|Ouch. That is all.|
Novartis argued that the "2-10 mg once a year" passage is applicable to all modes of administration as the disclosure of the US application does put forward that one of the preferred methods of administration is intravenous administration and that osteoporosis is one of the highlighted target conditions. As regards Example 5, other study arms used less than 4 mg of zoledronate, albeit at more frequent intervals. Therefore 4 mg would not be understood by the skilled person as the only possible dose.
The Court of Appeal did not accept those submissions as they depended on reading the "2-10mg once a year" passage as saying that:
"no matter how you administer zoledronate and no matter what condition you administer it for, 2-10 mg is a suitable dosage range. To put it another way, it would be read as saying that this particular dosage range can be used independently of the condition being treated and independently of the method of administration."The Court of appeal therefore held that:
- Because the US patent application's specification expressly states prior to the "2-10mg once a year passage" that the dosage is dependent on method of administration and condition, the passage could only be read by the skilled person as teaching that depending on the method of administration and the condition being treated, some doses within this range may be suitable.
- The skilled person knows from her common general knowledge that dosage is critically dependent on condition and method of administration. Intravenous administration delivers the drug directly to the bloodstream without the loss of drug via the excretion which would occur in oral administration. A lower dose would apply in such a case.
- Other dosage ranges are given in the patent. These examples cannot be taken as disclosing that they are suitable for every condition and every means of administration. For example, the reference to a dose of 0.005-20 mg/kg would be an enormous dose for a 75kg man. This does not therefore support the argument that the "2-10mg once a year passage" is of general application.
- The expert evidence at first instance indicated that the skilled team would think that the "2-10mg once a year" passage"was intended to account for various modes of administration, not specifically intravenous. This is because some of the range would be suitable for intravenous, whilst the higher range would be suitable for other modes such as transdermal. Although one of the experts stated that the 2-10 mg range would be "in play" for intravenous administration, that fell short of disclosing that this range was suitable for treating osteoporosis by intravenous administration.
|The only priority for the AmeriKat|
is to get some sleep
On the other hand the AmeriKat feels a bit unsatisfied by the way in which the Court of Appeal did (or , more accurately, did not) address Novartis's arguments head on about the need to read the priority document as a whole (see Jacob LJ in Unilin at paragraph 61), not each passage in isolation.