Pharma in Brief – Federal Court dismisses application for a prohibition order regarding prasugrel hydrochloride under the old PM(NOC) Regulations

By Corey McClary, David Yi and Allyson Whyte Nowak on August 13, 2018 Posted in Uncategorized

The Federal Court dismissed an application by Eli Lilly Canada Inc., Ube Industries, Ltd., and Daiichi Sankyo Company, Limited (the Applicants) seeking a prohibition order regarding Apotex’s generic version of Lilly’s EFFIENT^® (prasugrel hydrochloride). While the Court rejected Apotex’s allegations of overbreadth, insufficiency, and non-patentable subject matter, it held that the claims were obvious.

Background

The claims of Canadian Patent No. 2,432,644 (the 644 Patent) relate to pharmaceutical compositions comprising prasugrel and aspirin. Prasugrel is a member of the thienopyridine family of compounds. The asserted claims of the patent claimed the use of prasugrel for simultaneous or sequential, separate administration with aspirin and the compound prasugrel for use in combination with aspirin, in preventing or treating a disease caused by thrombus or embolus.

Obviousness

In its obviousness analysis, the Court accepted the Applicants’ construction of the inventive concept: the combination of prasugrel plus aspirin with an antithrombotic effect that is greater than the sum of the effects of each agent alone. The Court also found that this inventive concept had not previously been disclosed and therefore differed from the state of the art.

However, in applying the “obvious-to-try” test, the Court held that the claims were obvious finding that there was a motivation in the art to try the combination of prasugrel with aspirin and that there was a “reasonable expectation” that combining prasugrel, a thienopyridine, simultaneously or sequentially with aspirin would produce a beneficial, complementary mechanism of action.

The Court acknowledged that:

The test for obviousness is a difficult test to meet and had not been changed by the recent Federal Court of Appeal decisions in Ciba Specialty Chemicals Water Treatments Ltd. v. SNF Inc., 2017 FCA 225, and Bristol-Myers Squibb Canada Co. v. Teva Canada Limited, 2017 FCA 76;
The specific combined use of prasugrel and aspirin, as claimed in the 644 Patent, could not be predicted with exact certainty;
There was a lack of knowledge of metabolic pathways of thienopyridines as well as of the potential mechanisms of synergy; and
The prior art did not consistently show that the use of ticlopidine with aspirin produced synergistic effects.

Central to the Court’s analysis was evidence that the prior art had shown that the substitution of one thienopyridine (ticlopidine) for another (clopidogrel) to use in combination with aspirin had been positive.

Despite finding that one of only two thienopyridines approved for sale did not consistently demonstrate synergy with aspirin and that there was no information in the state of the art regarding the mechanism by which clopidogrel and aspirin had developed a synergy, the Court nevertheless concluded that there was a reasonable expectation that the combined use of prasugrel and aspirin could reasonably be expected to achieve a synergy similar to the combination of clopidogrel with aspirin.

This analysis minimizes the well-known unpredictability of structural changes on biological effect. In combination with the “obvious to try” test, this may create a low bar to obviousness that disproportionately impacts pharmaceutical inventions.

Patentable Subject Matter

The Court held that the patent disclosed that the use of prasugrel combined with aspirin results in an effect on platelet aggregation that is new, useful, and more than the mere sum of the effects of the two agents taken alone. The Court accepted as sufficient, data showing that the combination produced a numerically greater inhibition rate than prasugrel or aspirin alone and did not require a more formal statistical analysis.

Insufficiency & overbreadth

The Court rejected Apotex’s argument that the patent failed to disclose how to administer prasugrel and aspirin sequentially. Although time intervals were not specified in the patent, the experts were able to determine an appropriate interval using the patent and common general knowledge. The Court similarly rejected the argument that claim 29 of the 644 Patent was overly broad for failing to include a maximum time interval.

Link to Decision:

Eli Lilly Canada Inc., Ube Industries, Ltd. and Daiichi Sankyo Company, Limited v. Apotex Inc., 2018 FC 736

Health Canada Releases Updated Guidance on Amended PM(NOC) Regulations

By Morgan Westgate, Tracey Stott and Kristin Wall on August 13, 2018 Posted in Life sciences and healthcare

As we reported, Canada implemented sweeping amendments to the Patented Medicines (Notice of Compliance) Regulations on September 21, 2017. Health Canada has now issued an updated guidance document on the administration of the Regulations in light of these amendments. The update also reflects administrative practices. The guidance document is effective as of May 11, 2018 and is applicable to all drugs that receive a notice of compliance (NOC).

