Hospira UK Generics (UK) Ltd (t/a Mylan) v Novartis AG

Hospira UK Generics (UK) Ltd (t/a Mylan) v Novartis AG

PD2 does not directly and unambiguously disclose the use of 2-10mg zoledronate once a year by intravenous administration for the treatment of osteoporosis. The 2-10mg once a year passage is not linked to intravenous administration or osteoporosis, and Example 5 only supports 4mg once yearly. Therefore, claim 7 is not entitled to priority from PD2 and is invalid.

Parties
Claimant/respondent: Hospira UK Generics (UK) Limited trading as Mylan; Defendant/appellant: Novartis AG
Jurisdiction
England and Wales
Judgment Date
19 December 2013
Procedural Posture
Civil Appeal / Appeal From High Court (chancery Division) to Court of Appeal
Outcome
Appeal dismissed; claim 7 not entitled to priority; patent invalid.
Legal Topics
Patent Priority, Pharmaceutical Patents, Revocation of Patent, Interpretation of Patent Claims
Intellectual Property Patents Patent Priority Pharmaceutical Patents Revocation of Patent Interpretation of Patent Claims

Case Brief

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Parties

Hospira UK Generics (UK) Limited trading as Mylan

Claimant/respondent

Novartis AG

Defendant/appellant

Procedural Posture

Civil Appeal / Appeal From High Court (chancery Division) to Court of Appeal

Legal Issues

  1. 1 Whether claim 7 of European Patent (UK) 1 296 689 is entitled to priority from US Patent Application No 267689 (PD2)
  2. 2 Whether PD2 discloses the subject matter of claim 7 directly and unambiguously as required by law

Ratio Decidendi

PD2 does not directly and unambiguously disclose the use of 2-10mg zoledronate once a year by intravenous administration for the treatment of osteoporosis. The 2-10mg once a year passage is not linked to intravenous administration or osteoporosis, and Example 5 only supports 4mg once yearly. Therefore, claim 7 is not entitled to priority from PD2 and is invalid.

Court Disposition

Appeal dismissed; claim 7 not entitled to priority; patent invalid.

Orders

  • Appeal dismissed
  • Patent declared invalid