Federal Court upholds cancellation of reconsideration of Apotex’s ANDS for Apo-omeprazole

The Federal Court dismissed Apotex’s application for judicial review of the Minister of Health’s withdrawal of a notice of compliance (NOC) granted to Apotex Inc. for Apo-omeprazole. Health Canada withdrew the NOC because Apotex had not demonstrated bioequivalence. Health Canada also rejected Apotex’s request for reconsideration. The court found Apotex did not have legitimate expectations that the reconsideration panel would review Apotex’s questions, and the minister did not fetter her discretion in requiring bioequivalence.

Case:                                     Apotex Inc v Canada (Minister of Health), 2017 FC 857

Nature of case:                   Application for judicial review of refusal to reconsider an Abbreviated New Drug Submission (ANDS)

Successful parties:           The Minister of Health and the Attorney General of Canada

Date of decision:                September 25, 2017

Background

Apotex was granted an NOC in 2003 for Apo-omeprazole, pending expiry of the patent covering the innovator’s product. However, Health Canada later revoked this approval as the ANDS did not include a study showing bioequivalence under specific feeding circumstances. Health Canada requested this study, but Apotex instead brought an application for judicial review on the basis that it had a vested right in the NOC.

The Federal Court dismissed Apotex’s application because it was out of time and held that there is no vested right until an NOC is issued. The Federal Court of Appeal upheld this decision.

Apotex refiled its ANDS for Apo-omeprazole in 2013 with the required study, but the minister again did not issue an NOC because of concern that the study was poorly designed. Apotex requested reconsideration of the minister’s decision on the basis of safety and efficacy. The minister’s position was that the issue for reconsideration was bioequivalence, and cancelled the reconsideration process after the parties were unable to agree. Apotex then commenced this application for judicial review.

Apotex alleged the minister fettered her discretion in requiring the reconsideration process to focus on bioequivalence, and it had a legitimate expectation to a reconsideration process dealing with the issues that Apotex put forth.

No legitimate expectation

The court found Apotex had no legitimate expectation that the minister’s discretion would be exercised in its favour. Justice Roy held that Health Canada’s reconsideration policy does not contemplate a process where the reconsideration panel will consider any issues raised by the manufacturer, and Apotex had been given a fair opportunity to draft an eligible reconsideration question.

No fettering of discretion

The court found the minister did not fetter her discretion by requiring the reconsideration panel to apply Health Canada’s bioequivalence guidelines. Justice Roy held that under the Food and Drug Regulations, the minister did not have discretion to not consider bioequivalence. Although the bioequivalence requirement is absolute, the minister did not restrict how bioequivalence should be assessed.

The court also dismissed Apotex’s argument that other products had been approved without strictly meeting the bioequivalence criteria of the guidelines. Justice Roy found that the examples put forward by Apotex showed bioequivalence remained the requirement for an ANDS, and the minister had been flexible in applying this requirement. In these prior cases, Apotex had obtained approval after supplementing deficient studies, but chose not to do so for Apo-omeprazole.

Link to decision:

Apotex Inc v Canada (Minister of Health), 2017 FC 857

Bill 148 : A Bill to limit generic medication procurement by owner pharmacists

Bill 148, An Act to regulate generic medication procurement by owner pharmacists and to amend various legislative provisions, was tabled in the National Assembly on October 5. It will amend An Act respecting Prescription Drug Insurance, introducing the Regulation to govern generic medication procurement by owner pharmacists. The new Regulation will provide, subject to certain exceptions, that an owner pharmacist may not, in a given calendar year, procure generic medications from the same manufacturer for an amount in excess of 50% of the monetary value of all the generic medications purchased by that pharmacist during that year.

Pharmacists will have to report annually on their purchases of each brand of generic medication. The Bill also will provide for fines of up to $100,000 for owner pharmacists who fail to comply with the new Regulation.

The Bill has been referred to the Committee on Health and Social Services for special consultations, with public hearings scheduled for November 7 and 8. Comments on the Bill can be made online, but only until November 8 (see here).

