Ontario considers requiring disclosure of drug company payments to healthcare providers

The Government of Ontario has announced it is consulting with patients, healthcare providers, and the pharmaceutical and medical devices industries about current regulations and guidelines that govern the disclosure of payments from the private sector to healthcare professionals. Although some innovative pharmaceutical companies already voluntarily disclose payments to healthcare providers, Ontario is assessing what additional measures should be implemented to increase transparency, including possibly mandating disclosure of payments by private drug companies to healthcare providers.

Link:

Ontario Consulting on Transparency in the Health Care Sector

FCA upholds Gilead victory invalidating Idenix patent relating to anti-HCV compounds

In a brief decision, the Federal Court of Appeal dismissed Idenix’s appeal of a Federal Court decision which found that a patent owned by Idenix and purporting to claim anti-HCV compounds was invalid for: (i) failing to sufficiently disclose a synthetic method by which the claimed compounds could be made; and (ii) for lack of sound prediction of utility. The Federal Court of Appeal held that Idenix had not identified any errors in the Federal Courts decision with respect to insufficient disclosure that warranted intervention. Given those findings, the Federal Court of Appeal did not address the other issues raised in detail.

Norton Rose Fulbright Canada LLP represented Gilead Sciences, Inc., Gilead Sciences Canada, Inc. and Gilead Pharmasset LLC (Gilead) in the Federal Court and Federal Court of Appeal.

Case:  Idenix Pharmaceutical Inc. v Gilead Pharmasset LLC, 2017 FCA 161 (Court File No. A-483-15), affirming 2015 FC 1156

Nature of case:  Appeal from action for patent invalidity with cross claim for patent infringement and invalidity.

Successful party:  Gilead Sciences, Inc., Gilead Sciences Canada, Inc., and Gilead Pharmasset LLC

Date of decision:   July 24, 2017

 

Summary

Gilead initiated the underlying invalidity action based on a belief that the manufacture, use or sale in Canada of sofosbuvir (marketed in Canada as SOVALDI®) would be impugned by Idenix as an infringement of the patent. Idenix counterclaimed, and indeed claimed that Gilead’s sale of sofosbuvir in Canada constituted infringement of its patent. Idenix also sought to invalidate a Gilead owned patent on the basis that it was not novel in light of the Idenix patent.

The Federal Court allowed Gilead’s claim, finding that each claim of the Idenix patent was invalid for: (i) failing to sufficiently disclose how to synthesize the compounds at issue; and (ii) for lack of sound prediction of utility. The Court also dismissed Idenix’s counterclaim, finding that the Idenix patent did not enable (and therefore did not anticipate) the Gilead patent.

Idenix appeal

Idenix argued on appeal that the Federal Court made multiple errors in reaching its conclusions on insufficiency and lack of sound prediction. The Federal Court of Appeal dismissed Idenix’s appeal finding no error warranting the Court’s intervention.

The Court of Appeal rejected Idenix’s argument that the Federal Court applied an incorrect test for insufficient disclosure. Rather, the Court of Appeal found that, read in context, the Federal Court correctly considered how the skilled person would have understood the patent when it concluded that the Idenix patent, together with the common general knowledge, did not sufficiently disclose how to synthesize the compounds at issue.

Idenix had argued that the synthetic method was sufficiently disclosed by virtue of certain aspects of the method being included in schemes directed to other compounds in the patent and in other prior art. The Court of Appeal rejected Idenix’s argument and agreed with the Federal Court that “the fact that, in hindsight, individual steps in a chemical synthesis have some precedent in the literature does not mean that the overall sequence of steps for making a new compound was easy to determine.” The Court of Appeal analogized the lack of an appropriate synthetic method in the patent to the situation considered by the Supreme Court of Canada in Teva Canada Ltd. v Pfizer Canada Inc., 2012 SCC 60 and found that rather than leading the skilled person step by step through the synthesis of the claimed compounds, the specification necessitated the working out of a problem. The Court of Appeal held that in the absence of any teaching in the Idenix patent, the problem left to be worked out by the person of ordinary skill was “a burden beyond that borne by” the Patent Act as interpreted by the jurisprudence.

