TLSR: Are you doing anything to rework Relenza (zanamivir) to extend the patent?
JP: No.
TLSR: But you've filed a request for a rehearing in a pending patent related to Relenza. Can you tell me a little more about that?
JP: It's interesting. This goes back to a 1994 patent application that was filed specific to the method of treatment by inhalation of Relenza. That patent was issued—and has since expired—in every country where an application was filed, except the U.S. In the United States, for whatever reason, we've never been able to get claims allowed for that application.
The issue stems from the patent office examiners' view of the claims as "obvious." We've tried for years, through expert witnesses, to make the counterargument—that in 1994 it wasn't obvious that an inhaled neuraminidase inhibitor would be effective for the treatment of influenza.
"We have extensive patent coverage on composition of matter, method of use and method of manufacturing for all of our clinical programs."That's gone back and forth. We most recently filed an appeal because the previous brief was denied. Now we're waiting to see what the patent office comes back with. If we're denied again, we still have a few legal avenues to pursue. We'll work with GlaxoSmithKline to determine whether we pursue them.
If we were to allow that application to be abandoned, and did nothing more to get the claims allowed, we would no longer receive royalties in the U.S. for Relenza.
My comment:
This is interesting, because investors were always told that there is specific IP and patentability in the compound-inhaler combination.
This states that it isn;t the case: that the delivery device is obvious, and doesn;t form a new patent.
3 issues:
1. I need to look back, but I'm pretty sure investors in Biota were always told (or assumed) that there was a patent for the combined compound - device
2. Glaxo could have pursued a change in delivery device at any time because it was not part of the patent. Not sure what FDA would have thought though, but if inhalation was obvious, then maybe a few extension studies with an MDI rather than the idiotic diskhaler might have been adequate
3. That the LANI compound - device combination may also not be patentable. The patent may extend only to the compound. Do we know this? If so, it means the patent clock is further advanced than previously thought.
As I interpret it, the argument is that in 1994 Relenza - an inhalable flu antiviral formulation - was both novel and inventive and thus patentable. The argument doesn't rest upon the delivery device per se - simply that the compound was an inhalable formulation. The patent life of LANI effectively extends to the patent life of the Twin Caps device because FDA approval of LANI (hopefully) will be limited to application through that specific device. Hence generic Relenza will necessarily have to use a generic Diskhaler (by which time, hopefully, US LANI-Twin Caps will be the go-to treatment).
ReplyDeleteFurther, it seems to me a supporting argument that Biota/GSK ought to advance with the US PTO is: when BTA signed an exclusive license with GSK to develop Zanamivir it was not obvious that this compound would be administered by inhalation. If it was, Biota would have INSISTED in its exclusive license to GSK, that royalties would accrue for the term of the patent life of the inhalation device since FDA approval would intrinsically tie the marketing of BTA's compound zanamivir to this device. Let's hope BOTA and GSK have this understanding between them in the event that the Relenza patentability continues to be denied in the US.
ReplyDeleteOne more thought before bedtime: is it possible do you think that GSK and BTA made a strategic decision early in the piece to develop zanamivir into an inhalable treatment (as opposed to an oral formulation) on the basis that the novel and inventive inhalable Relenza would effectively extend the patent life of zanamivir? Presumably, we shall never know. But if that was the decision, it would surely have to go down in the big pharma annals as a strategic blunder of monumental proportion given the runaway success of oral Tamiflu. I mean, the logical assumption would have to be that, at the outset, zanamivir would be born as a tablet - if the inhalable form was not obvious in 1994... just sayin'
ReplyDeleteAndrew
ReplyDeleteRandom thoughts.
Relenza was always planned as an inhalation. Not to extend the patent life, though.
The GSK diskhaler was already in use for other compounds when applied to relenza. If there was a patent on the device it was already years down the track. I guess I could check. GSK abandoned the diskhaler for all drugs after relenza.
But if the relenza patent interpretation holds then it has signifcant impact on the patent life of Inavir/LANI.
Why do you say that the argument is different for LANI? It would have been developed and presumably patented in exactly the same way. So, if its a novel inhalable compound, and a patent is issued, the delivery device itself may be irrelevant (obvious) to the patent. Thus the specific compound-device combination may not form a new patent or restart the patent clock. And so, as I said, the patent clock on Inavir is much further advanced than previously thought.
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ReplyDeleteIf it was always planned as an inhalation then my musings were off the mark. Doesn't really matter anyhow. Ancient history. I'm pretty sure the patent for the Diskhaler expires in Aug 2016. No generic equivalents have been approved in the US suggesting that competition from generics will not be a factor until at least a year from now.
ReplyDeleteI don't say the argument is different for LANI. If FDA approves, it will be for application in the TwinCaps device which Biota exclusively licenses for influenza treatment from Hovione. The device has a patent expiry of 2027 which is thus the the effective patent life of LANI unless a competitor develops and seeks approval for use in a new device - but this is unlikely given the expense and time-frame involved.