Since 2015, Bills 28, 81 and, most recently, 92 have made significant changes to the way the prescription drug insurance regime is governed in Quebec. The province has given itself the right to enter listing agreements with drug manufacturers, has allowed private insurers to reimburse drug purchases on the basis of the lowest cost alternative on the market, thereby favouring generic over innovative drugs, has given itself the power to issue calls for tenders for listing of drugs, and has introduced new “prohibited commercial practices” transforming the relationships between all the actors in the chain of distribution.  Most of these new measures aimed to reduce the cost of providing public drug insurance. A number were intended to enhance competition in the hope of reducing drug prices and, hence, insurance costs.  Bill 148 appears intended to fit within the latter policy, designed to encourage a multiplicity of suppliers, presumably with a view to increasing competition and, therefore, reducing prices.  Whether this will have the desire effect remains to be seen.  It is also plausible that it might have the opposite effect, forcing pharmacists to diversify their sources of supply even if doing so increases costs.

Patented Medicine Prices Review Board releases its 2016 Annual Report

In its 2016 Annual Report, the Patented Medicine Prices Review Board (PMPRB) provides  a detailed summary and analysis of its findings concerning the 1,435 patented drug products under its jurisdiction. These products represent $15.5 billion in sales and account for 60.8% of all drug sales in Canada.

The 2016 Annual Report reflects the current climate of change at the PMPRB. This includes new strategic objectives and the PMPRB’s Rethinking the Guidelines consultation (reported here), which was put on hold following the close of the stakeholder-feedback process while Health Canada conducts its own consultation on changes to the Patented Medicines Regulations (reported here). The 2016 Annual Report indicates that these amendments are expected to be pre-published in Canada Gazette, Part I, this fall.

Highlights

The 2016 Annual Report includes the following highlights:

  • Price trends. Prices of existing patented drug products were stable versus 2015, while the consumer price index rose by 1.4%. Overall, Canada’s prices are fourth of the PMPRB7 countries (lower than the United States, Switzerland, and Germany).
  • Failure to report, failure to file. There were six failure-to-report incidents and two board orders for failure to file. A judicial review of the PMPRB’s failure-to-file panel decision against Galderma Canada Inc. (reported here) is ongoing. The PMPRB’s failure-to-file proceeding against Baxalta Canada Corporation was discontinued on consent. One failure-to-file matter remains before the PMPRB involving Apotex Inc.
  • New patented drug products. 128 new patented drugs were reported, more than in any other year in the PMPRB’s history.
  • Existing patented drug products. Of the 1,307 existing patented drug products, 89 were the subject of investigations, 39 were identified as patented generic drugs, and 60 were subject to voluntary compliance undertakings (VCUs).
  • The PMPRB received no complaints regarding over-the-counter or veterinary products. As we reported, the PMPRB switched to a complaints-based process for generics in February 2017.
  • During 2016 (up to May 31, 2017), the PMPRB accepted 13 VCUs.
  • Sales growth. Sales of patented drug products grew by 2.6% over 2015, the lowest rate since 2012. Growth was driven primarily by increases in the quantity of new drugs being sold and strong sales for new drugs.
  • Price change by country. Drug prices fell by 0.5% in Canada. According to the report, however, Canadian prices exceed those in all of the additional countries being considered for inclusion in the proposed new list of comparator countries (Australia, Belgium, Japan, Netherlands, Norway, South Korea and Spain).
  • R&D. The R&D-to-sales ratio for 2016 was 4.4%/4.9%.

Link

  • The PMPRB’s 2016 Annual Report can be found here.

Ontario health sector disclosure legislation referred to committee

As we reported, Ontario has introduced legislation that will require pharmaceutical and medical device manufacturers to disclose financial relationships with healthcare professionals and organizations to the government.

The legislation has passed second reading and has been referred to committee.  The Standing Committee on General Government will hold public hearings on November 15, 16, 20, and 22, 2017.

Those wishing to make oral submission must provide contact information by November 8 (to speak on November 15 or 16) or November 15 (to speak on November 20 or 22).  Written submissions will be accepted until noon on November 23, 2017.

Details can be found in the notice of hearing.

Link:

Bill 160, Strengthening Quality and Accountability for Patients Act, 2017

FCA Limits Scope of Dutch Industries and Declines to Invalidate Patent on the Basis of Administrative Non-Compliance with Patent Act in latanoprost s. 8 case

Pfizer Canada Inc. successfully resisted Apotex’s appeal of the Federal Court’s dismissal of Apotex’s motion for summary judgment for invalidity based on a failure to pay the correct “final fee” owing prior to patent grant. The Federal Court of Appeal upheld the lower court’s decision and held that alleged infringers of a patent cannot rely on administrative defects occurring prior to patent issuance to invalidate a patent post-issuance.