The guidance document elaborates on a number of elements of the new regime, including:

The scope and application of section 5 of Regulations, including providing clarification for the types of submissions that will be captured by the provision when a second person applies for an NOC.
Information on the TPD’s process for assessing submissions (including supplements) under the new regime. This includes details on the process for submitting Form Vs and addressing additions to the Patent Register, as well as certification letter issuance and service.
Situations in which a second person must retract a notice of allegation, including screening rejections, notices of non-compliance-withdrawal, and notices of deficiencies-withdrawal.
How parties are to disclose litigation information to the TPD given that the Minister of Health is no longer a party to actions commenced under the amended Regulations. Health Canada has emphasized the importance of complying with this procedure in order to avoid the issuance of an NOC while a proceeding under the Regulations is still ongoing.
The TPD’s process for assessing CSPs under the Regulations, and in particular the manner and circumstances in which CSPs will be added to the Patent Register.
The process for placing submissions on Intellectual Property Hold.
The process for requesting that the TPD verify portions of a submission or supplement under the Regulations
The process for a first person to renounce the twenty-four month stay .
The TPD’s procedure for maintaining the Patent Register, including the removal of patents and CSPs that are found to be ineligible for listing. Notably, the guidance document states that patents and CSPs declared invalid or void will be deleted after an initial finding and will be added back to the Patent Register if the decision is subsequently reversed. Second persons who file submissions while the patent or CSP is not on the Patent Register will not need to address that patent or CSP.

Link to Guidance Document:

Guidance Document: Patented Medicines (Notice of Compliance) Regulations

Advisory Council on the Implementation of National Pharmacare – Consultation with Canadians

By Ian Trimble, Sara Zborovski and Kristin Wall on July 31, 2018 Posted in Pharmaceuticals and life sciences

Advisory Council on the Implementation of National Pharmacare – Consultation with Canadians

The Advisory Council on the Implementation of National Pharmacare (“Council”) is consulting with Canadians on the implementation of a national program to fund prescription drugs. The consultation is open until September 28, 2018.

The Council, which reports to the Minister of Health and the Minister of Finance, was created following an announcement in the 2018-2019 federal budget (reported here).

Canadians can provide their views on national pharmacare through various means, including: (i) an online questionnaire; (ii) by providing written submissions to the Council; and (iii) by engaging in the discussion through an online discussion forum.

To guide the consultation, the Council has published a discussion paper entitled Towards Implementation of National Pharmacare. In the paper, the Council has identified the following key issues for consideration and questions for discussion:

Issue: Who will be covered and under what circumstances
- Who should be covered under national pharmacare?
- How should national pharmacare be delivered?

Issue: Which drugs will get coverage
- Which drugs should be covered as part of a national pharmacare plan?
- How much variability across different drug plans or jurisdictions should there be in the list of drugs covered by national pharmacare?

Issue: Who pays
- Should patients pay a portion of the cost of prescription drugs at the pharmacy (e.g., co-payments or deductibles)?
- Should employers, who currently play a significant role in funding drug coverage for their employees, continue to do so (either through contributions to a private plan or through a public plan)?

Links:

Canadians invited to share their views with the Advisory Council on the Implementation of National Pharmacare

PMPRB update: SCC dismisses appeal regarding constitutional issues concerning the PMPRB in eculizumab case

By Christopher A. Guerreiro, Chelsea Nimmo and Kristin Wall on July 31, 2018 Posted in Pharmaceuticals and life sciences

The Supreme Court of Canada has denied leave to appeal on a question regarding the constitutionality of the Patented Medicine Prices Review Board (PMPRB) raised in Alexion’s ongoing dispute with the Board regarding prices of SOLIRIS (eculizumab). In addition, we report on a number of updates in Alexion’s challenge of the Board’s excessive-pricing order in respect of SOLIRIS.