The Court of Appeal also rejected a number of other grounds of appeal argued by Idenix finding that either no error was made, or that even if an error was made, any error did not impact the Federal Court’s core finding that the patent failed to sufficiently disclose a method for making the compounds claimed.

Given the Court’s finding on sufficiency, it was not necessary for the Court to consider Idenix’s arguments with respect to sound prediction or anticipation of the Gilead patent in detail.

 

Links:

Idenix Pharmaceuticals, Inc. v Gilead Pharmasset LLC, 2017 FCA 161

 

Apotex continues battle to prevent release of ANDS information: FCA upholds decision that Commissioner of Information is a proper respondent to Apotex’s judicial review

As we reported, Apotex Inc. applied for judicial review of the Minister’s decisions to disclose information from Apotex’s abbreviated new drug submission in response to an access to information request. The Federal Court of Appeal upheld an order adding the Commissioner of Information as a respondent, holding that the test was whether the Commissioner’s participation would assist the court, and that there was sufficient evidence for the prothonotary to grant the Commissioner’s motion.

Case:   Apotex Inc v Canada (Minister of Health), 2017 FCA 160

Nature of case:   Appeal from Order granting leave to add respondent to application for judicial review of decision to disclose information

Successful parties:   The Minister of Health (Minister), the Attorney General of Canada and the Commissioner of Information of Canada (Commissioner)

Date of decision:   July 20, 2017

Background

On September 8, 2015, Apotex commenced three applications for judicial review of the Minister’s decisions to disclose Apotex’s information as the information contained (i) trade secrets; (ii) confidential financial, commercial, scientific or technical information; (iii) information that could reasonably expect to cause material financial loss or gain, or prejudice Apotex’s competitive position if disclosed; and (iv) information that could reasonably be expected to interfere with contractual or other negotiations of Apotex if disclosed. Apotex also alleged a lack of procedural fairness. The Commissioner successfully brought a motion to be added as a respondent under the Access to Information Act.

On appeal, the Federal Court (FC) found that the prothonotary had sufficient grounds under the Access to Information Act to add the Commissioner as a respondent and dismissed Apotex’s allegation that the prothonotary breached procedural fairness by failing to consider its submissions and request for an oral hearing.

Standard of review

The Federal Court of Appeal (FCA), following its previous application of the standard of review set by the Supreme Court in Housen v Nikolaisen, 2002 SCC 33 to all appeals (reported on here and here), considered whether the FC’s refusal to interfere with the prothonotary’s order was an error in law or a palpable and overriding error.

Adding the Commissioner as a respondent

The FCA held that the FC did not err by not interfering with the prothonotary’s order. Although the FCA acknowledged that the Commissioner had not demonstrated it was a “necessary” party to the proceedings, as required under the Federal Courts Rules, Justice Near agreed that the court was not bound to strictly apply this requirement. Given the governing state, the court was also required to give effect to Parliament’s intent to have an agent of Parliament appear as a party. The statute grants the Commissioner the clear possibility of appearing as a party, and the court must consider whether an added party will be of assistance to the court on a case-by-case basis.

The FCA held that there was sufficient basis for the FC to find that the prothonotary did not commit a reviewable error in granting the Commissioner’s motion, and dismissed the appeal.

Links to decisions:

FCA Decision: Apotex Inc v Canada (Health), 2017 FCA 160

FC Decision: Apotex Inc v Canada (Health), 2016 FC 776

Order of Prothonotary (unreported): Order dated April 4, 2016

Mid-year roundup – 2017

Hard to believe, but we are halfway through 2017 already! It has been a busy six months, with major developments, including Canada preparing to implement CETA and the Supreme Court of Canada abolishing the “Promise Doctrine.” Below, Pharma in Brief has compiled the top headlines so far this year.

The Big Three:

Utility and the promise of the patent. In a landmark ruling, the Supreme Court of Canada has rejected the “Promise Doctrine” as a basis for invalidating patents for lack of utility.

