Date: 20250227

Docket: T-938-24

Citation: 2025 FC 379

Toronto, Ontario, February 27, 2025

PRESENT: Mr. Associate Judge Michael D. Crinson

BETWEEN:

VIIV HEALTHCARE COMPANY, SHIONOGI & CO., LTD. AND VIIV HEALTHCARE ULC

Plaintiffs

and

JAMP PHARMA CORPORATION

Defendant

ORDER AND REASONS

[1] This motion to amend brought by JAMP Pharma Corporation (“JAMP”) arises in an action brought by Shionogi & Co. Ltd. (“Shionogi”), ViiV Healthcare Company, Shionogi & Co. Ltd. and ViiV Healthcare ULC (together “ViiV”) against JAMP pursuant to section 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the “Regulations”).

[2] JAMP had filed an Abbreviated New Drug Submission (“ANDS”) comparing its proposed dolutegravir/abacavir/lamivudine product (the “JAMP Product”) with the Plaintiffs’ TRIUMEQ product. In respect of TRIUMEQ, the Patent Register lists Canadian patent number 2,606,282 (the “282 Patent”), patent number 2,967,453 (the “453 Patent”), patent number 3,003,988 (the “988 Patent”) and Certificate of Supplementary Protection number 900051 (the “CSP 900051”). JAMP served notices of allegation (“NOAs”) on the Plaintiffs in March 2024 addressing the 282 Patent, the 453 Patent and the 988 Patent. The NOAs did not address CSP 900051.

I. The Facts

[3] The Statement of Claim, issued on April 26, 2024, alleges the making, constructing, using, offering for sale, selling, importing or exporting of the JAMP Product would infringe claims of the 282 Patent, the 453 Patent and the 988 Patent. JAMP served a Notice of Intention to respond on May 10, 2024, stating at “this time, JAMP does not intend to serve and file a counterclaim seeking a declaration of invalidity and impeachment”. JAMP served a Statement of Defence, without a Counterclaim, on June 10, 2024. As there was no Counterclaim, the Plaintiffs reply was due within 10 days and was timely served.

[4] The Statement of Claim seeks an injunction in paragraph 1(c) to prevent the alleged infringement by the JAMP Product

…until after the expiry of the 282 Patent, the 453 Patent, and the 988 Patent and any applicable Certificates of Supplementary Protection setting out any of those patents that are included on the Patent Register for TRIUMEQ and are not the subject of an allegation pursuant to the Regulations.

[5] The Statement of Claim, at paragraph 52, alleges that the 988 Patent is also the subject of CSP 900051, which expires on January 24, 2033 and is listed on the Patent Register in respect of TRIUMEQ.

[6] The basis for the relief sought by ViiV regarding applicable Certificates of Supplementary Protection included on the Patent Register for TRIUMEQ and not the subject of an allegation pursuant to the Regulations, is further elaborated in paragraphs 59 to 61 of the Statement of Claim. In paragraph 62 the Plaintiffs “reserves their rights to amend this Statement of Claim” if JAMP does make an allegation in respect of CSP 900051.

[7] JAMP responds to these allegations regarding CSP 900051 at paragraph 31 of the Statement of Defence and adds that its allegations of invalidity against the 988 Patent also apply to CSP 900051and that if the 988 Patent is not infringed or is invalid, CSP 900051 is similarly not infringed or is invalid:

31. JAMP denies the allegations in paragraphs 59 to 62 of the Statement of Claim and puts the Plaintiffs to the strict proof thereof. JAMP denies that it is required to separately address CSP 900051 aside from addressing the 988 Patent in its Notice of Allegation. JAMP’s allegations in its Notice of Allegation with respect to the 988 Patent also apply to CSP 900051. In addition, JAMP’s allegations in this Statement of Defence with respect to the 988 Patent also apply to CSP 900051. Furthermore, any finding that the 988 Patent (or a claim thereof) is not eligible for listing on the Patent Register, is not infringed or is invalid will result in a finding that CSP 900051 (or a claim thereof) is not eligible for listing on the Patent Register, is not infringed or is invalid, respectively.

