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11 October 2021Big Pharma

English High Court finds Bayer patent obvious in win for Teva

The English High Court has found that a challenged claim of Bayer's targeted cancer drug sorafenib is invalid due to obviousness, in a win for Israeli pharmaceutical company Teva Pharmaceuticals.

High Court judge James Mellor, who was appointed to the judiciary in January 2021, delivered judgment at the High Court of Justice, Chancery Division, Patents Court, on Friday, October 8.

At the centre of the dispute is sorafenib, a targeted drug used to treat forms of kidney, liver, and thyroid cancer.

German pharmaceutical company Bayer owns European Patent number 2,305,255 for “Aryl urea compounds in combination with other cytostatic or cytotoxic agents for treating human cancers”, with claim 12 of the patent covering an aryl urea compound—that being the tosylate salt of sorafenib.

The ‘255 patent, which has UK designation, has a priority date of December 3, 2001.

According to Teva, claim 12 is invalid due to obviousness. The Israeli company filed its lawsuit against Bayer in the UK 2020 in efforts to make way for its own generic version of sorafenib.

As noted by Mellor on Friday, the decision to be made by him was, in short, “whether it was obvious to make something which fell within claim 12”. A patent will be invalid due to obviousness if someone skilled in the relevant art finds an invention obvious, in light of existing relevant information.

During the trial, Bayer argued that to establish obviousness it is not enough that a skilled person could develop the invention: “The question is whether there is something that will in fact spur him/her on to do it—whether, in all the circumstances, s/he would do it.”

In closing submissions, Bayer identified no less than 20 steps that would have to be taken to achieve claim 12. Bayer accepted that whilst some of these steps may be obvious, others were not and, overall, the process was a step-by-step approach.

Meanwhile, Teva suggested that the word “would” in relation to the law on obviousness is not straightforward; rather, the law is “multifactorial and based closely on the particular circumstances”.

Central to Teva’s argument was prior art called Lyons, which was an article about sorafenib and its utility in cancer therapy. Lyons disclosed that sorafenib (in some form) was proving effective in phase 1 of clinical trials in relation to three forms of cancer. The clinical testing had commenced in 2000.

Bayer countered that “Lyons contains no direction to the skilled person to tosylate as the appropriate salt of sorafenib”.

On Friday, Mellor said: “I find that Lyons provided the Skilled Team with a strong (but not irresistible) motivation to investigate this chemical entity with a view to identifying a formulated drug, preferably for oral administration to humans.”

In his view, it was obvious for a skilled formulator to include the tosylate salt of sorafenib in the salt screen. The formulator would have directed their medicinal chemists to make sorafenib tosylate and the other selected salts.

Ultimately, Mellow held that those skilled in the art would have thought to include the tosylate salt as a result of standard and routine considerations, including having considered Lyons and other texts relating to pharmaceuticals and formulas.

“Hence, claim 12 was obvious,” the High Court judge concluded.

As a post-script, Mellor added that the German Federal Patent Court had found claim 12 of the German designation of the ‘255 patent invalid for lack of inventive step on September 29, 2021.

Mellor said he “had forgotten all about that opinion and had no regard whatsoever to it” in making his own decision, though he added that it is “pleasing” to see the different courts of signatories to the European Patent Convention reaching consistent conclusions in their decisions.

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