Canada awaits CETA implementation. Bill C-30 – the act intended to implement the Comprehensive Economic and Trade Agreement (CETA) into Canadian law – will bring significant change to the pharmaceutical industry as it provides for certificates of supplementary protection for patents relating to pharmaceutical products and for proceedings under the Patented Medicines (Notice of Compliance) Regulations (Regulations) to proceed as full actions that will result in final determinations of patent infringement and validity. Draft regulations for both have been released, but are not yet in force. The Federal Court is also preparing for the upcoming changes to the Regulations, and has released new practice guidelines for the trial management of actions. The reforms were originally scheduled to come into force on July 1, 2017; however, the government is now reporting a provisional application date of September 21, 2017.

PMPRB – jurisdiction and proposed amendments. In December 2016, the Federal Court issued a decision on the regulation of excessive pricing in relation to  Alexion’s SOLIRIS® (eculizumab). In dismissing Alexion’s two appeals, the court upheld the constitutionality of the Patent Act’s price control provisions and the PMPRB’s powers to amend excessive pricing allegations shortly before a PMPRB hearing. In May 2017, Health Canada published a consultation paper titled “Protecting Canadians from Excessive Drug Prices,” in which a number of amendments to the Patented Medicines Regulations were proposed. The proposal outlined new tools and information that would assist the PMPRB in exercising its power to regulate excessive drug pricing, including new pricing factors, new price comparator countries, a complaints-based system for generic drugs, and new disclosure requirements for patentees.

Patent Validity:

In April, the FCA provided guidance on obviousness and “inventive concept” in Bristol-Myers Squibb Canada Co v Teva Canada Limited, a case relating to REYATAZ® (atazanavir bisulfate). The FCA held that there is no one mandatory approach to assessing obviousness and “obvious to try” is not an appropriate test in every case. Furthermore, “inventive concept” is not materially different from the “solution taught by the patent,” which, in turn, is often treated as synonymous with “what is claimed” or “the invention.”

Damages: 

The FCA has released one decision on damages so far this year, relating to apportionment of profits. In an appeal relating to Servier Canada’s COVERSYL® (perindopril), the FCA held that Apotex was not entitled to apportion its export profits when paying damages to Servier Canada for patent infringement. The indemnity revenues included in the price of Apotex’s export profits were part of the damage calculation because, had perindopril not been patented, there would have been no need for Apotex to provide such a clause. Profits resulting from the sale of perindopril were thus entirely causally attributable to the invention.

Update on Health Canada:

Continued litigation with Apotex. Apotex was unsuccessful in overturning two Health Canada decisions this year. In February, the Federal Court dismissed Apotex’s application for judicial review of Health Canada’s dismissal of its abbreviated new drug submission for Apo-Progesterone. Despite Apotex’s allegations that “suggested that it was somehow led on” by Health Canada and Health Canada was “somehow antagonistic” to Apotex, the court held that Apotex was afforded a fair and impartial procedure, with sufficient opportunity to respond, and that the decision was reasonable. The Federal Court also upheld Health Canada’s decision to require additional information on certain Apotex drugs (varenicline and sitagliptin) manufactured in India prior to the issuance of a notice of compliance. Health Canada pointed to real data integrity concerns associated with Apotex’s Indian affiliates, including evidence of Apotex’s own dealings with regulatory authorities. The additional information was required pursuant to Health Canada’s general policy requiring additional information for any drug for which there exists concerns about data integrity. Health Canada’s decision was found to be legitimate and reasonable.

Future reforms. Health Canada has made several proposals for regulatory reform this year, most notably proposals regarding changes to regulation of non-prescription drugs, natural health products and cosmetics, public release of clinical information contained in drug and medical device submission, and changes to broaden access to generic drug equivalence. Health Canada also released a revised guidance document on data protection, which reflects judicial consideration of the term “innovative drug” and includes new guidelines for submissions relying on third-party data, drugs containing the same medicinal ingredient as an innovative drug, biosimilars, and pediatric population extensions. Draft regulations under Vanessa’s Law have also been published that elaborate on the Minister of Health’s powers to require tests, assessments and studies of a drug post-market authorization and set out additional reporting requirements for manufacturers based on the actions of foreign regulators and eliminate the need for individual clinical case reports filed with a new drug submission.

