- Regulations For Extraordinary Use New Drugs (EUNDs)
- Health Canada Forums this Fall
- Health Products & Food Branch Policy on Counterfeit Health Products
- Guidance Document Relating to Non-Clinical Good Laboratory Practice
- Recent Cases
Regulations For Extraordinary Use New Drugs
(EUNDs)
By: Jennifer Wilkie
Regulations to Amend the Food and Drug Regulations have been published, which would permit a new type of drug submission for certain types of drugs where there is a requirement to provide substantial evidence of safety and efficacy of the drug and, while there are ethical and/or logistical challenges in designing appropriate clinical trials for a small number of emergency use drugs, such as anthrax and pandemic influenza vaccines. The proposed regulations outline inclusion criteria for EUND submissions, as well as the requirements of EUNDs, labelling, post-market safety and efficacy studies and reporting. The intention regulations are intended to replace the current practice of using the Special Access Programme (SAP) to authorize the sale of EUNDs for broad distribution.
The regulatory impact statement notes that the cost to government stakeholders is not expected to be significant, given that their current roles and responsibilities within the existing drug development and authorization framework. It is anticipated that there will be significant benefit to Canadian patients who might use EUNDs, since there would be a pre-market review and enhanced post-market surveillance of these drugs. Further, the proposed regulatory framework would be aligned with the requirements set by U.S. and European regulatory authorities for drugs determined to be EUNDs.
Consequential amendments are proposed for the PMNOC Regulations. These amendments to the Food and Drug Regulations and the PMNOC Regulations have been published in Gazette, Part I, and interested persons may make representations with respect to these proposed regulations within 75 days of March 25, 2010.
For more information, please see the following links:
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-04-03/html/reg3-eng.html
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-04-03/html/reg4-eng.html
Health Canada Forums this Fall
By: Jennifer Wilkie
Health Canada has sent out notices indicating that the Health Products & Food Branch (HPFB) will hold an international regulatory forum in September 2010 relating to medical device regulations in Canada and, in October, and a separate forum in October relating to a workshop on biologics and pharmaceutical regulations in Canada.
The medical device regulation workshop will be held September 20-24, 2010 and will provide an advance examination of the medical device program, with specific focus on quality management systems, inspection and compliance. The workshop on biologics and pharmaceutical regulations in Canada will be held October 18-22, 2010 and will provide a detailed overview of Canadian regulatory process for biologics (including vaccines) and pharmaceuticals throughout the pre- and post-market life cycle.
For more information, please see the following link:
Health Products & Food Branch Policy on Counterfeit
Health Products
By: Jennifer Wilkie
By a document posted May 14, 2010, the Health Products & Food Branch Inspectorate have set out guiding principles of Health Canada's decision making framework for identifying, assessing and managing health risks to identify the issues of counterfeit health products. In the background of this document it is set out that, while these issues of counterfeit health products is infrequent, the document is intended to focus on potential vulnerabilities into the regulated supply chain which includes manufacturing, packaging, labelling, wholesaling, importation, distribution and sale of health products. Counterfeit health products are described as follows:
"A counterfeit health product is one that is represented as, and likely to be mistaken for, an authentic product. Counterfeiting can apply to both branded and generic products, and could relate to a product's identity or source, could include products with the corrected ingredients/components, with the wrong ingredient/components, without active ingredients, with insufficient active ingredients or with misleading packaging or labelling."
The Inspectorate would consider health products to be counterfeit if they are unapproved and fraudulently labelled with respect to identity, composition, origins and/or source, have falsifications which may look genuine or forgeries, i.e. printed. It is known that typically counterfeit products are illegal products which are packaged or marked to indicate they have been legally manufactured by the market authorization holder. It is noted that "diverted products" may be considered counterfeit, if proven to be so. A diverted product is a genuine product manufactured by an authorized manufacturer which ends up on a different market than intended, one for which they are not specifically authorized. Examples include: theft of expired or recalled product, illegal redirection of prescription drugs from legitimate sources.
The policy is noted to cover topics such as policy for compliance, verification and enforcement as required. The Inspectorate also plans to educate the public, health professionals and members of the supply chain of the risks of counterfeit products.
For more information, please see the following link:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/activit/pol_0048_counterfeit-contrefacon-eng.php
Guidance Document Relating to Non-Clinical Good
Laboratory Practice
By: Jennifer Wilkie
On April 30, 2010, Health Canada released a finalized guidance document relating to non-clinical laboratory study data reporting drug product applications and submissions: adherence to good laboratory practice. The documents stated to apply to all sponsors to submit non-clinical study data from a clinical trial application and other various applications and non-clinical studies include all in vitro and in vivo testing not involving human subjects performed to determine the safety of human drugs. It is noted that the final guidance documents addresses comments received as a result of the August 27, 2009 to October 26, 2009 consultations on the draft guidance. The document is effective April 30, 2010.
