Prohibition Order Issued for One of Two Patents on Formulations of Clarithromycin
Abbott Laboratories v. Canada (Health), 2009 FC 648 (Heneghan, J.)

July 7, 2009

Andrew Reddon and Steven Mason, David Tait for the Applicants, Abbott Laboratories
Edward Hore and Kevin Zive for the Respondent, Sandoz Canada Inc.

Justice Heneghan held that the respondent’s allegations of invalidity against the ‘266 Patent were not justified and issued an Order of Prohibition. The Court held that the respondent’s allegations of invalidity of the ‘395 patent with regard to double patenting were justified and that aspect of the applicant’s request was dismissed.

There were two patents at issue. The ‘266 Patent related to an extended release formulation of clarithromycin. During prosecution of the ‘266 Patent, the Patent Office required Abbott to divide out claims relating to an improved taste profile, which resulted in the ‘395 Patent, the second patent at issue.

To construe the claims, the Court considered the proper construction of claims with multiple dependencies of the form, “the composition according to any one of claims 1 to 10, wherein…” The Court held that the claims build upon earlier claims “providing the skilled person with the ability to choose from amongst a range of possibilities in creating the claimed composition” and identified key limitations from earlier claims that were incorporated into the claims at issue.

Regarding obviousness, the Court identified the inventive concept of the claims, compared the concepts to the state of the art and considered whether these differences were inventive.  The Court held that the differences, namely the selection of HPMC, the specific claimed viscosity, the percentage of the composition, and the precise formulation that demonstrates the particular p-kinetics were all inventive aspects of the claimed invention over the state of the art.

The Respondent argued that the ‘395 Patent simply repeated the state of the art and did not offer any improvement in taste profile over extended release equivalents and therefore lacked utility. The Court agreed with the applicant’s evidence and rejected this argument. Justice Heneghan also observed that there was a motive to provide an improved taste profile and it was disingenuous of the respondent to seek to market a generic version of the product, while alleging the produce did not exhibit an improvement.

Regarding double patenting, the respondents alleged that the ‘395 Patent was invalid for obvious-type double patenting over the ‘266 and a second patent, the ‘541 Patent.  Abbott had dedicated the ‘541 Patent to the public during the course of the proceeding, after the date of the NOA. The Court held there was no double patenting with the ‘395 Patent because the division was required by the patent office. Regarding the ‘541 Patent, the Court applied Justice Hughes’ decision in Bristol-Myers Squibb, which considered the timing of a disclaimer, to Abbott’s dedication of the ‘541 patent to the public and held that the status of the ‘541 Patent must be considered as of the date of the NOA. The Court held the ‘395 Patent invalid for double patenting over the ‘541 Patent since the dedication of the ‘541 Patent occurred after the issuance of the NOA and both patents claimed the same improved taste profile.

In conclusion, the Court issued a prohibition order for the ‘266 Patent but dismissed the request for a prohibition order against the ‘541 Patent on the basis of the justified double patenting allegations.

By Alan Macek, Dimock Stratton LLP