Novartis Ag & Ors v Focus Pharmaceuticals UK Ltd & Ors [2016] EWCA Civ 1295 (21 December 2016)

Novartis Ag & Ors v Focus Pharmaceuticals UK Ltd & Ors [2016] EWCA Civ 1295 (21 December 2016)

The patent is invalid for added matter because it discloses the use of a specific starting dose for rivastigmine delivered by a TTS, and that this starting dose may be delivered by TTSs not having the structural and compositional features disclosed in the application, which was not directly and unambiguously disclosed in the application as filed. The patent is also invalid for lack of inventive step (obviousness) because it would have been obvious to the skilled team, in light of US 031 and the common general knowledge, to try the claimed starting dose in a small scale clinical trial. The judge's construction of the claim was correct.

Citation
[2016] EWCA Civ 1295
Parties
Claimant/appellant: Novartis AG; Claimant/appellant: LTS Lohmann Therapie-Systeme AG; Claimant/appellant: Novartis Pharmaceuticals UK Ltd; Defendant/respondent: Focus Pharmaceuticals UK Ltd; Defendant/respondent: Actavis Group PTC EHF; Defendant/respondent: Actavis UK Ltd; Defendant/respondent: TEVA UK Ltd
Jurisdiction
England and Wales
Judgment Date
21 December 2016
Procedural Posture
Patent Appeal / Appeal From High Court (patents Court) to Court of Appeal
Outcome
Appeal dismissed; patent held invalid for added matter and lack of inventive step.
Legal Topics
Patent Validity, Added Matter, Obviousness, Claim Construction, Pharmaceutical Patents
Intellectual Property Patents Patent Validity Added Matter Obviousness Claim Construction Pharmaceutical Patents

Case Brief

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Parties

Novartis AG

Claimant/appellant

LTS Lohmann Therapie-Systeme AG

Claimant/appellant

Novartis Pharmaceuticals UK Ltd

Claimant/appellant

Focus Pharmaceuticals UK Ltd

Defendant/respondent

Actavis Group PTC EHF

Defendant/respondent

Actavis UK Ltd

Defendant/respondent

TEVA UK Ltd

Defendant/respondent

Procedural Posture

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

Legal Issues

  1. 1 Whether European Patent (UK) No. 2,292,219 is invalid for added matter
  2. 2 Whether the patent lacks inventive step (obviousness) over US Patent No. 6,335,031
  3. 3 Proper construction of the patent claim

Ratio Decidendi

The patent is invalid for added matter because it discloses the use of a specific starting dose for rivastigmine delivered by a TTS, and that this starting dose may be delivered by TTSs not having the structural and compositional features disclosed in the application, which was not directly and unambiguously disclosed in the application as filed. The patent is also invalid for lack of inventive step (obviousness) because it would have been obvious to the skilled team, in light of US 031 and the common general knowledge, to try the claimed starting dose in a small scale clinical trial. The judge's construction of the claim was correct.

Court Disposition

Appeal dismissed; patent held invalid for added matter and lack of inventive step.

Orders

  • Appeal dismissed
  • Patent remains revoked