In Janssen-Ortho Inc. and Alza Corp. v. Novopharm, Justice Zinn dismissed a prohibition proceeding allowing Novopharm to bring its generic version of CONCERTA methylphenidate extended release tablets to market. The main issue in the Janssen-Ortho case was the interpretation of the term “in a sustained-ascending dose” in each of the three independent claims of Canadian patent No. 2,264,852 (the “852 Patent”), and whether the Novopharm product would infringe those claims. Specifically, those claims refer to the dosage form releasing methylphenidate “in a sustainedascending dose over time.” Janssen-Ortho asserted that the term referred to a methylphenidate plasma concentration profile, while Novopharm alleged it referred to the release rate of methylphenidate from the dosage form. In short, Justice Zinn agreed with Novopharm that the term referred to the release rate of methylphenidate from the dosage form, and Novopharm therefore did not infringe any of the claims of the 852 Patent.

The case is of particular interest as it contains a lengthy discussion of the principles of claims construction and the relevant authorities in the area. In this regard, Justice Zinn determined that, after looking at the language of the independent claims, one ought first to look at the dependent claims as an aid to interpreting the independent claims, before one resorts to the disclosure. By considering the disclosure before considering the dependent claims, one runs a risk of forming an opinion as to the proper construction of the independent claims based on the content of the disclousre when that interpretation is not supported, or may, in fact, be contrary to the dependent claims. As noted by Justice Zinn, while the claims must be construed with reference to the entire specification, the patentee must not be allowed to expand his monopoly specifically expressed in the claims by borrowing this or that gloss from other parts of the specification:  

Mr. Stainsby, counsel for Novopharm, put that principal more colourfully when he said in his oral submissions that the “jurisprudence does not permit an unescorted and unchaperoned romp through the disclosure.” I agree.

The purpose of claim construction, at the end of the exercise, is to ascertain what exactly is contained within the garden bounded by the fences set out by the inventor. To wander afield, outside the garden’s fences, picking sunflowers and petunias, and then say the garden is a flower garden, when all that one can see when standing within the garden’s fences are red zinnias, illustrates why one must first have some view of the scope of the garden from the inside before one traipses through the adjoining fields seeking clarification or confirmation of the nature of the garden. Without such an initial view, one may inappropriately borrow the flora outside to define that which grows inside the fence. In short, one should not take an unescorted and unchaperoned romp through the disclosure; one must have a guide or compass which one obtains from first examining all of the claims of the patent.

Justice Zinn based his initial interpretation of the independent claims on (1) the express wording of the claims being to the release of the drug from the dosage form; (2) the background of the prior art known to a person of skill in the art; and (3) the fact that there is no reference at all in the independent claims to concentration in blood plasma. With this initial interpretation in hand, Justice Zinn turned to the dependent claims of the 852 Patent, and found that the dependent claims clearly used the word “dose” in reference to an “amount” of methylphenidate contained in the dosage form. Justice Zinn determined that this initial interpretation of the claims was confirmed by the disclosure. While the patent specification makes reference to blood plasma concentration in the text, examples and charts, the entirety of the specification shows that the patent truly discloses and claims compositions that release methylphenidate into the patient in a sustained ascending manner.

In the result, Justice Zinn rejected the interpretation of the 852 Patent urged on the Court by Janssen-Ortho and accepted as correct that submitted by Novopharm. Because Novopharm’s product was determined to release methyphenidate from its dosage form in a manner other than a sustained-ascending dose over time, Justice Zinn held that it would not infringe the claims of the 852 Patent.

Novopharm was represented by Jonathan Stainsby, Andrew Skodyn and Julian Worsley of Heenan Blaikie LLP.