Consistent Claim Construction Makes The Difference

N. Belmore, L. Neidrauer, G. Beach, & M. Wolanski for the Applicants, Janssen-Ortho Inc. et al.
J. Stainsby, A. Skodyn & J. Worsley for the Respondent, Novopharm
No one appearing for the Minister of Health

This was an Application pursuant to the PM(NOC) Regulations to prohibit the Minister of Health issuing a Notice of Compliance to the Respondent, Novopharm, in respect of its methylphenidate product until after expiry of Canadian Patent No. 2,264,852 (the “852 Patent”). In its Notice of Allegation, Novopharm alleged non-infringement and improper listing against the 852 Patent. At this hearing the Court only considered the allegation of non-infringement as Novopharm had not brought a motion to dismiss the Application pursuant to Section 6(5) of the PM(NOC) Regulations on the basis of the alleged improper listing.

The case depended upon the interpretation of the phrase “in a sustained-ascending dose” as found in the three independent claims at issue (claims 1, 41 and 78). The Applicants maintained that these words referred to an ascending methylphenidate concentration in the patients blood plasma over time. Novopharm on the other hand maintained that these words did not refer to blood plasma concentration at all, but rather to the specific amount of methylphenidate released from the dosage form over time and to the increase of that amount over that time following administration. Novopharm argued that since its product does not release an increasing amount of methylphenidate over time it cannot be infringing the 852 Patent.

Methylphenidate was a drug used to treat the neurobehavioural disorders Attention Deficit Hyperactivity Disorder (“ADHD”) and Attention Deficit Disorder (“ADD”) in both adults and children. Novopharm also argued that there was no infringement since the relevant claims required that the dosage form be used to regulate tolerance to methylphenidate. Novopharm argued that the phenomenon of tolerance to methylphenidate had not been proven to exist by clinical data. The Court gave little weight to Novopharm’s claim that clinical data to test the phenomenon could be readily obtained. The Court noted that obtaining permission for such clinical testing would not be so easy. In addition, the Court noted that those most likely to observe the effect of tolerance were generally of the view that the phenomenon exists. Accordingly, the Court dismissed this argument of Novopharm.

The parties agreed that the Applicants had the burden of proving the alleged infringement. All parties agreed that the person skilled in the art would be a composite of multiple people. They also agreed generally on the skill sets that person would possess but disagreed on the relative importance of those skill sets. The Court set out the characteristics of that person skilled in the art.

The parties disagreed on the proper approach to claim construction. The Applicants accused Novopharm of excessive literalism and alleged Novopharm had: failed to approach the patent with a mind willing to understand; failed to consider the patent’s inventive concept; and failed to consider the entire disclosure in arriving at its construction. Novopharm alleged the Applicants had ignored the clear language of the claims and had relied upon a “spirit of the invention” approach, and had picked words or phrases from the disclosure and imported them into the claims, when those words or phrases did not exist in the language of the claims. The Court in response set out the following principles and approach to claim construction:

Construction by the person skilled in the art (“PSIA”) is limited to the four corners of the patent document based on his general common knowledge at the relevant date;
As the role of the expert is not to interpret the claims but to put the trial judge in a position of being able to do so in a knowledgeable way, it is dubious that the direction on patent construction provided to an expert will result in an opinion that is to be preferred to the opinion of an equally qualified expert who has not been given such instruction;
The phrase “mind willing to understand” simply means the claims must be construed in a manner that is fair to the inventor whose expertise is not language but the science that underlies the invention;
The whole of the specification (including the disclosure and claims) may be examined to ascertain the nature of the invention. Where the words of the claims are plain and unambiguous and capable of only one interpretation by a PSIA, recourse to the disclosure is unnecessary;
Recourse may be had to the disclosure for the purpose of confirming the interpretation arrived at from examining the claims alone or to disclose an ambiguity in the language of the claims that was not otherwise evident;
When one looks beyond the language of the claims at issue one ought first to look at the dependent claims as an aid to interpreting the independent claims, before one resorts to the disclosure – there must be consistency between dependent and independent claims;
If one considers the disclosure before considering the dependent claims, one runs a risk;
One should not reach a firm conclusion as to the meaning of the words in the claims being construed without having tested one’s initial interpretation against the words of the disclosure. If the disclosure suggests another interpretation of the terms used in the claims, then resort to the meanings given in the disclosure is proper, subject to the proviso that the invention that is protected is what is expressed in the claims which cannot be added to by anything mentioned in the disclosure that has not found its way into the claims as drafted;
Where two possible interpretations of a patent are available, but only one produces a novel invention, that interpretation is to be preferred.

The Court found that none of the experts took the proper approach to construction. Applying the above principles, the Court concluded that a PSIA would interpret the relevant phrase in the claims to mean that methylphenidate is being released from the composition in a sustained-ascending amount over time. As Novopharm’s product does not release methylphenidate from its dosage form in a sustained-ascending dose over time, the Court concluded it does not infringe.

The Application was dismissed with costs to the Respondent.

By: Michael Crinson, Dimock Stratton LLP