New procedures in effect. Health Canada has also released the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products (GLPP Guide) in June as part of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use). The GLPP Guide offers direction in terms of compliance with the new Plain Language Labelling Regulations and the Canadian Drug Facts Table’s requirements, as well as general information on label and packaging design and contents.

Sections of Vanessa’s Law regulating drugs for urgent public health need come into force

On July 12, 2017, section 5 and subsections 6(3) and 6(4) of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) came into force. These sections amend the Food and Drugs Act to require healthcare institutions to report serious adverse drug reactions and permit the Governor in Council to make regulations that specify what this reporting will be and how it will be done. The amendments will also allow for the importation and sale of foreign drugs that have not been authorized for sale in Canada, but for which there is an urgent public health need.

Vanessa’s Law, which amended the Food and Drugs Act, came into force on November 6, 2014. While most of the act’s amendments came into force immediately, some required supporting regulations.

As we reported, the Government of Canada published draft regulations amending the Food and Drug Regulations on April 22, 2017. However, the draft regulations did not come into force at that time, as the necessary provisions in Vanessa’s Law were not yet in force.

These newly in force sections of Vanessa’s Law introduce those necessary provisions. They will allow the amendments to the Food and Drug Regulations that will (i) require healthcare institutions to report serious adverse drug reactions associated with foreign drugs sold for use regarding an urgent public health need, and (ii) permit the importation and sale of foreign drugs that have not been authorized for sale in Canada, but for which there is an urgent public health need.

This will be the first time that healthcare facilities will be required to report serious adverse drug reactions under the Food and Drugs Act. Currently, the manufacturer or importer of a drug authorized for sale in Canada is required to report. However, given that no authorization will be issued for foreign drugs imported in connection with an urgent public health need, responsibility for reporting has  been shifted to healthcare institutions, which will be best placed to identify serious adverse drug reactions that may be associated with the use of these foreign drugs in Canada.

Links:

Canada Gazette Part II, Vol. 151, No. 14 – July 12, 2017

Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) (S.C. 2014, c. 24)

Updated statistics on protection of patented and innovative drugs released in the Therapeutic Products Directorate Statistical Report for PM(NOC) Regulations and Data Protection

 

Innovators’ growing use of the Patent Register is highlighted in the annual statistical report on the Patented Medicines (Notice of Compliance) Regulations and Data Protection issued by the Therapeutic Products Directorate (TPD) on July 14, 2017. This report includes data up to the end of fiscal year (FY) 2016/2017, which ended March 31, 2017.

As we reported, significant changes are coming to the Regulations and Patent Act in connection with the Comprehensive Economic and Trade Agreement (CETA) with the European Union. As a result, FY 2016/2017 is likely to be the last complete period of data under the existing scheme.

Statistics on the Patent Register and Patented Medicines (Notice of Compliance) Regulations

The growing use of the Patent Register and historically low rates of patent list rejection are contrasted by shrinking numbers of generic submissions addressing patents or involved in prohibition applications in this year’s figures from the TPD.

  • Patent lists. More patent lists were added to the Patent Register in FY 2016/2017 than in any of the previous four periods. A total of 769 patent lists were added, including 430 patents that were not previously listed. The total number of patent lists received was similar to the last fiscal year, while there were fewer rejections.
  • Patent register. As of March 31, 2017, there were 1,070 patents listed against 1,451 drug identification numbers (DINs) representing 583 drugs. Forty-six per cent of the drugs had only one patent listed against them, while an additional 47% had two to four patents listed.
  • Prohibition proceedings.
    • Generic submissions addressing patents. FY 2016/2017 saw the lowest number of submissions containing Form V and notices of allegation (NOAs) of any of the last five periods. The 126 Form Vs and 105 NOAs received are similar in number to FY 2014/2015, but lower than FY 2015/2016, which saw 200 Form Vs and 176 NOAs.
    • Applications.  Thirty-two prohibition applications were commenced in FY 2016/2017, up from 18 in the previous period; 14 prohibition applications were pending as of March 31, 2017. Over the last several periods, prohibition applications have taken much of the available 24 months but none have exceeded this time since FY 2012/2013.

