Coulda, Shoulda, but Not Likely Woulda: Federal Court of Appeal affirms finding that generic would not have used a non-infringing alternative

The Federal Court of Appeal has affirmed the Federal Court’s decision awarding an accounting of profits to ADIR and Servier Canada Inc. (Servier), concluding that Apotex Inc. and Apotex Pharmachem Inc. (Apotex) would not have used a non-infringing alternative (NIA).

Background

In 2008, the Federal Court found that Servier’s patent for the drug perindopril was valid and infringed by Apotex. Apotex’s liability was affirmed on appeal. A trial on an accounting of profits ensued and Apotex was ordered to remit the aggregate amount of C$61 million plus interest. In a first appeal by Apotex, the Court of Appeal held in 2017 that the Federal Court had erred in the profits determination by finding that the NIA defence was not available to Apotex as a matter of law. The Court of Appeal sent the matter back to the Federal Court for re-determination.

On redetermination, the Federal Court found in 2018 that while Apotex could have obtained non‑infringing perindopril, Apotex had not established that it was more likely than not that it would have done so. No reduction to Apotex’s profits over the infringing period was granted, as we reported.

On this latest appeal, Apotex sought to overturn the re-determination decision on the bases that (i) the Federal Court committed a palpable and overriding error in finding that it was more likely than not that Apotex would have declined to acquire non-infringing perindopril from foreign suppliers and that (ii) the Federal Court did not apply the correct legal test for a NIA in the hypothetical world.

No errors of law

In disposing of Apotex’s appeal, the Court of Appeal provided an overview of the legal principles and jurisprudence applicable to consideration of NIAs as a defence in the assessment of damages and the accounting of profits.

The Court of Appeal rejected Apotex’s argument that the approach to NIAs in an accounting of profits should be distinguished from that in an assessment of damages. As similar principles apply, the Federal Court did not err in applying the “could” and “would” analysis to an accounting of profits.  What is important is that the four questions identified in Lovastatin be considered and weighed in determining whether an infringer’s profits should be reduced because of the availability of NIAs:

(i) Is the alleged non-infringing alternative a true substitute and thus a real alternative?

(ii) Is the alleged non-infringing alternative a true alternative in the sense of being economically viable?

(iii) At the time of infringement, does the infringer have a sufficient supply of the non-infringing alternative to replace the non-infringing sales? Another way of framing this inquiry is could the infringer have sold the non-infringing alternative?

(iv) Would the infringer actually have sold the non-infringing alternative?

These four questions are not in silos and there may be overlap.  In this context, the economic viability of a NIA may pertain to whether an NIA could have been used (i.e., whether it is a true substitute) and also whether it would have been sold by the defendant.

The Court of Appeal confirmed that a defendant’s subjective preferences and intentions are relevant to the would have component of the test. Evidence demonstrating that a party could have done something is not sufficient. Rather, a party must demonstrate that events would have transpired in such a way as to put them in a position to do something in the hypothetical world. Thus, the Federal Court did not err in taking the evidence of Apotex’s subjective preferences into account.

The Court of Appeal rejected Apotex’s argument that the Federal Court improperly focused on the “brazen” nature of Apotex’s infringement. Nothing in the Court’s reasons suggested that “brazen” infringement is something more than intentional or wilful infringement. Rather, the word is used in its dictionary meaning of “obvious, without any attempt to be hidden”. In this regard, the Federal Court did not err in taking into consideration the brazen nature of Apotex’s conduct.

No errors of fact

The Court of Appeal also rejected Apotex’s argument that the Federal Court had made palpable and overriding errors of fact.  The evidence, including the testimony of Dr. Bernard Sherman, supports the Federal Court’s finding that, in the hypothetical world, Apotex would more than likely have done exactly what it ended up doing in the real world: waited for its foreign affiliates to be ready to supply it with non-infringing perindopril.

As Apotex did not demonstrate an error of law or palpable and overriding error by the Federal Court, the appeal was dismissed.

