Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd & Anor [2009] EWCA Civ 646 (02 July 2009)

Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd & Anor [2009] EWCA Civ 646 (02 July 2009)

The patent for levofloxacin was not obvious over Gerster IP because the skilled person would not have been motivated to apply the disclosed method to ofloxacin, would not have had the necessary common general knowledge, and could not have reasonably predicted success. The SPC for levofloxacin is valid because levofloxacin is a new active ingredient requiring its own marketing authorisation, and the earlier authorisation for ofloxacin (a racemate) does not count as the first authorisation for levofloxacin under the Regulation.

Citation
[2009] EWCA Civ 646
Parties
Appellant/claimant: Generics (UK) Ltd; Respondent/defendant: Daiichi Pharmaceutical Co Ltd; Respondent/defendant: Daiichi Sankyo Co Ltd
Jurisdiction
England and Wales
Judgment Date
02 July 2009
Procedural Posture
Patent Appeal / Appeal From High Court (patents Court) to Court of Appeal
Outcome
Appeal dismissed
Legal Topics
Patent Validity, Obviousness, Supplementary Protection Certificate (spc), Pharmaceutical Inventions, Interpretation of EU Regulations
Intellectual Property Pharmaceutical Law European Union Law Patent Validity Obviousness Supplementary Protection Certificate (spc) Pharmaceutical Inventions Interpretation of EU Regulations

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Parties

Generics (UK) Ltd

Appellant/claimant

Daiichi Pharmaceutical Co Ltd

Respondent/defendant

Daiichi Sankyo Co Ltd

Respondent/defendant

Procedural Posture

Patent Appeal / Appeal From High Court (patents Court) to Court of Appeal

Legal Issues

  1. 1 Whether Daiichi's patent for levofloxacin is invalid for obviousness over Gerster IP
  2. 2 Whether the supplementary protection certificate (SPC) for levofloxacin is valid under Regulation 1768/92

Ratio Decidendi

The patent for levofloxacin was not obvious over Gerster IP because the skilled person would not have been motivated to apply the disclosed method to ofloxacin, would not have had the necessary common general knowledge, and could not have reasonably predicted success. The SPC for levofloxacin is valid because levofloxacin is a new active ingredient requiring its own marketing authorisation, and the earlier authorisation for ofloxacin (a racemate) does not count as the first authorisation for levofloxacin under the Regulation.

Court Disposition

Appeal dismissed

Orders

  • Patent for levofloxacin upheld as valid
  • SPC for levofloxacin upheld as valid