Background

Alexion has marketed SOLIRIS in Canada since June 2009. SOLIRIS is indicated for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uremic syndrome (aHUS). The Board described SOLIRIS as a “breakthrough drug”, with no other medicines in the same therapeutic class. The PMPRB first advised Alexion that it was investigating the price of SOLIRIS in June 2010 and several related legal proceedings have been commenced since that time, including those discussed below.

Constitutionality proceedings (Court Files No. T-1537-15, A-51-17, and 37949 (SCC))

Context. As we reported, Alexion challenged the constitutionality of sections 80 through 86 of the Patent Act, as well as the words “in any proceeding under section 83” in subsection 87(1) (the Impugned Provisions) on the basis that they are ultra vires the federal powers granted to Parliament. Alexion also sought an order prohibiting the PMPRB from continuing the proceeding against it. Subsequently:

Canada moved successfully before Aalto P. to strike the constitutionality judicial review on the basis that the issue had been decided, including by the Federal Court of Appeal (FCA) in Attorney General (Canada) v. Sandoz Canada Inc., 2015 FCA 249 (Sandoz).
On appeal to the Federal Court, Simpson J. agreed that the Court was bound as a matter of stare decisis by the Sandoz case
As we reported, on further appeal in the SOLIRIS case, the FCA held that Alexion was not entitled to bring the underlying application as it had not first raised the constitutionality issue before the PMPRB and, in any event, agreed with the lower courts that the constitutionality issue had already been decided. The FCA therefore dismissed the appeal.

Leave application dismissed. On June 28, 2018, the SCC dismissed Alexion’s application for leave to appeal from the FCA’s decision. As is customary, the SCC did not provide reasons.

Excessive price proceedings (Court Files No. T-1596-17 and T-1855-15)

Context. As we reported, the PMPRB issued an excessive-pricing order against Alexion in respect of SOLIRIS based on the application of a Lowest International Price Comparison (LIPC) test. In public reasons issued September 27, 2017, the PMPRB ordered Alexion to: (i) repay excess revenues to the Crown from the date of introduction through the date of the decision; and (ii) lower its prices to match the lowest international price going forward. As we also reported, Alexion commenced an application for judicial review of the PMPRB’s decision on the merits in late 2017.

Updates in the file. Since we last reported, there have been a number of developments in Alexion’s judicial review application concerning the Board’s decision on the merits:

Intervention by the Minister of Health for British Columbia. On March 19, 2018, the Minister of Health for British Columbia moved to be added as a respondent to the application. This motion was initially contested. The parties subsequently submitted a consent Order that resulted in the Minister being added as an intervener with the right to make limited written submissions and oral submissions at the discretion of the application judge.
On April 23, 2018, the matter was consolidated with Alexion’s earlier application for judicial review in Court File No. T-1855-15, by which it seeks to quash the PMPRB’s decision dismissing Alexion’s motion to quash the Notice of Hearing and Statement of Allegations in the proceeding and disqualify Ms. Isabel Raasch from having future involvement in the proceeding. That application was previously stayed pending disposition of the PMPRB’s decision on the merits of the excessive pricing hearing giving rise to the main application.
Motion to stay PMPRB’s Order. On July 6, 2018, the Court vacated the hearing of Alexion’s motion to stay the effect of the PMPRB’s Price-Reduction Order and granted a stay in part, pending disposition of the application and subject to a number of conditions. This motion was initially contested; subsequently, an Order issued on consent.
Hearing date. The hearing of the application on the merits was originally scheduled for September 17-18, 2018. On July 6, 2018, Alexion wrote to the Court seeking to adjourn the hearing to November 8–9, 14–15, or 15–16, subject to the Court’s availability.

Links

Constitutionality proceedings:
- Supreme Court of Canada: Alexion Pharmaceuticals Inc. v Canada (Attorney General), SCC Case No. 37949
- Federal Court of Appeal:Alexion Pharmaceuticals Inc. v Canada (Attorney General), 2017 FCA 241
- Federal Court (Appeal Judge):Alexion Pharmaceuticals Inc. v Canada (Attorney General), 2017 FC 22
- Federal Court (Prothonotary):Alexion Pharmaceuticals Inc. v Canada (Attorney General), 2016 FC 716
- SandozFederal Court of Appeal: Canada (Attorney General) v Sandoz Canada Inc., 2015 FCA 249
Excessive pricing proceedings: The PMPRB’s decision on the merits can be found here.

