This article summarises the highlights in Canadian life sciences IP and regulatory law which took place in the first half of 2019.
While originally proposed to come into force on 1 January 2019, sweeping amendments to the Patented Medicines Regulations governing pricing criteria were still not released as of 30 June 2019 (for further details please see "Canada releases proposed amendments to patented medicines pricing regulations"). Assuming that they are released, they are expected to come into force 12 months thereafter. Therefore, the earliest expected in force date is July 2020 (for further details please see "Amendments to Patented Medicines Regulations expected to come into force no earlier than Spring 2020"). Work on guidelines modernisation to accompany these amendments continued through the first half of 2019, including the release of the steering committee's final report (for further details please see "Update on PMPRB guidelines modernisation").(1)
There were two court decisions issued in June 2019:
- First, the Federal Court upheld the Patented Medicine Prices Review Board's (PMPRB's) excessive pricing decision, which required a C$4.2 million payment regarding Alexion's Soliris (eculizumab) (for further details please see "Federal Court upholds PMPRB's pricing decision regarding Alexion's Soliris"). The court held that the PMPRB had not been unreasonable in:
- following its guidelines in one respect (in determining permitted increases); and
- not following its guidelines in another respect (in assessing the appropriate benchmark). Alexion has appealed.
- Second, in a closely watched case, the Federal Court of Appeal sent back to the PMPRB the question of whether an invention (in this case, the use of 0.3% adapalene) "pertains to" Differin (0.1% adapalene). While the determination of an invention is not an exercise of claim construction, the PMPRB must consider the patent as a whole, including the claims. In determining whether "an invention pertains to the medicine", the phrases "rational connection or nexus" or "merest slender thread" cannot supplant the statutory language, which requires that "the invention is intended or capable of being used for the medicine".
Court decisions on merits (polymorph, salt and formulation patents)
There have been two Patented Medicines (Notice of Compliance) (PMNOC) Regulations decisions on the merits so far in 2019 and a pair of appeal decisions:
- Pfizer succeeded in Apotex and Teva's appeals regarding the validity of a patent claiming Form I o-desmethyl-venlafaxine (ODV) succinate (Pfizer's Pristiq) (for further details please see "Order of prohibition relating to polymorphic form patent for Pristiq upheld on appeal").
- Valeant succeeded against Generic Partners Canada, which alleged invalidity of Valeant's patent for a controlled-release dosage form of metformin (Valeant's Glumetza) (for further details please see "Federal Court finds invalidity allegations relating to patent for metformin formulations unjustified").
- Apotex succeeded in its obviousness and claim overbreadth allegations relating to Servier's patent claiming the arginine salt of perindopril and its hydrates in connection with Apotex's perindopril arginine/amlodipine product (Servier's Viacoram) (for further details please see "Federal Court dismisses Servier's application for order of prohibition regarding salt patent").
Almost two years have passed since substantial amendments to the PMNOC Regulations came into force on 21 September 2017 (for further details please see "Publication of final regulations on patent linkage and term restoration relating to CETA"). As of 30 June 2019, 78 actions (relating to 26 drugs) had been commenced and 56 (relating to 17 drugs) were ongoing. The first trial, Janssen v Teva, is scheduled to start on 30 September 2019. It relates to paliperidone palmitate (Invega Sustenna).
The procedural decisions thus far have included as follows:
- Common invalidity issues raised by different generic manufacturers were ordered to be heard concurrently.
- Only 'second persons' can be named as defendants (although this could include a person other than the regulatory submission filer) (for further details please see "Procedural decisions under PMNOC Regulations: common validity issues and naming of defendants").
- An infringement claim based on making and selling under a notice of compliance for one strength was struck from an action triggered by a notice of allegation based on a different strength (for further details please see "Infringement based on making and selling under existing NOC struck from action").
On the eve of a Section 8 trial relating to lansoprazole (Abbott's Prevacid), the Ontario Superior Court granted Abbott and Takeda leave to amend their pleadings to assert that Apotex's purported non-infringing alternative was unlawful, as it would have infringed a third party's patent (for further details please see "Abbott and Takeda plead third party's patent would be infringed by non-infringing alternative"). Apotex discontinued the Section 8 action before trial.
The Supreme Court of Canada declined to grant Apotex's request to hear an appeal of a decision permitting Sanofi and Schering to amend their defences to Apotex's claims, including under the Ontario Statute of Monopolies, grounded on a decision which found certain claims of a patent invalid (for further details please see "Supreme Court of Canada denies Apotex leave to appeal in two cases"). The defendants were permitted to plead that the Supreme Court of Canada's decision in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 – which rejected the promise doctrine as unsound – rendered the invalidity decision suspect. The first Statue of Monopolies trial (relating to atomoxetine; Eli Lilly's Strattera) was scheduled for May 2019 but was adjourned.
Cefaclor and non-infringing alternative defence The Supreme Court of Canada denied Apotex leave to appeal a Federal Court of Appeal decision, which concluded that a non-infringing alternative defence to Eli Lilly's damages claim relating to cefaclor was not available (for further details please see "Supreme Court of Canada denies Apotex leave to appeal in two cases"). The Federal Court of Appeal had remitted the Federal Court's decision (awarding Eli Lilly more than C$100 million and C$75 million in interest) for reconsideration solely on the issue of pre-judgment interest; the hearing is scheduled for September 2019 (for further details please see "Federal Court of Appeal overturns cefaclor damages decision on pre-judgment interest issue").
Final Competition Bureau IP Enforcement Guidelines, USMCA Implementation Bill and new Patent Rules
In March 2019 the Competition Bureau released its final updated IP Enforcement Guidelines (with modest updates) (for further details please see "Competition Bureau publishes final updated IP Enforcement Guidelines").
In May 2019 Bill C-100 was published to implement the United States-Mexico-Canada Agreement (USMCA), which would extend data protection for biologics from eight to 10 years. The USMCA is presently before the Standing Committee on International Trade.
(1) The status of the steering committee's final report is available here.
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