[8] ViiV, in its Reply to paragraph 31 of the Statement of Defence goes further than simply denying JAMP’s allegations, and alleges that CSP 900051 is valid for the same reasons the 988 Patent is alleged to be valid:

74. Contrary to the Defendant’s assertions at paragraph 31 of the Statement of Defence, the Plaintiffs maintain that the Defendant was required under the Regulations to address CSP 900051 and thus, to make specific allegations of non-infringement or invalidity against it in a Notice of Allegation and Detailed Statement. Because the Defendant has not made such allegations, no NOC for the proposed JAMP Product can currently issue until after the expiry of CSP 900051. In any event, to the extent the Defendant alleges in its Statement of Defence that CSP 900051 would cease to have effect if the 988 Patent is found to be invalid, and/or that CSP 900051 is indeed invalid, the Plaintiffs maintain that CSP 900051 is valid, for the same reasons that the 988 Patent is valid and repeat and rely on the Statement of Claim and the pleadings above. The Defendant has not pleaded any other independent basis for the non-infringement, invalidity, voidness, applicability or lack of force and effect in respect CSP 900051 beyond the non-infringement and invalidity of the 988 Patent.

[9] The ViiV Plaintiffs, but not Shionogi, are involved in another proceeding under the Regulations relating to TRIUMEQ. The defendant in that action is not a party to this proceeding. In that action against Sandoz, Sandoz counterclaimed alleging that if the 988 Patent is found to be invalid “CSP 900051 in respect of the 988 Patent ceases to have effect as there is no monopoly to supplement”.

[10] The proposed amendments comprise the addition of a counterclaim to the existing Statement of Defence, which proposed counterclaim is set out below:

156. JAMP, Plaintiff by Counterclaim, claims:

a) A declaration pursuant to subsection 60(1) of the Patent Act that the 988 Patent, and each of the claims of the 988 Patent, are and always have been invalid, void, and of no force and effect;

b) A declaration pursuant to subsection 60(2) of the Patent Act that none of the claims of the 988 Patent would be infringed by JAMP;

c) A declaration pursuant to subsections 106(1) and 125(1) of the Patent Act that CSP 900051 is, and always has been, invalid, void, and of no force and effect;

d) A declaration pursuant to subsections 60(2) and 125(2) of the Patent Act that CSP 900051 would not be infringed by JAMP;

e) Its costs of this action; and

f) Such further and other relief as this Honourable Court may deem just.

157. CSP 900051 is invalid and void, cannot take effect, and will not be infringed by JAMP, for the reasons set out in this Counterclaim.

158. The 988 Patent, and each of the claims of the 988 Patent, are and always have been invalid, void, and of no force and effect. Also, none of the claims of the 988 Patent would be infringed by JAMP. JAMP pleads and relies upon the allegations set out in the Statement of Defence above.

159. JAMP pleads and relies upon subsections 106(1)(a) and 116(2) of the Patent Act, and states that because the 988 Patent is invalid and void, CSP 900051 cannot take effect, and is invalid and void.

160. CSP 900051 does not comply with paragraph 106(1)(c) of the Patent Act. The 988 Patent does not pertain in the prescribed manner to a medicinal ingredient, or combination of medicinal ingredients, contained in TRIUMEQ, as required by subsection 3(2) of the Certificate of Supplementary Protection Regulations.

161. CSP 900051 does not comply with paragraph 106(1)(d) of the Patent Act. CSP 900051 was issued in respect of DOVATO (dolutegravir (dolutegravir sodium) / lamivudine). The authorization for sale of DOVATO (dolutegravir (dolutegravir sodium) / lamivudine) is not the first authorization for sale that has been issued with respect to the combination of medicinal ingredients. The first authorization for sale that has been issued with respect to the combination of medicinal ingredients was the authorization for sale for TRIUMEQ, which was granted before the authorization for sale for DOVATO.

