This will change almost nothing, as to Merck’s consolidated results of operations, since generic versions of Sustiva® (known chemically as efavirenz) have been available for some time, now (thus the other generics’ logos in the graphic at right). And add to this that Merck’s MSD sub only collects a license royalty in the UK, for efavirenz (from BMS) — so its share of any damages are going to be “mere shillings, on the pound.” It is an interesting case, at least partially involving Merck’s UK operations, though — under British law — on a slow news week at Whitehouse Station.
Under British patent law, it seems, the branded manufacturer (here BMS) may ask a would-be generic competitor to clarify its intentions, in writing, about whether it will conduct an “at risk” launch of a given proprietary biotech product, prior to the expiration of the branded’s UK patent rights. [And that’s somewhat akin to the opening moves, in a Hatch-Waxman challenge, here in the US. But then the paths through the wood diverge. . . here’s a similar prior case writeup I did, on the same topics — with Sustiva and Merck, from 2010.]
And that’s what BMS/Merck did. It asked. But Teva coyly said its plans were confidential, as trade secrets. The UK Judge didn’t buy that answer — noting the ambiguity of the answer, as to BMS/Merck’s still-active proprietary patent interests, in Sustiva — and granted an injunction. Here’s a very well-thought out run-down of the whole case history — and a bit from it:
. . . .[It was alleged that] Teva intended to infringe the patent and SPC by launching a generic efavirenz product at risk in the UK. BMS’ evidence was centred on (i) a positive opinion on the grant of a marketing authorisation by the Committee for Medicinal Products for Human Use, (ii) the grant of a marketing authorisation to Teva by the European Medicines Agency, and (iii) the refusal by Teva in correspondence to provide details of its intentions regarding the launch of generic efavirenz in the UK – Teva stated that its intentions were confidential:
“It is not Teva’s policy to disclose to its competitors information relating to the date on which any product the subject of a Marketing Authorisation will be launched in any given country. This is regarded by Teva, and we believe by all our competitors, as being confidential information.”
At the same time as commencing the proceedings, BMS also issued an application for an interim injunction to prevent Teva from launching generic efavirenz pending trial. In March 2012, HHJ Birss QC (as he then was) granted the interim injunction. . . .
However, the Judge rejected the notion that telling an originator patentee that Teva had an unequivocal plan to launch only after expiry of the patent or SPC would cause Teva any damage at all, particularly if that information was imparted to the patentee under terms of confidentiality to prevent wider dissemination (e.g. to other generics). . . .
Do go read it all — but the grant of the UK injunction was proper. That’s a bit different than how Hatch-Waxman works, here, no? Have a great weekend.