Court of Appeal gets strict with priority in Novartis v Hospira (Part II)

The Court of Appeal's decision

Ouch.  That is all.  

In light of how one can lose priority, the problem Novartis faced in seeking to establish that Claim 7 was entitled to priority from the US application was that disclosure of the US application was either too general or too narrow.  The "2-10 mg once a year" passage did not teach the skilled person about the dosage range for any particular method of administration for zoledronate (i.e., the passage was too general).  Example 5, was specific as to intravenous administration but only in patients with post-menopausal osteoporosis with a 4 mg, once a year administration (i.e., the passage was too narrow).

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 Court of Appeal therefore held that Claim 7 could not benefit from the earlier priority of the US application and therefore the patent was invalid.  

Comment

Although this decision may appear harsh given that the elements of Claim 7 were disclosed in the US application, the AmeriKat questions whether it is correct to characterize this decision as\indicative of an increasingly strict treatment of priority in the English courts. 

The only priority for the AmeriKat
 is to get some sleep

On one view, it is clear that without linkage of the features of Claim 7 in any passage in the US application, the subject matter was not unambiguously disclosed to the skilled person.  The mere planting a priority flag without ensuring that the priority document embodies the subject-matter of the invention, especially in circumstances where the patent claims have been amended, can be a recipe for a finding of invalid priority.  This is not new.  Indeed, following the Court of Appeal's 2004 decision in Unilin, many commentators issued such warnings. 

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.

But whether the decision is harsh depends on whether there was anything that could and should have been done when publishing the patent to rescue the priority entitlement?  The AmeriKat defers to the IPKat's learned readers as to what they would do, in light of the Court of Appeal's decision, to rescue or prevent a perished priority.