Canada: Pharmacapsules @ Gowlings - June 19, 2008

Last Updated: June 25 2008

Edited by Jennifer Wilkie and Chantal Saunders

Contents

  • Amendments to the Patented Medicines (Notice of Compliance) Regulations-registered on June 12, 2008

  • 30 Year Cancer Prevention Study Launched in Canada

  • European Commission Has Medical Devices in Its Sights

  • Ontario Considers Prescriptions by Pharmacists

  • Recent Cases

Amendments to the Patented Medicines (Notice of Compliance) Regulations-registered on June 12, 2008
By: Grant W. Lynds

In our Pharmacapsules edition that was published on May 8, 2008, we reported on the proposed amendments to the Patented Medicines (Notice of Compliance) Regulations ("Regulations") that the Canadian Government recently published in the Canada Gazette. After an abbreviated comment period, the Canadian Government registered these amendments on June 12, 2008.

The final form of the amended Regulations was consistent with the previously published version. Innovator companies should take note that a 30-day time period, from June 12, 2008, has started to run to request that any patent be re-listed on the Patent Register if the patent was submitted for listing before June 17, 2006, and was subsequently removed from the Patent Register or if the Minister refused to add the patent to the Register after March 29, 2007, solely on the basis that the patent was not relevant to the submission for the NOC to which the patent list relates.

In addition, the final form of the amendments emphasizes that any second person that filed its abbreviated new drug submission ("ANDS") at a time when an innovator's patent was not on the Register need not address that patent since the Register is "frozen" as of the date that the second person filed its ANDS. The Government stated in its Regulatory Impact Analysis Statement that this transitional provision of these recent amendments would ensure that this approach was consistent with the "frozen" Register mechanism brought into effect as part of the 2006 amendments to the PM(NOC) Regulations.

As such, innovators should ensure that if they had patents that are impacted by these amendments, where the patents were removed from the Register or if the Minister refused to add such patents to the Register, written requests to add the patents to the Register are submitted prior to the expiry of the above-noted 30-day period.

For more information, please see the attached documents, namely the registered Regulations which will be published June 25, 2008 as well as the Regulatory Impact Analysis Statement.

Amendments to PM(NOC) Regulations
REGULATORY IMPACT ANALYSIS STATEMENT
RÉSUMÉ DE L'ÉTUDE D'IMPACT DE LA RÉGLEMENTATION

30 Year Cancer Prevention Study Launched in Canada
By: Natalie de Paulsen

On June 11, 2008, the Canadian Partnership Against Cancer announced the launch of The Canadian Partnership for Tomorrow Project. The Project will track 300,000 randomly selected Canadians for the next 20-30 years to explore how genetics, lifestyle and behaviour contribute to the development of cancer. The Project will examine people's health and habits such as their eating and exercise habits, as well as environmental factors. The Project will also gather data on the impact of screening and prevention programs. Federal Health Minister Tony Clement is quoted "The Canadian Partnership for Tomorrow Project is an example of how Canada is forging ahead as a leader in the field of cancer prevention research worldwide. Over the coming years, this study will be a major contributor to global research to identify the causes of cancer and ultimately prevent people from getting the disease in the first place."

For more information, please see the Canadian Partnership Against Cancer web-site:
http://www.partnershipagainstcancer.ca/inside.php?lang=EN&ID=127

European Commission Has Medical Devices in Its Sights
By: Scott Robertson

Thomas Lonngren, executive director of the European Medicines Agency (EMA), recently stated that proposed changes to current legislation may result in his agency evaluating high-risk medical devices. The EMA is already responsible for approving almost all new medicines in Europe.

Currently, medical devices are approved by eight different governing bodies from across Europe under the CE mark scheme. According to Lonngren the European Commission is not satisfied with the quality of the current system and discussions are under way to harmonize it.

The United States Food and Drug Administration uses a system which evaluates both drugs and medical devices. The EMA may be looking to a similar system to coordinate the evaluation of medicines and high-selling medical devices such as orthopaedic implants and coronary stents.

For more information, please see:
http://www.reuters.com/article/rbssHealthcareNews/idUSL0689072420080606

Ontario Considers Prescriptions by Pharmacists
By: Marc Richard

The Ontario Government is studying the issue of whether pharmacists should be able to prescribe certain classes of drugs and re-fill prescriptions without a doctor's consent. This follows a trend in other jurisdictions, such as New Brunswick, where pharmacists have greater prescribing power. The move is seen as a means of relieving pressure on emergency rooms and doctors' offices.

For more information, please see:
http://www.cbc.ca/health/story/2008/06/02/pharmacists-ontario.html

Recent Cases
By:Beverley Moore

Abbott Laboratories Limited v. Canada (Minister of Health); Judicial Review of Listing Decision; June 4, 2008; Sibutramine

The Court upheld the Minister's decision that the NOC approved use is different from the claimed use in the patent. Thus, there was no basis for adding the patent to the Patent Register.

The Court held that as the proceeding is a judicial review, the Court should only be looking at the record the Minister had before him or her in arriving at the decision under review. The Court thus disregarded the expert affidavit filed by the applicant with the exception of the five paragraphs that dealt with claim construction.

The Court held that the standard of review in decisions such as the one at issue is reasonableness as the Court is dealing with questions of mixed fact and law. However, the Court held that on this standard, considerable deference should still be given to decision of the Minister. The Court approved the previous decision holding that this standard of review on questions of law must be correctness.

The full text of the decision can be found at:
http://decisions.fct-cf.gc.ca/en/2008/2008fc700/2008fc700.html

Pfizer Canada Inc. et al. v. Novopharm Limited et al.; Appeal of Interlocutory Motion Dismiss; May 29, 2008; sildenafil

The patent at issue had been the subject of a judicial review proceeding against another generic company. That application was dismissed and the dismissal was upheld by the Court of Appeal. The second generic company (Novopharm) sent an NOA using all of the same allegations of invalidity that the first generic company (Apotex) had used. Novopharm then brought a motion to dismiss the proceeding on the basis of abuse of process and this motion was granted.

Pfizer sought to set aside that decision on the basis that the trial decision in Apotex was made solely on a failure to meet the burden of proof and Pfizer had not appreciated the need to bring the evidence needed to meet that burden. This argument was rejected by the Prothonotary. It was further rejected on appeal. The Court held that Pfizer was simply making thinly veiled collateral attack on the decision of the Federal Court of Appeal decision in the Apotex proceeding. This cannot not be permitted.

The full text of the decision can be found at:
http://decisions.fct-cf.gc.ca/en/2008/2008fc674/2008fc674.html

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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