Data protection

Data protection under section C.08.004.1 of the Food and Drug Regulations continued to provide a means of protecting market exclusivity for innovative drugs with a minimum of litigation in FY 2016/2017.

  • Human drugs. In FY 2016/2017, 31 human drugs were added to the Register of Innovative Drugs, nine with paediatric extensions. This trend is driven by a shrinking number of innovative pharmaceuticals (17); new biologics (12) and radiopharmaceuticals (2) are the highest that they have been in the past five periods.
  • Veterinary drugs. One innovative veterinary drug was added to the Register in FY 2016/2017.
  • Disputes. There were no judicial review applications concerning data protection in FY 2016/2017.

Submissions on IP Hold

Submissions on intellectual property (IP) Hold are those for which an NOC would be issuable, but for the operation of either the Regulations (“Patent Hold”) or data protection. The TPD reports these figures in the aggregate; it does not indicate what proportion of IP Holds are due to patents vs. data protection.

  • Submissions previously on IP Hold. In FY 2016/2017, 201 submissions received notices of compliance (NOCs) following expiry of IP Hold. This number has increased in each of the last three periods and is the highest since at least FY 2012/2013.
  • Time on IP Hold. For the 201 submissions that received NOCs in FY 2016/2017, the average length of the IP Hold was 271 days. This number has decreased in each of the last three periods and is the lowest since at least FY 2012/2013.
  • Submissions remaining on IP Hold. As of March 31, 2017, 14 submissions were on IP Hold. While lower than the peak reached at the end of FY 2015/2016, when 29 submissions were on IP Hold, more submissions were on hold at the end of FY 2016/2017 than in five of the last nine periods.

Links:

The Therapeutic Products Directorate Statistical Report 2016/2017 for the Patented Medicines (Notice of Compliance) Regulations and Data Protection can be found here.

 

CETA tracker: CETA Upends the Once-Delicate Balance

New CETA regulations impacting pharmaceuticals published but not yet in force

The Canadian government has published the proposed patent term restoration / Certificate of Supplementary Protection (CSP) and Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) under Bill C-30.  A 15-day consultation is open for interested parties to make submissions.

Since their first enactment, the PM(NOC) Regulations were intended to strike a “delicate balance” between the rights of patent holders and timely access to generic medicines. With the enactment of Bill C-30 that balance has been upended. Ironically, this sea-change in how patented medicines will be treated in Canada comes at the same time as the government has announced its intention to develop a new intellectual property strategy over the coming year purportedly “in recognition of the importance of a well-functioning intellectual property regime.”

Background

Canadian and European Union leaders signed the Comprehensive Economic and Trade Agreement (CETA) on October 30, 2016. CETA and Bill C-30 provide key reforms to the Patent Act affecting the pharmaceutical industry, including a so-called “single track” pharmaceutical patent litigation regime and up to two years of supplementary protection for patented pharmaceuticals.

Today, the government has provided additional details about the new regime affecting pharmaceuticals under Bill C-30.

Single Track Patent Litigation

The government has stated that replacing the current summary proceedings under the PM(NOC) Regulations with full actions (resulting in final determinations of patent infringement and validity) will provide all litigants with “equivalent and effective” rights of appeal and allow “for more robust scrutiny of issues and greater overall efficiency”  and “greater legal and market certainty.”

