N4 Pharma Share Discussion Threads

[eddie_yates] 27/7/2018 11:27

What a complete and utter Bell End!!!

[hughwilson] 27/7/2018 09:39

Nobby, I know the person who actually spoke to Pfizer's CEO about N4 and it's sildenafil reformulation so I wouldn`t be so sure about the zero interest if I was you.

[nobbygnome] 27/7/2018 09:17

A low price will always win.

And as for Pfizer being interested in N4, I just spoke to my relative about that. I hope it is not giving too much away but she actually asked the Pfizer people she was dealing with about this subject because I had discussed this reformulation with her. They said that there is absolutely no interest in this form of sildenafil within Pfizer so my previous supposition that there is virtually no chance of Pfizer buying them is wrong. The chance is actually zero! They have accepted there will be reduced returns from viagra because of generic competition albeit Connect was a good effort to slow the decline.

This is where your understanding of Pharma is fatally flawed. They don't defend their drugs endlessly when there is no point, they just move on to new drugs in other areas. Generic competition is a reality of every day life for Pharma.

[hughwilson] 27/7/2018 09:05

Cross wires there Nobby, I see where you are coming from with that comment. So with that in mind the current sildenafil market will see market erosion to the cheapest suppliers. That will mean profit erosion for the big players like Pfizer. What is needed is something better than the imperfect viagra, something that will stand out from the rest of the generics and one that can be sold at a premium, something that will make all the rest of the generics yesterdays product.
As I said before, a successful tweak of Sildenafil by N4 will see Pfizer`s interest reawaken in N4.

[nobbygnome] 27/7/2018 08:52

>> hugh

Your comment about being market leader referred to sildenafil not Nuvec (post 390). Please try to be consistent.

So you really think the reformulation will be market leader? There really is zero chance of that. A more expensive version of a drug never ever will be the market leader even if it has marginal extra benefits.

[hughwilson] 27/7/2018 08:45

One thing that does surprise me about the Hugh/N4P bashers is that while they claim to be the highest authority on anything pharma they let themselves down by their comments showing that they have not done even the most basic of research about N4P.

Edit, I said they when it should have been singular. The other is just a Hugh hater with no knowledge whatsoever but is consumed by hatred against me.

[dplewis1] 27/7/2018 08:10

Oh the joys of reading back last night's posts.. A conversation quite clearly about the sildenafil reformulation yet an unrelated response about Nuvec becoming the industry standard. Remarkable from someone claiming to be of sound mind.

[hughwilson] 26/7/2018 22:37

Nobby, it is N4 who say that Nuvec is being positioned to replace the current lipid system and become the industry standard.

Perhaps you would like to ask them what planet they are on and see if they are seriously deluded and for your information progress on Nuvec is going very well with further deals expected this year.

[gettingrichslow] 26/7/2018 20:53

HughWilson, can you give us your take on Ken Chung's predictions please? Could he be right?

[nobbygnome] 26/7/2018 18:19

>> hugh

'The chance to be market leader'. What planet are you on? I am truly astonished by that statement; is that what Nigel told you? At best this will be an also ran and at worst a non runner!

As you know I always try to be polite but you are showing with your recent statements that you are seriously deluded. You don't understand how the Pharma market works. A fool and his money are easily parted....

[hughwilson] 26/7/2018 18:10

dplewis1,
You are such a complete idiot that you are not worth responding to.

I would suggest you seek help right away but you may be too far gone.

[dplewis1] 26/7/2018 18:07

That's it Hugh, let it all out. Don't worry though..psychology is on your side, here's an article that might help you:https://www.psychologicalscience.org/news/why-its-so-hard-to-admit-youre-wrong.html

[hughwilson] 26/7/2018 18:01

dplewis1, ok you idiot, let me try and explain it so that even someone who is stupid and twisted like you can understand it.
Viagra cannot be taken with food IF YOU WANT IT TO WORK.

[dplewis1] 26/7/2018 17:56

Hugh I can be as pedantic as I like, the fact is you have contradicted yourself. Your words are there in black and white, I am merely stating that the FAQ page says that you can take it with food but that there may be a delay in its effect. You clearly stated that it cannot be taken with food, which is either a lack of knowledge, a lie or a "mis-speak" if you are Hillary Clinton.

[hughwilson] 26/7/2018 17:51

Nobby, if the tweak is successful then we will see about that. There are plenty in the market who are looking for market share in the viagra market. A successful tweak would give them the chance to be market leader and that applies to all the majors and not just Pfizer's.

[nobbygnome] 26/7/2018 17:41

There is virtually zero chance of Pfizer buying N4P. I really don't think you understand how big companies work and anyway there is nothing worth buying IMHO.