Norton Rose Fulbright Canada LLP represented Servier at all stages of this litigation, which commenced in 2006.

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New Federal initiatives to combat pandemic: Patent Act amended to allow limited government use of patented inventions for public health emergencies

On March 25, 2020, the Canadian Government passed into law Bill C-13, An Act respecting certain measures in response to COVID-19, following emergency sittings of Parliament and the Senate. Bill C-13 amends both the Patent Act and the Food and Drugs Act and may have implications for the pharmaceutical industry.

Patent Act – Limited government use of patented inventions for public health emergencies (s. 19.4)

A new stand-alone provision has been added to the Patent Act: section 19.4. This section allows the Minister of Health to apply for government authorization to make, construct, use, and sell a patented invention for a public health emergency. Section 19.4 comes into force immediately.

Section 19.4 will have limited use. The Minister of Health can only apply for government authorization under section 19.4 until September 30, 2020. Further, any authorizations will expire either a year after grant or when the Minister of Health deems it no longer necessary, whichever comes earlier.

The Patent Act already included provisions that authorized the government’s use of a patented invention under sections 19–19.3. However, under these pre-existing provisions, the government is first required to negotiate use with the patentee, except in cases of “national emergency or extreme urgency”. This is not required under newly enacted section 19.4. The patentee will, however, be notified of any such authorization.

Under section 19.4, the patentee will be compensated in an “amount that the [Patent] Commissioner considers to be adequate remuneration in the circumstances, taking into account the economic value of the authorization and the extent to which they make, construct, use and sell the patented invention.”

Food and Drugs Act – Additional regulatory powers

Bill C-13 also amends the Food and Drugs Act to allow the Minister of Health to make regulations “for the purpose of preventing shortages of therapeutic products in Canada or alleviating those shortages or their effects, in order to protect human health”. The Minister may also request information not otherwise required by the Food and Drugs Act in respect of these products. Additional regulations have not been posted at this time. These temporary provisions are set to be automatically repealed on October 1, 2020.

Government funding for coronavirus research

The Canadian Government has also pledged $275 million to coronavirus research and medical countermeasures. This funding will go to research projects underway at universities and private entities, and will also be used to ensure a domestic supply of potential vaccines.

Thank you to Colin Hyslop and John Greiss for their help in drafting this article.

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For more information on the legal implications of COVID-19, please consult our COVID-19 Hub. As a full service global firm with offices across Canada, Norton Rose Fulbright is closely monitoring this evolving situation over a number of practice areas including employment and labour, risk advisory, banking and finance, corporate, M&A and securities, and dispute resolution and litigation, and across a variety of industries including energy, infrastructure, mining and commodities, financial institutions, life sciences and healthcare, technology and innovation, and transport.

Ontario and Quebec Introduce Changes to Pharmacy Practice and Highlight the Drug Supply Chain as an Essential Service

Changes Affecting Ontario

The Government of Ontario has made changes to the Ontario Drug Benefit (ODB) Program in an effort to reduce the risk of drug shortages in the province during the COVID-19 outbreak. Effective immediately, ODB eligible drugs are subject to the following changes to rules on dispensing and fees:

  • The dispensing of medication is limited to no more than a 30-days’ supply. Dispensers may use professional judgment to provide a longer supply in exceptional cases, but should not exceed the patient’s usual supply
  • Prescriptions should not be refilled more than 10 days in advance of a patient depleting their current supply. In exceptional cases where there is a clinical reason to refill a prescription early, the dispenser may provide a refill and document the reason.
  • Previously, dispensing fees would only be paid for 100-days’ supply of medication or the total quantity of the prescription. Now, all medicines on the ODB Formulary and accessible through the Exceptional Access Program (EAP) are eligible for a dispensing fee based on a 30-days’ supply even if dispensed quantity is less than prescribed or less than the 100-days supply payable under the ODB program.
  • The list of chronic medications subject to a limit of 5 dispensing fees per 365 days is temporarily removed.

