English court finds in favour of access to generic TDF/FTC
19 September 2018. Related: Antiretrovirals, HIV prevention and transmission, Other news.
Simon Collins, HIV i-Base
On 19 September 2018, the English High Court issued a judgment over the challenge by four generic manufacturers to Gilead’s application to extend the patent on TDF/FTC. [1]
This case was previously referred to the European courts reported in October 2017. [2, 3]
The details of the judgment are very difficult to understand, but the outcome appears to be that the NHS England are now legally able to buy generic TDF/FTC.
NHS Scotland have been using generic TDF/FTC since November 2017. [3]
comment
Access to generic TDF/FTC should dramatically change earlier cost-effectiveness analyses that were used to restrict access to PrEP across the UK.
NHS England need to rapidly respond to this judgment in order to expand access to PrEP.
The only phrases that are easy to understand in the 12 page judgement are “in a nutshell” (though not the following sentence) and a reference to Gilead trying to “get a second bite of the cherry”.
It does conclude that as tenofovir DF was approved in 2002, less than five years after filing the first patent, the company didn’t suffer from any regulatory delay.
The final sentence appears to also suggest that perhaps the original patent for the dual formulation of TDF/FTC wasn’t justified: “Gilead made no invention in devising the combination which warranted the grant of a patent, let alone an SPC”.
A legal interpretation of this sentence would be interesting.
Currently, PrEP is only available in England at clinics that are participating in the open label IMPACT study. The demand for PrEP meant than many of these sites enrolled within months and are now closed to new participants. [4]
References
- England and Wales High Court (Patents Court) Approved Decisions. Teva UK Ltd & Ors v Gilead SciencesNeutral, second judgment. Citation Number: [2018] EWHC 2416 (Pat).
http://www.bailii.org/cgi-bin/format.cgi?doc=/ew/cases/EWHC/Patents/2018/2416.html - England and Wales High Court (Patents Court) Decisions. Teva UK Ltd & Ors v Gilead Sciences Inc [2017] EWHC 13 (Pat) (13 January 2017).
http://www.bailii.org/ew/cases/EWHC/Patents/2017/13.html - Generic PrEP in France and Scotland challenges access across the UK. HTB October 2018.
https://i-base.info/htb/32501 - Update on the PrEP IMPACT Study. HTB January 2018.
https://i-base.info/htb/33315