ratiopharm (UK) Ltd v Alza Corp [2009] EWHC 213 (Pat) (12 February 2009)

ratiopharm (UK) Ltd v Alza Corp [2009] EWHC 213 (Pat) (12 February 2009)

The patent is infringed by the defendants' products as they fall within the claims, but the patent as granted lacks novelty over Comparative Example 2 of Samyang. This invalidity can be cured by amendment, which is not opposed. The claims are sufficiently clear and not ambiguous, and the patent is not anticipated by Roy nor rendered obvious by the cited prior art. The construction of 'monolithic' excludes multilaminate and binary systems, and the requirement for 'sufficient to induce and maintain analgesia in a human for at least three days' is satisfied if the patch induces analgesia in some humans for three days, not all.

Citation
[2009] EWHC 213 (Pat)
Parties
Claimant: ratiopharm (UK) Limited; Defendant/claimant (part 20): Alza Corporation; Part 20 Claimant: Janssen-Cilag Limited; Defendant (in Part 20 Claim): Sandoz Limited
Jurisdiction
England and Wales
Judgment Date
12 February 2009
Procedural Posture
Patent Infringement and Revocation / High Court Trial Judgment
Outcome
Patent as granted invalid for lack of novelty over Samyang Comparative Example 2; amendment allowed; patent as amended valid and infringed.
Legal Topics
Patent Infringement, Patent Validity, Novelty, Obviousness, Insufficiency, Claim Construction, Amendment of Patent
Intellectual Property Patents Patent Infringement Patent Validity Novelty Obviousness Insufficiency Claim Construction +1 more

Case Brief

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Parties

ratiopharm (UK) Limited

Claimant

Alza Corporation

Defendant/claimant (part 20)

Janssen-Cilag Limited

Part 20 Claimant

Sandoz Limited

Defendant (in Part 20 Claim)

Procedural Posture

Patent Infringement and Revocation / High Court Trial Judgment

Legal Issues

  1. 1 Whether the defendants infringed European Patent (UK) No 1 381 352 by selling fentanyl transdermal patches
  2. 2 Whether the patent is invalid for anticipation (novelty), obviousness, or insufficiency
  3. 3 Proper construction of the claims, particularly 'monolithic' and 'sufficient to induce and maintain analgesia in a human for at least three days'

Ratio Decidendi

The patent is infringed by the defendants' products as they fall within the claims, but the patent as granted lacks novelty over Comparative Example 2 of Samyang. This invalidity can be cured by amendment, which is not opposed. The claims are sufficiently clear and not ambiguous, and the patent is not anticipated by Roy nor rendered obvious by the cited prior art. The construction of 'monolithic' excludes multilaminate and binary systems, and the requirement for 'sufficient to induce and maintain analgesia in a human for at least three days' is satisfied if the patch induces analgesia in some humans for three days, not all.

Court Disposition

Patent as granted invalid for lack of novelty over Samyang Comparative Example 2; amendment allowed; patent as amended valid and infringed.

Orders

  • Declaration of invalidity of the patent as granted for lack of novelty over Samyang Comparative Example 2
  • Amendment of the patent allowed as unopposed