October 2017

Pfizer obtains orders of prohibition on polymorphic form patent

On September 22, the Federal Court, in a pair of decisions, granted Orders of prohibition under the Patented Medicines (Notice of Compliance) Regulations preventing Apotex and Teva from marketing their generic o-desmethyl-venlafaxine (“ODV”) products (Pfizer’s PRISTIQ) until expiry of Patent No. 2,436,668 (the “668 Patent”): Pfizer Canada Inc v Apotex Inc, 2017 FC 774; Pfizer Canada Inc v Teva Canada Limited, 2017 FC 777. Both Apotex and Teva have appealed. 

Read More >>

Update on AstraZeneca SCC and developments on “overpromising” under grounds other than utility

SCC Update. On October 23, 2017, the Supreme Court of Canada dismissed Apotex’s motion to amend the Supreme Court of Canada’s judgment in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 (reported here, relating to esomeprazole, AstraZeneca’s NEXIUM).  Apotex had asked that the case be remanded to the Federal Court to determine if “overpromising” renders the 653 patent invalid on the basis of insufficient disclosure, overbreadth and willful misleading.  Apotex had also asked that anticipation and obviousness, rejected by the Federal Court, be remanded to the Federal Court of Appeal.

Two recent Federal Court decisions also illustrate attempts to raise “overpromising” as a ground of invalidity outside of the “promised utility” doctrine rejected in AstraZeneca.

Read more >>

Idenix seeks leave to Supreme Court in SOVALDI dispute

As previously reported, the Federal Court of Appeal affirmed the trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). The Court of Appeal upheld the validity of Gilead’s Patent No. 2,527,657, and declared Idenix’s Patent No. 2,490,191 invalid on the basis of insufficiency of disclosure and inutility. On September 29, 2017, Idenix applied to the Supreme Court of Canada for leave to appeal (docket no. 37781).

Canadian government issues statement of intended actions to implement CETA 

Global Affairs Canada published its statement of intended actions regarding the implementation of the Canada-EU Comprehensive Economic and Trade Agreement (CETA), which has been provisionally applied since September 21, 2017: Canadian Statement on Implementation of CETA. The document summarizes the Canadian government's position on its obligations and how it intends to implement the treaty. Portions of the document relevant to the pharmaceutical industry include Chapter 4 (a statement on reciprocal recognition of Good Manufacturing Practice (GMP) certifications) and Chapter 20 (referring to the implementation of Certificates of Supplementary Protection and revised Patented Medicines (Notice of Compliance) Regulations which we previously reported).

Ontario bill proposes mandatory disclosure of financial relationships between pharmaceutical companies and health care professionals 

On September 27, 2017, the Ontario Legislature introduced Bill 160, Strengthening Quality and Accountability for Patients Act, 2017, which would, if passed, enact the Health Sector Payment Transparency Act, 2017.  This would require disclosure of financial relationships between health care professionals and pharmaceutical or medical device manufacturers and would require the reporting of information such as the names of the parties, value of any transfer (or an estimate if non-monetary), and the reasons for the transfer. The reported information is to be made publicly available. More details are to be prescribed by regulation, such as the manner and frequency of reporting. 

Health Canada News

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

Health Canada has issued a Notice of Intent soliciting comments on possible changes to the Food and Drug Regulations relating to pharmaceutical equivalence of a proposed generic drug to a Canadian Reference Product (CRP). The Notice of Intent states that the proposal is intended “to address some concerns arising from the comparison of generic drug products to the CRP and create greater alignment and convergence with the practices of other major regulatory jurisdictions for pharmaceuticals.” Key concepts outlined include:

• providing definitions of “medicinal ingredient”, “therapeutic moiety” and “drug product”, such that the medicinal ingredient will be defined as the active substance that contains the therapeutic moiety in the drug product that is administered to or consumed by Canadians; and

• allowing Abbreviated New Drug Submissions (ANDS) to be filed for “pharmaceutical alternatives” (generic drugs with different salts, esters or complexes of the medicinal ingredient and/or generic drug products with different but comparable dosage forms as the CRP, when bioequivalence has been demonstrated and has the same safety and effectiveness as the CRP) in addition to the currently allowed “pharmaceutical equivalents” (generic drugs with identical medicinal ingredients in comparable dosage forms as the CRP). Upon issuance, a Notice of Compliance would constitute a declaration of therapeutic equivalence in both instances.

