UK Patent Court Delivers Setback to Biosimilar Bevacizumab Launch

A UK court has denied biosimilar developer Pfizer an Arrow declaration in its pursuit of a 2020 launch of biosimilar bevacizumab, Zirabev, which was approved by the European Commission in February of this year. Pfizer hoped to supply the biosimilar to the UK market via Belgium, where bevacizumab is subject to Belgian designations of patents.

An Arrow declaration is one in which the UK High Court can use its discretionary power to grant a declaration that a product was known or obvious at the date of a patent application. Such a declaration can be useful to a generic or biosimilar developer seeking to gain certainty in launching competitive products.

In this case, Pfizer hoped to launch its biosimilar bevacizumab in the UK market after the basic patent on the reference product, Genentech and Roche’s Avastin, expires in June 2020. However, the biosimilar maker has been hindered by what it has termed a patent thicket related to secondary patents.

Pfizer had argued in this case that using bevacizumab in combination with other relevant cancer drugs in treating relevant indications was obvious, and that the patents on using bevacizumab in such indications were creating uncertainty.

Roche disagreed, arguing that it had not deliberately created uncertainty, and indicated that carrying a portfolio of patents on a drug is commonplace. Roche also pointed out that it has no relevant UK patents on the drug. Pfizer contended that the de-designation of the United Kingdom was a deliberate act by Roche to “prolong commercial uncertainty,” however.

The court, under Sir Colin Ian Birss, judge of the Patents Court, held that, by the earliest priority date for Roche’s relevant patents, there existed various standard combination therapies for treating cancers, and given that bevacizumab was an established agent, there is a strong case for the obviousness of using bevacizumab in combination.

Birss also agreed with Pfizer that Roche had de-designated the United Kingdom as a means to shield itself from an adverse decision by the UK court. However, Birss’ decision indicated that Roche’s activities were not unlawful.

Finally, the decision read, if there were pending UK applications for patents on bevacizumab, the court would have a plain case for an Arrow declaration, but given the absence of possible UK rights, “Pfizer does not need the Patents Court to tell it or anyone else that it can freely sell bevacizumab in this country without risk from the Roche patent families.”

However, “what Pfizer really wants,” according to the decision, “is a UK judgment so as to use it in Belgium.” Birss declined to grant an Arrow declaration, saying that “What will happen in Belgium is likely to affect the UK market but that is only because of the local effect in Belgium of a Belgian designation of a European patent. It is nothing to do with any UK legal right.”