NATURE OF REPORT: PM(NOC) Regulations and Data Protection – Statistical Data

DATE OF REPORT: September 9, 2009 (published in early-2010)

SUMMARY:

Health Canada recently issued its annual report pertaining to the administration of the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”) and the data protection provisions of the Food and Drug Regulations (“Data Protection Regulations”). The report provides statistical information up to December 31, 2008. This report provides useful information for brand-name pharmaceutical companies carrying on business in Canada. Notable statistics include:

PM(NOC) Regulations

(a) Patent Lists  

  • 627 patent lists were submitted in 2008. 483 of these were added to the Patent Register (77%).  
  • 495 different medicines are currently listed on the Patent Register. 49% of these products have one patent listed on the Register (by DIN). 23% have two patents on the Register. 43% of products have three or more patents on the Register. One product has 22 patents listed on the Register.  
  • The report provides a table of patent list statistics up to December 31, 2008.

(b) Generic Drug Submissions  

  • 248 generic drug submissions were accompanied by patent declarations in 2008.  
  • 47% of these declarations indicated that the generic manufacturer intended to challenge the listed patent(s) by serving a notice of allegation.  
  • 52% of these declarations indicated that the generic manufacturer would wait until patent expiry to obtain marketing approval.  
  • In 1% of cases, the generic manufacturer obtained the consent of the patent owner to market its product in Canada prior to patent expiry.

(c) Court Proceedings  

  • 590 notices of allegation were served from 1998 until 2008. This resulted in 447 court proceedings.
  • 145 of these cases were decided by the Court. The remaining cases are pending or were discontinued.  
  • Generic manufacturers were successful in 67% of all cases that were decided by the Court. The brand manufacturer / patent owner was successful in the remaining 33% of cases.  
  • The resolution time for cases under the Regulations in 2007 has ranged from 0.6 months to 22.6 months. There has been a steady decline in resolution time since 1998.  
  • The report provides a table of all court cases under section 5 of the Regulations up to December 31, 2008.

Data Protection Regulations

  • 64 drugs were added to the Register of Innovative Drugs from 2006 to 2008.  
  • 14 of these products qualified for the six-month pediatric extension of data protection.  
  • 4 court proceedings were initiated under the Data Protection Regulations.  

LINK TO REPORT:

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/docs/patmedbrev/patmrep_mbrevrap_2008-eng.php