Questions or comments relating to the consultation should be provided to Health Canada before October 27, 2017.

Related to the above Notice of Intent, Health Canada has issued an Updated Notice: Interim Policy on Health Canada's Interpretation of Medicinal Ingredient and Assessment of Identical Medicinal Ingredient. This updates Health Canada’s 2015 Interim Policy regarding the interpretation of “medicinal ingredient” (reported here). According to the Updated Notice, if the medicinal ingredient is the same at the input stage and in the finished dosage form (FDF) as the Canadian Reference Product, an Abbreviated New Drug Submission (ANDS) is the appropriate route. The Updated Notice clarifies that Health Canada also considers the following scenarios in determining whether an ANDS may be also be the appropriate route:

• if (i) the input medicinal ingredients are the same but diverge to different physicochemical forms in the FDF, or (ii) the input medicinal ingredients are different physicochemical forms and remain different in the FDF, an ANDS may be appropriate though additional safety, effectiveness and quality data may be required; and

• if the input medicinal ingredients are different physicochemical forms but converge to the same physicochemical form in the FDF, an ANDS may be appropriate without additional safety, effectiveness and quality data.

The Updated Notice also notes that this issue will be further developed with the larger policy framework that includes the above potential amendments to the Food and Drug Regulations, at which point a guidance document will issue.

The Patented Medicines (Notice of Compliance) Regulations will continue to apply if the generic drug submission makes a comparison or reference to a drug on the Patent Register, regardless of the determination of pharmaceutical equivalence.

Consultation on Health Canada proposals for prescription drug transparency

Health Canada is soliciting online comments (until October 28, 2017) regarding proposed pre-market transparency initiatives for human prescription drugs (pharmaceuticals and biologics). Feedback may only be submitted through the consultation document, which contains additional information on the following proposals:

• publishing a summary explaining Health Canada’s decision on certain prescription generic drug submissions;

• publishing a list of prescription generic drug submissions sent to Health Canada for review;

• expanding the scope of the current Regulatory Decision Summary initiative to include more drug submissions; and

• adding company (sponsor) names and submission ‘class’ to entries on the Submissions Under Review List.

PMPRB News

SOLIRIS decision. The Patented Medicine Prices Review Board (PMPRB) announced the release of a hearing panel’s Decision regarding the pricing of Alexion’s SOLIRIS (eculizumab), sold in Canada since 2009.

SOLIRIS is a breakthrough drug indicated for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, both rare and life-threatening disorders. According to the Board’s Guidelines, as a breakthrough drug, the highest price at introduction (the Maximum Average Potential Price, MAPP) is the median price of the seven comparator countries listed in the Patented Medicines Regulations. In subsequent years, the highest price is the lower of (i) the price from the previous year increased by the Consumer Price Index (CPI) or (ii) the highest price in the comparator countries (the Highest International Price Comparison, HIPC). 

The Board considered its consumer protection mandate in determining whether the pricing was excessive according to the factors set out in s. 85(1) of the Patent Act which include: the prices at which the medicine has been sold in the relevant market; the prices at which the medicine has been sold in other countries; and changes in the CPI.

The Panel agreed with the Board Staff that the Guidelines were appropriate in assessing increases, but not in assessing the appropriate benchmark, agreeing with Board Staff that in “the unique circumstances of this case”, the appropriate benchmark was the LIP (the lowest international price), which was the United Kingdom price. The Panel assumed that by selling at the LIP in the UK, Alexion was covering its costs and earning a normal rate of return, found that no justification was provided as to why Canadians should be paying significantly more than in the UK (and the US), and considered the significant impact that the cost was having on the provinces’ health care budget. 

The Panel rejected Alexion’s main argument that the Guidelines were not appropriate regarding the permitted increases in subsequent years as the fluctuations in the exchange rates and the appreciation of the Canadian dollar resulted in the Canadian price appearing higher than the international comparators, while the Canadian price remained unchanged, and in fact, decreased based on changes in the CPI. The Panel concluded that foreign prices must be converted to Canadian dollars for comparison purposes; exchange rate fluctuations are the responsibility of the patentee.

The Panel concluded that Alexion was selling SOLIRIS at an excessive price from 2009-2015, as the price exceeded the LIP. While the Panel believed the correct benchmark was the LIP as of the date of first sale, it only required Alexion to comply with this as of the date of the decision, as Board Staff had consistently applied the HIPC test until 2015. For the 2009-2017 period, the Guidelines were to be applied to calculate excess revenues, and the Panel will then issue a further decision, after which Alexion is to make payment.

