On
Litigation background
In 2015, under the pre-amended PMNOC Regulations, the Federal Court dismissed
537 patent
The 537 patent was filed in 1986 and issued in 2007. As an "Old Act" patent, the 537 patent will expire 17 years after issuance,
Issues
Obviousness
The Court adopted the claim construction as the inventive concept of the asserted claims, including the polypeptide of the protein (claim 43), the recombinant DNA molecule for expressing the polypeptide (claim 44) and the process for making the polypeptide that had granulocyte colony-stimulating activity (claim 47). Only claim 47 required that the inventive concept had the requisite biological activity.
The Court found that, as of the priority date of
The Court analyzed the steps a skilled person would have undertaken to arrive at the invention, finding that a skilled person would expect potential challenges at each step, without one guaranteed solution to such challenges. Notwithstanding that success could not be predicted at each of the steps required to achieve the claimed invention, the skilled person "is not risk averse and would not be discouraged from attempting the G-CSF project by known potential problems with identifiable solutions," and that "[a]ny potential challenges they would encounter could be addressed with skill and did not require inventiveness." [emphasis in original]
The Court found it compelling that
The Court concluded it was more or less self-evident to try to obtain the claimed invention, and this was not a situation with a mere possibility that something might turn up. As a result, the Court concluded that each of the asserted claims was invalid for obviousness.
Material misrepresentation and insufficiency
The 537 patent described the G-CSF as 'pluripotent', meaning that it stimulated growth of multiple lineages of mature blood cells from progenitor cells. However, G-CSF stimulates only the growth of granulocytes but not other cell lineages, and thus is not considered 'pluripotent.'
The Court dismissed both grounds of invalidity, finding that the skilled person would have understood the 537 patent's use of the term 'pluripotent' referred to the naturally occurring protein that was named 'pluripotent' in the prior art. Therefore, there was no material misrepresentation. Furthermore, the disclosure of the 537 patent was sufficient since there was no requirement for the patent to teach a protein that stimulates growth in multiple cell lineages.
Prior user rights
Originally published
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