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In a nation where most people don't know the branches of govt or that the civil war came after the revolutionary war maybe they didn't know what the word "placebo" meant.
Nice to see AVXL is someones top pick for 2017.
Wow, not sure if that's a stock chart or a seismograph prediction of the next "big one" in California. ;)
"That they found a non-obvious "golden ratio" of A2-73 and donepezil that instead of showing antagonism used together that it shows at normal Rx'd dose of donepezil that it shows synergy"
According to the article I posted yesterday, the question is whether the synergy produces a result greater than what would be expected if the drugs were used separately. In other words the combo drug would have to at least show results measurably better than 2-73 alone (and may have to show results better than the sum of the individual results if each drug were applied separately).
Good article on patenting combination drugs. It suggests the bar you have to get over is very high.
http://www.insidecounsel.com/2014/11/11/patenting-combination-drugs-effective-strategies-a#
Well said. I wish I had been that comprehensive in so few words.
"Either 2-73 is significant alone or it is additive/synergistic."
My recollection of the arguments is that "additive" implies some sort of "linear" predictable result based on dosing and is therefore obvious, but "synergistic" (in the way they are using it) is not obvious if the result is non linear with unexpected spikes in efficacy at particular dosing combinations and potentially negative efficacy at others.
I had counted this patent as dead prior to the last conference call with the USPTO, and not being a patent attorney I have no idea of its chances. I only started to see a glimmer of hope in the fact that the company's patent lawyer did the work of adding dosing data. Wouldn't you imagine in that phone discussion the examiner would at least say "yes you can add that data but it still is not going to overcome the "obvious" rejection"? You'd at least expect the Anavex lawyer to ask if it would. Why even bother with another submission if you know you're adding nothing that will overcome the rejection? Seems to me the company lawyer saw a crack in the wall somewhere.
The examiner's argument is that the combo's is obvious because someone skilled in the art would see the effects as "additive". If in actuality the effects are not additive and the data shows that, I don't know why they cannot show data to make their case and win that argument. If it's not additive then the "obvious" argument needs another basis. I don't recall if the examiner cited others.
"You seem to think, by your post, that a patent is somehow contingent upon being better than the SOC. "
Learn how to read. I said...
"The patent can have value as long as the combo is better than the current standard of care (donepezil)."
Notice the words "have value". I said nothing about a patent being approved based on it being better than SOC.
"The Examiner's answer to date has nothing to do with efficacy,
Nor will it down the road. "
I never suggested it did.
Yeah Leo I know the difference between the functions of the FDA and the USPTO and you keep responding to my posts as if I need a basic primer and you somehow addressed or even commented on my point when you did not.
Seems to me if any combo concoction (optimized or not) is better than the current SOC then a patent on that could have value if they decide it's best to get FDA approval for the combo instead of 2-73 alone. All they have to beat is Donepezil alone to become the new SOC.
"Had the A2-73+DZP combo performed worse than A2-73 Alone the patent would have no merit. "
That's not necessarily true. The patent can have value as long as the combo is better than the current standard of care (donepezil). They could go for FDA approval of the combo even if 2-73 alone is better especially if there's a way for the donepezil part to be dropped in actual practice (not sure if that is possible which is why I just asked about restrictions on manufacturing the combo).
Question on the 2-73 combo. If the company gets FDA approval for the combo, what actual restrictions does the FDA put on how the combo is manufactured and sold? Do combo drugs have to be mixed such that they are inseparable before they are made into pills/capsules? Or can the two components be kept distinct so that the ratio of one to the other can be varied (or one part like the Donepezil could be totally eliminated) ?
I should've put "nucular" in quotes. Some people I'm sure didn't even get the joke.
"when we get some good news this thing is going to fly"
as they say down it Texas, it could soon go nucular.
;)
The volume is so low right now the current small gain could be just as contrived and temporary as the daily pops seen for the last 5 weeks.