Alexion has sought judicial review of the Panel’s decision.

Report comparing drug coverage by Canadian public drug plans. On October 11, 2017, the PMPRB announced the publication of a report titled “Alignment Among Public Formularies in Canada - Part 1: General Overview”. The report, based on 2015 data, compares lists of drugs covered by the public drug plans to determine the extent of overlap in drug coverage. The report’s key findings include:

• “There is a reasonably high degree of alignment among public drug plan formularies in Canada.”

• “Alignment among public plans is greatest for multi-source drug listings, which generally have a higher use and lower cost”; and

• “Public plans are less well aligned in their listing decisions for single-source drugs, with more variability for high-cost drugs.”

Apo-Salvent proceeding discontinued. On September 21, 2017, in response to an unopposed request filed by PMPRB staff to discontinue the proceeding, a hearing panel discontinued an excessive-pricing proceeding relating to Apotex’s Apo-Salvent CFC Free (Order). The panel held that it was not in the public’s interest to continue the proceeding because, among other things, it had been on hold for approximately nine years and, given the passage of time, PMPRB staff “would face significant evidentiary challenges” if the proceeding was to continue.

Competition Bureau reaches agreement with Abbott Laboratories

On September 28, 2017, the Competition Bureau announced it has reached an agreement with Abbott Laboratories that resolves the Bureau’s concerns related to Abbott’s proposed acquisition of Alere Inc. The Bureau had concerns that the acquisition could result in a substantial lessening of competition in the supply of certain types of medical diagnostic testing products. To resolve these concerns, Abbott agreed to the sale of some of Alere’s diagnostic systems to two separate companies. Given the global nature of the proposed acquisition, the Competition Bureau coordinated its review with other jurisdictions, including the European Commission and the US Federal Trade Commission. The Bureau determined that the sales of Alere’s diagnostic systems to two other companies will preserve competition in Canada.

Federal Court rejects application for judicial review for Apotex’s omeprazole magnesium tablet submission

In a decision dated September 25, 2017, Justice Roy rejected Apotex’s judicial review regarding Health Canada’s review of Apotex’s omeprazole magnesium tablet regulatory submission: Apotex Inc v Canada (Health), 2017 FC 857. Apotex originally filed its Abbreviated New Drug Submission (ANDS) in 2000 and its submission was put on patent hold, which was later revoked because the ANDS lacked a high-fat study. Apotex re-submitted an ANDS in 2013 with a high-fat study. The Minister issued a Notice of Non-Compliance on the basis that the high-fat study did not meet the standards for bioequivalence and that the study protocol was inadequate. Apotex applied for reconsideration. The Director cancelled reconsideration due to a disagreement on an eligible question to pose to the Reconsideration Panel. Apotex focused the question solely on safety and efficacy, while the Minister required that the question consider bioequivalence. Apotex sought judicial review of the Director’s decision to cancel reconsideration.

The Federal Court dismissed the application, finding that (1) Apotex’s legitimate expectation was the opportunity to draft a question eligible for submission to the Reconsideration Panel, which Apotex had fair opportunity to do, and (2) the Minister of Health was required by the Food and Drug Regulations to consider bioequivalence in assessing safety and efficacy and had no discretion to do otherwise, therefore her discretion was not fettered. Apotex has appealed.

Federal Court of Appeal declares that administrative errors during application cannot void an issued patent

The Federal Court of Appeal ruled that the failure to pay the correct issue fee did not render a patent void: Apotex Inc v Pfizer Inc, 2017 FCA 201. In the context of a s. 8 case relating to latanoprost (XALATAN), Apotex brought a partial summary judgment motion to have Pfizer’s Patent No 1,339,132, which Pfizer relied on in its defence, as void for failure to comply with s. 73 of the 1989 Patent Act. The Court of Appeal dismissed Apotex's appeal of the Federal Court’s decision (reported here) and stated the general principle that "pre-patent issuance defects in the administrative process for applying for a patent cannot be relied upon by an alleged infringer to render a patent void".

New Court Proceedings

For complete details about these pharmaceutical proceedings, click here.

rituximab (RITUXAN): Hoffmann-La Roche v Celltrion

abiraterone acetate tablets (ZYTIGA): Janssen v Teva

bevacizumab (AVASTIN): Pfizer v Genentech, F Hoffmann-La Roche

Selected Rankings