Novartis AG v (1) Teva UK, (2) Dr Reddy’s Laboratories (UK), and others [2022] EWHC 959 (Ch)
Novartis is the owner of a patent application covering the use of the pharmaceutical ‘fingolimod’ (which Novartis sells under the brand name ‘Gilenya’) for the treatment of relapsing multiple sclerosis. With the end of data exclusivity imminent, Novartis sought to prevent generic launch via an interim injunction on the basis of its pending patent.
The facts were unusual, because fingolimod is supplied only in secondary care such that its price is not determined by the NHS drug tariff. Instead, in the expectation of generic launch, the NHS had invited interested suppliers to partake in a central tender process. On those facts, the Court considered that generic launch was unlikely to cause an irrecoverable downward price spiral [44]-[54], and rejected Novartis’ contentions of other non-quantifiable financial and reputational damage [55]-[71]. Thus damages would be an adequate remedy for Novartis if the patent were ultimately held to be valid and infringed, and interim relief was refused.
A novel twist was that Novartis’ patent was still pending grant at the EPO, in part because it was a second divisional from a much older parent application. The Court held that this did not present a bar to interim relief [16]-[39], but considered obiter that the practice of making repeated divisional filings and amendments so as to prevent generics from effectively seeking to clear the way is a factor that weighs against the granting of interim relief [77]-[79].
Christopher Hall acted for Dr Reddy’s. Adam Gamsa acted as junior counsel for Teva.