Additionally, pharmacists may be reimbursed for MedsChecks performed virtually, or over the phone. Proper documentation is required and subject to audit and inspection.

Finally,  the EAP is authorising the automatic extension of all EAP approvals that have expired or are expiring between February 1, 2020 to May 31, 2020 by an additional 90 days from the expiry date listed on the original approval letter.

Separately, Ontario has declared the drug supply chain to be an essential service during the outbreak, including “manufacturers, wholesalers, distributors and retailers of pharmaceutical products and medical supplies, including medications, medical isotopes, vaccines and antivirals; medical devices and medical supplies”.

Changes Affecting Quebec

Quebec’s Bill 31 An Act to amend mainly the Pharmacy Act to facilitate access to certain services received Royal Assent on March 17, 2020. The bill specifies that pharmacists may, in certain cases or in accordance with the conditions and procedure determined by regulation:

  1. prescribe and administer vaccines and, in emergency situations, certain other medications;
  2. prescribe all non-prescription medications;
  3. administer a medication by intranasal route;
  4. adjust or renew prescriptions of all prescribers, not only those of physicians;
  5. stop medication therapy according to a prescription or following a consultation conducted at the request of a prescriber;
  6. substitute, for a prescribed medication, another medication even if it does not belong to the same therapeutic subclass; and
  7. prescribe and interpret not only laboratory analyses but also any other test, for the purpose of monitoring medication therapy.

Similar to Ontario, Quebec has also listed the drug supply chain as an essential service, including pharmacies and wholesalers and manufacturers of medication accredited by the Minister of Health and Social Services.

 

For more information on the legal implications of COVID-19, please consult our COVID-19 Hub. As a full service global firm with offices across Canada, Norton Rose Fulbright is closely monitoring this evolving situation over a number of practice areas including employment and labour, risk advisory, banking and finance, corporate, M&A and securities, and dispute resolution and litigation, and across a variety of industries including energy, infrastructure, mining and commodities, financial institutions, life sciences and healthcare, technology and innovation, and transport.

PM(NOC) Statutory Deadlines Still Applicable

As we reported, the Federal Court (FC) has suspended its hearings scheduled between March 16, 2020 and April 17, 2020 (the Suspension Period) sine die. Proceedings brought in accordance with the Patented Medicines (Notice of Compliance) Regulations (Regulations) fall under the FC’s jurisdiction. However, certain deadlines related to these proceedings are set by the Regulations themselves. Such ‘statutory’ deadlines are not subject to the FC’s Suspension Period.

As the FC states in its recent FAQ on its COVID-19 Practice Direction and Order, the deadline for commencing a proceeding pursuant to section 6 of the Regulations continues to apply and cannot be extended or varied. This is because the power to vary or suspend this deadline (and other statutory deadlines) lies with the Government of Canada and not with the Court.

While some provinces, such as Ontario and Québec, have suspended limitation periods and procedural time periods in light of the COVID-19 pandemic, the Government of Canada has yet to do the same. Thus, parties receiving a notice of allegation must still bring an action within 45 days of being served, and must still complete the proceeding within the 24-month stay period.

Although statutory deadlines for PM(NOC) proceedings cannot be varied, many steps following the initiation of a PM(NOC) proceeding are subject to the FC’s Suspension Period (e.g., hearings for interlocutory motions such as refusals motions and related motion materials). The postponement of  interlocutory steps may eventually add additional pressure to the parties and the Court in trying to complete these proceedings within the 24-month stay period.

In light of this, parties (and prospective parties) may wish to prioritize PM(NOC) proceedings and deadlines during the pandemic. Counsel who are effective at working cooperatively with both the opposing side and the Court will best navigate this challenging time. Parties should seek guidance from counsel on their specific matters to formulate a plan for proceeding during the pandemic so as to preserve the rights granted to them by the Regulations.

