AstraZeneca loses interim injunction bid against generic manufacturers in dapagliflozin dispute

On 21 July 2025, the Court of Appeal delivered a significant ruling in AstraZeneca AB & Anor v Generics (UK) Limited & Ors, addressing the pharmaceutical company's attempt to secure interim protection against generic competition for its diabetes drug dapagliflozin, marketed as Forxiga.

Background to the dispute

The case originated from challenges brought by multiple generic manufacturers, including Viatris, Teva, Glenmark, Sandoz, and Bestway, seeking revocation of AstraZeneca's Supplementary Protection Certificates (SPCs). These certificates extend patent protection beyond the standard twenty-year term, granting exclusive marketing rights after the original patent expires.

Following a High Court hearing before Dr Michael Tappin KC on 28 April 2025, AstraZeneca's patent was declared invalid. The pharmaceutical giant subsequently appealed, requesting an interim injunction to prevent generic market entry whilst awaiting Supreme Court determination.

Court of Appeal decision

The three-judge panel, comprising Lord Justice Arnold, Lord Justice Stuart-Smith, and Lady Justice Andrews, faced the complex task of balancing competing commercial interests. Whilst granting AstraZeneca a temporary injunction until 30 July 2025, the Court ultimately rejected the company's application for extended interim relief.

Crucially, the Court determined that AstraZeneca's appeal lacked any real prospect of success. In paragraph 2 of the judgement, Lord Justice Arnold outlined this reasoning, emphasising that previous injunctive relief did not automatically justify continued protection post-judgement.

Legal principles applied

The Court applied established precedent from American Cyanamid Co v Ethicon Ltd, requiring demonstration of a real prospect of success for appeals seeking interim relief. The judges acknowledged the significant timeframe for Supreme Court resolution—estimated between 15 and 23 months—but determined this did not warrant maintaining the status quo against generic competitors.

The decision reflects careful consideration of market dynamics affecting both pharmaceutical innovation incentives and consumer access to affordable medications. The Court recognised that prolonged delays to generic market entry would impact healthcare providers and patients requiring accessible treatment options.

Market implications

This judgement represents a notable shift in the pharmaceutical patent landscape, demonstrating judicial reluctance to extend interim protection without substantive grounds for appeal success. The ruling may influence future patent enforcement strategies, particularly regarding SPC validity challenges.

Generic manufacturers now face reduced barriers to market entry in similar circumstances, potentially accelerating competition in pharmaceutical markets. The decision underscores the importance of maintaining robust patent portfolios, as courts increasingly scrutinise requests for interim relief following adverse validity findings.

The judgement exemplifies the continuing evolution of UK pharmaceutical patent law, balancing intellectual property protection with competitive market principles. As generic manufacturers play an increasingly vital role in healthcare affordability, this decision may signal judicial recognition of the broader public interest in accessible medications.

The ruling establishes important precedent regarding the threshold for interim relief in pharmaceutical patent appeals, particularly where High Court invalidity findings lack apparent grounds for successful challenge. This development will likely influence strategic decision-making in future patent disputes within the pharmaceutical sector.