Pfizer was represented by Norton Rose Fulbright Canada LLP in this matter.

CaseApotex Inc v Pfizer Canada Inc et al, 2017 FCA 201 (Court File Nos. A-78-16)

Drug: XALATAN® (latanoprost)

Nature of case: Appeal from dismissal of motion for summary judgment to invalidate a patent

Successful party: Pfizer Canada Inc.

Date of decision: October 2, 2017

Background

As we reported, the Federal Court dismissed a motion for summary judgment brought by Apotex that sought to invalidate Canadian Patent No. 1,339,132 (the 132 Patent) in a section 8 action brought by Apotex, with a counterclaim for infringement by Pfizer. The Federal Court substantially relied on the Federal Court of Appeal’s decision in Corlac Inc v Weatherford Canada Inc, 2011 FCA 228 (Weatherford).

On appeal, the Federal Court of Appeal once again rejected Apotex’s arguments, finding they were unsupported by a purposive interpretation of the Patent Act informed by the case law and the evolution of the Patent Act.

Weatherford and Dutch Industries

The FCA in this case addressed two cases relied on by the parties: Weatherford, and Dutch Industries Ltd v Canada (Dutch Industries). It found that Dutch Industries was distinguishable, and agreed with the principles set out in Weatherford.

Dutch Industries was an application for judicial review, and the decision addressed whether or not the Commissioner of Patents had the authority to accept top-up payments for deficient fees in respect of both a patent application and an issued patent.

The court in Dutch Industries found that the commissioner had no discretion to accept top-up payments for deficient fees; however, Dutch Industries did not address the validity of the issued patent as the fees for the issued patent were held to have been made correctly. Further, Dutch Industries was not an action for infringement or impeachment of a patent, and as such the court did not consider whether section 59 provided a basis to void an issued patent on the basis of non-payment of application fees.

The FCA distinguished Dutch Industries as it did in Weatherford. It also reaffirmed the distinction between patent applications and issued patents, and agreed that Weatherford supported that non-compliance with section 73 of the Patent Act was not a basis to invalidate a subsequently issued patent. Rather, section 73 provides for certain requirements during the prosecution of a patent application and its effects are extinguished upon patent issuance.

History of the Patent Act

The court found that the history of the Patent Act sections at issue in the appeal (s. 27, 59, and 73) further supported that Parliament did not intend for all forms of non-compliance with the Patent Act to be a basis to invalidate an issued patent. In particular, the Patent Act uses explicit wording when it intends that matters relating to a patent application can void an issued patent. No comparable wording is found within section 73.

The court also found that both sections 27 and 59 have existed in the Patent Act in substantially the same form since 1869. Accordingly, the court felt bound by the long line of cases starting in 1927 that declined to invalidate patents for non-compliance with administrative requirements relating to the underlying patent applications. Further, the court was troubled by the disproportionate consequence of patent invalidity many years after a payment default of several hundred dollars. It confirmed that courts will apply the law even if it leads to absurd results, but only if it is impossible to interpret the law another way. The court found this not to be such an instance.

This decision confirms that non-compliance with administrative provisions of the Patent Act that do not underlie the heart of the patent bargain, cannot be relied upon by potential infringers as a basis to invalidate patents in the absence of express language to the contrary in the Patent Act.

Links to decisions:

Federal Court confirms innovator must be named as respondent when PM(NOC) Regulations engaged

The applicant brought a judicial review of Health Canada’s decision that its new drug submission triggered the PM(NOC) Regulations, and moved for a confidentiality order. The Federal Court has now upheld a decision requiring notice of the motion to another innovator company, confirming that the second innovator has a legal interest in the determination of the issue under review and must be notified.

Case:                                     Innovator Company v Canada (Attorney General), 2017 FC 864 (Court File No. T-485-17), affirming 2017 FC 548.

