Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd & Anor

Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd & Anor

The patent for levofloxacin is valid because the skilled person would not have found it obvious to resolve ofloxacin using the method in Gerster IP, given the lack of common general knowledge, unpredictability of the chemistry, and absence of motivation. The SPC is valid because levofloxacin is a novel and inventive product, distinct from ofloxacin, and the first marketing authorisation for levofloxacin is the relevant authorisation under the Regulation.

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
Civil Appeal (patents) / Appeal From High Court (patents Court) to Court of Appeal
Outcome
Appeal dismissed
Legal Topics
Patent Validity, Obviousness, Supplementary Protection Certificate (spc), Pharmaceutical Patents, Enantiomers, Marketing Authorisation
Intellectual Property Law Patent Law Pharmaceutical Law Patent Validity Obviousness Supplementary Protection Certificate (spc) Pharmaceutical Patents Enantiomers +1 more

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Parties

Generics (UK) Ltd

Appellant/claimant

Daiichi Pharmaceutical Co Ltd

Respondent/defendant

Daiichi Sankyo Co Ltd

Respondent/defendant

Procedural Posture

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

Legal Issues

  1. 1 Whether Daiichi’s patent for levofloxacin was invalid for obviousness over Gerster IP
  2. 2 Whether the Supplementary Protection Certificate (SPC) for levofloxacin was valid under the relevant EU Regulation

Ratio Decidendi

The patent for levofloxacin is valid because the skilled person would not have found it obvious to resolve ofloxacin using the method in Gerster IP, given the lack of common general knowledge, unpredictability of the chemistry, and absence of motivation. The SPC is valid because levofloxacin is a novel and inventive product, distinct from ofloxacin, and the first marketing authorisation for levofloxacin is the relevant authorisation under the Regulation.

Court Disposition

Appeal dismissed

Orders

  • The appeal is dismissed; the patent is valid; the SPC is valid.