This page contains a Flash digital edition of a book.
SELECTION PATENTS


by prior art, or whether it was double-patented. In this case, by definition, the ‘113 patent was anticipated by the ‘687 patent and olanzapine was considered as double-patented by the ‘687 and the ‘113 patents.


Lilly appealed against the trial judgment.


Appeal decision On appeal, the crux of the issue was whether there was foundation in law for an independent attack of the validity of a patent based solely on the conditions for a valid selection patent.


Te Federal Court of Appeal determined that although selection patents are vulnerable to attack on the grounds of novelty, obviousness, sufficiency and utility, the selection patent conditions


themselves cannot be exclusively


relied upon to invalidate a patent. Te court held that the trial judge erred in determining the validity of the ‘113 patent on the basis that he did. Te Federal Court of Appeal allowed the appeal on the issues of anticipation, obviousness and double-patenting, but returned the issues of utility and sufficiency of disclosure to the trial division for determination.


Regarding anticipation, the Court of Appeal applied the principles enunciated in Sanofi to separately consider the requirements of prior disclosure and enablement. It is worth noting that in the court’s view, at the stage of disclosure inquiry, it is the content of the prior art that is relevant, not whether the content is true. Te Court of Appeal went on to conclude that the “disclosure” requirement had not been met and therefore the ‘113 patent was not anticipated by the ‘687 patent:


“...Olanzapine was not one of the examples described in the ‘687 Patent. It was one of a large class of most preferred compounds described by reference to several criteria. It was not specifically disclosed in the ‘687 Patent. Nor had it been made before. Since its advantages (as alleged in the ‘113 Patent) could not have been ascertained until it was made, it was not disclosed...by the ‘687 Patent.”


In reversing the trial judge’s finding on anticipation, the Court of Appeal emphasised that the trial judge’s failure to conduct an analysis in accordance with the approach set out in Sanofi was an error of law. Te court cautioned that treating a selection patent differently from any


other patent may result in a misguided or tainted approach to assessing a patent’s validity.


On the issue of obviousness, the Court of Appeal acknowledged that the trial judge cited the correct test for obviousness endorsed in Sanofi. However, the court took issue with the trial judge’s finding that “the development of olanzapine was neither obvious nor an invention”. Te Court of Appeal viewed such determinations of non-inventiveness and non- obviousness as being inconsistent and unable to stand together, and constituting palpable and overriding error. Further, in concluding that there was no inventive step, the trial judge was misled by his independent determination that the conditions of a valid selection patent had not been met. As such, his analysis was again tainted.


Applying the Sanofi test for obviousness, the Court of Appeal stated that the inventiveness of selection patents lies in the making of a compound that is advantageous over the genus patent. Te Court of Appeal concluded that the inventive concept in this case is the olanzapine compound that was selected from the 15 trillion compounds disclosed in the ‘687 patent and that this, coupled with its advantages, was non-obvious.


54 Life Sciences Intellectual Property Review 2011


www.worldipreview.com


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84