For more information on the legal implications of COVID-19, please consult our COVID-19 Hub. As a full service global firm with offices across Canada, Norton Rose Fulbright is closely monitoring this evolving situation over a number of practice areas including employment and labour, risk advisory, banking and finance, corporate, M&A and securities, and dispute resolution and litigation, and across a variety of industries including energy, infrastructure, mining and commodities, financial institutions, life sciences and healthcare, technology and innovation, and transport.

COVID-19: Health Canada simplifies regulatory requirements for COVID-19-related products

Health Canada is taking measures to help expedite the importation and sale of certain licensed products required to combat COVID-19.

Expedited review of Health Product Submissions and Applications

Health Canada has announced that it will expedite the review of any COVID-19 related vaccines, therapeutic products and other health product submissions and applications. Until a vaccine or therapeutic product is available on the Canadian market, the Special Access Program will continue to be available for COVID-19 related treatments.

Submissions or applications to Health Canada should be directed to the appropriate bureau using the contact information found on this page.

Diagnostic tests and medical devices

The Minister of Health has signed an Interim Order to expedite market access for COVID-19 related medical devices. The Interim Order simplifies the requirements for approval of a medical device. Class III and IV devices will also have to provide details of the manufacturing materials and its history of sales. The Interim Order allows Health Canada to look to foreign regulatory approvals in deciding whether to approve an application for the importation or sale of COVID-19 related medical devices.

Under the Interim Order, the Minister must issue the authorization for importation or sale if the following requirements are met:

  1. the applicant has submitted an application to the Minister that meets the prescribed requirements in the Interim Order
  2. the applicant has submitted to the Minister all additional information or material, including samples, requested by the Minister;
  3. the Minister has sufficient evidence to support the conclusion that the benefits associated with the COVID-19 medical device outweigh the risks, having regard to the uncertainties relating to the benefits and risks and the urgent public health need; and
  4. the Minister determines that the health or safety of patients, users or other persons will not be unduly affected.

Health Canada has already approved the importation and sale of two commercial COVID-19 diagnostic tests under the Interim Order.

The Interim Order will remain in effect for a minimum of 14 days, at which point it can be extended for up to one year. The full text of the Interim Order, including the application requirements, is available online.

Disinfectants, Hand Sanitizers, Personal Protective Equipment and Swabs

As an interim measure Health Canada is also expediting access to certain supplies, including: 1) disinfectants;  2) hand sanitizers; and 3) Class I personal protective equipment (such as masks and gowns) and swabs for testing.

Disinfectant products are classified as non-prescription drugs. Hand sanitizers are classified as natural health products (NHPs) or non-prescription drugs, depending on the ingredients. Class I personal protective equipment and swabs are regulated as medical devices in Canada. Typically, these products require authorization from Health Canada before they are sold in Canada and importers require a Drug Establishment Licence or Site Licence for NHPs.

Health Canada will facilitate the importation of the following:

  • Products that are already authorized for sale in Canada but are not fully compliant with Health Canada requirements (e.g., English-only labelling).
  • Products that are not authorized for sale in Canada, but are authorized or registered in other jurisdictions with similar regulatory frameworks and quality assurances.

Companies are required to maintain records to facilitate product recalls if needed.

Thank you to Daniel Weiss for his help in drafting this article.

For more information on the legal implications of COVID-19, please consult our COVID-19 Hub. As a full service global firm with offices across Canada, Norton Rose Fulbright is closely monitoring this evolving situation over a number of practice areas including employment and labour, risk advisory, banking and finance, corporate, M&A and securities, and dispute resolution and litigation, and across a variety of industries including energy, infrastructure, mining and commodities, financial institutions, life sciences and healthcare, technology and innovation, and transport.

 

COVID-19: Federal Courts Announce Special Measures

In light of the COVID-19 pandemic, the Federal Courts have issued statements on the temporary procedures they will follow to balance health and safety with the need to remain accessible to Canadians. The Federal Court (FC) and the Federal Court of Appeal (FCA) had earlier issued statements on March 13, 2020, which are superseded by this week’s updates.

