Hospira UK Generics (UK) Ltd (t/a Mylan) v Novartis AG [2013] EWCA Civ 1663 (19 December 2013)

Hospira UK Generics (UK) Ltd (t/a Mylan) v Novartis AG [2013] EWCA Civ 1663 (19 December 2013)

Claim 7 is not entitled to priority from PD2 because 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 relevant passage in PD2 is not specific to intravenous administration or osteoporosis, and Example 5 only discloses 4mg once a year. Therefore, the patent is invalid.

Citation
[2013] EWCA Civ 1663
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
Patent Appeal / Appeal From High Court (chancery Division) to Court of Appeal
Outcome
Appeal dismissed; patent invalid.
Legal Topics
Patent Priority, Pharmaceutical Patents, Disclosure Requirements, Validity of Patent Claims
Intellectual Property Patent Law Patent Priority Pharmaceutical Patents Disclosure Requirements Validity of Patent Claims

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Parties

Hospira UK Generics (UK) Limited trading as Mylan

Claimant/respondent

Novartis AG

Defendant/appellant

Procedural Posture

Patent 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

Ratio Decidendi

Claim 7 is not entitled to priority from PD2 because 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 relevant passage in PD2 is not specific to intravenous administration or osteoporosis, and Example 5 only discloses 4mg once a year. Therefore, the patent is invalid.

Court Disposition

Appeal dismissed; patent invalid.

Orders

  • Appeal dismissed
  • Patent declared invalid