Similar info from another source which also backs up Spontan/Roxus as being novel due to the "new mode of administration" or "treatment regime".
In fact according to the following, it is "a means to overcoming a problem or providing an advantage over the prior art and that it was the contribution, i.e. overcoming a disadvantage in the art, which was patentable".
I.e. using the nasal spray to deliver the drug into the bloodstream in a much faster time AND without the need for fasting AND possibly/probably also the advantage of delivering a lower dose to reduce side effects is what might be most important in making the claim patentable.
From everything I can find on the subject, I agree with LTR Pharma that their patent position is strong.
Has anyone seen any evidence from those questioning the patents to suggest otherwise?New mode of administration or treatment regime
As noted above, the interpretation of “previously unrecognised advantageous properties in a chemical compound” also encompasses a novel dosage regime or mode of administration, see the hearing decisions of Merck P3/2006 and Genentech P1/2007.
In Genentech, the Assistant Commissioner when discussing the allowability of Swiss-type claims (where the novelty resides in a new mode of administration or treatment regime) noted that the new method of treatment in the application under review provided a means to overcoming a problem or providing an advantage over the prior art and that it was the contribution, i.e. overcoming a disadvantage in the art, which was patentable:
“Although IGF-1 clearly has valuable therapeutic properties, there are apparently serious problems concerning observed side-effects and the fact that IGF-1 becomes ineffective with continued use. The Applicants have produced a means of overcoming or alleviating these problems by the application of a specific dosage regime and I think it proper that they should be able to obtain patent protection for their contribution” (Emphasis added).
Where the purported new use in a Swiss-type claim relates to a novel dosage regime or mode of administration then an objection generally shall not be made if the claimed subject matter overcomes a particular disadvantage or provides an advantage over the prior art (see Merck, Genentech and T1020/03 Genentech). Mere novelty in a dosage regime or mode of administration will not automatically render a Swiss-type claim as a new invention unless the new use is a “new result”
https://www.iponz.govt.nz/get-ip/patents/patents-act-1953/1953-patents-act-practice-guidelines/examination-of-patent-applications/
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