Jump to content

BLT


colaiscute

Recommended Posts

  • Replies 10k
  • Created
  • Last Reply

Top Posters In This Topic

Top Posters In This Topic

Posted Images

I seems as if Benitec now has a future ... well done holders.

 

If we had this announcement back in early 2008 - the shareprice would now be over 50cents - possibly testing $1.

 

However, in 2010 - even great news is barely good tidings for a cash strapped biotech. Look at Novartis passing on Alnylam trigger IP for $100m. The US$1.1b Merck paid for Sirna is but a distant memory of better days.

 

A Benitec capital raising is inevitable. Formally, the company is insolvent and reliant on the La Jolla convertable note to pay the bills. This albatross remains and will dampen any resurgence in the shareprice.

 

I'd like to think that some kind of transaction is near - but in the current investment climate the chances of this happening are practically zero.

 

Everything is now in place - delayed by 2-3 years :(

Link to comment
Share on other sites

good to see you're still around Enu.

 

we ought to try and get a handle on the dilution since early 2008 to

weigh against the very material outcome of the CoH HIV therapy safety

study in humans - not many RNAi outfits have gone even close to this

 

from what i can tell the investment climate has definitely turned a corner

- in all parts of the globe for resources that is

Link to comment
Share on other sites

i agree Enu - 50c to $1 would be fair to say if it were early '08

based on an upheld patent ann (we saw what it did on lesser 'big' news)

 

so here's my sanity check on the dilution factor:

- 286M ordinary shares at end of 2006/07 FY

- 415M ordinary shares at end of 2009/10 FY

assume just pro-rata on options.

 

so if we say 50c to $1 a fair call on upheld patent ann if it were

early 08, from a share dilution point of view 34c to 69c is actually

appropropriate from today's ann at this point in time.

 

So dilution is one factor for sp, but i'd suggest fatigue another possibly,

but actually more like market doesn't give a toss for patent in any case, but

will act when they see the $$.

 

This of course doesn't factor in the latent value build up such as

the CoH safety trial, & other programmes - which need accounting

for :wacko: . suggest we wait and let the pharma co's do this for us.

Link to comment
Share on other sites

Benitec Wins Important Victory at the USPTO

http://blog.nerac.com/rnailitigation/wp-content/themes/RNAiLitigation7/images/postdateicon.png September 30th, 2010 | http://blog.nerac.com/rnailitigation/wp-content/themes/RNAiLitigation7/images/postauthoricon.png Author: johnleavitt

 

http://blog.nerac.com/rnailitigation/files/2010/09/benitec.jpg

 

Today, Benitec Limited in Melbourne Australia announced the USPTO Board of Patent Appeals and Interferences decision reversing all previous claim rejections for US 6,573,099, a basic patent covering DNA-directed RNAi interference in humans (the "Graham patent"). Benitec appears to own gene therapy for RNA interference with a June 19, 1998, priority date.

 

Here is the information on this decision posted at Benitec's website www.benitec.com :

 

USPTO Board of Appeals Decision

 

Benitec's Media Release

 

Benitec will now be able to extend their therapeutic programs in HIV/AIDS, Hepatitis B, and Lung Cancer.

 

 

 

 

http://blog.nerac.com/rnailitigation/

Link to comment
Share on other sites

Thursday, September 30, 2010

 

"http://rnaitherapeutics.blogspot.com/2010/09/beniteccsiro-win-major-patent-battle-in.html"

 

Benitec/CSIRO Win Major Patent Battle in US

One of the sadder stories in RNAi Therapeutics history is the many years lost in the commercial development of drugs based on DNA-directed RNAi (ddRNAi) as the space had become embroiled in litigation instead of investing in the science. In a sign that this chapter may be behind us and that ddRNAi Therapeutics can now look forward to a time where the significant medical potential of the technology can be realized, the USPTO Board of Patent Appeals and Interferences (BPAI) just reversed an earlier (2008) decision to revoke the previously issued and fundamental Graham patent that is controlled by Benitec and CSIRO. This had followed a re-exam prompted by their archrival Nucleonics Inc, now bankrupt and buried on the corporate graveyard underneath its legal bills.