Key aspects of the new PM(NOC) Regulations include:

  • Patent Register. Patent list eligibility criteria are unchanged. The Minister of Health (Minister), however, is required to add and delete patents from the register, in certain circumstances. Discretionary reviews of the register to assess eligibility are also permitted, upon notice to patentees.
  • Generic Notice of Allegation. The NOA must address each claim of the listed patent. Patent list ineligibility may be addressed in the NOA, but can no longer result in dismissal of the proceeding. The NOA is still required to be a detailed legal and factual basis of the invalidity allegation, but the generic/second person is no longer bound by it since the action will be governed by pleadings.
  • New Production Obligations. Generics are now required to serve relevant ANDS information and prior art with the NOA. Generics may also request in the NOA that innovators provide: (i) inventor contact information; and (ii) “any laboratory notebook, research report or other document that may be relevant to determine whether a particular property, advantage, or use asserted by the second person to be part of the invention was established as of the filing date of the application for the patent” (i.e., invention information). The generic must make specific allegations on the latter, including by identifying the relevant portions of the patent. Innovators must either serve the requested information upon commencing the action or advise of steps taken to respond.  Litigants may each impose reasonable confidentiality terms on their respective production obligations, subject to review by motion or the Federal Court.
  • The Proceeding. A first person still has 45 days to start what will now be an action seeking a declaration of infringement in response to an NOA. However, the first person can now assert all claims of any listed patent and the court may order any remedy at law or equity. Like any other action, the proceeding will include full pleadings, discovery and viva voce evidence at trial. The Minister is no longer a party to the proceeding. Parties have a duty to act diligently and reasonably cooperate.
  • Where a first person/patentee, having received an NOA, does not start a proceeding within 45 days, they are thereafter prohibited from bringing a subsequent infringement action against the second person, unless they can later establish they lacked a “reasonable basis” for bringing the action at the time.
  • The statutory stay prohibiting generic market entry remains capped at 24 months, despite the adoption of more procedural complexity by way of action. Key differences between the current and new regimes are: (i) the first person now has the ability to renounce the stay at the outset (thereby opting out of s. 8 liability); (ii) the stay will be lifted for ineligible patents, but the action itself will not be dismissed on this basis; and (iii) the stay may no longer be shortened or extended on the consent of the parties.
  • Motions. Motion rights are provided: (i) for litigants to compel ANDS/ “invention information”; (ii) for litigants on confidentiality of ANDS/“invention information”; (iii) for generics to challenge patent/CSP eligibility for listing on the Patent Register (whereby the Minister will have automatic rights to intervene); (iv) for generics to seek to dismiss action in whole/part for abuse of process (however parties also retain access to Rule 221 motions to strike). Leave to appeal interlocutory orders may be sought with leave to the Federal Court of Appeal in accordance with the Federal Courts Rules.
  • Section 8. Generics maintain a right of action under section 8, but under new parameters. The innovator’s liability start date is now stated as the later of (i) date of NOA service; or (ii) date of generic approvability (i.e., “patent hold” date). Start date also remains subject to the court’s discretion. The innovator’s liability end date is no longer stated as “any loss suffered during the period”, but to “any loss suffered after” the start date.  The Regulatory Impact Analysis Statement (RIAS) states that generics may “seek compensation for any loss suffered as a result of delayed market entry after the date specified in the proposed Regulations. It would be left to the Court to determine whether the loss is properly recoverable.” Joint and several liability of defendants is also provided for.
  • Related rights of action. Innovators also have a new right of action to assert unlisted patents based on NOA service (i.e., quia timet). However, such an action cannot be joined to a listed patent proceeding under the PM(NOC) Regulations until the 24-month stay expires. Generics, having filed an ANDS, are also deemed an “interested person” for purposes of a related patent invalidity action.
  • Once in force, the new PM(NOC) Regulations will apply immediately to any matters for which an NOA is served after the coming into force date. The current summary regime will continue to apply to any matter that relates to an NOA served before the coming into force date.

Certificates of Supplementary Protection (“CSP”)

As stated in the RIAS, the protection given under a CSP is intended to “partly compensate for time spent in research and obtaining marketing authorization.” A CSP provides “patent-like rights” that take effect after patent expiry, and is subject to the “same limitations and exceptions” as the patent. Like a patent, a CSP is subject to the jurisdiction of the Patented Medicine Prices Review Board and can be listed on the Patent Register.