[hughwilson] 26/7/2018 17:34

donk7,
You are quoting from the risk section of the admission document. Every company has to have a risk section as policy. If you wanted to focus on the risk section alone then you would not invest in any company at all as even very large companies can run into trouble.
What N4 has done is to team up with one of the best patent writers in the world and the reason there is so many patents surrounding N4`s sildenafil is to cover the risks from all angles. That not only protects N4 but would also protect Pfizer if it were to buy out N4 and would be a prime factor in that instance.

[donk7] 26/7/2018 13:53

Nuvec patent issues ... 7.2 from page 53



Nuvec
We understand that the pending international patent application no. PCT/AU2016/050283, entitled
“Composition, particulate materials and methods for making particulate materials”, relates to the
Nuvec technology.
The PCT application has not yet entered the national phase, so substantive examination of the
application in individual countries has not yet begun. It is not therefore known at this time what
objections will be raised by the patent offices that will examine the respective national and regional
phase applications, if and when such national and regional phase applications are filed based on
the PCT application.
However, as discussed above, the Australian Patent Office, in its capacity as International Searching
Authority (ISA), has searched and examined claims 1-63 of the PCT application.
The Written Opinion of the ISA indicates that the subject matter defined in claim 1 namely
“particulate material comprising rough mesoporous hollow nanoparticles” is considered by the
ISA to lack novelty over prior art that is cited in the ISR. It also indicates that the scope of claim
1 is too broad because claim 1 embraces particles that can be made of materials other than silica,
whereas the only class of particles defined in claim 1 which the ISA considers to be supported by
and sufficiently disclosed in the application appears to be silica nanoparticles which have silica
projections, prepared by competitive deposition between silica precursors and resourcinol-
formaldehyde, aminophenol-formaldehyde or dopamine.
The fact that the ISA has raised these lack of novelty and undue breadth-of-claim issues, indicates
that such issues will probably also be raised as objections by the national and regional patent offices
that will in due course examine the respective national and regional phase applications based on
the PCT application, if and when such national and regional phase applications are filed.
It is also of course possible that one or more of those national or regional patent offices will find
further relevant prior art, which has not thus far been cited, and raise additional or different
objections of lack of novelty and/or lack of inventive step, based on such prior art. Also, as is the
case with any patent application, it is possible that one or more of the national or regional patent
offices will raise further objections that are not based on the prior art, but on other grounds such
54
as, for example, that the claims of the application lack clarity or lack support by the description,
or that the invention as defined in the claims is not disclosed sufficiently clearly and completely
e
nough in the application.
Turning however to the particular issues of lack of novelty and undue breadth-of-claim that have
been raised by the ISA against claim 1 of the PCT application, it is possible if not likely, in our view,
t
hat the issues could be overcome by amending claim 1.
Indeed, as discussed above in the comments on the prosecution of this patent family, the Written
Opinion identifies particular subject matter which the ISA Examiner considers to be novel. This
includes the subject matter defined in claim 4 of the PCT application, which relates to rough
mesoporous hollow nanoparticles which comprise a mesoporous shell, the external surface of
which has projections thereon, the projections having smaller sizes than the particle size, and the
size of the projections being from 100 nm to 500 nm.
Accordingly, an amendment to restrict the particles defined in claim 1 to the particular particles
defined in claim 4, could well address the particular lack of novelty issue raised by the ISA.
Whether or not such an amendment would be acceptable to N4 from a commercial perspective
would depend on whether or not the resulting claim embraces the particles currently employed in
the Nuvec technology.
A further amendment to claim 1, which additionally limits the particles of claim 1 to silica particles,
having silica projections, could well address the particular breadth of claim issues raised by the ISA.
A combination of the two amendments discussed above may well therefore be sufficient to
overcome the specific novelty and breadth-of-claim issues raised by the ISA.
Although it may be possible to address the breadth of claim issues raised by the ISA by argument
alone, such an approach in our view is less likely to be successful than amending claim 1 to define
the particles as being silica particles, having silica projections. Besides, we understand from N4 that
rough silica nanoparticles, having silica projections, are commercially the most important
embodiment of the invention as defined in claim 1 of the PCT application, because such particles
are employed in the Nuvec technology. Accordingly, we understand that making the further
amendment discussed above would probably be acceptable, in that it could still result in valuable
patent protection for N4 which embraces the Nuvec technology.
In addition to the novelty and breadth-of-claim issues raised by the ISA, it will most likely be
necessary to address the issue of inventive step. In general, inventive step can be addressed by
arguing, or amending the claims to clarify, that the subject matter defined in the claims would not
have been obvious to a person skilled in the art, in view of the cited prior art.
If amendments along the lines suggested above were made in order to address the particular novelty
and breadth-of-claim issues raised by the ISA, the issue of inventive step were also addressed
successfully, and no other objections were raised against the national and regional phase
applications, there does in our view seem to be a reasonable chance of obtaining granted patents.
Assuming that the amendments in question result in a scope of claim that embraces the current
Nuvec technology, such resulting granted patents should provide effective patent protection for
N4’s Nuvec technology.
However, it should be again be noted that even if prosecution is successful granted patents are open
to challenge, including on the basis of prior art not considered in prosecution which might be
identified by a challenge

