Napp Pharmaceutical Holdings Ltd v Ratiopharm GmbH

Napp Pharmaceutical Holdings Ltd v Ratiopharm GmbH

The Cimex product infringes Napp's patents as it meets the claim requirements, including the use of HPMC as a spheronising agent and the dissolution parameters. The patents are not invalid for added matter, as no new technical teaching was introduced, and are not obvious over Oshlack, as there was no motivation or clinical reason to develop a 12-hour controlled release oxycodone formulation prior to the invention. The construction of the claims does not exclude products with some oxycodone outside the coating, and the dissolution test applies to individual dosage forms.

Parties
Appellant/respondent: Napp Pharmaceutical Holdings Ltd; Respondent/appellant: ratiopharm GmbH; Respondent: Sandoz Ltd
Jurisdiction
England and Wales
Judgment Date
01 April 2009
Procedural Posture
Civil Appeal (patents) / Appeal From High Court (patents Court)
Outcome
Appeal by Napp allowed; cross-appeal by ratiopharm/Sandoz dismissed.
Legal Topics
Patent Infringement, Patent Validity, Added Matter, Obviousness, Claim Construction, Divisionals
Intellectual Property Patents Patent Infringement Patent Validity Added Matter Obviousness Claim Construction Divisionals

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Parties

Napp Pharmaceutical Holdings Ltd

Appellant/respondent

ratiopharm GmbH

Respondent/appellant

Sandoz Ltd

Respondent

Procedural Posture

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

Legal Issues

  1. 1 Whether the Cimex product infringes Napp's patents EP (UK) 722730 and 1258246
  2. 2 Whether the patents are invalid for added matter
  3. 3 Whether the patents are obvious over prior art (Oshlack)

Ratio Decidendi

The Cimex product infringes Napp's patents as it meets the claim requirements, including the use of HPMC as a spheronising agent and the dissolution parameters. The patents are not invalid for added matter, as no new technical teaching was introduced, and are not obvious over Oshlack, as there was no motivation or clinical reason to develop a 12-hour controlled release oxycodone formulation prior to the invention. The construction of the claims does not exclude products with some oxycodone outside the coating, and the dissolution test applies to individual dosage forms.

Court Disposition

Appeal by Napp allowed; cross-appeal by ratiopharm/Sandoz dismissed.

Orders

  • Declaration that Napp's patents EP (UK) 722730 and 1258246 are valid and infringed by the Cimex product.
  • Dismissal of ratiopharm/Sandoz's validity challenge.