Yes that too. I don't work in this field but do have a scientific background and when you're talking a brand new platform of drugs with a brand new approach it's hard to see how you can tell if someone will respond without actually giving them the drug. I'm sure someone eventually could crack that nut but it could take longer than a few months of analysis on 6 or 7 people.
(I removed my last post since some may have perceived it overly negative).
So if you're right and big money investors agree 2-73 is safe from generics then it seems they must think it's way too early (i.e. they have not seen enough to convince them of efficacy) to be doing anything other than taking small speculative positions that are inconsequential to the stock price.
"Seems clear that Anavex 2-73 has intellectual property protection until at least 2035."
The 2015 patent which expires in 2035 gives protection for treating cancer, but only in combinations with those 3 other compounds listed in the patent (and it's only for treating cancer, not AD). See my first post of the day.
I don't know the FDA side of things very well. Having said that, I've never heard that they have protections for new "platforms" that is more expansive than just a new drug. Until I see something definitive in contradiction I'm of the belief that once you finish your exclusivity for a new drug you can't extend it by just targeting a new ind with the same drug. Now if you do a combo drug I guess they start a new clock for that.
For those brave enough to delve into the Orange Book Legalese..
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm
Most of it is all the hoops a generic must go through. Patent handling further down in the preface.
good grief...
"Patent Certification(s) and Reference Standard based upon a suitability petition. An ANDA that utilizes as a reference standard a product approved pursuant to a suitability petition must demonstrate that the proposed product can be expected to have the same therapeutic effect as the reference listed drug. It must include appropriate patent certification(s) and an exclusivity statement with respect to the reference listed drug that served as the basis for the approved suitability petition. (This concept also generally applies to an ANDA applicant that utilizes a reference standard that is not a reference listed drug, i.e., such an application must include appropriate patent certification(s) and an exclusivity statement with respect to the reference listed drug.)
Waived exclusivity. If an NDA submitted under section 505(b) of the FD&C Act qualifies for exclusivity under the FD&C Act, the exclusivity is generally listed in the Patent and Exclusivity Section of the Orange Book. If a drug product has received this exclusivity, the FDA will not accept for review and/or will not approve a 505(b)(2) application or an ANDA under section 505(j) of the FD&C Act, as applicable, in accordance with the relevant exclusivity. If the listed drug is also protected by one or more patents, the approval date for the ANDA or 505(b)(2) application will be determined by analysis of the applicant’s patent certification(s) or statement(s) for each relevant patent and the effect of relevant exclusivity listed in the Orange Book. However, the holder of the NDA may waive its exclusivity as to any or all ANDAs and 505(b)(2) applications that might otherwise be blocked by such exclusivity. If an NDA sponsor waives its right to the exclusivity protection, qualified ANDAs or 505(b)(2) applications may be accepted for review and/or approved, as applicable, pursuant to the NDA holder's exclusivity being waived. An NDA for which the holder has waived its exclusivity as to all ANDAs and 505(b)(2) applications will be coded with a “W” in the Patent and Exclusivity Section of the Orange Book. The applicant whose product might otherwise be blocked by this exclusivity should indicate in the exclusivity statement in its application that the holder of the listed drug has waived its exclusivity. "
I think that statement sokol made is in the context of being within the 5 or 7 year exclusivity window. I grant that within that window no generic is going to be using the drug for anything. The question I was trying to get at is what happens after the exclusivity.
sokol, I need to modify that question. When you said the statement below is it in the context of the drug being within the 5 or 7 year exclusivity for a newly approved drug? If so then it makes sense. My previous question was more general in terms of what happens AFTER the exclusivity ends. I assume at that point a method of use patent on file at the FDA is not going to stop generics from going after other indications.
"Patents too are listed in the FDA's Orange Book in the FDA's ministerial capacity. As long as any patent for AVXL 2-73 is listed in the FDA's Orange Book, it will not authorize a generic version of AVXL 2-73 for any use."
Zena, I don't know about the Orange book but that is an issue of FDA exclusivities not patent protections. I may have found the Orange Book related post you were talking about and have ref'd it in my new post to sokol.
sokol, question for you. You said..
