On February 19, 2013, Justice Snider dismissed Teva’s and Apotex’s actions to impeach Novartis’s patent claiming imatinib mesylate (GLEEVEC) (“imatinib”): Teva Canada Limited v Novartis AG, 2013 FC 141. On the same day, she also granted Orders of prohibition under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) against Teva and Apotex regarding the same patent: Novartis Pharmaceuticals Canada Inc v Apotex Inc, 2013 FC 142.
The decisions were the result of the consolidation of four proceedings: an impeachment action brought by Teva, an impeachment action brought by Apotex, and two applications under the PMNOC Regulations for Orders of prohibition brought by Novartis separately against Teva and Apotex.
Teva and Apotex both acknowledged that imatinib is an “extraordinary drug that offers extraordinary therapeutic benefits to those who are suffering from an insidious disease” and did not argue that imatinib was anticipated or obvious. The validity issues were limited to utility, both demonstrated and soundly predicted, and sufficiency of disclosure.
The parties disagreed on the construction of two phrases: “use in the chemotherapy of tumours” and “can be used.” Snider J. emphasized that a patent should be approached with a mind willing to understand and that the claims are the “essence” of the patent, and she preferred Novartis’s construction on both points. She construed the phrase “use in the chemotherapy of tumours” as selective inhibitors of either kinase PDGF-R or ABL (two different types of kinases) as opposed to as inhibitors of both. She also construed the phrase in the disclosure “can be used” to mean that the compounds have the potential to be used as tumour-inhibiting active ingredients, not as a guarantee.
Construction of the promise of the patent was central to Snider J.’s findings on utility. Teva and Apotex had conceded that Novartis had established or at least predicted the in vitro activity of imatinib and that if the promise was not construed as in vivo therapeutic utility then Novartis would be successful.
Teva and Apotex asserted that the promise of utility for every claim must be the same. Snider J. disagreed and found a differentiated promise depending on the subject matter of the claim. The patent included claims to compounds (both genus and species), pharmaceutical compositions, processes and uses. Snider J. characterized the compound claims as following the format of many pharmaceutical patents with “cascading claims.” The broadest claim covers “billions” of compounds, and the claims become narrower as they descend. For the compound claims, she held that the promise is that the compounds will selectively inhibit one of three types of kinases (PKC, PDGF-R or ABL). This utility could be established with only in vitro testing. In contrast, she held that the promise for the use claims is that the compounds can be used to treat atherosclerosis and for the chemotherapy of tumours, which incorporates in vivo efficacy.
Based on in vitro testing, Snider J. determined that the utility of claims to individual compound claims, including the claim specifically to imatinib, was demonstrated.
For the genus and use claims, Snider J. considered whether utility was met by sound prediction, which requires a factual basis, an articulable line of reasoning and proper disclosure, noting that:
Sound prediction is not a free-standing statutory requirement. Rather, it is a way of showing that an invention is useful when the invention has not been directly demonstrated to work. Its introduction into Canadian law was not, as I understand it, to give a crushing hammer to those who challenge patents.
For the broad genus claims (claims 1-4), Snider J. held that utility had neither been demonstrated nor soundly predicted. For the narrowest genus claims (claims 5 and 7), she held that it is a “reasonable inference” that any of the claimed compounds would be likely to exhibit the same inhibitory characteristics as the tested compounds and thus that these claims were soundly predicted. She also held that the utility of the process claim was established.
Regarding the use claims, Snider J. determined that the inventors had a factual basis for the prediction for one of the two groups of compounds that included imatinib. Although some of the tests may have been inconclusive, none demonstrated a negative result and all testing pointed to the conclusion that this group of compounds would be useful in treating tumours in warm-blooded animals.
She also held that there was an articulable line of reasoning. The soundness of the prediction was assessed by considering whether it was a reasonable theory or a reasonable hypothesis as of the relevant date.
Teva and Apotex had also asserted that a sound prediction needed disclosure of the test data in the patent. Although Snider J. acknowledged that the patent must provide more disclosure than the prior art, she disagreed with Teva and Apotex. Reviewing the disclosure and taking into account the common general knowledge, Snider J. held that there was proper disclosure.
Regarding sufficiency, Snider J. applied the three-part test articulated in the recent Supreme Court VIAGRA decision (2012 SCC 60, reported here):
- What is the invention?
- How does it work?
- Having only the specification, can a person of ordinary skill in the art produce the invention using only the instructions contained in the disclosure?
Snider J. found that the disclosure was sufficient and that the patentee did not “game” the system.
The parties disagreed on the first and last points of the test. Regarding the nature of the invention, Snider J. agreed with Novartis that the invention was a class of compounds that can selectively inhibit kinases (although she considered each of the two groups of compounds to represent an invention). Snider J. also rejected Teva's and Apotex’s arguments on alleged omissions from the patent that prevented the skilled person from putting the invention into practice. She held that there was no attempt to hide the best inhibitors and that the omission of information about the testing of the compounds was not fatal to the patent as, among other things, an absence of data does not go to sufficiency where the data was not required for the skilled person to “use” or work the invention. She also noted that there is no best mode requirement for inventions that are not machines.
On the infringement issue, Snider J. held that Apotex could claim non-infringement under the regulatory and experimental use exemptions but denied Novartis’s request for delivery up of the remaining material. Dr. Sherman, the Chairman of Apotex, undertook that none of the material would ever be used commercially.
Snider J. also granted the prohibition Orders in the two applications, citing her decision in the actions that the patent was not invalid.
Teva and Apotex may appeal as of right.
Tracey L. Stott, Toronto
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