Patent invalidity

Teva and Bristows win obviousness claim against Bayer cancer drug

The UK High Court has invalidated a Bayer patent covering cancer drug sorafenib, known as Nexavar, in a dispute with Teva. In Germany, the Federal Patent Court handed down the same finding a month previously, citing lack of inventive step. Now the way could be clearer for generic manufacturer Teva to launch its own version of the drug.

21 October 2021 by Amy Sandys

Bayer, Teva, sorafenib After two decisions from parallel proceedings in the UK and Germany, Teva has succeeded in invalidating Bayer's EP 255 for sorafenib ©Art_freeman

The UK High Court has found a patent owned by Bayer, which protects the compound of a tosylate, of active ingredient sorafenib, invalid for obviousness. Sorafenib forms the basis of Bayer’s drug Nexavar, which is used to treat various types of cancer, including kidney, liver cell and thyroid cancer. Claim 12 of EP 2 305 255, which was valid until December 2022, covers the tosylate salt of sorafenib.

Initially, Teva had levied more invalidity attacks than just obviousness against Bayer’s patent. For example, the generic drug company had argued that the patent contained lack of novelty on the basis of loss of priority and intervening prior art. However, Teva dropped the claim once Bayer agreed to drop a conditional amendment to claim 12.

Thus, Teva argued solely that claim 12 was obvious over the prior art. Originally three patents, including EP 255, were in dispute. However, the parties settled over EP 18 68 579 and EP 17 97 037. Both patents are still in force.

Bayer stumbles in Germany

Parallel proceedings are ongoing in Germany. When the SPC based on the basic patent expired in mid-July 2021, imitation products threatened to enter the German market. Seven generic drug companies applied to the IFA to list their products containing the active substance sorafenib in the German pharmaceutical database “Lauer Taxe”.

Initially, the Munich Regional Court issued several preliminary injunctions, which were effectual until the Federal Patent Court ruled the patent invalid in September, following Ratiopharm and Stada bringing nullity suits against Bayer. The court found the patent invalid for lack of inventive step.

Rob Burrows

A lack of ongoing opposition proceedings at the European Patent Office meant that, unusually, parallel revocation proceedings could happen in Germany and the UK almost simultaneously. In the Netherlands, preliminary injunction proceedings are pending, with a first-instance hearing scheduled for 5 November 2021.

International frontiers

In the first-instance dispute, Teva relied on a team from Bristows, led by partner Rob Burrows. The firm is also helping coordinate Teva’s European litigation relating to EP 255, including in Germany,  Spain, France and Slovakia.

In Germany, Tobias Wielcke of Bird & Bird’s Düsseldorf office represents Teva/Ratiopharm. Bristows has instructed Teva as a client since 2016.

Bayer, Teva, sorafenib

Andrew Hutchinson

Bayer relied on one of its go-to firms in Simmons & Simmons, led by partner Andrew Hutchinson, to co-ordinate its defence against Teva. Scott Parker, another partner at Simmons & Simmons, was also involved in the case’s early stages.

In the Netherlands, partner Bas Berguis leads the team. Peter Mayer takes the main role in Germany.

Bayer has instructed Simmons & Simmons for over 20 years. However, this is the first patent case that the firm’s UK office has conducted for the pharmaceutical company for a while. Given its cross-border elements, the case is an example of the firm cementing its expertise in such disputes involving partners from its multiple European offices.

For Teva
8 New Square (London): Daniel Alexander
11 South Square (London): Anna Edwards Stuart
Bristows (London): Rob Burrows (lead), Rachel Mumby (partners); associate: Emma Irwin
In-house (London): Alpha Indraccolo, Steven Willis

For Bayer
Three New Square (London): Thomas Mitcheson, Stuart Baran
Simmons & Simmons (London): Andrew Hutchinson (partner, lead); associates: Amy Crouch, Christina Thompson, Elsa Glauert

UK High Court, Chancery Division, London
James Mellor (presiding judge)