Federal Court

On March 17, 2020, the FC announced it has suspended all General Sittings and hearings scheduled between now and April 17, 2020 (the Suspension Period) sine die. On March 20, 2020, the FC issued an update containing an FAQ, as well as a statement that the Court intends to issue an amended Practice Direction and Order in the coming days, to address issues that have been identified.

The Suspension Period is subject to two exceptions: (1) urgent matters and (2) matters that need to proceed as previously scheduled for exceptional reasons, which will be determined by the FC on a case-by-case basis. Any such matters will be heard by teleconference.

For the hearings that have been adjourned, the Parties are required to provide their mutual dates of non-availability between May 1 and May 15, 2020 to reschedule.

Timelines

The running of all timelines under Orders and Directions of the Court made prior to March 18, 2020, as well as under the Federal Courts Rules, subsection 18.1(2) of the Federal Courts Act, and paragraph 72(2)(c) of the Immigration and Refugee Protection Act, is also being suspended for the Suspension Period. If parties are unable to meet other filing deadlines during the Suspension Period, they may request an extension of time in light of the current circumstances.

PM(NOC) Proceedings

Discussions between the bench and bar result in our understanding as follows. Cases under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) will be included in the Suspension Period for the timelines that follow commencement of the proceedings, and are not otherwise mandated by the PM(NOC) Regulations. In other words, while all steps following the commencement of a PM(NOC) action will be pushed back, we understand that these matters will still need to be completed within the 24-month stay, which will add pressure on the parties and the FC. However, specific guidance should be sought on each matter.

Filing

The FC encourages parties to use the E-filing portal or email to submit documents, subject to certain restrictions. Parties filing documents electronically during the Suspension Period will be exempted from the requirement to file paper copies. A modified process for filing paper copies during the Suspension Period is provided.

Federal Court of Appeal

On March 16, 2020, the FCA issued a notice that it is adjourning all hearings scheduled between March 16, 2020 and April 17, 2020, with the exception of urgent matters that will be heard by teleconference.

Until April 13, 2020, the FCA will exceptionally accept electronic filing of court documents by email, subject to certain restrictions. Parties proceeding this way will be exempted from filing paper copies.

All filing deadlines continue to apply. Parties may request an extension of time if they are unable to meet the deadlines in light of the circumstances. However the parties are asked to do so once the FCA operations return to normal after April 17, 2020.

The Federal Courts will continue to monitor the situation and will continue to update the public with regards to their operations.

Please consult with counsel on each matter to obtain more information applicable to your case.

Thank you to Caroline Henrie and Christopher A. Guerreiro for their help in drafting this article.

COVID-19: Sharing information for licensed health products during a pandemic

The public health call for social distancing to help curb the COVID-19 pandemic has no doubt already affected how companies will be sharing information about pharmaceuticals and other licensed health products with healthcare professionals (HCPs), patients, and the public. As industry plays its part in keeping sales representatives and medical science liaisons (MSLs) home to help “flatten the curve”, many interactions between HCPs and companies are moving to the virtual world. At the same time, HCPs will look to the industry to provide timely and accurate information through their medical teams or patient support programs (PSPs) about how to manage medications for patients who have COVID-19 or who are self-isolating at home and cannot come to the clinic. Here are things to keep in mind when sharing information about licensed health products.