[donk7] 26/7/2018 13:48

Hughwilson - where are N4P with the patent risks? Are they overcome or still exist? Apologies but the text doesn't format well here. Looks to be some obtacles with prior-claims for their reformulations and Nuvec..

(from about page 49)

7. Adequacy of the Patent Portfolio and Risks
Comments will be provided below on the adequacy of N4’s patent portfolio for obtaining patent protectionin N4’s key development areas, the risks associated with N4’s patent strategy, and actions that may needtaking in light of those risks.
7.1
sildenafil, losartan, valsartan, tadalafil and aprepitant
There is a risk, however, that one or more of the claims that will be included in the priority-claiming
PCT applications upon filing will not be considered to be entitled to priority.
One possible reason for this is that the relevant UK priority application for the API may not be
considered to provide an enabling disclosure of the subject matter that is claimed in the PCT
application. A patent examiner might for instance consider that a particular formulation of the API
is not disclosed sufficiently clearly and completely enough in the priority application for a skilled
person to be able to make the formulation. Alternatively, a patent examiner might consider that the
priority application does not make it plausible that a particular formulation of the API will achieve
the intended effect (e.g. a fast-acting and long-lasting effect). Such objections can be raised, for
instance, if there is a lack of experimental evidence in the priority application which supports that
a compound or formulation achieves the intended effect.