"Patents too are listed in the FDA's Orange Book in the FDA's ministerial capacity. As long as any patent for AVXL 2-73 is listed in the FDA's Orange Book, it will not authorize a generic version of AVXL 2-73 for any use."
I noted the "for any use" there at the end. Is the FDA not sensitive to the type of patent (composition vs method of use)? What about the case where a drug's original "composition of matter" patent has expired and the only non-expired patent is a method of use patent for a particular indication? It seems to me if what you said is true then pharma's could almost indefinitely hold off a generic for ALL possible indications by submitting a new method of use patent for their drug to the Orange book every so often. That doesn't seem like the way it works. What am I missing?
"In either case, the patent protects the compound, does it not? "
A method of use patent targeting a particular indication prevents someone else from using that compound to treat that indication. If the original "composition of matter" patent has expired then others are free to use that compound to treat any indication OTHER than the one you have a method of use patent for. So in the most broad sense, a method of use patent does NOT protect a compound if the original "composition of matter" patent has expired.
Yes, and the problem with your argument is that a "new use" patent IS A NEW PATENT and therefore is NOT a part of or legally attached to a previous patent, it's claims, and duration.
The underlying foundation for the disagreements here IMO is that the words "Extend" and "Extension" are used in a completely different manner by the authors of article snippets posted here (along with CEO's, PR, IR folks making comments about their IP) when compared to how the Patent Office uses those terms.
To "Extend" a patent as defined by the USPTO you file for a "PTA" (patent term adjustment) which is done to reclaim time from processing delays, the regulatory review time, etc. I can find NO other reasons cited for why someone can get a patent term extended by the patent office. You wont find any text saying a new use patent provides an extension (in this legal sense) to a patent that came before it. If you disagree give me a USPTO link that makes your case. The FDA may grant exclusivity but that has nothing to do with nor does it make any modification to a patent.
Laymen (article writers, CEOs, PR/IR folks) are using the words "extends" and "extension" MUCH more loosely. In many cases they mean an IP portfolio has been "expanded" or "added on to" in terms of breadth of scope. And of course this new breadth of scope (e.g. a new use patent) comes with it's own time duration in terms of protection.
So when Missling said that 2-73 protection was "extended" when they announced the 2015 cancer patent he simply meant that they "expanded" their patent coverage of 2-73 into a new use for cancer and that particular "additional use" will last until 20xx. He could not possibly have meant that all previous 2-73 patent claims were having their terms extended just because the company had been granted a new use patent. That is absurd and there is nothing I've ever seen on the USPTO site to back that up. If you disagree, show me a USPTO link.
Again, authors writing non-legal material such as online articles and patent tutorials for the public are free to use the word "extends" and "extension" in any way they choose and most are NOT using those terms in the strict sense that the USPTO uses it.
That is not how it works and the material you quoted didn't at all say what you claim. Extensions for a new use only protect that new use. If you want to extend an old use you have to come up with a new combo drug for that use that works well enough to become the new SOC.
Point taken since it's obviously not possible for anyone to factually show there's a hold up in the partnering process or P3. It's just my perception given how long the P2 has been running.
So then what's the hold up on a deal or in Missling giving us even a date for a date on the P3 in your opinion?
Yes I forgot the 3-71 patents, my mistake, but an honest one since the subject at hand has been 2-73 and it's coverage.
I disagree. I was specifically talking about NOW not what the company might do in the future. Your linked material describes a "new use" patent for an original composition of matter patent. So where is it then for 2-73? I'd like to know the approved patent number. The company already tried for a new use patent for 2-73 in treating AD (which orveko_inc talked about below). It never went anywhere and was abandoned. If if was approvable it certainly would not have been abandoned since it would be orders of magnitude more valuable than the Plus patent.
As per oveko_inc...