First motion for early patent dismissal fails to meet high burden under newly-amended PM(NOC) Regulations

By Chelsea Nimmo, Paul Jorgensen, Kristin Wall and Jordana Sanft on July 30, 2018 Posted in Intellectual property, Pharmaceuticals and life sciences

On July 6, 2018, the Federal Court dismissed the first motion brought under section 6.08 of the newly-amended Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court’s public reasons were released July 30, 2018. The moving party, Amgen Canada Inc. (Amgen), was seeking an order dismissing the Plaintiffs’ action in respect of two of the patents in suit on the ground that the action is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process. Amgen contended that it was plain and obvious that the Plaintiffs’ infringement allegations had no chance of success.

Norton Rose Fulbright Canada LLP represented the Plaintiffs, Genentech, Inc. and Hoffmann-La Roche Limited.

Background

Amgen is seeking Health Canada’s approval to market a biosimilar version of HERCEPTIN^®for the same indications as HERCEPTIN^®. The Plaintiffs commenced an action against Amgen seeking a declaration that the making, constructing, using or selling of Amgen’s biosimilar would infringe four patents. Amgen brought a motion to dismiss the action in respect of two of the patents, Canadian Patents No. 2,376,596 (596 Patent) and 2,407,556 (556 Patent). Amgen argued that the Plaintiffs’ allegations that Amgen would induce infringement of the 596 Patent and the 556 Patent were clearly futile.

Motion to dismiss under section 6.08

This was the first motion to dismiss brought under section 6.08 of the newly-amended Regulations. The Court found, however, that the jurisprudence under section 6(5)(b) of the previous Regulations – which had essentially the same language as section 6.08 – was applicable.

Therefore, as set out in the section 6(5)(b) case law, dismissing an action under section 6.08 remains an extraordinary remedy. The moving party bears the onus of demonstrating that the claim is so clearly futile that it has not the slightest chance of success. The Court is to determine whether the plaintiff raises an arguable case. In doing so, the Court is not to embark on anything resembling a trial of the action in order to evaluate the strength of either party’s case.

The Court found that it should exercise a heightened level of caution in dismissing actions under the newly-amended Regulations, as – unlike the previous Regulations – if the action is dismissed, the plaintiff may be precluded from suing for patent infringement if the proposed product comes to market.

The Court also observed that, because the newly-amended Regulations provide for discovery, in cases that – like this one – concern induced infringement of use claims, there may be many key documents in addition to the proposed product monograph.

An arguable case of induced infringement

The Court found that it was not plain and obvious that the Plaintiffs’ allegations of induced infringement had no chance of success. With respect to the 596 Patent, the Court found that the parties had engaged in legal and factual disputes during the motion. The Court determined that it was at least arguable that Amgen would exert the requisite influence leading to direct infringement of the 596 Patent by physicians and patients. With respect to the 556 Patent, the Court determined that there was a debatable issue regarding claims construction and that the Plaintiffs had otherwise raised an arguable case of induced infringement.

Links

Genentech, Inc. and Hoffmann-La Roche Limited v Amgen Canada Inc., 2018 FC 694

Federal Court Judicial Review Application initiated by a Generic in connection with Patent Hold Letters

By Allyson Whyte Nowak and Kristin Wall on July 19, 2018 Posted in Pharmaceuticals and life sciences

On July 3, 2018 generic manufacturer, Pro Doc Ltée (Pro Doc), commenced a judicial review application (the Application) in connection with the Minister of Health’s decision to release patent hold letters and Drug Identification Number (DIN) assignment dates in response to a request made under the Access to Information Act.

The Application has significant implications for the innovative industry not only because of the relevance of patent hold letters to section 8 damages actions, but because of the breadth of the relief sought by Pro Doc. That relief includes an order restraining the Minister from disclosing the records and Pro Doc’s confidential information, as well as “an order directing the Minister to issue a policy relating to the disclosure of confidential information from drug submissions filed with Health Canada”.

