Our pro-patent neighbors to the North deliver a victory for big Pharma
The Supreme Court of Canada recently dismissed a challenge to a patent held by pioneer pharmaceutical company Sanofi‑Synthelabo for its anticoagulant medicine Plavix. Apotex, a generic drug manufacturer seeking to market its version of the drug, challenged the patent based on prior art and double patenting grounds. While the decision has an interesting evergreening aspect, its ultimate significance may lie in the stark contrast it draws between the state of obviousness law in the United States and that in Canada.
The opinion pays little attention to the double patenting/evergreening issue, dismissing it in very short order. The Sanofi “selection” patent at issue claims a species of, but does not claim priority to, an earlier genus patent. While recognizing that “attempts to extend the time limit of exclusivity of a patent may be contrary to the objectives of the Patent Act,” the Court reasoned that evergreening strategies - such as selection patents - do not necessarily lead to illegal double patenting. Indeed, the Court recognized the benefit provided by selection patents:
“…selection patents encourage improvements over the subject matter of the original genus patent because that selection does something better than or different from what was claimed in the genus patent.”
While the evergreening/double patenting aspect of the decision is significant, the Court’s treatment of the obviousness challenge is perhaps more interesting. In considering whether the claims of the selection patent are obvious over the disclosure of the genus patent (”the ‘875 patent”), the Court stated:
“Here, when the relevant factors are considered, the invention was not self‑evident from the prior art and common general knowledge in order to satisfy the test. While there were five well‑known methods to separate this racemate into its isomers, there was no evidence that a person skilled in the art would have known which of the five known separation techniques would work with this racemate. Further, [Sanofi] spent millions of dollars and several years developing the racemate up to the point of preliminary human clinic trials before it was discovered that the dextro‑rotatory isomer was active and non‑toxic. As the ‘875 patent did not differentiate on the basis of efficacy and toxicity, what to select or omit was not then self‑evident to a person skilled in the art. It was also not self‑evident from the ‘875 patent or common general knowledge what the beneficial properties of the dextro‑rotatory isomer of this racemate or its bisulfate salt would be and therefore what was being tried ought to work. The course of conduct and the time involved throughout demonstrate that the advantage of the dextro‑rotatory isomer was not quickly or easily predictable.”
That language has to encourage the pioneering side of the pharmaceutical industry, which seems to have suffered blow after blow from United States patent law in recent years. Indeed, in the waning days before the Supreme Court of the United States issued its landmark obviousness decision in KSR v. Teleflex, the Court of Appeals for the Federal Circuit issued an opinion in Pfizer v. Apotex (yes, that Apotex) that treats the “science of selection” quite differently than the Supreme Court of Canada did in Apotex v. Sanofi-Synthelabo.
The Pfizer court considered the validity of a patent that can fairly be characterized as a ’selection’ patent - Pfizer scientists had identified and patented a salt form of a compound it disclosed in an earlier patent. The later patent did not claim priority to the earlier patent, giving Apotex an opening for its obviousness argument.
The court flatly rejected Pfizer’s argument that a conclusion of obviousness would disregard the ‘discovery’ made by its scientists through ‘trial and error procedures.’ Indeed, the court turned this argument on its head, considering the nature of the testing in precisely the opposite manner intended by Pfizer. While careful to note the statutory requirement that “patentability shall not be negatived by the manner in which the invention was made” (citation omitted), the Court concluded that consideration of the ‘routine testing’ performed by Pfizer, which led to the ‘discovery’, was appropriate here because “the prior art provided not only the means for creating acid addition salts but also predicted the results, which Pfizer merely had to verify through routine testing.”
The court even went so far as to distinguish the ‘routine testing’ involved in ’selection science’ from the work of an inventor:
“At most, then, Pfizer engaged in routine, verification testing to optimize selection of one of several known and clearly suggested pharmaceutically-acceptable salts to ease its commercial manufacturing and marketing of the tablet form of the therapeutic amlodipine. Creating a “product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient . . . to enhance commercial opportunities . . . is universal - and even common-sensical.” (citing Dystar Textilfarben v. C.H. Patrick).
“The experimentation needed, then, to arrive at the subject matter claimed in the…patent was nothing more than routine application of a well-known problem solving strategy and, we conclude, the work of a skilled artisan, not of an inventor.” (internal citation and quotations omitted) (citing Dystar).
The Pfizer decision issued just 39 days before KSR did. In the days and months leading up to the Supreme Court’s KSR decision, the CAFC seems to have set out on a path of tightening its obviousness law, with Dystar and Pfizer as visible trail blazes. Interestingly, the Court of Appeals for the Federal Circuit considered Apotex’s challenge of Sanofi’s US patent after Dystar but before Pfizer and KSR. Sanofi, no doubt, benefitted from this timing - the court rejected the obviousness argument at that time. You’ve got to wonder whether the court would have decided the issue differently if it had been considered later in the journey down the new path.
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- CAFC: Hey reformers…obviousness law is just fine, thank you In Dystar Textilfarben v. C.H. Patrick, the Court of Appeals...
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