Some insight into the relenza patent issue

From the interview listed as news today


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.

Latest update

I have been away.
And for disclosure, I sold the majority of my holding since the last post, although it was to raise capital for other matters. I am still holding and would have held the whole amount due to the below. As you know it breached the 2.00 floor briefly. And why not, the Anaconda deal is such nonsense.

As I have mentioned before, the only value proposition in BTA is the value in Inavir.
We got a little more sense of that value in CSLs latest deal with Biocryst for permavir.
That is worthy of mention on a few fronts.

1. CSL has established influenza as a separate arm of the business bioCSL with its own executive director. Until now, it held the vaccines business. CSL is a major biopharmaceutical with its roots in Australia and has played big in plasma, vaccines and also developed the HPV vaccine. It has learnt through its activity in plasma that global market domination pays dividends.

2. It's strange that Biocryst would come up on CSLs radar. And the price it paid for permavir IV is higher than I would have expected. Biocrysts share price has done well.

3. The influenza treatment market is undervalued, and fragmented. No-one markets it well because they fear being labelled anti vaccine, even though with influenza vaccine that's a nearly reasonable proposition. That fragmentation leads to value, as we know looking at Biota's SP.

So, the CSL - Biocryst deal does put a better value on inavir.
It also signals a move by CSL into influenza treatment, albeit IV.
Further, CSL would already know Biota and probably watched with amusement at its value destruction over the decade. The attempted extension of relenza patent might be part of a wider deal.

Whether CSL is looking at inavir remains to be seen.
But if so, why look at raising more capital, as they seem to be preparing to do? The potential issue of another tranche of shares being issued by the company might be linked. Even in the US biotech bubble, its so hard to see them raising more capital to trial inavir themselves when they have burnt many bridges with capital markets and because the patent clock on inavir is ticking so fast.If some of their recent major holders think they should go it alone, and will back them, then quite frankly they are nuts.

So, in summary: if you think CSL has an interest in inavir, prospects might be brighter. Of course, that's difficult to assess unless you are an insider.
But if they announce a new capital raise to trial inavir themselves, it's good night from me. In that event I will sell the rest of my holdings.