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 requirements are nevertheless inconsistent with the Government's intention and purpose to shield the grandfathered patents from the 2006 amendments.
The Government feared that later cases would follow this precedent, further broadening unsettling jurisprudence and creating uncertainty in the state of the law. Accordingly, it introduced amendments that have the following effects:
- Subject to four basic "common-sense" grounds,
the Minister is prevented from deleting grandfathered patents
from the register (i.e., the patent has expired or has been
found to be null or void, the DIN has expired or the court
has found it otherwise ineligible for listing on the
register).
- The Minister is prevented from refusing to add
grandfathered patents to the register on the basis that the
patent is not relevant to the supplemental submission for a
Notice of Compliance (NOC) to which the patent list relates.
The Minister can still refuse the addition on the basis of
other grounds.
- If, after March 29, 2007, the Minister
of Health deleted a grandfathered patent from the register
solely on the basis that the patent is not relevant to the
supplemental submission for a NOC to which the patent
relates, the first person may apply by written request by
July 14, 2008 requesting that the patent be
added to the register. The Minister shall add the patent to
the register within 30 days of receipt of the request.
- If, after March 29, 2007, the Minister
of Health refused to add a grandfathered patent from the
register solely on the basis that the patent is not relevant
to the supplemental submission for a NOC to which the patent
relates, the first person may apply by written request by
July 14, 2008 requesting that the patent be
added to the register. The Minister shall add the patent to
the register within the later of 30 days of the receipt of
the request or 30 days after issuance of the NOC.
- In respect of the grandfathered patents, a second person
is prevented from bringing a motion to dismiss solely on the
basis that the patent is not eligible for inclusion on the
register. However, these amendments do not prevent a second
person from bringing a dismissal motion prior to
April 26, 2008.
In light of the deadlines, those whose patents were either refused or deleted from the register should apply to the Minister to have them either added or put back on the register as quickly as possible. Taking that step will benefit drug manufacturers, who will increase their protection as well as reduce the possibility of generic drug companies filing for NOC submission and infringing on these grandfathered patents. Manufacturers should act by July 14th, 2008.
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.