The Application relates to a request from an unidentified person or entity under the Access to Information Act. The request was for records reflecting the date on which Health Canada (a) assigned DINs to certain (but undisclosed) Pro Doc products; and (b) certified that the examination of the Pro Doc products was complete. Pro Doc alleges that the Minister initially refused the request only to initiate a new consultation process and which resulted in the Minister’s decision to release the information sought. Pro Doc alleges that the records at issue contain confidential information supplied to Health Canada and are valuable commercial, scientific or technical information.

Patent hold letters (also called “certification letters”) are provided by Health Canada to advise a generic manufacturer of the date when Health Canada completed its review and approval of that manufacturer’s abbreviated new drug submission such that a Notice of Compliance would have issued but for the Patented Medicines (Notice of Compliance) Regulations) (the Regulations).

These letters play a central role in damages actions commenced by generic manufacturers under section 8 of the Regulations.

Subsection 8(2) of the Regulations provides that the presumptive start date for an innovators’ liability is the later of the date that the generic served a notice of allegation addressing relevant patents, and the day, as certified by the Minister, on which a notice of compliance would have been issued in the absence of the Regulations. In a typical section 8 damages action, the Court will need to understand the patent hold dates of not only the section 8 claimant, but other generic manufacturers who would have competed in the hypothetical generic market. Despite being expressly referenced in the Regulations, innovators have been forced to obtain these administrative documents through Access to Information requests and non-party production motions.

Pro Doc alleges that the information contained in the records is not public and reveals information originating from Pro Doc. According to Pro Doc, the company would be harmed if this information were to be disclosed.

Pro Doc will have to overcome clear judicial authority which has held that the Access to Information Act is not intended to exempt from disclosure knowledge of how the regulatory process works, including information about timelines related to specific drug submissions, which is exactly the kind of information sought from a patent hold letter. Pro Doc’s allegations regarding the confidentiality of patent hold letters is also inconsistent with the treatment of patent hold dates by generic manufacturers and courts alike. Section 8 claimants routinely plead their patent hold dates in their statement of claims and to-date, no Court has redacted a patent hold date in any section 8 decision.

The Minister of Health has filed a Notice of Appearance. It is unclear whether the person or entity seeking the release of Pro Doc’s patent hold letters will be added as a party to the application or whether any industry associations will seek leave to intervene.

Links:

Notice of Application

Getting the Deal Through – Pharmaceutical Antitrust

By Kevin Ackhurst on July 19, 2018 Posted in Pharmaceuticals and life sciences

Norton Rose Fulbright has published a new edition of Getting the Deal Through – Pharmaceutical Antitrust. This edition is an updated, thorough overview of the application of antitrust law to the pharmaceutical sector worldwide. The pharmaceutical sector remains a priority area for antitrust enforcement in most major jurisdictions, where enforcement agencies have been increasingly prone to use antitrust rules to protect innovation and control drug prices along the value chain.

You may access a copy here.

Federal Court upholds patent validity and grants prohibition order against generic lisdexamfetamine in pre-CETA PM(NOC) application

By Jonathan Chong, Brian R. Daley and Jordana Sanft on July 16, 2018 Posted in Uncategorized

The Federal Court dismissed Apotex’s action to invalidate the claims of Canadian Patent No. 2,527,646 (the 646 Patent), which was consolidated with Shire’s application to prohibit the Minister of Health from issuing a Notice of Compliance for Apotex’s generic version of VYVANSE^® (lisdexamfetamine). Shire’s counterclaim for infringement in the action was dismissed but the Court granted the prohibition order against the Minister.

Patent found to be valid

Amphetamines are used to treat attention deficit and hyperactivity disorder (ADHD), but are controlled substances because they can be abused for their euphoric effect. Abuse typically occurs when tablets are crushed into a powder that is snorted or dissolved and injected. Sustained-release formulations improve convenience for patients but are more susceptible to abuse because they contained greater amounts of amphetamines.

Invention of the 646 Patent

The 646 Patent claimed prodrugs of amphetamines and derivatives or analogs formed by covalent attachments of chemical moieties to the amphetamine. These prodrugs are converted in the body to the active amphetamine over time, providing sustained release of amphetamine while reducing abuse potential. The asserted claims of the 646 Patent covered lisdexamfetamine (LDX), consisting of d-amphetamine conjugated to the amino acid L-lysine. The claims at issue also cover certain salts of LDX, pharmaceutical compositions containing LDX, and use of LDX to treat ADHD.

