currently has an Adalimumab biosimilar (FKB327) at Phase III in clinical trials; however, pharmaceutical giant AbbVie holds a portfolio of patents for Adalimumab, marketing its antibody under the trade marked name Humira.

Humira is one of AbbVie’s blockbuster drugs and is the highest selling prescription drug in the world, with a global turnover of more than $16 billion and daily UK sales of around £1.4 million.

Abbvie’s US patent for Humira expired in 2016, so the company has submitted several dosage patents for the administration of Adalimumab.

Patents that are in prosecution for an indefinite or prolonged period of time are protected until granted, which can prevent competing drugs entering the market.

AbbVie has also made it clear that it intends to prosecute any business globally for any infringements regarding its patents.

Paul England, Senior Associate in the patents team at Taylor Wessing, commented: "The criticism is sometimes made that the number of follow-up patents that protect some drugs, prevent competing products entering the market for too long after expiry of the original compound patent. Furthermore, patents that are still at the application stage cannot be challenged in the courts, to clear the way for competitor launch, until they have been granted.”

FKB sought after declaration relief for its biosimilar product for when it is brought to market. This would protect the company from any subsequent infringement action by AbbVie in the future, once the patents have been processed.

Special circumstances regarding this case heavily influenced the decision to grant FKB the declaration relief. This included AbbVie’s behaviour, whereby the company had previously threatened another company with infringement, whilst abandoning proceedings at last minute as a method to shield its patent portfolio from scrutiny.

Partner Paul Inman commented: “Importantly, the court clearly indicated that "unusual circumstances" will be required for such relief to be granted. In this case, the court found the patentee's behaviour to have created those circumstances and granted the remedy required to give FKB commercial certainty.”

Ruling in FKB’s favour, the declaration relief has managed to “clear the way” for AbbVie’s pending patents, allowing a certain route to market.

For now, the world is watching the biosimilar pharmaceutical market, especially businesses and industries that rely on patents for key competitive advantage.

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