The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: NDS

Health Canada’s Statistics on Patent Listings and Generics Litigation

In Canada, Under the PM(NOC) Regulations, the Minister of Health maintains a Patent Register (the analog to the U.S. Orange Book).  Health Canada collects statistics on patent listings and litigation, and Ogilvy Renault’s Life Sciences team recently put out a bulletin summarizing some of the data.  A few highlights:

  • Out of 248 applicable generic drug submissions, the generic manufacturer obtained the consent of the patent owner to market its product in Canada prior to patent expiry in only 1% of cases; and in 47% of cases the generic manufacturer intended to challenge the listed patent(s).
  • In litigated cases, generic manufacturers were successful in 67% of all decided cases, and the brand manufacturer / patent owner was successful in the remaining 33% of cases.
  • 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.

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