Astellas Pharma Industries Limited v Teva Pharmaceutical Industries Limited & Ors
[2023] EWHC 2571 (Pat)
Teva Pharmaceutical Industries Limited & Anor. v Novartis AG & Anor.
10 November 2022
[2022] EWHC 2847 (Pat)
High Court
Novartis had a patent for a new type of iron medicine tablet. A different company, Teva, argued that the new tablet was just an obvious improvement on existing tablets, and that their own medicine didn't copy the patent. The judge agreed with Teva: the new tablet was too similar to old ones, and Teva's medicine didn't infringe the patent.
Key Facts
- •Teva brought an action for revocation of two Novartis patents (EP 202 and EP 018) for a swallowable film-coated deferasirox tablet.
- •Teva also sought a declaration of non-infringement regarding their product, Teva DFX.
- •Novartis counterclaimed for infringement.
- •The patents claimed a further improvement on existing deferasirox formulations (dispersible tablets), namely a swallowable film-coated tablet.
- •The patents were upheld in the EPO Opposition Division with amended claims; applications to amend UK claims to match were before the court.
- •A key point of contention was the inventive concept: Novartis argued it lay in the unexpected higher bioavailability and reduced food effect; Teva argued it was the 45-60% deferasirox content range.
- •The skilled team consisted of a clinician, formulator, and pharmacokineticist.
- •Prior art included Battung (dispersible deferasirox tablets), Zadok (method for reducing API agglomeration), and Séchaud (bioavailability study of deferasirox in various drinks).
Legal Principles
Common General Knowledge (CGK): The knowledge possessed by the skilled person in the art at the priority date.
KCI Licensing Inc v Smith & Nephew plc [2010] EWHC 1487 (Pat)
Inventive step: The invention must not be obvious to the person skilled in the art in light of the CGK.
Pozzoli SpA v BDMO SA [2007] EWCA Civ 588
Problem-solution approach: A structured approach to assessing inventive step.
EPO Guidelines for Examination
Doctrine of equivalents: Infringement can be found even without literal infringement if the variant achieves substantially the same result in substantially the same way and the patentee did not intend strict compliance with the literal claim.
Actavis UK Ltd v Eli Lilly & Co [2017] UKSC 48
Invention is prima facie that specified in the claim. The inventive concept is the core of the invention claimed.
s.125(1) of the 1977 Act; Conor Medsystems Inc v Angiotech Pharmaceuticals Inc [2008] UKHL 49; Actavis UK Ltd v Eli Lilly & Co [2017] UKSC 48
A claim lacks inventive step if any product falling within it was obvious at the priority date.
Brugger v Medicaid Ltd [1996] RPC 635
Outcomes
Patents EP 202 and EP 018 are invalid for lack of inventive step over Battung and Zadok.
The claimed swallowable film-coated deferasirox tablet with specified excipients was found to be an obvious modification of the prior art, even considering the claimed 45-60% deferasirox range.
Teva DFX does not infringe the patents.
Teva DFX's deferasirox content is outside the claimed range, and the inventive concept does not encompass equivalents outside this strictly interpreted range.
Proposed amendments to the patents are refused.
The amendments did not overcome the lack of inventive step, or introduced unallowable matter.