Last updated: 24 December 2025
To view updates, click on the ‘+’ sign below.
The table below is an attempt to present some court cases involving Supplementary Protection Certificates.
- Where a blog post (concerning a particular case) has been published on the Pharmavibes blog, a link is provided in the ‘Outcomes’ column in the table below.
- For other cases, brief information on the outcome of a case is provided in the ‘Outcomes’ column and links to an article(s) concerning a case are provided in the ‘Articles on the case column’ of the table.
You can read more about Supplementary Protection Certificates (SPCs) and Supplementary Protection Certificate (SPC) manufacturing waivers in this blog post.
| Case No/Court | Parties concerned | What the case is about | Outcome date | Outcome | Article(s) on the case |
|---|---|---|---|---|---|
| In the high court of justice, business and property courts of England and Wales intellectual property list patents court | Regenron Pharmaceuticals Inc. and Bayer Plc (the claimants) vs Alvotech HF and Fisher Clinical Services UK Limited (the Defendants) | The court had to decide whether a notification is valid, if it does not include the reference number for the intended country of export (here, Japan) because it was not publicly available when the notice was given. | 4 November 2025 | Justice Meade concluded as follows: The Claimants fail on the Export Issue. The First and Second Notifications are not invalidated by reason of the fact that they did not contain MA reference numbers for Japan. I refuse the Claimants’ claim to an injunction. You can view the full judgement here. | The SPC “Waiver Regulation” means what it says: Regeneron v Alvotech, Justin Lambert 1 December 2025, Mischon De Reya Regeneron & Bayer v Alvotech & Fisher [2025] EWHC 3050 (Pat), Andrew Lykiardopoulos KC, 24 November 2025, 8 New Square |
| Court of appeal | AstraZeneca vs Glenmark | The underlying dispute involves Glenmark’s challenge to the validity of AZ’s SPC which protects dapagliflozin, the active ingredient in Forxiga | 31 July 2025 | On 9 April 2025, the UK Court of Appeal awarded AstraZeneca (AZ) an interim injunction keeping Glenmark’s dapagliflozin (dapa) off the UK market until the form of order hearing in the parallel validity action. The interim injunction could remain in place until June, or for a longer (or shorter) period of time depending on the timing of the validity action. Source: UK Court of Appeal grants AstraZeneca an interim injunction against Glenmark’s generic dapagliflozin for type II diabetes, Helen Poulson et al, 10 April 2025, Hogan Lovells In its decision of 28 April 2025, the Patents Court decided that the Patent is invalid and so also were the SPCs. The Court followed the guidance in the earlier pregabalin and apixaban cases and applied a stricter threshold than the EPO in relation to plausibility. In the meantime, the Court has granted AZ an interim injunction pending appeal of the validity decision, which is listed before the Court of Appeal on 25 June 2025, with decision expected to be handed down within a few weeks later at most. Source: The dapagliflozin case: guidance on generic launches, Yael Givon, 6 June 2025, Mishcon de Reya. On 31 July 2025, the decision to appeal was refused. Source: Supreme court UK | Court of Appeal hands down reasons for awarding AZ an interim injunction in the UK against Glenmark’s generic dapagliflozin for type II diabetes, Helen Poulson et al, 24 April 2025, Hogan Lovells UK Court of Appeal overturns refusal of interim injunction against generic companies, Heidi Hurdle et al, 26 June 2025, Bird & Bird |
| Court of appeal (Civil Division) on appeal from the high court of justice (UK) | Merck Serono S.A. Appellant – and – The Comptroller-General of Patents, Designs, and Trade Marks | SPC protection for second medical use | Judgment 28 January 2025 | The appeal was dismissed. This means that pharmaceutical companies cannot obtain UK supplementary protection certificates (SPCs) for medicinal products for which a second medical use has been found where those products have already been the subject of a marketing authorisation issued by regulators, the Court of Appeal in England and Wales has confirmed.1 1. UK court shuts door on ‘second medical use’ SPCs, Alasdhair McDonald et al, 4 February 2025, Pinsent Masons | UK court shuts door on ‘second medical use’ SPCs, Alasdhair McDonald et al, 4 February 2025, Pinsent Masons SPC protection for second medical uses post-Brexit – UK Court of Appeal clarifies test, Laura Whiting et al, 14 February 2025, Freshfields |
| Business Court Brussels (Belgium) | Amgen vs Samsung Bioepis NL BV | SPC manufacturing waiver | Judgement 23 Dec 2024 | The President, hearing this case as in summary proceedings: — ——etc. Declares Amgen’s claim regarding compliance with the notification requirement and -conditions admissible but unfounded and dismisses it; — Declares Amgen’s claim relating to the unfair commercial practices inadmissible and dismisses it; — ———–etc. | SPC manufacturing waiver ruling offers legal clarity, say experts, Charlotte Weekes et al, 22 January 2025, Pinsent Masons |
| Case C-119/22 and C-149/22 | MSD vs Teva MSD Vs Clonmel | Conditions under which SPCs may be granted for combination products in the EU | 6 June 2024 (opinion) 19 December 2024 (judgement) | Blog post | |
| The Regional Court Munich , Germany | Janssen Biotech vs Formycon | SPC manufacturing waiver | Blog post | ||
| UK high court | Halozyme Inc. vs the UK Intellectual Property Office | Question whether one of the ingredients in a combination product is an active ingredient. | 16 Dec 2024 | Blog post | |
| Preliminary ruling on Case C‑181/24 by the CJEU | Genmab A/S vs Budapest High Court, Hungary | SPC application rejected on the basis that the subsequent MA was not the first MA. | 16 July 2024 | Blog post | |
| Case C-473/22 | Mylan vs Gilead | Judgement 11 January 2024 | Blog post |