Amendments To The Patented Medicines (Notice Of Compliance) Regulations: Subsequent Changes Voicing Government Intent

In light of recent amendments to the Patented Medicines

(Notice of Compliance) Regulations, patents that

previously may have been rejected or found not eligible for

listing on the Health Canada patent register may now be

eligible to be listed. The non-extendible deadline for

reviewing and submitting a request for reconsideration of

eligibility to the Office of Patented Medicines Liaison is

July 14, 2008.

The changes affect all patent lists filed prior to

June 17, 2006 where the Minister made a decision

after March 29, 2007 to refuse to add to or

delete a patent from the patent register. As such, we advise

our clients to review all of their patent lists filed prior to

June 17, 2006 and any patent listing rejections to see if they

qualify.

By way of background, the recent amendments to the

Regulations came into force on June 12, 2008. The amendments

curtail both the Minister's and the second person's

ability to render ineligible from inclusion on the patent

register those patents "grandfathered" by earlier

amendments to the Regulations that took force on October 5,

2006. The 2006 amendments to the Regulations imposed new

      requirements regarding the eligibility of patents for inclusion

      on the patent register that significantly limited the ability

      to list a patent on the patent register, especially with regard

      to supplemental new drug submissions (SNDS). However, the

      amendments contained specific "grandfathering"

      provisions that shielded certain patents from the amendments,

      i.e., those patents submitted on a patent list prior to June

      17, 2006.

      According to the Regulatory Impact Analysis Statement

      accompanying the current amendments, the government was

      concerned by developing caselaw that had essentially nullified

      these grandfathering provisions. In particular, following the

      reasoning in the Supreme Court's decision in

      Astrazeneca Canada Inc. v. Canada (Minister of

      Health) (2006), 52 C.P.R. (4th) 145, (S.C.C.), the Federal

      Court of Appeal in Wyeth Canada v Ratiopharm

      Inc. (2007), 60 C.P.R. (4th) 375 (FCA), held that in order

      for a patent submitted with a SNDS to be eligible for inclusion

      on the register "there must be relevance between the

      invention claimed in the patent and the change to the drug

      effected by the SNDS." This ratio applied to patents

      "grandfathered" under the 2006 amendments.

      Though the eligibility requirements on the grandfathered

      patents imposed by Wyeth Canada is consistent with the

      2006 amendments to the Regulations, the...