  1. Consider preparing a COVID-19 focused FAQ. Many HCPs will be concerned about how to manage medications for patients who present with COVID-19 and look to industry to respond in a timely fashion. A prepared set of answers of anticipated questions helps ensure your medical team is ready to field these questions while ensuring compliance in the dissemination of the information. Staff should be informed when it is appropriate to provide on-label and off-label information, including changes in dosing or how to safely initiate or discontinue therapy. According to Health Canada’s The Distinction Between Advertising and Other Activities, responses to requests for information that are reactive or as part of person-to-person dialogue are considered non-promotional so long as they focus on the exchange of scientific and clinical information.
  2. Consider corporate messages instead of discussing pre-market products. There is a lot of interest among the public about what the pharmaceutical industry is doing to help respond to the COVID-19 crisis, whether through antivirals in the pipeline or the creation of a vaccine. Permitted communications about a product prior to receiving market authorization are limited to specific circumstances, and should be careful not to be promotional in nature or discuss the safety or efficacy of a product in the pipeline. To remain engaged, consider the use of corporate messages that do not promote a specific product or product portfolio. These may discuss a company’s commitment to responding to the COVID-19 crisis more generally without mention of any product in the pipeline, and may be permitted to both HCPs and the general public without being characterized as direct-to-consumer advertising. Messaging for non-prescription drugs or natural health products should avoid making any claims, express or implied, that their products can treat COVID-19 unless it is explicitly stated on their product licence.
  3. Consider digitizing existing materials. Materials that will be disseminated by sales reps or MSLs to all HCPs will likely occur through email or through the company’s HCP-gated portal. Existing print aids can be disseminated as a PDF without being resubmitted to PAAB, so long as the content and layout appear as they would have in print. This can be done by way of a simple “FYI” notice to the Pharmaceutical Advertising Advisory Board (PAAB) office for PAAB-approved materials. Emails that will be used to disseminate these materials may need to be submitted for PAAB preclearance review. PAAB recently issued a notice stating it is working to expedite such requests.
  4. Monitor social media activity. With many more patients staying at home, online forums and social media will no doubt be one of the primary ways of sharing experiences and disease management strategies while under self-isolation. A manufacturer is responsible for any social media channels, forums, or hashtags that it owns, creates, or promotes, even if they were created before the COVID-19 pandemic. Ensure teams are especially vigilant in ensuring that these discussions remain on-label and monitor for reports of adverse events. For hashtags or forums that have not been created by the manufacturer, company staff should refrain from engaging directly with patient-generated content, including “liking” or “retweeting” a post, and continue ensuring that adverse events reports are quickly acted upon.
  5. Consider the requirements of your risk management plan (RMP). Many RMPs require manufacturers to have a robust post-marketing surveillance and pharmacovigilance program. Ensure accurate and timely reporting of any adverse events related to patients who are experiencing COVID-19 symptoms or have tested positive for COVID-19, and ensuring that COVID-19 status is included in any adverse event reporting. This will help ensure the company is meeting its requirements while monitoring the longer-term associations of COVID-19 with your products.
  6. Remind PSP providers and other vendors of patient privacy requirements. Patient support programs have become an indispensable method of delivering healthcare to patients. However, many programs are designed with the understanding that care will take place in an infusion clinic or physician’s office, where maintaining patient confidentiality is the norm. However, some PSPs may need to shift to being delivered in the home, where the usual protections are not in place. Alternatively, caregivers may be calling PSP staff on patients’ behalf to help coordinate or gather information. Ensure your PSP vendor and other service providers have the proper consent before delivering the PSP services. This includes the delivery of medications to a patient home instead of a clinic, or the use of emergency couriers. Note also that some couriers are no longer obtaining signatures, even if requested to do so, to help limit the number of close contacts between individuals.

*The purpose of this communication is to provide general information of a legal nature. It does not contain a full analysis of the law nor does it constitute an opinion of any Norton Rose Fulbright entity on the points of law discussed. You must take specific legal advice on any particular matter which concerns you. If you require any advice or further information, please speak to your usual contact at Norton Rose Fulbright.

Bill C-4: New CUSMA Implementation Act Received Royal Assent

On March 13, 2020, the Government passed Bill C-4 to implement the Canada-United States-Mexico Agreement (CUSMA). Canada will be the third and final party to ratify the treaty.

