CaseNovartis Pharmaceuticals Canada Inc. v Teva Canada Ltd. 2015 FC 770

Drug: EXJADE® (deferasirox)

Nature of case: Prohibition proceeding under Section 6 of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations)

Successful party: Novartis Pharmaceuticals Canada Inc

Date of decision: June 19, 2015

Summary

O’Reilly J. granted a prohibition order sought by Novartis Pharmaceuticals Canada Inc. (Novartis) under section 6 of thePM(NOC) Regulations against Teva Canada Ltd. (Teva) in respect of its generic version of EXJADE® (deferasirox) and Canadian Patent No. 2,255,951 (‘951 Patent). Teva alleged that the ‘951 Patent was invalid on various grounds, including inutility, obviousness and insufficiency of disclosure. In his assessment of utility, O’Reilly J. held that the use claims were subject to an explicit promise of use for treatment of excess iron in a human or animal body, and that this use was neither demonstrated nor soundly predicated as of the patent’s filing date. The Court concluded, however, that this elevated promise did not extend to the compound claims of the patent. Teva’s allegation that the ‘951 Patent as a whole was invalid for lack of utility was deemed unjustified.  

Claim differentiation in an allegation of inutility

Teva alleged that the explicit promise of the ‘951 Patent is that the claimed compounds had been shown to be valuable in the treatment of disorders involving excess iron in humans. Absent evidence of testing in humans as of the filing date, Teva contended that the stated utility of the patent had not been demonstrated; nor could any sound prediction be made that that utility could be achieved. Teva further alleged that this broad and overarching promise applies across all of the patent’s claims, including the claims for novel compounds, whether or not the claims reference any particular utility.

O’Reilly J. emphasized that the utility requirement for patentability represents a fairly low threshold, unless the inventors explicitly promise a specific result, particularly if the stated utility is set out in the claims as opposed to the disclosure. However, as per the principles of claim differentiation set out by the Federal Court of Appeal in Apotex Inc v Pfizer Canada Inc, (2014 FCA 250 re: CELEBREX®), he reiterated that an explicit promise set out in the disclosure can apply to all claims but that it may be appropriate to distinguish between the promise of the compound claims, on the one hand, and the promise of the use claims, on the other, as in the present case.

In consideration of the above, O’Reilly J. rejected the part of Teva’s allegation pertaining to the application of this promise to the patent’s claims for novel compounds. In distinguishing these claims, he placed considerable emphasis on the ‘951 Patent’s abstract, which makes clear that compounds claimed in the patent have “valuable pharmaceutical properties” which can be used for the treatment of iron overload conditions. It does not say that they have been used for that purpose, and it makes no reference to use in humans. He consequently held that all of the statements in the ‘951 Patent’s disclosure cited by Teva merely provide support for the patent’s use claims and not the compound claims.

The availability of prior art relied upon for an allegation of obviousness

In support of its allegation for obviousness, Teva argued that that the Patent Act (as per s 28.3) “no longer requires that the relevant prior art be discoverable on a reasonably diligent search” and that it merely has to be “publicly available” at the relevant date, citing the Federal Court of Appeal’s discussion on anticipation inWenzel Downhole Tools Ltd v National-Oilwell Canada Ltd, (2012 FCA 333) and claiming that it equally applies to the obviousness analysis. O’Reilly J. pointed out that there nevertheless exists a body of jurisprudence that applied the test of the “reasonably diligent search” even after the enactment of s. 28.3 and that there is no reason to take a different approach here.

In addition, O’Reilly J. expressed “considerable doubt” that some of the sources cited by Teva would have formed part of the relevant prior art, namely papers that were published in “obscure journals” that would likely not have been located by the skilled person looking for information on iron chelators.

Allegation of insufficient disclosure

Teva alleged that the disclosure of the ‘951 Patent does not allow a skilled person to work the invention claimed in the patent, that the skilled worker would not know which of the 30 novel compounds claimed would be effective in treating iron overload disorders and that the “real invention” of the patent was “buried” in claim 32. O’Reilly rejected this argument as being premised on a faulty construction of the ‘951 Patent by Teva. He held that the patent in suit relates to novel compounds that bind markedly to iron, are soluble in vivo, and induce excretion of the resulting iron complex. He emphasized that all 30 of the claimed novel compounds were demonstrated or soundly predicted to have those properties, and the patent describes how to synthesize all of them. The patent also provides the skilled person with information about the tests that were used to assess the activity of the compounds in vivo.

Link to decision:

The decision may be found here.