Nature of case:                   Appeal of a prothonotary’s decision denying a 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:                September 26, 2017

Background

The applicant’s new drug submission contains information that Health Canada determined makes a direct or indirect comparison to a product for which another innovator has patents listed on the Patent Register.  Health Canada therefore required the applicant to give notice to the other innovator pursuant to section 5 of the Regulations. The applicant disputed the necessity of giving such notice and filed for judicial review.

The applicant (identified only as “Innovator Company” in the decisions) moved for a confidentiality order in respect of its identity, the identity of the drug product, the contents of the submission to Health Canada, and any other information provided in support of the submission.  Innovator Company did not serve notice of the motion on the other innovator.

The Government of Canada responded that the other innovator was a necessary respondent to the application and the confidentiality order could not be granted without notice to the other innovator. As we reported, Prothonotary Tabib agreed, and adjourned the motion until Innovator Company had served notice on the other innovator.

Innovator Company appealed her decision.

Other innovator directly affected

The court rejected Innovator Company’s submission that the other innovator is not a person directly affected by its application for judicial review, unless and until the application failed. The court held instead that Health Canada’s decision that the Regulations are engaged conferred rights on the other innovator, making it a person affected and that there is no compelling reason why a patentee with listed patents should be required to await the issuance of market approval to a competitor before being able to address the issue in dispute in this judicial review.

The court also rejected the argument that alerting the other innovator, a known competitor, of the possible timing of market entry was business information that ought to be protected to prevent unfair commercial use.

The court therefore found that the prothonotary did not err and Innovator Company must serve notice on the other innovator before a confidentiality motion could be considered.

Link:

Innovator Company v Canada (Attorney General), 2017 FC 864

PMPRB applies unknown test against patentee to make excessive-pricing order outside of the Guidelines

The Patented Medicine Prices Review Board (PMPRB) has issued an excessive-pricing order against Alexion Pharmaceuticals Inc. (Alexion) in respect of SOLIRIS (eculizumab) 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.

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. In January 2015 Board Staff filed a Statement of Allegation that the price of SOLIRIS was excessive between 2012 and 2014. These allegations were later amended to include the entire period since launch and the application of the LIPC test. All of the “International Price Comparison” tests are based upon the seven countries listed in the schedule to the Patented Medicines Regulations, i.e., France, Germany, Italy, Sweden, Switzerland, the U.K., and the U.S. As we reported, Health Canada has proposed changes to this list that include removing the U.S. and adding several additional countries.

As we reported, Alexion’s application for judicial review of the decision to allow these amendments was unsuccessful.

As we also reported, Alexion has also applied for a declaration that several of the PMPRB’s enabling provisions in the Patent Act are ultra vires and an order prohibiting the PMPRB from proceeding with the hearing in respect of SOLIRIS. An Order striking Alexion’s application is currently under appeal.

Deviating from the Guidelines: The LIPC Test

The PMPRB’s holding in this case turned on its decision to deviate from the price tests contained in the Compendium of Policies, Guidelines, and Procedures (the Guidelines) and apply the LIPC test. Although this test is not contained in the Guidelines, the PMPRB found that its overriding obligation was to apply a reasonable interpretation of the excessive-pricing factors in subsection 85(1) of the Patent Act to SOLIRIS. On the facts of this case, the PMPRB concluded that this could not be achieved with the Highest or Median International Price Comparison tests (HIPC and MIPC, respectively).

The PMPRB’s decision to apply the LIPC test was based on evidence that it can be assumed Alexion was covering its costs and earning a normal rate of return in the U.K., the country which had the lowest international price. The PMPRB found that given the evidence it heard regarding the significant impact SOLIRIS has on the provincial health-care budgets, there was no reason for Canadians not to benefit from the same price offered to purchasers in the U.K.

For the purpose of applying the LIPC, the PMPRB compared the publically-available ex-factory price of SOLIRIS in each jurisdiction, without regard to discounts or rebates. Although Alexion argued that this factor was unreliable and should be given less weight because it is not based on a comparison of actual prices, the PMPRB held that its methodology was a proper implementation of paragraph 85(1)(c) of the Patent Act.

The PMPRB also rejected Alexion’s argument that its prices were only excessive because of fluctuations in the foreign exchange rate, a factor outside its control for which it said it should not be held responsible. The PMPRB disagreed, holding that the Guidelines properly require patentees to bear the risk of currency fluctuations and provide a mechanism to account for excess revenues resulting therefrom. It held that Alexion bears the responsibility of having failed to do so.