162. CSP 900051 was issued in respect of New Drug Submission No. 220275, which was for DOVATO (dolutegravir (dolutegravir sodium) / lamivudine), and it was not issued in respect of New Drug Submission No. 169297, which was for TRIUMEQ (dolutegravir sodium / abacavir sulfate / lamivudine). No CSP has been issued for the 453 Patent, New Drug Submission No. 169297, TRIUMEQ, or the combination of dolutegravir sodium / abacavir sulfate / lamivudine. By listing the 988 Patent and CSP 900051 on the Patent Register in respect of TRIUMEQ (dolutegravir sodium / abacavir sulfate / lamivudine), the Plaintiffs are improperly attempting to do indirectly what they would otherwise not be allowed to do directly.

163. As a result of the above, CSP 900051 should be removed from the Register of Certificates of Supplementary Protection and Applications.

164. JAMP is an interested person within the meaning of subsections 60(1) and 125(1) of the Patent Act and section 8.1 of the PMNOC Regulations because the Plaintiffs have commenced this action against JAMP asserting that JAMP’s activities in respect of the JAMP Product infringe the 988 Asserted Claims and CSP 900051.

[11] A review of these proposed amendments by way of addition of a counterclaim shows that they relate to non-infringement and invalidity of the 988 Patent, invalidity of CSP 900051, and the relationship of CSP 900051 to another drug, DOVATO.

[12] The trial in this proceeding is set to commence on November 24, 2025.

II. The Issues

[13] This motion by JAMP is for leave to amend its Statement of Defence to add a Counterclaim that seeks declaratory relief against both the 988 Patent and CSP 900051. The motion to amend raises two issues:

1. Is the proposed amendment or any part thereof barred by the Regulations?

2. If the proposed amendment, in whole or in part, is not barred by the Regulations should those proposed amendments be permitted pursuant to the Federal Courts Rules SOR/98-106 (the “Rules”)?

III. Application of Law

A. Is the proposed amendment or any part thereof barred by the Regulations?

[14] This Court has previously addressed the issue whether the scheme of the Regulations restricts the allegations of invalidity that may be raised in a defence to an action for infringement under section 6(1) of the Regulations to those that have a detailed statement of fact and law in the generic’s NOA. The answer to this question is “no”,

…rather, the amendments must be considered under the principles relating to pleadings amendments and with respect to their impact in the present proceedings.

Sunovion Pharmaceuticals Inc. v Taro Pharmaceuticals Inc., 2021 FC 37 at para. 11

[15] The rationale applied in Sunovion, supra that pleadings amendments to a statement of defence be governed by the principles relating to pleadings amendments applies equally to a statement of defence and counterclaim.

[16] The Regulations, in section 6(3) explicitly permit a Defendant in a proceeding brought pursuant to the Regulations (the Second Person) to bring a counterclaim and do not limit the grounds to those set out in a notice of allegation:

6 (3) The second person may bring a counterclaim for a declaration (a) under subsection 60(1) or (2) of the Patent Act in respect of any patent claim asserted in the action brought under subsection (1); or (b) under 125(1) or (2) of that Act in respect of any claim, asserted in the action brought under subsection (1), in the patent set out in the certificate of supplementary protection in question in that action.

[17] For the purposes of this motion the relevant claims that have been asserted in the action are claims 1 to 10 of the 988 Patent. Hence it is clear that the Defendant is entitled, subject to the principles relating to pleadings amendments, to bring a counterclaim in respect of these claims of the 988 Patent. Such a counterclaim is permitted, not prohibited, pursuant to the Regulations.

[18] It is not disputed in this proceeding that the 988 Patent is set out in CSP 900051. Indeed, the following existing allegations in the pleadings make clear the relationship between CSP 900051 and the 988 Patent. Those allegations include:

1. A request for an injunction “until after the expiry of the 282 Patent, the 453 Patent, and the 988 Patent and any applicable Certificates of Supplementary Protection setting out any of those patents … for TRIUMEQ”;

2. “JAMP’s allegations in this Statement of Defence with respect to the 988 Patent also apply to CSP 900051”;

3. “Any finding that the 988 Patent (or a claim thereof) is not eligible for listing on the Patent Register, is not infringed or is invalid will result in a finding that CSP 900051 (or a claim thereof) is not eligible for listing on the Patent Register, is not infringed or is invalid, respectively”; and

4. “The Plaintiffs maintain that CSP 900051 is valid, for the same reasons that the 988 Patent is valid”.