 

Benitec shares went up 50% on the news.

 

The Graham patent as issued first in 2003 broadly covered the use of double-stranded DNA capable of driving the expression of double-stranded RNAs (dsRNA) for sequence-specific gene silencing in animal cells. The compositions included the expression of sense and antisense RNAs from either separate promoters or in the form of a self-complementary hairpin RNA from a shared promoter. Because the latter construction (single promoter) is the commercially more valuable claim, it will be the focus of my following discussion.

 

The previous re-examiner had rejected these claims as obvious in light of the famous Fire and Mello studies where the Nobel Laureates (btw, watch out for announcements next week- microRNAs this time?) applied dsRNA (not dsDNA) directly to animal cells and showed that it is in fact dsRNA and not antisense that is by far the more potent trigger for gene silencing. In a mixture of valid scientific speculation and boilerplate legal language, the Fire-Mello patent also contemplated dsRNA generated by transcription in animal cells as well as self-complementary RNAs as variations of the dsRNA RNAi trigger theme. The patent, however, does not provide examples that these methods in fact would work.

 

Specifically, this examiner argued that the claim in Graham covering the one promoter with the two identical gene copies in inverted orientation and separated by a 'stuffer' (i.e. driving the expression of hairpin RNAs) was obvious over Fire in light of antisense literature that described the use of hairpin structures at the end of antisense molecules so as to stabilize them from exonucleolytic degradation. The examiner therefore concluded that it would have been obvious to modify the Fire dsRNAs with hairpins to similarly stabilize them from degradation.

 

The new examiner, however, concluded that this is not so. In fact, since Fire-Mello already specifically stated that dsRNAs are naturally stable, more stable than antisense, changing this stable structure with things like hairpins would only have risked adversely affecting the stability of the dsRNA. That is, Fire-Mello in fact taught away from such modifications. Moreover, the dsRNA portion of the hairpin elements generated by the antisense stabilization technique would not have had the capacity for being silencing triggers themselves, whereas in Fire-Mello the dsRNA was the silencing trigger. Indeed, in order for the antisense to work efficiently, the target mRNA would first have to displace and disrupt the protective hairpin at the end. Thus, the hairpins in Graham and the antisense literatures served entirely different functions (Graham: efficient production of dsRNA; antisense: stabilization), and to draw such parallels was inappropriate.

 

In short, the USPTO found that RNAi is Not Antisense and reversed its earlier decision. As a result, when it comes to RNAi Therapeutics, the two fundamental patents are now Fire-Mello for the application of dsRNA to the target cells, and Graham for ddRNAi approaches.

 

Given the importance of the US market for the pharmaceutical industry, this decision has a number of implications for the RNAi IP landscape. First, of course, is that ddRNAi Therapeutics would likely require a license to Graham for their commercialization until ~2018 (priority date for Graham: 1998). Currently, there are two ddRNAi candidates in phase I clinical development, one for HIV by Benitec itself, and one for the treatment of cancer by US-based Gradalis; another one is a ddRNAi development candidate for HCV that originated with Benitec and is now with Tacere/Pfizer and appears close to the clinic. Considering the time it takes from discovery to the commercialization of new drug candidates and the so-called 'research exception', the demand for Graham as a gate-keeping ddRNAi therapeutic patent may therefore be somewhat limited.

 

Of more immediate financial benefit to Benitec could be the research and reagent market where there are a number of companies that have been selling ddRNAi vectors and transgenic RNAi mice and have yet to obtain a license from Benitec/CSIRO. Because of the complexities of the Benitec-CSIRO-Sigma relationship, we probably have to wait to hear more from the company about the anticipated financial impact here.

