Updates: fourth anniversary of major amendments to Patented Medicines (Notice of Compliance) Regulations

Status of actions
Trial decisions on the merits
Appeal decisions on the merits
Procedural matters
Comment

On 21 September 2021 it was the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (the regulations). This article provides an update on activities in the fourth year following the amendments, including new actions and a wave of court decisions, both on the merits and procedural matters.(1)

Status of actions

From 21 September 2020 to 21 September 2021, approximately 29 sets(2) (43 in total) of actions were started. This is a drop from the past two years (49 in 2019-2020 and 35 in 2018-2019).

Of the approximately 186 actions started since the amendments, the majority were resolved before a decision on the merits (114, in grey below), 19 actions were pursued to a decision on the merits, with the majority of actions dismissed (13, in red below). Appeals are pending from 18 actions and one trial decision was affirmed on appeal.

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Figure 1: status of actions started since the amendments

The following table shows the drugs for which there is at least one active section 6 action (although some of the actions may be stayed or adjourned pending appeal).

Over the past four years, Sandoz was the most active patent challenger (it was a defendant in 47 actions relating to 23 drugs), followed by Apotex (29 actions relating to 17 drugs) and Teva (20 actions relating to 15 drugs).

In the past year, there were also actions commenced further to section 8(1), which permits "an interested person" to bring an action for the declaration that the patent or certificate of supplementary protection or any claim is invalid or void, and section 8(2), which permits a first person or patentee to bring an infringement action regarding a patent not listed on the Patent Register once served with a notice of allegation (NOA):

• section 8(1) – four actions relating to adalimumab (Abbvie's HUMIRA) commenced by JAMP; and
• section 8(2) – four actions relating to Merck's sitagliptin (JANUVIA) and one action relating to Merck's sitagliptin and metformin (JANUMET XR).

Several actions have also been commenced in the past year pursuant to section 8 of both the amended and pre-amended regulations, seeking damages following unsuccessful patent litigation:

• Abiraterone acetate (commenced by each of Dr. Reddy's Laboratories and Apotex);
• Silodosin (commenced by Sandoz);
• Pirfenidone (commenced by Sandoz); and
• Amlodipine and perindopril (pursuant to pre-amended Regulations, commenced by Apotex).

The first (and only other) amended section 8 action was commenced by Pfizer in 2020, seeking damages after Amgen was unsuccessful in filgrastim litigation, and was discontinued following the pleadings stage. The first amended section 8 trial (relating to Apotex's abiraterone) is scheduled for June 2023.

Trial decisions on the merits

A number of decisions on the merits were released in the fourth year. Here are some mid-year highlights:

• Allergan v Sandoz (silodosin, RAPAFLO) – claims to a capsule of silodosin that achieves a defined rapid dissolution profile were valid but not infringed.

• Teva v Pharmascience (glatiramer acetate, COPAXONE, GLATECT) – claims to the use of glatiramer acetate in treating patients who have had a single clinical attack suggestive of multiple sclerosis before a confirmed diagnosis (the 437 patent) were invalid (not anticipated but obvious) and claims to the use of 40 milligrams of glatiramer acetate administered by subcutaneous injection three times per week for the treatment of relapsing-remitting multiple sclerosis (the 802 patent) were valid (not obvious, useful) and infringed.

• Bristol-Myers Squibb v Pharmascience, Sandoz (apixaban, ELIQUIS) – claims to apixaban and the use of apixaban in the treatment of thromboembolic disorders (the 202 patent) were valid (attacks included inutility of selection) and infringed and claims to the formulation of 2.5 and 5 milligrams of apixaban (dry granulation) tablets (the 171 patent) were also valid (attacks included obviousness) and infringed.

• Janssen v Pharmascience (abiraterone acetate, ZYTIGA) – claims to the use of a combination of abiraterone acetate and prednisone for the treatment of prostate cancer were invalid (obvious).

• Hoffmann-La Roche v Sandoz (pirfenidone, ESBRIET) – claims to pirfenidone for use in a specific dose escalation regimen (the 654 patent) and for use at a specific dose in a patient that experiences a specific liver abnormality (the 997 patent) were invalid (method of medical treatment and obvious).

Appeal decisions on the merits

The Federal Court of Appeal released two decisions upholding the lower court's decisions granting applications for orders of prohibition:

• Apotex v Janssen (abiraterone acetate, ZYTIGA) – the prohibition order under the pre-amended regulations was affirmed by the Federal Court of Appeal. Claims to the use of abiraterone acetate and prednisone for the treatment of prostate cancer were valid (patentable subject matter (synergy not required), not obvious, useful) and infringed (note that the opposite result was reached following a trial under the amended regulations – see the previous section).

• Apotex v Shire (lisdexamfetamine, VYVANSE) – the prohibition order under the pre-amended regulations and the dismissal of an impeachment action were affirmed by the Federal Court of Appeal. Claims to lisdexamfetamine were valid (not anticipated based on disclosure of genus, not obvious). Apotex has sought leave to appeal to the Supreme Court.

Additionally, the Federal Court of Appeal dismissed Amgen's appeal of the trial judge's finding that Amgen's patent claiming granulocyte colony-stimulating factor made using recombinant genetic technology was obvious. Amgen's leave to appeal to the Supreme Court was also dismissed.

Procedural matters

There have been the following mid-year highlights:

• A defendant was permitted to amend its statement of defence to plead validity attacks beyond its notice of allegation and the decision was upheld on appeal.
• Section 8(2), which permits a claim on an unaddressed patent (eg, an unlisted patent) once a NOA is served, does not impose a deadline for commencing an action.
• A re-examination proceeding was stayed pending Pharmascience's appeal of a patented medicines notice of compliance judgment finding the patent valid and infringed.
• A plaintiff was denied leave to amend its statement of claim to plead infringement of further patents more than 45 days after receipt of NOAs.

Comment

The past year brought further decisions on procedure and an influx of new decisions on the merits.

For further information on this topic please contact Katie Lee or Urszula Wojtyra at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected] or [email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.

Endnotes

(1) See also the first, second and third anniversary updates.

(2) Actions between the same parties in respect of the same innovator reference drug are considered one "set". The statistics are provided as of the fourth-year anniversary, 21 September 2021.