[19] These allegations and the state of the pleadings prior to this motion establish that the claims of the 988 Patent and CSP 900051 are both in question in this action.

[20] The proposed amendments by way of counterclaim also fall within the description of allegations in respect of claims in the 988 Patent asserted in the action brought under subsection 6(1) of the Regulations which patent is set out in CSP 900051 and has been brought into question in the action. The conclusion to be drawn is that the proposed amendments by way of counterclaim are not barred by the Regulations.

B. If the proposed amendment, in whole or in part, is not barred by the Regulations should those proposed amendments be permitted pursuant to the Rules

[21] While the allegations in the proposed amendments are not prohibited by the Regulations, the question still remains whether this Court should exercise its discretion and permit the amendments at this stage of the proceedings. Are the proposed amendments consonant with the principles relating to pleadings amendments?

[22] The guiding principle for a motion to amend pleadings pursuant to Rule 75 is:

The general rule on amendment of pleadings is that “an amendment should be allowed at any stage of an action for the purpose of determining the real questions in controversy between the parties, provided, notably, that the allowance would not result in an injustice to the other party not capable of being compensated by an award of costs and that it would serve the interests of justice.

Sunovion Pharmaceuticals Inc. v Taro Pharmaceuticals Inc., 2021 FC 37 at para. 32

[23] The application of this standard can be achieved applying the test:

1. Does the proposed amended pleading have a reasonable prospect of success, i.e. it is not plain and obvious that the proposed amendment would be struck if pleaded? If the answer is no, the pleading should not be allowed;

2. If the answer to the above question is yes, the Court should consider factors consonant with the interests of justice including: (1) the timeliness of the motion to amend; (2) the extent to which the proposed amendments would delay the expeditious trial of the matter; (3) the extent to which a position has led another party to follow a course of action in the litigation which it would be difficult or impossible to alter; (4) whether the amendments sought will facilitate the Court’s consideration of the true substance of the dispute on its merits. In considering the factors, consideration in each case will be given to simple fairness, common sense and the interest that the courts have that justice be done.

[24] The Plaintiffs did not seriously argue that any of the proposed amendments would be struck if pleaded and it is not plain and obvious to this Court that the proposed amendment would be struck if pleaded.

[25] In considering whether the proposed amendments should be permitted as being in the interests of justice one of the factors to be considered is the timeliness of the motion to amend. This action was commenced by Statement of Claim dated April 26, 2024, and pleadings closed on June 20, 2024. The notice of motion for this motion was dated September 16, 2024, only 8 days before the affidavits of documents in this proceeding were due to be exchanged.

[26] The Defendant states that the motion has been brought early in the proceeding. However, that this is an action pursuant to the Regulations which is proceeding to get to trial 19 months after commencement provides some context to what is or is not early. No explanation has been provided by the Defendant to explain the almost five-month period from the commencement of the action to the bringing of the motion to amend.

[27] There was no evidence on this motion to suggest that the Defendant had only recently learned of the new allegations proposed in the amendment, particularly the allegations relating to DOVATO as an independent ground for challenging CSP 900051. The absence of such evidence has given rise to the argument advanced by ViiV that the timing of the new proposed counterclaim is tactical and is prejudicial to the Plaintiffs as it will “result in a merry-go-round of pleadings amendments when the parties should be focussed on discoveries”.

[28] The trial of this matter is scheduled to begin on November 24, 2025. JAMP argues that the scheduled trial in this proceeding will not be in jeopardy but provides no evidence to support such statements. There is no evidence of a proposed schedule to accommodate additional time for the subsequent pleadings such as a defence to counterclaim or a reply to the defence to counterclaim, followed by additional documentary and oral discovery that may be required of or by ViiV. JAMP does however state it “does not expect any additional documentary productions or oral discovery to be required as a result of the Proposed Amendments”. This could be expected to be true in respect of amendments that add as a counterclaim allegations found in the Statement of Defence with respect to whether CSP 900051 is invalid, for the same reasons the 988 Patent is valid. However, there is no basis provided on this motion to reach the same conclusion with respect to the allegations proposed in the counterclaim relating to the medication DOVATO as a basis for the invalidity of CSP 900051.

