The Decision of the Court of Appeal in Hospira UK Generics Ltd. v. Novartis AG,  EWCA Civ. 1663 was issued on 19 December 2013.
The case was initially heard in the High Court and raised the issue of entitlement of a patented invention to priority. The patent in question was European Patent (UK) 1 296 689, owned by Novartis AG, which related to the use of a particular member of the bisphosphonate class of drugs for the treatment of osteoporosis, amongst other things.
The particular claim in question was Claim 7 which can be expressed as the combination of the following features:
(i) the use of a zoledronate medicine
(ii) for the treatment of osteoporosis
(iii) where the medicine is adapted for intravenous administration in a unit dosage form
(iv) comprising from about 2 up to about 10 mg of zoledronate
(v) wherein the period between administrations is about one year
Claim 7 claimed priority from two priority documents. The case, in part, related to whether the second of these priority documents, namely United States patent application number 267689 (hereinafter referred to as 'the priority document'), disclosed the subject matter of Claim 7. It was agreed that Claim 7 would be invalid if it was not entitled to priority since an intervening publication would become available for an attack on validity.
In the High Court, Mr Justice Arnold held that the Claim 7 was not entitled to priority since there was no disclosure in the priority document linking all of the features of Claim 7. Thus, the claim was rendered invalid.
Novartis appealed the Decision of the High Court.
Novartis argued that the judge in the court of first instance was led into error by failing to read the priority document as a whole. Novartis added that had the priority document been read as a whole, the judge would have appreciated the clear link between zoledronate, osteoporosis and intravenous administration which ran through the entire document.
In addressing Novartis' argument, Lord Justice Floyd outlined the law on the approach to priority, noting that although the language of Section 5 of the UK Patents Act and Article 87 EPC (which relate to priority) is different, the two formulations must be taken to mean the same thing (see Jacob LJ in Unilin Beheer BV v Berry Floor NV  EWCA (Civ) 1021;  FSR 6 at ). More specifically, Article 87 EPC states that for a valid priority claim, the later patent application must be in respect of the same invention. The Enlarged Board of Appeal in G2/98 held that the requirement for claiming priority of the same invention was met if the skilled person could derive the subject matter of the claim directly and unambiguously, using the common general knowledge, from the priority application as a whole.
Following this, Lord Justice Floyd asserted that the problem for Novartis in seeking to establish that Claim 7 was entitled to priority was that the disclosure of the priority document was either too general or too specific.
In particular, the passage relating to zoledronate in an amount of from about 2 up to about 10 mg once a year told the skilled person nothing about the dosage range for any particular method of administration. Further to this, it did not tell the skilled person about the dosage range for any particular condition, for example osteoporosis, i.e., the passage was too general.
Contrary to Novartis' assertion that the passage relating to zoledronate in an amount of from about 2 up to about 10 mg once a year was applicable to all modes of administration and all conditions, Lord Justice Floyd held that the passage would be read by the skilled person as meaning that depending on the method of administration and the condition being treated, some doses within the range may be suitable.
Example 5, on the other hand, disclosed 4 mg of zoledronate taken once a year, administered intravenously to patients with post-menopausal osteoporosis as being effective. However, it was held that Example 5 did not disclose any other doses that could be used at that dosage interval, i.e., the passage was too narrow.
Since there was no disclosure in the priority document linking all of the features of Claim 7, Lord Justice Floyd concluded the claim was not entitled to priority from United States patent application number 267689 and thus, it followed that the patent was invalid.
Even though each of the features of Claim 7 was disclosed in the priority document, without the explicit linking of these features, the subject matter was not considered clearly and unambiguously disclosed to the skilled person (in accordance with G2/98). In view of this Decision, it is advisable to take extra care when drafting priority documents to ensure that there are clear linking statements for all the claimed subject matter.