If this is the case, the subject matter (formulation) in question may not be considered to be entitled
to the priority date provided by the UK patent application. Claims in the PCT application that cover
the subject matter in question may not then be considered to be entitled to priority.
There are other possible reasons as to why one or more of the claims that are drafted for the PCT
applications may not be considered to be entitled to priority. One possibility is that thedevelopmental work carried out on the particular API during the priority year, reveals further formsand formulations of the API that are not disclosed in the priority application and/or which are
beyond the scope of the statements of invention in the priority application, such that claims that are
included in the priority-claiming PCT application, which are directed to such formulations, will not
be entitled to priority.
Another possibility is that the relevant UK patent application from which the PCT claims priority
does not contain language that is substantially the same as the language that is eventually chosen
for one or more of the claims of the PCT application; this could also result in the claims in question
not being considered to be entitled to priority.
In view of this risk of lack of entitlement to priority, it is critical to ensure that none of the details
of any of N4’s proposed forms and formulations for each API is publically disclosed before the PCT application relating to the API is filed. Such a public disclosure could invalidate the claims of a resulting patent based on the PCT application, in the event that the patent claims in question are
not considered to be entitled to the priority date.
We understand that N4 is aware of this risk and will not disclose details of its products before the
PCT applications are filed.
Consideration should also be given to filing one or more supplementary UK priority applications
during the priority year if any changes or developments to the inventions are made during that
period which should be protected; it could well be desirable to protect such developments via a
priority application rather than waiting until the relevant PCT application is filed.
A further risk associated with the patent strategies in relation to sildenafil, losartan, valsartan,
tadalafil and aprepitant, is that, after a priority-claiming PCT application is filed for the API, the
PCT application will not result in any valid, granted patents that cover N4’s products containing
the API.
51
This may be because, in the period between filing the PCT application and one or more patents
being granted, N4’s products containing the APIs evolve to such an extent that they are no longer
c
overed by the patents. However, this risk may be mitigated to a certain extent by ensuring that at
least some of the claims that are included in the PCT applications for these APIs are of sufficient
breadth to embrace future developments of N4’s products relating to the APIs. We understand that
N
4 is aware of this risk and is planning to have the claims of each PCT application drafted
accordingly.
Alternatively, the PCT application may not result in patents that cover N4’s products because objections
that are raised by patent examiners (or indeed third parties) during the application process prevent such
patents being granted. Such issues might also be raised during opposition, invalidation or revocation
proceedings against a patent after it has been granted. Types of objection that might be raised are
discussed below.
One possibility is that subject matter claimed in the patent application will be found to lack novelty
over, or lack an inventive step in view of, the prior art. We do not yet know what prior art will be
found by the various patent offices when they search the claims of the applications, meaning that
at present this is something of an unknown quantity. This risk may nonetheless be mitigated to a
certain extent by ensuring that the PCT application contains, in addition to broad claims, a range
of progressively narrower claims that focus on specific formulations of the relevant API that are
of commercial interest and that N4 is confident are likely to be novel. We understand that N4 is
aware of this risk and is planning to have the claims of each PCT application drafted accordingly.
For the APIs other than sildenafil, where there still may be adequate time, consideration should also
be given to filing a further supplementary UK priority application during the priority year, which
contains claims and is filed together with a request for Search. The Search could be requested on
an accelerated basis in the hope that the UKIPO issues a Search Report before the end of the priority
year. This would have the advantage that N4 would be able to see what prior art exists, in relation
to that API, before the claims of the priority-claiming PCT application are drafted. The claims of
the PCT applications could then be drafted in the light of any relevant prior art that is found, which
could result in a more robust set of claims in each case.
A further possible objection is that subject matter claimed in the patent application will be found
to lack an inventive step, not in this instance based on prior art which has been cited, but instead
because the examiner considers there to be insufficient evidence in the patent application that the
claimed invention works. Such objections can be raised if there is a lack of experimental evidence,
or a lack of scientific explanation, in the patent application to support that a particular compound
or formulation achieves the intended effect. For instance, it might be considered that there is
insufficient experimental evidence in an application to support that a particular form or formulation
of an API achieves an intended fast onset of action and long-lasting effect. Claims that embrace that
form or formulation of the API could then be considered to lack an inventive step.
We understand that N4 is aware of this risk and the fact that it may be mitigated to a certain extent
by including explanations in the PCT application as to why the intended effect would be expected
to be achieved by the claimed subject matter, e.g. by the various forms and formulations of the
API in question that are embraced by the claims. Better still, experimental evidence can be included
in the PCT application which supports that the effect would indeed be achieved for those forms and
formulations. Ideally such evidence should support that substantially all variants falling within the
claims would be expected to provide the intended effect, in order to reduce the risk of objections
being raised that the breadth of claim is too great. We understand that N4 is carrying out
developmental work which could yield such evidence for inclusion in the various PCT applications.
A further possible objection is that subject matter that will be claimed in the priority-claiming
application will be found to lack sufficiency of disclosure. Such an objection would be raised if a
patent examiner considered that subject matter (for instance a particular form or formulation of an
API) embraced by one or more claims of the application was not disclosed sufficiently clearly and
completely enough for a skilled person to be able to put it into effect.
52
In the case of a claimed form or formulation of an API, the objection may be that the skilled person
would not be able to make the form or formulation in the first place, because there is insufficient
d
etail in the patent application to enable the skilled person to do this. Alternatively, the objection
may be that, once the form or formulation had been made, the skilled person would not then be able
successfully to use the invention because there is insufficient evidence in the patent application that
t
he treatment for which the form or formulation is intended would work.
This risk may be mitigated to a certain extent by including examples which describe how the various
forms and formulations of the API that will be claimed the PCT application can be produced. The
risk may be further mitigated by including an explanation in the PCT application as to why the
intended effects would be expected to be achieved by the various forms and formulations of the API
or, better still, by including experimental evidence in the PCT application which supports that the
intended effects will indeed be achieved. Ideally, such evidence should show that substantially all
variants falling within the scope of the claims can be prepared and would be expected to provide
the intended effect, because this will reduce the risk of objections being raised that the breadth of
claim is too great.
Again, we understand that N4 is aware of this risk and has been carrying out developmental work
during the priority year with the aim of providing further exemplification and evidence for inclusion
in the PCT applications before the PCT applications are filed.
Finally, the 12-month deadlines for filing applications (such as a PCT application) which claim
priority from one or more of the UK patent applications in each of these patent families are
approaching. The deadlines are also inextensible. We strongly therefore recommend that N4 engages
a professional firm of patent and trade mark attorneys at the earliest opportunity, in order to ensure
that the PCT filing deadlines for the sildenafil, losartan, valsartan, tadalafil and aprepitant portfolios
are properly monitored, that suitable PCT applications are prepared and filed for each of these APIs,
in a timely manner by the deadline, and to ensure that the future prosecution of patent applications
in these families is professionally managed.

[nobbygnome] 26/7/2018 13:41

The answer is clearly ‘no’.

[dplewis1] 26/7/2018 13:38

It's also too easy to prove you wrong.."yet you can't take viagra with food.."From viagra FAQ page:"Eat smart before you start. VIAGRA CONNECT can be taken with or without food. If you take VIAGRA CONNECT after a high fat meal, for example burger and chips, it may take a little longer to start working."Like I said, even if they can get it to work faster in a fed state - is it differentiated ENOUGH?