[29] The trigger for this action is the medication, TRIUMEQ, and the patents listed in the Patent Register in respect of that medication, specifically the 282 Patent, the 453 Patent, and the 988 Patent. The pleadings to date make clear that the true substance of the dispute between the parties in this dispute is whether the 282 Patent, the 453 Patent, and the 988 Patent are valid and would be infringed by the JAMP Product as defined in the pleadings. The dispute extends to CSP 900051 only insofar as JAMP’s allegations in the Statement of Defence with respect to the 988 Patent also apply to CSP 900051 or whether CSP 900051 is valid, for the same reasons that the 988 Patent is valid. Nothing in the existing pleadings refers to the medication DOVATO. It has not been established on the motion the true substance of the dispute on its merits in this proceeding relates to the relationship between the medication DOVATO and CSP 900051.

[30] It is not sufficient on this motion to amend a pleading merely to rely on the proposed amended pleading unless it is apparent on the face of the proposed pleading that it is in the interest of justice that the pleading be permitted. In this case, the proposed addition by counterclaim of grounds already asserted in the existing pleadings and thus the true substance of the dispute on its merits fall into this category. Accordingly, the proposed amendments to add paragraphs 156-160, 163 and 164 are permitted.

[31] The proposed amendments to add paragraphs 161 and 162 are not allegations found in the existing pleadings. The burden of proof on a motion to amend lies with the moving party and here the moving party has not put forth evidence of the impact of these proposed amendments on the expeditious trial of this matter or the impact of this late addition of issues related to the medication DOVATO. JAMP has provided no explanation as to the timing of this motion and why the issues proposed in paragraphs 161 and 162 were not or could not have been raised earlier. This leads the Court to the inference that the timing of addition of these allegations is strategic rather than fairness to opposing parties. In this case consideration of “simple fairness, common sense and the interest that the courts have that justice be done” leads to the conclusion that proposed paragraphs 161 and 162 should not be permitted.

IV. Costs

[32] Success on this contested motion is divided. After consideration of the submissions of the parties and the outcome of the motion I conclude costs shall be in the cause calculated on the upper end of column 3 of Tariff B to the Federal Courts Rules.

ORDER

THIS COURT ORDERS that:

1. JAMP is granted leave to serve and file within 10 days of the date of this Order an Amended Statement of Defence and Counterclaim adding paragraphs 156-160, 163 and 164 as found in Schedule “A” to the notice of motion.

2. The motion for leave to serve and file an Amended Statement of Defence and Counterclaim adding paragraphs 161 and 162 as found in Schedule “A” to the notice of motion is dismissed.

3. Costs shall be in the cause calculated on the upper end of column 3 of Tariff B to the Federal Courts Rules.

"Michael D. Crinson"

Associate Judge

FEDERAL COURT

SOLICITORS OF RECORD

Docket:

T-938-24

STYLE OF CAUSE:

VIIV HEALTHCARE COMPANY, SHIONOGI & CO., LTD. AND VIIV HEALTHCARE ULC v JAMP PHARMA CORPORATION

PLACE OF HEARING:

Toronto, Ontario

DATE OF HEARING:

October 1, 2024

ORDER AND reasons:

CRINSON A.J.

DATED:

February 27, 2025

APPEARANCES:

Nicole Mantini

Tosh Weyman

Amanda Wolczanski

For The Plaintiffs

Raenaud Tiwari

Nathaniel Dillonsmith

For The Defendant

SOLICITORS OF RECORD:

Torys LLP

Toronto, ON

For The Plaintiffs

SPRIGINGS IP

Barristers & Solicitors

For The Defendant

Toronto, ON