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England and Wales Case Law

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Intellectual property [2025] EWHC 3050 (Pat)

Regeneron Pharmaceuticals, Inc & Anor v Alvotech HF & Anor

Regeneron Pharmaceuticals, Inc & Anor v Alvotech HF & Anor [2025] EWHC 3050 (Pat) (24 November 2025)

The High Court held that an SPC manufacturing-waiver notification can be valid before an export-country marketing authorisation is granted, so long as the MA number is supplied when publicly available.

  • Supplementary protection certificate (spc)
  • Spc manufacturing waiver
  • Patent infringement
  • Legislative interpretation
  • Notification requirements
  • Supplementary-protection-certificate
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Intellectual property

Regeneron Pharmaceuticals, Inc. & Anor v Alvotech HF & Anor

The High Court held that an SPC export-waiver notification can be valid before an export-country marketing authorisation is granted, so long as the MA number is supplied once publicly available.

  • Supplementary protection certificate (spc)
  • Spc manufacturing waiver
  • Patent infringement
  • Biosimilars
  • Notification requirements
  • Supplementary-protection-certificates
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Intellectual property law

Halozyme, Inc v The Comptroller-General of Patents, Designs and Trade Marks

Recombinant human hyaluronidase does not qualify as an active ingredient for the purposes of SPC grant because, even considering the basic patent and scientific literature, there is insufficient evidence that it has a pharmacological, immunological or metabolic action of its own in relation to the specific therapeutic indications of the marketing authorisation. The MA/SmPC/EPAR consistently characterise it as an excipient, and the additional materials do not demonstrate the required effect for the approved indications.

Source excerpt

  • Supplementary protection certificate (spc)
  • Active ingredient definition
  • Marketing authorisation
  • Pharmaceutical patents
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Intellectual property [2024] EWHC 2524 (Pat)

Accord Healthcare Ltd & Ors v Regents of the University of California & Anor

Accord Healthcare Ltd & Ors v Regents of the University of California & Anor [2024] EWHC 2524 (Pat) (08 October 2024)

The Patents Court rejected challenges to the enzalutamide patent and SPC, holding that prior-art Slides and Poster did not make the invention obvious.

  • Obviousness
  • Sufficiency
  • Plausibility
  • Prior art
  • Pharmaceutical patents
  • Supplementary protection certificate (spc)
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Intellectual property

Teva UK Ltd & Ors v Gilead Sciences Inc

The High Court held Gilead’s Truvada SPC invalid under Article 3(a) and refused permission to adduce further expert evidence after the CJEU ruling.

  • Supplementary protection certificate (spc)
  • Article 3(a) spc regulation
  • Extent of patent protection
  • Combination products
  • Interpretation of patent claims
  • Supplementary-protection-certificate
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Intellectual property

Teva UK Ltd & Ors v Merck Sharp & Dohme Corporation

The Patents Court held that MSD’s SPC for the Atripla combination was invalid because the product was not protected by the patent and Article 3(c) also barred it.

  • Supplementary protection certificate (spc)
  • Patent claim construction
  • Combination therapy patents
  • Spc regulation article 3(a) and 3(c) interpretation
  • Supplementary-protection-certificate
  • Patent-claim-construction
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Intellectual property law

Teva UK Ltd & Ors v Gilead Sciences Inc

The Patents Court considered whether Gilead’s SPC for Truvada complied with Article 3(a) of the SPC Regulation and referred the interpretation issue to the CJEU.

  • Supplementary protection certificate (spc)
  • Patent interpretation
  • Combination products
  • Article 3(a) spc regulation
  • Inventive advance
  • Supplementary-protection-certificate
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Intellectual property law [2017] EWHC 14 (Pat)

Abraxis Bioscience Llc v The Comptroller-General of Patents

Abraxis Bioscience Llc v The Comptroller-General of Patents [2017] EWHC 14 (Pat) (13 January 2017)

The High Court held that nab-paclitaxel was not a new active ingredient for SPC purposes and upheld refusal of the SPC application.

  • Supplementary protection certificate (spc)
  • Interpretation of spc regulation
  • Active ingredient definition
  • Article 1(b) and 3(d) of regulation 469/2009/ec
  • Patent protection for pharmaceutical formulations
  • Supplementary-protection-certificate
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Intellectual property law [2015] EWHC 1074 (Ch)

VIIV Healthcare UK Ltd v Teva UK Ltd

VIIV Healthcare UK Ltd v Teva UK Ltd [2015] EWHC 1074 (Ch) (23 April 2015)

The High Court refused an early reference to the CJEU on SPC interpretation, finding the application premature until key patent and factual issues were resolved at trial.

  • Supplementary protection certificate (spc)
  • Patent amendment
  • Article 3 of regulation (ec) no 469/2009
  • Reference to cjeu
  • Case management
  • Supplementary-protection-certificate
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Intellectual property law

VIIV Healthcare UK Ltd v Teva UK Ltd

The High Court refused ViiV’s application to refer questions on SPC interpretation to the CJEU, holding the request was premature and too contingent.

  • Supplementary protection certificate (spc)
  • Interpretation of article 3 regulation (ec) no 469/2009
  • Reference to cjeu
  • Patent amendment
  • Market authorisation
  • Supplementary-protection-certificate
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About this LexChat collection

England and Wales decisions are organised by court, judge, legal area and indexed issue so a practitioner can move from a proposition to a citable authority with the surrounding context intact.

Source links and collection timestamps are retained alongside the indexed records.