 

An even larger financial windfall would probably occur if CSIRO can get their ddRNAi patent issued for the plant field- despite Fire-Mello. It is CSIRO's dedication and attention to detail that was a major force in achieving the Herculean feat of turning around Graham.The financial windfall is due to the fact that, unlike therapeutics, ddRNAi plants are already a commercial reality and growing.

 

It is of note here that an interference proceeding against the Fire-Mello patent has been initiated by CSIRO and might even result in invalidating Fire-Mello altogether. In interference proceedings the aim is to determine the priority of patents (here Waterhouse vs Fire) that compete for coverage of the same subject matter, or at least subject matter that the USPTO holds to be the same. I indeed believe that there is a good chance that ddRNAi for plants will be found to have been conceived before Fire-Mello was. It is also possible that, in the end, Fire-Mello and Waterhouse will find a way to peacefully co-exist.

 

In the end, it is a relief that the USPTO did not lose sight of major themes in RNAi science and did not get lost in technical minutiae. It therefore also bodes well for should the time come that the Crooke antisense patents are moved to the frontlines of the patent battles. But wouldn't it be great to wait next time until real drugs have been developed before fighting over the spoils?

 

 

 

 

PS: It seems like there have been major developments on another prominent RNAi patent front, the Tuschl Litigation. As reported on the RNAi Litigation blog, it appears as if UMass is becoming increasingly isolated, and any attempt to rescue the therapeutic value of Tuschl-I is getting less likely by the day.

Link to comment
Share on other sites

the USPTO found that RNAi is Not Antisense and reversed its earlier decision. As a result, when it comes to RNAi Therapeutics, the two fundamental patents are now Fire-Mello for the application of dsRNA to the target cells, and Graham for ddRNAi approaches.

 

Sounds great. Where does this leave ISIS?

 

Considering the time it takes from discovery to the commercialization of new drug candidates and the so-called 'research exception', the demand for Graham as a gate-keeping ddRNAi therapeutic patent may therefore be somewhat limited

 

Doesn't sound great. Much better to sell the thing isn't it?

 

An even larger financial windfall would probably occur if CSIRO can get their ddRNAi patent issued for the plant field- despite Fire-Mello. It is CSIRO's dedication and attention to detail that was a major force in achieving the Herculean feat of turning around Graham.The financial windfall is due to the fact that, unlike therapeutics, ddRNAi plants are already a commercial reality and growing

 

Maybe this is the GENZ tie up. I know the NZ CRI's and CSIRO are involved with both them and the Chinese but haven't a clue what for.

Link to comment
Share on other sites

Before selling on issue of patent protection:

be worth investigating the entire patent estate (Graham, Roelvink, Kay, Brashears, etc),

including applications for the filing dates and subsequent protection periods - some of these would

go past 2020.

 

and it'd be worth confirming the scope of the patent ie: if it covers say

any HCV using ddRNAi and extends into 2020 and beyond??

 

Also exclusive access to Rossi's CoH / HIV patents Benitec have with the stem / T cell

work.

 

And all the above just for US patent system

 

So more due diligence then required to understand other patents such as China, Singapore,

Japan, and hell - even NZ!

 

Also - does Graham '099 upheld provide now a reinvigorated launch pad for a new crack

at EPO, and would such a successful patent then provide EU protection starting some time

in the future

 

 

Link to comment
Share on other sites

hi drafter, I don't know if you are aware the EPO has WebRegMT monitors changes of files.

It's a freebie, register and away you go

 

https://register.epoline.org/espacenet/regviewer

 

I have attached aword document to show some of the info there more to be found on the legal status

by looking around..

 

The Register alert service

 

The Register alert service WebRegMT allows you to automatically monitor changes to Online European Patent Register data in up to 1 000 files of your choice.

You can choose to have this service send you and up to four other addressees an automatic e-mail alert every time a change occurs to one of your selected files in the Online European Patent Register. Please click here to access WebRegMT.

History.doc

Link to comment
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now

×
×
  • Create New...