The PMPRB’s order

Although the PMPRB based its excessive-pricing finding on an application of the LIPC test, it did not actually order Alexion to repay excess revenues based upon that test. Rather, the PMPRB ordered Alexion to make payment to the Crown in an amount to be calculated based on the HIPC test. However, it also ordered that the price of SOLIRIS be reduced to the LIPC going forward.

Alexion argued that the excess revenues it was said to have earned were completely offset by four factors, each of which was rejected by the PMPRB:

  • Rebates under product-listing agreements (PLAs). On the facts and evidence of this case, the PMPRB determined that rebates paid to certain provinces under PLAs were not reportable. Notably, as we reported, Health Canada has proposed that the Patented Medicines Regulations possibly be amended to require reporting of third-party rebates, including under PLAs.
  • Credit notes to wholesaler. Alexion argued that it issued credit notes to Innomar, its wholesaler and only “customer” in Canada. The PMPRB rejected these rebates on the basis that Alexion failed to meet its evidentiary burden.
  • Infusion costs included in price. Alexion argued that its contract with Innomar included infusion costs for SOLIRIS. The PMPRB found that Alexion also failed to meet its evidentiary burden on this issue.
  • CPI adjustments foregone. Alexion argued that since it has never increased the list price of SOLIRIS in Canada, the real price had in fact decreased due to changes in the CPI. The PMPRB disregarded this argument, among other reasons because it incorrectly assumed that Alexion would have been permitted to take CPI increases.

The PMPRB’s order requires the parties to submit their calculations of the amount of excess revenues owed to the Crown by October 20, 2017.

It has been reported that Alexion intends to seek judicial review of this decision.

Links

The PMPRB’s decision on the merits can be found here.

Ontario introduces legislation requiring disclosure of payments to physicians

Following a consultation, legislation was introduced in the Ontario Legislature on September 27, 2017 that will require pharmaceutical and medical device manufacturers to disclose financial relationships to healthcare professionals and organizations.

The Health Sector Payment Transparency Act is one of several acts introduced by Bill 160. It will require manufacturers to periodically disclose details about transfers of value, both monetary and non-monetary, including the names of the parties to the transaction, a description of the transfer, and a dollar value for the transfer.  Many of the details, including the frequency and method of reporting are to be prescribed by regulation.

The Act, if passed, will come into force on a date to be set by proclamation.

Links:

Bill 160, Strengthening Quality and Accountability for Patients Act, 2017

Federal Court releases new guidelines for prohibition actions under the amended Patented Medicines (Notice of Compliance) Regulations

As we reported, amendments to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) took effect on September 21, 2017, as part of the broader roll-out of measures implementing the Comprehensive Economic and Trade Agreement (CETA) with the European Union. The amendments introduce significant changes to proceedings under the Regulations, which will now proceed by way of action rather than application.

The Federal Court has now released a Notice to the Parties and the Profession setting out guidelines (the Guidelines) for actions under the amended Regulations. The new Guidelines supersede the court’s earlier Case Management Guidelines for NOC Applications for applications under the new Regulations.

Streamlined process with co-operation expected

The Guidelines confirm that the Federal Court will manage prohibition actions under section 6 of the amended Regulations using a modified version of the rules governing actions.

At the outset of proceedings, parties will be required to make a number of elections. In a letter to be filed with the statement of claim, plaintiffs must indicate whether they renounce the statutory stay. Within 10 days, defendants must serve and file a Notice of Intention to Respond indicating whether they intend to defend by challenging the validity of any of the claims and whether they intend to counterclaim regarding validity. Where invalidity is asserted, defendants must also indicate whether or not they will seek a declaration of invalidity and impeachment.

The Guidelines also make clear that the Federal Court intends these proceedings to move quickly through the court: Trials are to be completed no later than 21 months from the date the action commenced, and are expected to take no more than two weeks. The court also expects parties to “reasonably cooperate and agree on expediting pre-trial procedures.”

Expedited timelines are set out in the Guidelines for case-management and trial-management conferences. In addition, appeals of interlocutory decisions of prothonotaries and judges must now be made directly to the Federal Court of Appeal, and require leave of that court.

