Hospira UK Ltd & Anor v Novartis AG

Hospira UK Ltd & Anor v Novartis AG

None of the claims are entitled to priority from PD2 as the disclosure does not directly and unambiguously support the claimed subject matter; the claims are not obvious over Boutsen due to uncertainty in efficacy and dosing; the open-ended claims are invalid for insufficiency as they require substantial clinical trials to determine effective doses and intervals.

Parties
Claimant: Hospira UK Limited; Claimant: Generics (U.K.) Limited trading as Mylan; Defendant: Novartis AG
Jurisdiction
England and Wales
Judgment Date
15 March 2013
Procedural Posture
Patent Revocation / Final Judgment
Outcome
Patents revoked
Legal Topics
Patent Validity, Priority, Obviousness, Insufficiency, Bisphosphonate Administration, Osteoporosis Treatment
Intellectual Property Pharmaceutical Law Patent Validity Priority Obviousness Insufficiency Bisphosphonate Administration Osteoporosis Treatment

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Parties

Hospira UK Limited

Claimant

Generics (U.K.) Limited trading as Mylan

Claimant

Novartis AG

Defendant

Procedural Posture

Patent Revocation / Final Judgment

Legal Issues

  1. 1 Are the claims of European Patents (UK) Nos. 1 296 689 and 1 591 122 entitled to priority from PD2?
  2. 2 Are the claims obvious over Boutsen et al?
  3. 3 Are the claims invalid for insufficiency?

Ratio Decidendi

None of the claims are entitled to priority from PD2 as the disclosure does not directly and unambiguously support the claimed subject matter; the claims are not obvious over Boutsen due to uncertainty in efficacy and dosing; the open-ended claims are invalid for insufficiency as they require substantial clinical trials to determine effective doses and intervals.

Court Disposition

Patents revoked

Orders

  • European Patents (UK) Nos. 1 296 689 and 1 591 122 declared invalid for lack of priority and insufficiency
  • No independent validity over Boutsen