Pharmacapsules @ Gowlings - April 14, 2011

Edited by Jennifer Wilkie and Isabel Raasch

In this issue:

• Two Amendments to Pharma Legislation Come into Force
  
  
• Other News Items of Interest to the Pharma Community
  
  
• Recent Cases
  
  
• Upcoming Trials, Judicial Reviews and Appeals of Interest
  
  

TWO AMENDMENTS TO PHARMA LEGISLATION COME INTO FORCE

The Amendments to The Food and Drug Regulations (1319- New Drugs For Extraordinary Use) came into force on March 25, 2011. These amendments affect the regulations regarding the design of appropriate clinical trials for a small number of emergency-use drugs, such as anthrax and pandemic influenza vaccines (collectively referred to as Extraordinary Use New Drugs or "EUND"). The Amendment creates a new type of drug submission for EUND within the Regulations and outlines the requirements for EUND submissions, labeling, plans for post-market safety and efficacy data acquisition, and annual reporting. Existing regulations that apply to other drugs such as data and patent protection apply to EUNDs as well. Because of the nature and intended purpose of EUNDs, manufacturers are only permitted to sell them to federal, provincial, territorial or municipal governments.

The full text of the EUND Amendments can be found at:
Regulations Amending the Food and Drug Regulations.pdf

The new Fees in Respect of Drugs and Medical Devices Regulations came into force on April 1, 2011. These new fees constitute an update and consolidation of the various user fees regulations. Key elements of the new fees regulations include (1) establishing fees for regulatory activities (e.g., submission and examination of NDSs and SNDSs, dealer licenses and medical device licenses) and stipulating their amounts in a schedule; (2) establishing timing and allotment of fees payable; (3) providing fee mitigation measures; and (4) providing for an annual adjustment of fees. The fees are designed to lessen the increasing funding pressures on Heath Canada.

The full text of the new fees regulations (including the fee tables) can be found at:
Fees in Respect of Drugs and Medical Devices Regulations.pdf

OTHER NEWS ITEMS OF INTEREST TO THE PHARMA COMMUNITY:

• Expanded pharmacy services available under the Ontario Drug Benefit Program beginning this month (March – April, 2011):
  
  Notice from the Executive Officer. Re: Implementation of the first stage of expanded services
  
  Notice from the Executive Officer. Re: Expanding Professional Pharmacy Services for April 1, 2011
  
  Notice from the Executive Officer. Re: Increase in Dispensing Fees, Effective April 1, 2011
  
  Notice from the Executive Officer. Re: New Regulation under the Drug and Pharmacies Regulation Act (DPRA)
  
  
• Former Bank of Canada Governor says Canada's healthcare system will have to make tough choices in the future to remain viable (April 6, 2011):
  
  http://www.reuters.com/article/2011/04/06/canada-health-idUSN0625574220110406
  
  
• Ontario to allow drug dispensing machines to roll out across the province (March, 2011):
  
  http://www.health.gov.on.ca/en/news/release/2011/mar/nr_20110318_1.aspx
  
  
• Quebec Minister of Health discusses status of electronic patient records in Quebec (March, 2011 – in French)
  
  http://communiques.gouv.qc.ca/gouvqc/communiques/GPQF/Mars2011/22/c5285.html?slang=en
  
  
• Electronic patient records a reality for 3 Canadian hospitals (April 13, 2011):
  
  http://www.theglobeandmail.com/news/national/toronto/electronic-patient-records-will-soon-end-doctors-scrawl-on-paper/article1982647/
  
  
• Scepticism about health claims made by the manufacturers of vitamins, herbal supplements and non-prescription drugs has edged up in the last five years (April 13, 2011)
  
  http://www.canada.com/health/Confidence+natural+health+claims+decline+Survey/4603371/story.html#ixzz1JPphOgJZ
  
  

RECENT CASES

Apotex Inc. v. Minister of Health (2011 FCA 86) Apo-ASA, March 8, 2011
Appeal of NOC decision

The Court of Appeal upheld a decision dismissing Apotex' application for judicial review of a Minister of Health decision refusing to issue a NOC for Apotex enteric-coated ASA. In particular Apotex had tried to argue to the Minister that certain data in its "fed" bioavailability study were mere outliers and should be disregarded. The Court of Appeal agreed with the Minister that all of Apotex' arguments were based on the incorrect premise that it was open to the Minister to assess the safety and efficacy of Apo-ASA without requiring proof of bioequivalence between Apotex' product and Bayer's product (the Canadian reference product). The Court of Appeal found the applications judge had applied the correct standard of review and stated that given the Minister's finding of no bioequivalence, it was not open to the Minister to grant the NOC on the basis of a comparison with the reference product.