Several steps that will streamline the proceeding and limit the evidence required at trial are also set out in the Guidelines, including the exchange of claim charts and discovery plans, pre-trial tutorials for the court, evidence-in-chief to be adduced by way of affidavit, and detailed advance statements for fact witnesses. The court is also encouraging parties to use requests to admit and stipulations to limit the trial time needed for viva voce evidence.

Links

  • The Notice to the Parties and the Profession: Guidelines for Actions Under the Amended PMNOC Regulations can be found here.

Update on utility and the impact of the SCC decision in NEXIUM case

The impact of the Supreme Court’s landmark ruling in AstraZeneca Canada Inc. v Apotex Inc., 2017 SCC 36 (NEXIUM decision) rejecting the “Promise Doctrine” is taking shape in the Federal Court. As we reported, the SCC held that the level of utility required of a Canadian patent is driven by the claims of the patent rather than the description, reversing years of jurisprudence. Recent decisions from the Federal Court of Appeal and the Federal Court have applied the NEXIUM decision. In addition, Apotex has brought a motion to the SCC to have certain issues remanded back to both the Federal Court of Appeal (FCA) and the Federal Court (FC).

FCA reverses lower court decision on utility in dasatinib case

As we reported, in a decision rendered before the NEXIUM decision, the FC dismissed Bristol-Myers Squibb’s (BMS) prohibition application relating to SPRYCEL® (dasatinib), finding that one of the patents had an overarching promise and lacked utility, and the other patent was “obvious to try.”

Post-NEXIUM, the FCA rejected the FC construction of an overarching promise for enzyme inhibition and therapeutic use. Applying the “fundamentally recast” approach to utility set out in the NEXIUM decision for the first time, the FCA first determined that the subject matter of the claim at issue – a “bare composition claim for dasatinib” – is the compound claimed, dasatinib. The FCA rejected Apotex’s assertion that the subject matter  of the claim was “potential therapeutic uses for dasatinib,” as it would be an error to expand the subject matter beyond what the claim states.

The FCA then determined that, as of the filing date, BMS has demonstrated that dasatinib inhibited certain enzymes. This inhibition was referred to in the patent and confirmed by the evidence, and is “doubtlessly a useful discovery.”

The FCA therefore allowed BMS’s appeal relating to this patent and issued a prohibition order. The FCA upheld the lower court’s decision on obviousness relating to the other patent.

Prothonotary rules on pleadings amendments allegedly made in light of NEXIUM decision

In an action relating to lisdexamfetamine dimesylate, Apotex’s statement of claim in this action was filed before the NEXIUM decision and contained “extensive” allegations of inutility. Following the NEXIUM decision, Apotex moved to amend its claim on the basis of NEXIUM and Shire moved to strike all of Apotex’s allegations of inutility.

Prothonotary Tabib described Apotex’s amendments as “slipshod, inconsistent and confusing,” reflecting Apotex’s “refusal to come to terms with and embrace” the essence of the NEXIUM decision and a “fairly desperate attempt to shoehorn Apotex’s promise allegations into each and every ground of invalidity known to law.” However, she allowed many of the amendments, as they were merely a recasting of the existing allegations and did not introduce new facts.

Prothonotary Tabib did not allow Apotex’s amendments relating to s. 53 of the Patent Act. Section 53 allegations amount to an allegation of fraud and state of mind, and require full particulars. She inferred that Apotex had no reasonable basis for the allegations, as it had failed to plead any facts about “any particular state of mind or knowledge in any particular persons at any particular time,” and that is was therefore not in the interests of justice to allow these amendments.

Apotex brings motion to amend and remand in NEXIUM case

On August 29, 2017, Apotex brought a motion to the SCC to have the NEXIUM case remanded back to the FC to determine whether the “unfulfilled promises” found by the trial judge render the 653 patent invalid on the basis of insufficient disclosure, overbreadth and wilful misleading. Apotex claims that this is necessary as no court has ever considered the “promise” of improved therapeutic properties on any of these grounds.

Apotex has also asked for the case to be remanded back to the FCA on the issues of anticipation and obviousness, as the FCA did not consider these issues.

Links:

Bristol-Myers Squibb Canada Co. v Apotex Inc., 2017 FCA 190

Apotex Inc. v Shire LLC et al, 2017 FC 831

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