CaseHorizon Pharma PLC v Minister of Health and Canada (AG), 2015 FC 744

Drug: RAVICTI (glycerol phenylbutyrate)

Nature of case: Uncontested motion for an Order staying the issuance of a Notice of Compliance

Successful party: Horizon Pharma PLC

Date of decision: June 12, 2015

Summary

Horizon Pharma PLC (Horizon) is seeking approval to market the drug RAVICTI (glycerol phenylbutyrate) for the treatment of urea cycle disorders (UCDs).  The Office of Patented Medicines Liaison (OPML) initially determined that RAVICTI was an “innovative drug” eligible for data protection, subject to final review upon issuance of the Notice of Compliance (NOC).  A competing product was subsequently approved and the OPML advised that RAVICTI was no longer eligible for data protection being a variation of a now previously approved product.  Horizon brought an application to judicially review the OPML’s decision denying data protection for RAVICTI and the within motion to stay the Minister of Health’s decision to issue the RAVICTI NOC pending the determination of entitlement to data protection. Justice Gagné of the Federal Court granted the NOC stay, as Horizon was able to satisfy the requisite three-part RJR-MacDonald1 test.

Background

On or about April 25, 2014, Horizon submitted an NDS and requested that RAVICTI be designated an “innovative drug” pursuant to section C.08.004.1 of the Food and Drug Regulations, CRC c 870 (Regulations), in order to benefit from an eight-year period of market exclusivity. The OPML initially determined that RAVICTI was an “innovative drug” eligible for data protection, subject to final review upon NOC issuance.

On November 13, 2014, the OPML issued a Notice of Deficiency with respect to the RAVICTI NDS and advised that its NOC would be delayed for six months.  In the interim, Medunik Canada, a generic competitor, obtained an NOC for PHEBURANE (sodium phenylbutyrate), a generic copy of BUPHENYL.  Horizon submits that Medunik received its NOC by relying on data from Hyperion Therapeutics Inc.’s (now Horizon post-merger) European reference product AMMONAPS (BUPHENYL) and its market experience over the past 10 years.  Medunik submitted its NDS for PHEBURANE in June of 2014 (i.e., after the RAVICTI NDS).

As a result, the OPML advised that RAVICTI was no longer eligible for data protection on the basis that it contained an ester variation of the now previously approved PHEBURANE.  Alternatively, the OPML advised that RAVICTI was “a second minor variation” of phenylbutyric acid, which was approved in PHEBURANE as a sodium salt.

Judicial review

Horizon brought an application to judicially review the OPML’s decision denying data protection for RAVICTI.  At the same time, Horizon also brought the within motion to stay the Minister’s decision to issue an NOC for RAVICTI pending the resolution of the judicial review application.  Horizon argued that absent a stay, and entitlement to data protection, it will have to withdraw its NDS for RAVICTI since it will be unable to recoup the investments needed to offer RAVICTI for sale in Canada.

Three-part test for stay is satisfied

Serious issue

The threshold for establishing a serious issue is a low one. Justice Gagné held that there is a “serious issue” of potential errors committed by the Minister of Health regarding interpreting and applying the definition of “variation” in section C.08.004.1(1) of the Regulations.

Irreparable harm

Irreparable harm will be found where an applicant will suffer incalculable and non-compensable losses. Horizon argued that both the company and patients with UCDs will suffer irreparable harm if the stay is not granted. Horizon stated that absent a stay it will need to withdraw its NDS to prevent generic manufacturers from relying on RAVICTI data to enter the market.  Horizon will be unable to recoup its research and development costs for RAVICTI. Justice Gagné held that this type of harm is non-compensable.

Although Justice Gagné already held that the irreparable harm branch of the stay test was satisfied, she also analyzed whether or not third-party harm could be considered at this stage. Justice Gagné held that the harm to patients with UCDs was not speculative, but the impact of such harm was left to the analysis of the balance of convenience.

Balance of convenience

Justice Gagné found that there was “compelling public interest in granting the stay” because if Horizon is successful on its judicial review, “Canadian patients with UCDs will have access to what could be a life-saving drug”.2 Additionally, since the respondents took no position on the motion, it was indicative of there being no harm in staying the issuance of the NOC for RAVICTI.

Link to decision:

Horizon Pharma PLC v Minister of Health and Canada (AG), 2015 FC 744