Canada: Court Of Appeal Upholds Decision Relating To Sildenafil; Antibody Patent Found Valid And Infringed (Intellectual Property Weekly Abstracts Bulletin: Week Of January 27, 2014)

Infringement Actions

Court of Appeal Upholds Decision Relating to Sildenafil Use Patent
Pfizer Ireland Pharmaceuticals v. Apotex Inc. , 2014 FCA 13
Drug: VIAGRA® sildenafil

In Apotex' action for impeachment of the Pfizer patent relating to the use of sildenafil to treat erectile dysfunction, Apotex brought a motion for summary judgment, which was granted by the Court. This is an appeal of that decision.

The Court of Appeal noted the litigation history of this patent, ending with a decision in a proceeding brought pursuant to the Patented Medicines (Notice of Compliance) Regulations (Regulations) by the Supreme Court of Canada (SCC) finding the patent invalid. This judgment was later amended by the SCC, resulting in the SCC dismissing the application for prohibition, instead of declaring the patent invalid.

In respect of Apotex' motion, brought and decided before the amendment by the SCC, the Court found that it was bound by the decision of the SCC finding the patent invalid because the disclosure is insufficient, even if the SCC ultimately amended the judgment. The Court of Appeal held that there was no error made by the Court in making this finding that warranted the intervention of the Court of Appeal.

Pfizer argued that the construction by the Court in the previous proceeding was not determinative for all purposes because the proceeding was brought pursuant to the Regulations. The Court of Appeal agreed but held that Pfizer should have provided evidence with respect to the construction.

The Court of Appeal considered the evidence that Pfizer adduced relating to testing that was done before the Canadian filing date and found "there is no disclosure that UK-114,542 was tested, and Pfizer has adduced no evidence that is capable of establishing that the skilled reader should have discerned from the specification that it was tested. Therefore, evidence that UK-114,542 was tested is not capable of established a genuine issue for trial on the question of the sufficiency of the disclosure."

Antibody Patent found Valid and Infringed
AbbVie Corporation v. Janssen Inc, 2014 FC 55
Drug: STELARA® ustekinumab

The Court recently decided a patent infringement case dealing with antibodies. The claims at issue in AbbVie's patent relate to the use of a human antibody that binds to IL-12 with certain binding and potency properties. The patent was found to be valid and infringed.

The Court considered the admissibility of testing performed by AbbVie. The tests were conducted at two independent laboratories, however, Janssen was not present for the testing. After considering the reliability of the testing, the Court held that STELARA® fell within the binding and potency parameters of the claims.

A central issue relating to infringement centred around patent construction. The Court held that Janssen essentially conceded that if the claims covered human antibodies made by any method, then its STELARA® product fell within the scope of the claims, subject to the binding and potency parameters. The Court then held that the claims should be construed so as to cover human antibodies made by any method. The Court also held that Janssen promotes and sells STELARA® in Canada for the purpose of administering it to humans to treat psoriasis. Thus, Janssen induces infringement and is itself an infringer.

In considering validity, the Court held that the patent was not obvious. The Court then considered whether the claims were overly broad, as they claimed any antibody, however created, meeting certain parameters, and only described in detail one such antibody. The Court dismissed Janssens's policy argument that functional claiming should not be permitted, with the acknowledgement that it was AbbVie who confirmed that if an antibody did bind to IL-12, psoriasis could be treated. Furthermore, other minimum parameters were required. The Court also dismissed Janssen's fairness argument based on independent development, prolonged clinical studies and regulatory approval, when AbbVie does not have approval to sell a similar drug. The Court held that this should not prevent the one who first applies for, and gets, a patent, from having a good patent. Finally the Court considered whether the phrase "or less" made the claims ambiguous, and held that they were not.

The Court held that the claims of the patent that were at issue were valid as between the parties, but that the Patent Act does not provide for such a declaration in rem. The Court was disappointed with Counsel for not taking advantage of Case- and Trial-Management to narrow the issues and get the matter ready for trial. A number of specific inefficiencies were discussed. Thus, each party was ordered to bear their own costs. A second trial will be held to determine remedies and quantum.

Other Industry News

Health Canada has announced a Consultation on the Draft Guidance Document Quality (Chemistry and Manufacturing): New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs); and the Certified Product Information - Chemical Entities (CPID-CE) Guidance Document and Template. The consultation is open for comment until April 13, 2014.

Health Canada has announced a Consultation on a Revised Approach to NHP Site Licensing. The consultation is open for comment until April 23, 2014.

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