In a significant reversal for the pharmaceutical industry, the UK Court of Appeal has awarded AstraZeneca an interim injunction against Glenmark Pharmaceuticals, preventing the latter from marketing its generic version of dapagliflozin in the United Kingdom until after the form of order hearing in their ongoing patent validity dispute.
The ruling, delivered on April 9, 2024, overturns a previous decision by the lower court that had refused the same injunction on March 28. Dapagliflozin, marketed by AstraZeneca under the brand name Forxiga®, is a blockbuster medication for the treatment of type II diabetes.
Court's Reasoning for Granting the Injunction
Lord Justice Arnold delivered the leading judgment, with which Lord Justice Coulson and Lord Justice Warby concurred. The Court found merit in two of AstraZeneca's four grounds of appeal.
The Court determined that the first instance judge had applied too high a standard when considering whether damages would be adequate for AstraZeneca and failed to account for relevant uncertainties. Additionally, the judge had not properly considered the potential losses AstraZeneca might suffer after the form of order hearing.
"Multiple generic entry was not just a real risk but a certainty," noted Lord Justice Arnold, referencing new evidence that both Teva and another generic manufacturer (referred to as "Generic X") had secured commitments with wholesalers for immediate market entry. This development meant that "a downward price spiral as a consequence of competition between the 3+ generic entrants was inevitable."
Impact of Generic Competition on Damages Assessment
The Court emphasized three key factors that typically distinguish successful pharmaceutical preliminary injunction applications:
- Single generic entry often leads to multiple generic entry, causing price-cutting and a downward spiral
- Patentees generally have limited practical ability to restore previous pricing if the patent is later found valid
- Courts should consider whether the generic manufacturer could have "cleared the way" before launch
The Court found that with multiple generic entrants now certain to enter the market sooner than anticipated, there was "real doubt about whether AstraZeneca would be forced to permanently reduce their price" before the validity hearing concluded.
Criticism of Glenmark's Conduct
In a pointed rebuke, Lord Justice Arnold criticized Glenmark for "jumping the gun" by launching mid-trial without waiting for judgment. The Court disagreed with the lower court's assessment that this behavior was not a significant factor.
"It is important that parties should behave in a manner which is conducive to an orderly resolution of disputes of this kind, and not attempt to gain a commercial advantage by disrupting such orderly resolution," Arnold LJ stated. He further noted that Glenmark's conduct had required "a day of argument in the Patents Court and a day of argument in this Court to be devoted to, and very considerable costs to be expended on, the question of what is to happen during a period of one to three months."
Preserving the Status Quo
While the Court found that damages would likely be inadequate for both parties, it determined that preserving the status quo was prudent given the relatively short duration of the injunction period. The Court also emphasized that Glenmark had failed to properly "clear the way" by not providing good reasons when applying for expedition of the case.
Implications and Timeline
The injunction will remain in place until the hearing following judgment in the validity action, anticipated to occur by mid-June 2024, though the exact timing depends on when the validity judgment is handed down.
The Court clarified that its decision does not dictate the outcome of any future application AstraZeneca might make for a further injunction after the validity judgment, stating that any such application would need to be considered on its merits based on the circumstances at that time.
Market Context
Dapagliflozin belongs to the SGLT2 inhibitor class of medications and represents a significant revenue stream for AstraZeneca. The case highlights the complex interplay between patent protection, generic competition, and healthcare economics in the pharmaceutical industry.
The Court's decision underscores the importance of procedural fairness in pharmaceutical patent litigation and may influence how generic manufacturers approach market entry strategies in the future, particularly regarding the timing of launches relative to ongoing litigation.
