Teva secures victory in iron overload treatment dispute

Judge Hacon rules that a skilled team “would have thought it obvious” to reformulate drug into a tablet | Teva DFX patents also found not to infringe, falling outside the claims on both a normal construction and under the doctrine of equivalents.

In a win for Teva, the English High Court has invalidated two patents owned by Novartis which cover a drug used for removing excess iron from a patient’s blood.

Handed down on November 10, the decision found that Novartis’ two patents— European Patent (UK) number 2,964,202 and European Patent (UK) number 3,124,018—lacked inventiveness over existing patents.

Both patents claimed an improvement to deferasirox (which is used as a treatment for excess iron), in the form of a swallowable film-coated tablet formulation of deferasirox.

“Novartis put higher bioavailability and reduced food effect front and centre of their characterisation of the inventive concept,” said Judge Hacon on behalf of the court, adding that Teva instead claimed that the range of deferasirox was the key feature of the inventive concept.

Rejecting Novartis’ argument, Hacon took the view that higher bioavailability and reduced food effect “cannot be imported into either the claims or the inventive concept”.

“It makes no difference, if it is the case, that the skilled team reading the patents would regard higher bioavailability and reduced food effect as the most significant technical insight conveyed by the description. They would read the claims and understand that this insight is not part of the inventive concept of the invention as the patentee has chosen to claim it,” said Hacon.

Instead, the court summarised the inventive concept as: “A swallowable film-coated tablet containing deferasirox in an amount between 45% and 60% of total tablet weight, containing (i) microcrystalline cellulose, (ii) crospovidone, (iii) povidone, (iv) poloxamer 188, (v) colloidal silicon dioxide and (vi) magnesium stearate and containing no SLS or lactose.”

The court went on to find that Novartis’ patents were not inventive over two prior patents.

“I have found that a skilled team would have thought it obvious to reformulate dispersible deferasirox to make a swallowable tablet, though there may have been limited commercial pressure to try,” said Hacon, when considering one of the prior patents.

Teva had also sought a declaration of non-infringement in relation to its product Teva DFX.

“The parties' arguments on infringement were ships passing in the night—unsurprisingly given the difference in their respective inventive concepts. One inventive concept points towards Teva DFX infringing the patents, the other leads away from infringement,” said Hacon.

The court concluded that Teva’s product was not infringing the patents, falling outside the claims on both a normal construction and under the doctrine of equivalents.

Hacon added: “I have found that in the present case the inventive concept of the patents would be seen by the skilled team as requiring strict compliance with the 45-60% range of deferasirox.

“On that basis a variant will not be substantially the same as the inventive concept unless it strictly complies. I need not investigate with precision what compliance means numerically as matter of general principle. In my judgment Teva DFX does not comply.”

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