Canada: Intellectual Property Weekly Abstracts Alert (Week of July 25, 2011)

Last Updated: July 29 2011

Edited by Chantal Saunders and Beverley Moore

ACTIONS

Failure to Reply in Good Faith not Basis to Challenge Issued Patent

Corlac Inc. et al. v. Weatherford Canada Ltd. et al.

The Appellants appealed the findings of the Judge that the patent was valid and infringed. Seven issues were raised on appeal: the Court of Appeal returned the issue of infringement of one claim to the Judge for redetermination and dismissed the remaining issues.

The Court of Appeal refused to interfere with the Judge's finding with respect to the issue of co-inventorship pursuant to section 53(1) of the Patent Act. In particular, the Court of Appeal agreed with the Judge that materiality is fact-specific, and the misstatement in this case was immaterial. The Court of Appeal agreed with the Judge that section 73(1)(a) of the Patent Act, abandonment by lack of good faith reply, applies only during the prosecution of patent applications, and is no longer is relevant once a patent issues. Section 53(1) governs misrepresentation in issued patents

Court Refuses to Allow Majority of Pleadings to Foreign Jurisdictions

Astrazeneca Canada Inc. v. Apotex Inc.

Drug: omeprazole

The Court heard the dispute between the parties as to whether certain amendments to the amended Statement of Defence and Counterclaim should be allowed. The Court allowed pleadings relating to a Korean action recited in U.S. decisions that the Plaintiffs put in play. However, pleadings requesting discovery relating to litigation in other foreign countries, pleadings alleging that as the plaintiffs did not assert claimsin the United States, they could not assert them in Canada, and pleadings alleging estoppel based on alleged contrary statements made by the Plaintiffs in the United States and Korean proceedings against other parties were not allowed.

NOC PROCEEDING

Order of Prohibition Granted with Respect To Prodrug of Known Compound

Hoffmann-La Roche Limited v. Apotex Inc.

Drug: CELLCEPT mycophenolate mofetil

The two issues raised in this prohibition proceeding related to whether the claimed compound's utility was demonstrated or soundly predicted, and whether the claimed compound was obvious. The Court described the patent as relating to a prodrug of a known compound that could be used as an immunosuppressive drug but had limitations. The Court found that the utility of the invention was demonstrated as of the filing date. The Court further found that the utility was soundly predicted. Finally, the Court found that the claimed compound was not obvious.

OTHER CASES OF INTEREST

Court Upholds Previous Rulings that a Final Action Must Contain All Issues

Bartley v. Commissioner of Patents

The Applicants brought judicial review of a decision of the Commissioner of Patents (Commissioner) and the Court allowed that judicial review. During the prosecution of the patent application, after numerous Office Actions, the Examiner issued a Final Action. The Applicant's Agent responded to this Final Action. Then, a Patent Appeal Board (Board) was constituted and had undisclosed discussions with the Examiner. Furthermore, the Examiner provided at least one memorandum to the Board with the Examiner's view as to the status of the application. The Board did not hold a hearing, but recommended that the Examiner's rejection be reversed and that the matter be returned to the Examiner to deal with the other "outstanding defects".

The Commissioner accepted these recommendations. These discussions and recommendations were made without input from the Applicant's Agent.

The Court reviewed the evidence put forward by the Commissioner and found that it did not support the argument that there were outstanding matters after the Final Action. Furthermore, the Court found that the Board's inquiries and recommendations as to the outstanding matters were unsatisfactory and lacking in due process. The Court also held that the Board acted contrary to Patent Rule 30(6) by failing to explicitly present the Applicant's Agents with the Board's view that there were outstanding matters and without clearly offering the Applicants an opportunity to be heard.

The Court then held that as in Belzberg, a Final Action is meant to be final and there is an obligation upon the Examiner to put everything on the table at that point. There is no provision to keep certain matters outstanding when a Final Action is issued. Furthermore, even if there were such a provision, this case fails to show that there were such outstanding matters. Since the application was returned to the Examiner having been reversed by the Commissioner, there are no grounds left for a further substantive requisition and allowance must follow as a consequence.

The Court held that the most appropriate action would be to allow the application and let the rest of the world challenge the validity of the patent if they wish.

Patent Appeal Board Finds No Double Patenting and that Monoclonal Antibody Claims are Sufficient When Target Polypeptide is Described

Commissioner's Decision 1307

The application related to human receptors for the platelet factor 4 superfamily antibodies. It was also the subject of a voluntary divisional. The final action raised issues of obviousness double patenting and lack of support for monoclonal antibodies.

The relevant claims at issue for the obviousness double patenting argument were a claim to an antibody capable of binding an isolated platelet factor 4 superfamily receptor and a claim to an isolated platelet factor 4 superfamily receptor polypeptide. The Board held that the subject matter in the claims does not reflect the same intended utility. Furthermore, the Court held that the claims were not obvious variations, modifications or combinations. Thus, the Board found no double patenting would exist.

The claims at issue in the rejection for lack of support related to antibodies and pharmaceutical compositions of antibodies as well as the use of antibodies as an anti-inflammatory agent. The Board considered the submissions of the parties and held that as of the laid open date of this application, the core steps for producing a monoclonal antibody were well known and reliable. Furthermore, the Board held that a person skilled in the art would not need to undertake considerable or protracted experimentation to make monoclonal antibodies capable of binding the particular polypeptides described in the figures. However, the Board did require limitation of the scope of the claims to an antibody capable of binding the particular polypeptides described.

Finally, the Board refused to allow the use claims. After conducting a sound prediction analysis,

the Board held that the factual basis in the specification would not lead a skilled person to conclude that blinding and/or blocking any one of the PF4AR polypeptides with a specific antibody would, on its own, necessary result in inhibition of inflammation.

OTHER INDUSTRY NEWS

Health Canada released a draft Guidance Document Part III: Consumer Information, Guidance Document: Product Monograph. The consultation period runs from July 21 to September 19, 2011.

Health Canada posted a Notice to Manufacturers/Sponsors of Nonprescription Drug Products: Emerging Regulatory Requirement for Non-Medicinal Ingredient Labelling

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