"U.S. application 12/522761 was filed in July of 2009 and based on Greek patent 1005865, filed in 2007. It covered, quite broadly, a method of using A2-73 as a pharmaceutical product with neuroprotective, anti-depressive, anticonvulsive, anti-cancer, anti-metastatic, and anti-inflammatory activity.
This application received a final rejection, was abandoned, was resubmitted in February of 2013 as 13/777471, and as of today, remains unpublished. I believe the problem here is Greek patent 1002616, filed in 1996. One of the claims covered the use of A2-73 "for the preparation of pharmaceuticals with anticonvulsant, antidepressive and nootropic activity." Thus, claims in 12/522761 that relate to neuroprotective, anti-depressive, and anticonvulsive activity were anticipated by Greek patent 1002616. Even if they went straight to the point and stated Alzheimer's, they'd get caught in the net cast by Greek patent 1002616. Regarding claims related to anti-cancer, anti-metastatic, and anti-inflammatory activity, the USPTO stated “a chemical composition and its properties are inseparable. Therefore, if the prior art [Greek patent 1002616] teaches the identical chemical structure, the properties applicant discloses and/or claims [in 12/522761] are necessarily present.” In other words, even though the original Greek patent does not mention anti-cancer, anti-metastatic, and anti-inflammatory activity, these properties must be present because the compound is present. "
The company currently has 1 US patent and several outstanding unapproved applications. The approved patent covers 2-73 in combination with 3 other drugs for cancer treatment. There are no other US approved patents. There is currently nothing for AD at least in the USA. There may be 4 remaining years of protection in Greece for the original 2-73 patent. Obviously the Plus application could protect 2-73+Donepezil combo for AD if it ever gets approved. Those are facts. Yes there are FDA granted exclusivities but I'm not mentioning those since the article you linked to was about patents.
So, "adequate and usual" is devoid of meaning unless you say specifically what is covered, where, and for how much longer. The patent situation certainly is not adequate at this time for protecting an AD treatment in the USA.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123682369
"no one has offered a satisfactory answer on the state of the patent"
"the" patent? Which specific patent or patent application are you referring to? You talk about "the patent" as if there is only one covering everything.
I've seen the Greek patent and it had a priority date sometime in Feb of 1996 so it's original 20 year term expired early last year. The Greeks allow for a 5 year extension which I assume Anavex filed for so that would mean about 4 more years, but that protection is only in Greece.
Re Greek patents.
"The total duration of a patent can be prolonged for up to 5 years in the case of medicinal or plant protection product inventions for which a valid
Supplementary Protection Certificate application is filed."
Zena, then is it your opinion that lack of patent protection has nothing to do with the reason why we are so deep into the P2 and still have no BP deal nor have we been given even a date for a date for a P3 AD trial? If not then what is the reason?
"So for once and for all: 2-73 either mono or combo is at the moment not protected by patents, pending a decision on the patent application."
For treatment of AD that is true.
2-73 IN COMBINATION with quinicrine, methylene blue, and atemazole is covered by the 2015 patent for treating cancer only.
There's also a patent application the company filed late last year that COULD be another combo patent using 2-73 but it is not published yet so nobody knows.
"I stand corrected ..this patent was issued 9,180,106 "
and if you read the claims of that patent it is for treatment of cancer only. It has nothing to do with protection for AD or any other use.
"So how can Missling say that IP is under control"
I maintain that he never did in the context being discussed by many on this board. This idea has grown into it's own self perpetuating myth. I recall way back in 2015 or early 2016 that he was asked on a conference call about the patent dispute with Dr. V and the basic response was "there is no patent issue". This basically meant Anavex owned that particular patent. If there is a transcript or audio available of a conference call where Missling gives that answer to a broader question on patent coverage I'll happily admit I'm wrong.
So why even do a pivotal trial for AD? Just go after Rhett's and keep looking for a patentable 2-73 combo for AD. If there is no good AD alternative then 2-73 off label use should spread like wildfire. Question is whether significant and successful off label use for AD would bring in the generic makers. If so then do you get the 5 year exclusion for AD if it's only approved for Rhett's?