A copy of this decision may be found at the following link:

http://decisions.fca-caf.gc.ca/en/2011/2011fca86/2011fca86.html

Phostech Lithium Inc. v. Valance Technology, Inc. (2011 FCA 107) March 18, 2011
Appeal of Stay of Execution

The Federal Court of Appeal granted a stay of execution pending appeal in a patent infringement action. The applicant Appellant (Defendant) had sought the stay. The Court of Appeal recited the 3 part test for granting a stay: (1) is there a serious issue on appeal, (2) will there be irreparable harm, and (3) where does the balance of convenience lie. This test is rarely satisfied, usually failing due to the difficulties of establishing irreparable harm. The Court of Appeal indicated that it was satisfied where there would be irreparable harm to the Appellant by reason of loss of key components to its business (key personnel, scarce suppliers, and customers with tight time requirements). With respect to the balance of convenience, the Court noted that the parties do not compete in the same market so it would only be inconvenient to the Respondent (Plaintiff) and if ultimately the appeal is dismissed, the Plaintiff would be able to obtain a monetary remedy which encompasses the longer time frame. Importantly, the Court did place some conditions/factors in order to grant the stay: (1) a written undertaking as to damages from the Defendant, (2) an additional undertaking not to make distributions to shareholders etc. during the stay period, (3) a bond was deposited with the Court in the amount of $250,000 and (4) the appeal should be expedited.

A copy of this decision may be found at the following link:

http://decisions.fca-caf.gc.ca/en/2011/2011fca107/2011fca107.html

Eli Lilly et al. v. Nu-Pharm Inc., (2011 FC 255), olanzapine, T-1548-10, March 3, 2011
Appeal of Order re. motion to strike Statement of Claim

In an action for patent infringement regarding olanzapine, Madam Justice Snider upheld a November 16, 2010 Order of Prothonotary Milczynski striking the Plaintiff's Statement of Claim and awarding costs to Nu-Pharm.

Justice Snider reviewed Prothonotary Milczynski's decision de novo and found that although the Statement of Claim showed facts by virtue of which the law recognizes a defined right as belonging to the Plaintiffs, the pleadings did not disclose a reasonable cause of action. In particular, although the pleadings alleged that Nu-Pharm's actions in obtaining a Notice of Compliance and a Drug Identification Number for its olanzapine product constituted infringement, the pleadings disclosed nothing beyond an assertion that Nu-Pharm was positioning itself (through an unnamed third party) to enter the market. The Court further stated that without something pleaded beyond the regulatory requirements, s. 52.2(1) (i.e., the exemption from infringement solely for the purposes reasonably related to the development and submission of information required for regulatory purposes) of the Patent Act applies.

A copy of this decision may be found at the following link:

http://decisions.fct-cf.gc.ca/en/2011/2011fc255/2011fc255.html

Apotex v. Pfizer, 2011 FCA 77, sildenafil, A-371-10, March 1, 2011
Appeal of interlocutory motion in impeachment action

Apotex appealed the finding of the Trial Court which allowed Pfizer's Statement of Defence to include pleadings of issue estoppel, collateral estoppel, comity and abuse of process based on related NOC litigation.

The Court of Appeal reaffirmed that NOC cases are summary in nature and that decisions as to validity or infringement made in an NOC case are not binding in the sense of cause of action estoppel. However, the Court of Appeal noted that depending on the evidence put forward in a subsequent proceeding the doctrines of res judicata and issue estoppel may apply to particular factual and legal findings of the previous application judge's findings. The Court offered the following illustration as an example: if a witness gives exactly the same evidence in both proceedings, and the judge found the witness to be credible in the NOC proceeding, it may be open to the trial judge in the action to bar re-litigation of the witness' credibility through issue estoppel or abuse of process; on the other hand, if the witness gives different or additional evidence at the action, the trial judge may be justified in reconsidering the witness' credibility.

In view of the above, the Court of Appeal found that portions of Pfizer's statement of Defence which contained general statements with regards to litigation bar should be struck, but that other paragraphs relating to specific findings of the previous judge should be allowed.

A copy of this decision may be found at the following link:

http://decisions.fca-caf.gc.ca/en/2011/2011fca77/2011fca77.html

RECENT CASES

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