Justice Phelan has dismissed an
Amgen to prohibit the Minister of Health from issuing a Notice
of Compliance to Mylan for Amgen's secondary
hyperparathyroidism medication cinacalcet (SENSIPAR®). In
reasons dated Nov. 3, 2015, Justice Phelan agreed with Mylan's
allegations that Amgen's Canadian Patent 2,202,879 (the
"879 Patent) was not a selection patent, and that the claim at
issue was not novel or inventive.
The 879 Patent was filed in October
1995 and contained claims to various compounds, including a claim
specific to the cinacalcet compound (claim 5). Claim 5 was the only
claim at issue. Critical in this proceeding was a different Amgen
patent with the same inventors. Canadian Patent 2,115,828 was
published in 1993 and disclosed an "enormous" genus of
compounds that encompassed cinacalcet. Both the 879 and 828 Patents
stated that the claimed compounds were active at calcium receptors
in the body.
Mylan alleged that claim 5 was
anticipated, obvious and double patented in light of the 828
Patent. Amgen argued that cinacalcet was a selection from the 828
Patent based on the fact that the calcium receptor theory
underlying the 828 Patent was not accepted by a skilled person
until after the 879 Patent was filed.
Justice Phelan found that the 879
Patent was not a selection patent. He found that the calcium
receptor theory was known and accepted in the art by the time that
the 828 Patent was filed. Thus, following Plavix
SCC1 and the IG
Farbenindustrie2 criteria, cinacalcet did not
possess any special advantage.
The Court also found that claim 5 was
not novel. Justice Phelan relied on a concession by Amgen's
expert that a skilled person working claim 1 of the 828 patent
would have made cinacalcet to establish disclosure, as well as the
fact that only "mechanical" testing of about 200 828
Patent compounds was needed to get to cinacalcet.
The Court also found that, as claim 5
was not an inventive selection, the inventive concept was the bare
compound itself. Thus, claim 5 was found to be obvious based on the
The Court's analysis raises some
questions. First, it seems peculiar that so much time was spent
analyzing the skilled person's knowledge as of the filing date
of the earlier 828 Patent for the purpose of selection. The
appropriate consideration for determining whether a substantial
advantage existed should not be based on the skilled person's
understanding at the time of the genus patent; rather, the
appropriate consideration is whether the species contains any
advantages as compared with the genus patent itself.
Second, the finding that the genus
disclosed the species for novelty purposes appears to run contrary
to Plavix SCC. The "mechanical" testing of 200
compounds would not meet the necessarily infringe test from
1. 2008 SCC 61
2. (1930), 47 RPC 289
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