Not a selection patent

Shire argued that LDX is selected from the class of amphetamine amino acid conjugates encompassed by Australian Patent No. 54168/65 (the AU 168 Patent). Apotex disagreed. Justice Fothergill doubted that the 646 Patent may be properly characterized as a selection patent. However, he found that nothing turned on this point because the outcome of his anticipation and obviousness analyses were not affected by it. In coming to his conclusion, he distinguished and rejected Apotex’s reliance on Hoffmann-La Roche Ltd. v Apotex Inc., 2013 FC 718, noting that there may be reason to approach this decision with caution.

Not anticipated

The Court held that the 646 Patent was not anticipated. Justice Fothergill found that the expert evidence raised many unanswered questions regarding the prior art, which did not clearly relate to prodrugs, did not disclose the process of making LDX, and did not teach that the compounds it disclosed provide a sustained release treatment for ADHD with, or even without, a reduced potential for abuse.

Not obvious

The Court held that the inventive concept for all the claims of the 646 Patent was a sustained-release formulation of a therapeutically useful dose of amphetamine that is resistant to abuse. Justice Fothergill found that the difference between the state of the art and the inventive concept was the compound LDX and its advantageous properties. He also found that the prior art did not indicate or suggest that LDX would provide sustained release of amphetamine with reduced abuse potential, and that the prior art did not suggest prodrugs would render a drug less susceptible to abuse.

The Court held that LDX was not obvious to try. There was no way to know the properties of LDX without testing, even if the testing was routine, and it was not more or less self-evident that the contemplated tests would overcome the differences between the starting point and the ending point

Not overbroad

Justice Fothergill found that the claims were not overbroad, as he construed the term “L-lysine-d-amphetamine” as only LDX and a group of compounds.

Specification is not insufficient

Justice Fothergill held that the specification of the 646 Patent is not insufficient because LDX’s advantageous properties exist regardless of whether it is in a particular salt form, or as a free base. He also held that the invention of the 646 Patent does not relate to scale-up synthesis or to a particular crystal form, and that the skilled person was capable of making the claimed compounds by following the 646 Patent.

No reliance on foreign decisions

In reaching the foregoing conclusions, Fothergill J. rejected Shire’s position that the Court should regard foreign judgments involving comparable patents, which consistently affirmed the validity of the patents, as being instructive.

No infringement because of experimental or regulatory use exception

The Court found that Apotex obtained LDX for experimental or regulatory use, and that it was a sufficient defence for Apotex to have an internal policy that the approximately 900,000 capsules containing LDX dimesylate in its inventory would be used entirely for future research or making demonstration batches. As a result, the Court dismissed Shire’s infringement action.

Minister prohibited from granting Notice of Compliance

Having decided that the patent was valid, Justice Fothergill also granted a prohibition order against Apotex’s Apo-lisdexafetamine product as the proceeding under the Regulations was confined to the validity issues in the case.

Links:

Apotex Inc v Shire LLC, 2018 FC 637

Pan-Canadian Pharmaceutical Alliance (pCPA) releases draft brand process guidelines

By Jillian Hyslop, Sara Zborovski and Kristin Wall on June 20, 2018 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On June 13, 2018, the pan-Canadian Pharmaceutical Alliance (pCPA) released its draft Brand Process Guidelines (Guidelines) for stakeholder feedback. As part of the consultation process, pCPA is planning a webinar for innovative manufacturers on June 22, 2018. The pCPA also released a Frequently Asked Questions (FAQ) document, and a Letter of Intent (LOI) template with the Brand Process Guidelines.

Brand Process Guidelines. The Guidelines are intended to promote a common understanding of the pCPA process, and provide an overview of the pCPA process broken down into the following phases: pre-pCPA, initiation, consideration, negotiation, completion, and post-pCPA. The Guidelines provide details on: (i) initiation of the pCPA process for new drugs, existing drugs and line extensions, (ii) the content expectations for manufacturer proposals, (iii) negotiation format and negotiator expectations, as well as (iv) communication, confidentiality and disclosure requirements during negotiation. The Guidelines also include target completion timelines for the pCPA process, which sets out an estimated timeline of ≤ 140 days from initiation to completion.

