Anavex Life Sciences Corp (AVXL)

[TrueTrades]

The clinical development and FDA approval is completely separate from patent protection. The drug can gain FDA approval regardless of patent status. The IP protection is for market exclusivity purposes. The FDA does have to keep track of patents for exclusivity/generic approval purposes, and does so in the Orange Book.

I really don't know how the combo therapy with donepezil affects the validation of A2-73 alone. The company has stated that the P2a study is intended to study the exploratory efficacy of both A2-73 and PLUS, though there has been no distinction reported in the results so far. Perhaps the independent results are being reserved for the design of a P3 study which will include separate arms.

We will certainly need a larger P3 trial to commence before the FDA approves.

I have no idea what will become of the PLUS patent. It does not look good, but patent issues are very seldom rosy pictures before granting. I believe we rely on the original Greek patent for basic protection of the composition of matter on an international basis. That is why there is no US application for composition, IMO.

UPDATE: Since writing that I dissected the examiner's responses further and noticed a few things:

1) "Specifically, claim 2 recites the limitation "A2-72" in claim 1.
There is insufficient antecedent basis for this limitation in the claims."

I don't know whether they are just pointing-out the typo or something else. It seems so with the rule quoted, "The specification shall conclude with one or more claims particularly pointing out and distinctly
claiming the subject matter which the applicant regards as his invention."

If it is just a matter of resubmitting the application correctly, well then...

2) All of the remaining claims (1-6) were also rejected for obviousness, which basically means you must state how/why A + B = C and not AB. Others have made good posts arguing the fact that you cannot just throw A and B together to create C, and I concur. I also agree we are not patent attorneys and should not attempt their job. Let the company provide direction.

Much of what I have read leads me to believe this particular patent has a ways to go:

"A USPTO examiner with technical training in the field of the invention conducts a prior art search and determines whether the application satisfies the legal requirements for patentability. The examiner issues an ‘office action’ setting forth the grounds for rejection. The applicant or his/her representative responds by amending the claims, submitting arguments, or doing both to overcome the rejections. The (examiner) reviews the response and (1) allows the claim or (2) issues another office action. This ‘back and forth’ with the USPTO continues until the examiner issues a ‘Notice of Allowance’ or the applicant abandons the application."
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146086/

If the trial results continue to show improvement I would say we have a 100% chance of FDA approval. The SOC in AD is begging to be bettered, if only by a slight margin. We have almost demonstrated that already. The 26, 38 and 52 week results will each be more telling than the last, and if the patients are actually experiencing disease cessation/regression there will be a media frenzy.

You are very welcome, and thank you for the nice comments. Thank you XenaLives for the OCR text.
§AVXL