Replies to post #356610 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

Why would a company not have the data to back up the patent.

If the company happens to be a biotech/pharma then they can only have data in humans from clinical trials.

With a technology, chemistry etc. company, things are easier since tests can be run to collect data and measurements to verify an invention actually works as claimed at least to an extend before a patent is filed.

To gain a patent the invention must not have been publicly disclosed prior to the patent filing, because then it would no longer be novel.

This presents a conundrum since a drug/treatment intervention must be described in detail to several parties before a clinical trial can be approved, initiated and eventually provide data that may support the invention.

From the document I previously posted:

Disclosed results of tests and examples, whether working or prophetic examples, in a patent application are not normally questioned unless there is a reasonable basis for doing so. However, when prophetic examples are described in a manner that is ambiguous or that implies that the results are actual, the adequacy and accuracy of the disclosure may come into question. If the characterization of the results, when taken in light of the disclosure as a whole, reasonably raises any questions as to whether the results from the examples are actual, the examiner will determine whether to reject the appropriate claims based on an insufficient disclosure under the enablement and/or written description requirements of 35 U.S.C. 112(a) following the guidance in MPEP 2164 and 2163, respectively. When such a rejection(s) is made, the applicant may reply with the results of an actual test or example that has been conducted, or by providing relevant arguments and/or declaration evidence that there is strong reason to believe that the result would be as predicted, being careful not to introduce new matter into the application. MPEP 707.07(l) and 2161-2164.08(c).

In general a drug without prior data in one or more indications can only rely on prophetic examples that appear reasonable and unambiguously stated. The patent examiner, or anyone else for that matter, will not be able to question let alone refute whether a treatment works. If that was possible with a level of certainty that rivals controlled clinical trials, well then controlled clinical trials would not be required.

Science is hard, very useful and often fascinating and engaging when done well! Patents must be secured while the understanding ongoing science and empirical tests can yield is still in progress and before the details are publicly disclosed.