The Bill, sponsored by Deputy Prime Minister Freeland, was introduced on January 29, 2020. The Bill was recently expedited in order to ensure that it passed before both Houses adjourned at the end of the week over concerns regarding the spread of COVID-19.

As we reported, Bill C-4 does not contain any amendments to the Patent Act. Canada is still expected to amend the Patent Act to include patent term restoration (PTR) in accordance with Article 20.44 of the CUSMA, but has four-and-a-half years from the date the CUSMA comes into force to implement this provision. PTR will provide patentees with an adjustment procedure to compensate for Patent Office unreasonable delays in issuing a patent. This obligation will likely be the subject of future legislation.

The obligation to provide increased data protection for biologics was removed in December 2019 amendments to CUSMA.

COVID-19: Health Canada Issues Bulletin Confirming Obligations of DEL Holders

In light of recent developments relating to the to the 2019 novel coronavirus (COVID-19), Health Canada recently sent a reminder to all Drug Establishment License (DEL) holders of their obligations under the Food and Drug Regulations (FDR) regarding reporting of events that could affect operations and lead to shortages or issues affecting quality, safety, and efficacy of products.

The bulletin reminded DEL holders of their obligations to notify or report to Health Canada any events that could have an impact on pharmaceutical operations. Specifically, a DEL holder should notify Health Canada within 15 days if an event occurs that could affect the quality, safety or efficacy of a drug fabricated, packaged/labelled, tested or stored by the DEL holder. The notification should include a description of the impact on the quality, safety, and/or efficacy of the product. If available at the time of notification, the DEL holder should also disclose any action that has been taken or is planned to address the situation and mitigate the health risk the drug may pose to the consumer

If foreign buildings have been affected by events impacting the supply chain of life-saving medicines, Health Canada will consider expediting the addition of new foreign buildings to DEL holders if the product is medically necessary or the product has been accepted for priority review.

The bulletin also reminds drug authorization holders that the FDR make it mandatory to report drug shortages and discontinuations of sale within the prescribed time frames (i.e., no less than six months in advance if it is likely to begin in more than 6 months, or, within 5 days of becoming aware of the drug shortage or discontinuation of sale if it will begin within 6 months). Further details on reporting drug shortages can be found in the guidance document Guide to Reporting Drug Shortages and Discontinuations.

Finally, clinical trial sponsors must notify Health Canada when there are changes that may affect the quality or safety of clinical trial drug supplies. If a sponsor of an already approved clinical trial is importing clinical trial drug supplies from impacted areas, and changes to the chemistry and manufacturing information become necessary, an amendment (CTA-A) or notification (CTA-N) may be needed, depending on the circumstances. Sponsors may consult the Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications for examples of situations that warrant the filing of a CTA-A or CTA-N.

The bulletin has been circulated to stakeholders, but Health Canada has not yet posted it online.

Bill C-4: New CUSMA Implementation Act Introduced

On January 29, 2020, the Government introduced Bill C-4 to implement the Canada-United States-Mexico Agreement (CUSMA). The Bill, sponsored by Deputy Prime Minister Freeland, was read for the first time the same day.

As we reported, the previous Government’s CUSMA implementation bill (Bill C-100) died on the Order Paper as it was not passed into law before the federal election in October of 2019. Subsequently, the Intellectual Property Chapter of the CUSMA was amended to remove extended data protection for biologics. Although Bill C-4 includes an amendment to the Food and Drugs Act that authorizes regulations to implement the remaining data protection provisions of the CUSMA, the Government has indicated that Canada’s data protection regime is already compliant and no changes to the existing regulations are required.

Like Bill C-100 before it, Bill C-4 does not contain any amendments to the Patent Act. Canada is still expected to amend the Patent Act to include patent term restoration (PTR) in accordance with Article 20.44 of the CUSMA, but has four-and-a-half years from the date the CUSMA comes into force to implement this provision. PTR will provide patentees with an adjustment procedure to compensate for Patent Office unreasonable delays in issuing a patent. This obligation will likely be the subject of future legislation.

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