As we reported, many CSP regime details have been available in Bill C-30, including the following:

  • Applicability. Only new drugs issued Notices of Compliance (NOC) after Bill C-30 is in force can be CSP-eligible.
  • Term. The term of the CSP will be calculated as the difference between the filing date of the patent application and the date of NOC issuance, minus five years, capped at a maximum of two years.
  • Different Medicinal Ingredients. Medicinal ingredients for human use will be treated as “different” medicinal ingredients eligible for CSP than when approved for veterinary uses. A first approval of a combination of medicinal ingredients will be treated as a “different” medicinal ingredient eligible for CSP.
  • Actions for infringement and impeachment of a CSP: Actions may be brought in the same manner as an action for the infringement or impeachment of a patent.
  • Export exemption: It is not an infringement of a CSP to make, construct, use or sell for the purpose of export from Canada.

Additional details relating to CSP eligibility are provided in the new CSP Regulations.

  • Timing of CSP application. CSP applications must be filed before the end of 120 days, which begins on (a) the day the NOC is issued, if the patent is granted on or before that day; or (b) if the patent is granted after the day on which the NOC is issued, the day on which the patent is granted. No CSP application can be filed within two years preceding patent expiry. CSP applications are subject to a fee of $9,011.00 CAD.
  • Same Medicinal Ingredients. Esters, salts, complexes, chelates, clathrates or any non-covalent derivative, enantiomers or mixture of enantiomers, solvates or polymorphs and in vivo or in vitro post-translational modification of a medicinal ingredient will be treated as the “same” medicinal ingredient. Combinations of medicinal ingredients that only differ with respect to the ratio between those ingredients will be treated as the “same” combination.
  • “Timely submission requirement”. To be CSP-eligible, the Canadian NDS for the drug in question must be filed within 18 months of any first international drug submission filing for the same drug in the European Union, United States, Australia, Switzerland or Japan. This period decreases to one year at the one-year anniversary of CETA being in force. According to the RIAS, this requirement is intended “to incentivize the early introduction of innovative drugs into the Canadian market”.
  • Eligible patents: To be eligible, a patent claim must pertain to the “same” medicinal ingredient or a combination of “same” medicinal ingredients, which requires at least one claim for: (i) the “same” medicinal ingredient or combination; (ii) use of the “same” medicinal ingredient; or (iii) a product-by process claim for the “same” medicinal ingredient.

Our team has in-depth innovator pharmaceutical industry expertise at all stages of product life cycle, including patent prosecution, regulatory advice and litigation services. Our litigation group focusses on pharmaceutical patent infringement/validity, damages and section 8 actions. Most significantly for CETA purposes – Norton Rose Fulbright is experienced in expedited trial procedure, having been successful counsel on one of the very few pharmaceutical patent actions taken to trial and decided within 24-months.

Are you CETA ready? Contact Norton Rose Fulbright with all your CETA questions.

Innovator must be named as respondent when PM(NOC) Regulations engaged

The applicant brought a judicial review application regarding the Minister of Health’s determination that it compared its product to a product with listed patents and was therefore required to address the listed patents. The Federal Court determined that the third-party innovator of the product with listed patents is a person “directly affected” by the application and ought to have been named as a respondent.

Case: Innovator Company v Canada (Attorney General), 2017 FC 548 (Court File No. T-485-17)

Nature of case: Motion for a confidentiality order in the context of an application for judicial review of a decision from the Minister of Health pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations).

Successful party: Attorney General of Canada

Date of decision: June 5, 2017

Background

The applicant, an innovative pharmaceutical company, filed a new drug submission (NDS) with Health Canada. Both the applicant’s and drug’s identities were undisclosed in the decision.

The Minister of Health determined that the applicant’s NDS makes a direct or an indirect comparison to a product for which another innovator has one or more patents listed on the patent register. The other innovator’s identity is also undisclosed. Section 5 of the Regulations is therefore triggered and the applicant is required to address the patents listed against the other innovator’s product.