Frequently Asked Questions (FAQ). The FAQ document provides an overview of some commonly asked questions such as: (i) factors that can impact negotiation timelines, (ii) whether a manufacturer can negotiate with individual jurisdictions after receiving a Close Letter (a letter indicating that the pCPA is not opening negotiation for a particular drug) from the pCPA, and (iii) whether a decision to close negotiations without an LOI can be reconsidered.

Letter of Intent (LOI) Template. The LOI template is a standard form document that will detail the agreed upon terms and conditions for funding reached between the lead province(s) and the manufacturer. Of note for manufacturers, the template sets out sample provisions for first dollar and incremental rebates. The template also states that participating jurisdictions may renegotiate the terms of the agreement through the pCPA where there are significant market changes or if expenditures for the drug product significantly exceed the participating jurisdictions’ budget impact. Finally, the template includes standard provisions for continued enrolment of patients in a manufacturer’s patient support program (PSP) for a specified period of time after listing or indefinitely where the patient does not meet the reimbursement criteria in the jurisdiction.

Interested stakeholders should consider attending the pCPA’s webinar for innovative manufacturers on June 22, 2018 as well as submitting additional comments on the Guidelines to the pCPA.

Links:

Brand Process Guidelines, FAQ Document, LOI Template

CETA Tracker: Update on section 6 actions under the Patented Medicines (Notice of Compliance) Regulations

By Christopher A. Guerreiro, Kristin Wall, Jordana Sanft and Judith Robinson on April 30, 2018 Posted in Intellectual property, Pharmaceuticals and life sciences

As we reported, Canada implemented a single-track pharmaceutical patent litigation regime through amendments to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) on September 21, 2017. Below, we provide an update on new actions and decisions under the amended Regulations.

New actions under the amended Regulations

Nearly seven months after the amended Regulations came into force, litigation is gathering steam. As we reported, the first action under the new regime was commenced by Norton Rose Fulbright Canada LLP on behalf of Genentech, Inc. and Hoffmann-La Roche Limited (collectively, Genentech) in respect of trastuzumab biosimilars on December 11, 2017. This was followed by three more trastuzumab-related actions in late December 2017.

Since the beginning of 2018, ten more actions have been commenced, for a total of fourteen actions currently ongoing:

Genentech, Inc. et al. v Amgen Canada Inc., Court File No. T-1921-17 (trastuzumab)
Genentech, Inc. et al. v Celltrion Healthcare Co., Ltd., Court Files No. T-1969-17, T-1970-17, and T-1971-17 (trastuzumab)
Bristol-Myers Squibb Canada Co. et al. v Apotex Inc., Court Files No. T-350-18 and T-351-18 (apixaban)
Janssen Inc. et al. v Teva Canada Limited, Court File No. T-353-18 (paliperidone)
Hoffmann-La Roche Limited et al. v Pfizer Canada Inc., Court Files No. T-401-18 and T-402-18 (trastuzumab)
Allergan et al. v Tillots Pharma AG, Court File No. T-503-18 (mesalamine)
Shire LLC et al. v Apotex Inc., Court File No. T-641-18 (lisdexamfetamine)
Bayer Inc. v. Jamp Pharma Corp., Court File No. T-666-18 (vardenafil)
Eli Lilly et al v Apotex Inc., Court File No. T-724-18 (teriparatide)
Amgen Inc. et al v. Pfizer Canada Inc., T-741-18 (filgrastim)

In order to manage the significantly increased number of deadlines in actions under the amended Regulations compared to applications under the former regime, the Court has applied its “Guidelines for Actions under the Amended PMNOC Regulations”, reported here. This includes early scheduling of the steps leading up to trial using a checklist developed by the Court, early assignment of trial judges, and early booking of trial dates to occur within 21 months of the statement of claim being filed.

Two motions have been decided under the amended Regulations. The court dismissed a motion to vary unilaterally imposed confidentiality rules as premature. The court also dismissed a motion to stay a 6.08 motion until after discovery.

Links