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Friday, 20 December 2013

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.  

8 comments:

Andy said...

This decision is consistent with the strict approach to priority which is inevitable if there is going to be certainty. I suppose G2/98 was the crucial decision which forever interpreted priority for the 'invention' as something which was determined by the language of the specification and not by the contribution as a whole.

MaxDrei said...

Me, I think the importance of setting one single standard for what a document discloses outweighs every other consideration. Imagine having to construe the disclosure in one way for Art 54 EPC, another way for the purposes of Art 123(2) EPC and yet a third to see whether a claim is entitled to a declared priority date.

The single unitary disclosure standard has become increasingly strict over the years because of Art 54(3) EPC, which forces judges to distinguish between novelty and obviousness. Three cheers for Art 54(3).

The test what disclosure is destructive of novelty has ratcheded down ever tighter, over the years, thanks to the ever more cunning wiles of patent attorneys striving to get their clients through to grant despite a prior-dated document that discloses almost the same thing as their client. It is hardly a surprise, therefore, that those same attorneys are finding it correspondingly hard, these days, to convince judges to recognise priority.

What to do to hang on to priority? Write the priority document with no lesser standard of care than that which you would devote to the writing of a PCT application which is to be the basis of a world-wide programme of patent protection. And, before you file it at your PTO, get it reviewed and edited by a senior European patent attorney who is an expert in the technical field of the invention under review.

Anonymous said...

The judgement held that "The skilled person knows from _his or her_ common general knowledge that dosage is critically dependent on condition and method of administration". Is there a subtle sexist agenda in the IPKat's reporting here?!

Annsley Merelle Ward said...

@Anonymous at 12:01: No agenda - it was meant to read "their" for which I will blame my jet lag, but interesting that you picked up on that.

In any event, that would be an interesting Ph.D. thesis: "The gender bias in legal terminology and what it means". Perhaps "the man skilled in the art" and "the man on the Clapham omnibus" are due for a 21st century refresh?

Anonymous said...

@Anonymous at 1201: Clearly no sexist subtext but perhaps just a little Novartis sympathizing...

Anonymous said...

Dear AmeriKat,

The European Patent Convention refers to "the person skilled in the art" and 35 U.S.C. § 103 (A) to "the person having ordinary skill in the art"...the legislator has thus long been careful to use gender-neutral language. Legal practitioners, on the other hand...

Roufousse T. Fairfly said...

The DE and FR versions of Art. 56 EPC are very much gendered:

... wenn sie sich für den Fachmann nicht in naheliegender Weise ...

... si, pour un homme du métier, elle ne découle pas d'une manière évidente ...


Anonymous said...

For the love of personkind can we stop with the political-correctness CRAP on gender neutrality of certain words?

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