The applicant sought judicial review of the minister’s decision and also brought a motion for a confidentiality order in respect of its own identity, the identity of its drug product, the entire content of its NDS and any information it provided to the minister in support of its NDS.

The other innovator is not named as a respondent to the judicial review and was therefore not served with or notified of either the notice of application for judicial review or the motion for a confidentiality order.

Regulations confer a “direct benefit” to the innovator

Following prior decisions of the Federal Court, the court concluded that once the minister decides the Regulations are engaged in favour of an innovator, “a direct commercial benefit is conferred on that innovator,” sufficient to provide standing.

The court noted the circumstances of this case are indistinguishable from those in Apotex Inc v Canada (Minister of Health), 2006 FC 846.

The court also considered the decisions in Forest Ethics Advocacy Association v Canada (National Energy Board), 2013 FCA 236 and Hospira Healthcare Corporation v Canada (Health), 2014 FC 179, upheld 2014 FC 235 and 2014 FCA 194 , which held that a proceeding seeking to set aside a decision by the minister that a patent listed on the register must be addressed directly affects the innovator who listed the patent against the referenced product. In Forest, the Court of Appeal clarified that a party has a direct interest not only when its legal rights are affected or legal obligations are imposed on it, but also when “it is prejudicially affected in some direct way.”

As the motion for a confidentiality order “cannot be isolated from the question of whether all of the necessary parties have been properly served notice of the underlying application,” the court adjourned the motion, holding that the motion could not go forward without giving the other innovator an opportunity to be heard. The court ordered that the motion materials be served on the other innovator.

Link:

Innovator Company v Canada (Attorney General), 2017 FC 548

CETA Tracker: Pharmaceutical patent reform to be provisionally implemented in September 2017

As we reported, the Canadian government has approved changes to Canada’s pharmaceutical patent regime, including the introduction of patent term restoration and the replacement of the current summary proceedings under the Patented Medicines (Notice of Compliance) Regulations with full actions.  The reforms were originally scheduled to come into force on July 1, 2017; however, the Government is now reporting a provisional application date of September 21, 2017.

Are you CETA ready?  Contact Norton Rose Fulbright with all your CETA questions. 

 

Links

Bill-30, Third Reading (House of Commons)

Text of the final Comprehensive Economic and Trade Agreement

Health Canada consults on changes to broaden access to generic drug equivalence

Health Canada is seeking input on potential changes to the Food and Drug Regulations affecting which drug products would be approvable by way of an abbreviated new drug submission (ANDS) and thus be designated therapeutically equivalent. Comments can be provided until October 13, 2017. This is the first in a series of consultations on the topic.

The proposed changes

Generic drug products can be approved via the ANDS pathway by making reference to a Canadian reference product (CRP), provided the manufacturer can demonstrate that its product is pharmaceutically equivalent and bioequivalent to the CRP, it has the same route of administration, and the conditions of use fall within those of the CRP. Approval through the ANDS pathway constitutes a declaration of “therapeutic equivalence.”

Products with the same medicinal ingredient in the same dosage form are currently considered “pharmaceutical equivalents.”  The proposed changes would allow drug products with different salts, esters, or complexes of the medicinal ingredient, and/or generic drug products with different but comparable dosage forms to the CRP to be considered “pharmaceutical alternatives.” Both pharmaceutical equivalents and pharmaceutical alternatives would be viewed as therapeutically equivalent, provided bioequivalence with the CRP has been demonstrated and the product has the same route of administration and the same safety and effectiveness.

Further, Health Canada is proposing a new definition for “medicinal ingredient” that would change when “sameness” between the generic product and its CRP is determined. Currently, the input material (i.e., the active pharmaceutical ingredient that goes into the manufacture of the drug product) is considered the medicinal ingredient. Health Canada is proposing to “add a definition of medicinal ingredient as the active substance that contains the therapeutic moiety in the drug product that is administered to or consumed by Canadians.”

Link:

Possible Changes to the Food and Drug Regulations: Generic Drug Equivalence and Related Terminology

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