Eli Lilly brought suit against Apotex alleging that it infringed eight (8) process patents. The trial decision is found here. Lilly appealed the finding of non-infringement with respect to 7,500kg of material and Apotex appealed the finding of infringement with respect to the other material it imported. The Court dismissed both the appeal and cross-appeal with costs.
The Court held that Lilly's appeal was essentially factual. The Court held that an appellate court should not reweigh the evidence and draw its own inferences, as to do so would otherwise usurp the role of the trial judge and unnecessarily burden the public and private resources.
With respect to Apotex' cross-appeal, the Court upheld the Trial Judge's analysis of the state of the law on the saccharine doctrine, upholding the ruling that a process patent can be infringed by the importation, use and sale of a product manufactured abroad using the patented process. This law only requires that the patented process play an important part in the manufacture of the imported product. In this case, the Court of Appeal concluded that there was no legal error in the Trial Judge's analysis.
The Court of Appeal upheld the decision of a Trial Judge granting a prohibition order preventing Novopharm from coming to market with a generic version of sildenafil until the expiry of the patent at issue. The appeal dealt with sufficiency of disclosure and utility.
The Court upheld its reasoning in previous decisions that where a single patent application separately claims a class of compounds and a single compound within that class, each claim discloses a separate invention. The Court also confirmed that the "best mode" obligation only arises in the case of a patent to a machine. Thus, the disclosure requirements are limited to the claim at issue. The patent need only describe what the invention is, which was found in the claim, and how it works, which was found in the rest of the patent.
With respect to utility, the Court of Appeal held that there is no requirement for a patent to demonstrate utility in the patent disclosure so long as it can be proven upon a legal challenge. There is nothing in the Patent Act which leads one to conclude that utility be demonstrated in the patent disclosure. The disclosure provides direction, not proof: it tells practitioners how to practice the invention, however, it does not prove to them its utility. Practitioners can require proof through invalidity proceedings.
The Court of Appeal confirmed that an inventor is not required to meet the regulatory testing standards in order to demonstrate utility, a mere scintilla of utility is all that is needed. Thus, the appeal is dismissed with costs.
The Federal Court granted a prohibition order, holding that Teva's allegation that the patent at issue was obvious was not justified.
The Court considered the experts from both sides on the issue of obviousness and held that while Teva's expert's process to answer the problem solved by the patent may have been "worth a try", that is not the applicable legal test. Furthermore, it was not obvious to try, nor was it more or less self-evident to obtain the invention in this way based on the prior art. The reality of Merck's efforts, the team working over an extended time, the time and money it expended, as well as the stops and starts, successes and failures, all belie Teva's expert's approach that everything was there in front of Merck and all they had to do was perform the additive sum.
The Court then held that Teva's expert knew what the result of his thesis should be and then developed the methodology to achieve it. In the non-technical sense, the Court held that he reverse engineered the patent. It is a simple human fact that matters are always simpler in hindsight. However, when working the prior art, Merck not only did not know the steps to take or the course to develop, it was not even certain of the destination. Thus the allegations as to obviousness were not justified.
OTHER JUDICIAL REVIEWS OF INTEREST
Drug: histamine dihydrochloride
This is a Judicial Review of a decision of the Minister of Health under the Data Protection provisions holding that CEPLENETM is not an innovative drug pursuant to the Food and Drug Regulations. The Court dismissed the application.
The Court summarized the drug approval process in Canada and the relevant statutes and treaties that lead to the Data Protection Regulations. The Court then came to a number of conclusions regarding the intent of the Data Protection Regulations.
The Court held that the medicinal ingredient in CEPLENETM is histamine dihydrochloride which has been previously approved in several drugs. The Court then dismissed the Applicant's argument that the Data Protection Regulations are to protect the extensive clinical data required to gain approval for a new drug. The Court held that the Data Protection Regulations provide protection for new chemical entities, not all new drugs, as set out in the NAFTA and TRIIPS division.
The Court held that histamine dihydrochloride is an old ingredient and that CEPLENETM falls under the definition of a "new drug" for the purposes of the Food and Drug Regulations as a new use but not as a new substance or chemical entity. Thus, the product was not eligible for data protection.
DECISIONS OF THE COMMISSIONER OF PATENTS
The Canadian Intellectual Property Office recently posted its July decision relating to this patent application. The Commissioner of Patents rejected claims to "a unit of totipotent plant tissue"; "a unit of plant embryonic tissue" or "a plant embryo comprising a shoot and a radical" as encompassing higher life forms, and thus non-statutory subject matter.
The Commissioner summarized the jurisprudence with respect to lower life forms and cells which are patentable and higher life forms including animals, plants and seeds which are not patentable.
The Commissioner held that the approach to assessing patentable subject matter is based on the form of the claims. It was held that what was being claimed in this case is neither an encapsulated plant cell nor a whole plant but something on a developmental continuum between the two. In the end, the Board was unable to agree with the applicant's views that the claimed subject matter is comparable to lower life forms; that a plant tissue or plant embryo is like a fertilized egg; and that the totipotent plant tissue, plant embryonic tissue and plant embryos are patentable under the Schmeiser case.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.