For more information, please see the following link:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/glp_bpl-eng.php
Recent Cases
By: Scott Foster
Pfizer v. Novopharm, interlocutory motion in PMNOC Regulations case, pregabalin, April 14, 2010
Novopharm served a NOA on Pfizer which it had designated confidential. Novopharm then brought a motion to have the NOA sealed in the Court record to try and keep the NOA confidential from other generic drug manufacturers - some of whom were already seeking a NOC and some of whom might subsequently seek a NOC for their own pregabalin product based upon the information in Novopharm's NOA.
In seeking the order, Novopharm wished to deny its competitors the opportunity to rely upon the substantial investment of time and effort Novopharm had expended in creating the NOA. While Novopharm conceded that the constituent parts of its NOA were not confidential, it sought the motion to protect the entire NOA which it said is potentially very useful to its competitors – affording them the opportunity to springboard onto the pregabalin market.
The Court rejected Novopharm's motion. In reaching its decision, the Court noted that there is no precedent for designating a NOA confidential in the manner which Novopharm sought. The Court highlighted the importance of the rule that court proceedings should be open and subject to public scrutiny. What Novopharm was seeking would, in effect, require the hearing on the merits, or an interlocutory matter, to be decided in camera. Absent, special reasons to justify such measures, the Court was not inclined to make a confidentiality order.
For more information, please see the following link:
http://decisions.fct-cf.gc.ca/en/2010/2010fc409/2010fc409.html
Novopharm v. Eli Lilly, appeals of decisions of the Case Management Prothonotary, atomoxetine, April 7, 2010
Eli Lilly appealed two interlocutory decisions made by the Case Management Prothonotary. Both appeals were dismissed. The first appeal challenged the decision of the Prothonotary to allow Novopharm to amend its Statement of Claim. By the amendment, Novopharm was permitted to plead additional prior art in support of its anticipation allegation. The Court agreed with the Prothonotary that the new evidence was potentially significant and dismissed the appeal thereby allowing the amendment.
The second appeal was on Eli Lilly's motion for production of a prior art search conducted by one of Novopharm's expert witnesses. The Prothonotary denied Eli Lilly's motion. The Court agreed with the Prothonotary and held that the motion was attempting a form of discovery of an expert which is not available under the Federal Court Rules. The Court also referred to a case where Justice Hughes held that the decision of a Prothonotary on the scope of discovery in a particular case should not be disturbed unless a clear error as to law or as to the facts has been made, or the matter is vital to an issue for trial.
For more information, please see the following link:
http://decisions.fct-cf.gc.ca/en/2010/2010fc368/2010fc368.html
AstraZeneca v. Apotex, interlocutory motion to strike affidavit in PMNOC Regulations case, esomeprazole magnesium, April 21, 2010
This was an appeal to the Federal Court of Appeal (FCA) of the decision of Justice Hughes refusing to strike an affidavit from the record. The affidavit indicated that Apotex had decided to only use one of the two suppliers it had identified in its ANDS. A portion of the ANDS was disclosed in Apotex's NOAs. AstraZeneca said that the affidavit indicated a significant change to the source of Apotex's drug substance set out in its NOAs and that Apotex should therefore withdraw the NOAs and initiate fresh ones. The FCA dismissed the appeal because the change of source of the drug substance (from two possible suppliers to one) did not materially alter the NOAs but narrowed them.
For more information, please see the following link:
http://decisions.fca-caf.gc.ca/en/2010/2010fca111/2010fca111.html
AstraZeneca v. Novopharm, appeal of decision to strike Statement of Claim, rosuvastatin, April 22, 2010
This was an appeal to the Federal Court of Appeal (FCA) of the decision of Justice Hughes to strike AstraZeneca's Statement of Claim. The FCA agreed with the Judge that the allegation of infringement by Novopharm was not based upon an evidentiary foundation and was therefore an abuse of process by AstraZeneca. The FCA referred particularly to AstraZeneca's submissions that its position would be fleshed out upon discovery and went on to confirm that such "fishing expeditions" are not acceptable. The FCA also held that the pleaded allegations of future infringement by Novopharm were too speculative to be pleaded – such allegations need to be more than a mere possibility.
For more information, please see the following link:
http://decisions.fca-caf.gc.ca/en/2010/2010fca112/2010fca112.html
Pfizer v. Apotex, PMNOC Regulations decision, latanoprost, April 26, 2010
Apotex alleged in its NOA that Pfizer's patent was invalid for double patenting, anticipation, obviousness, lack of utility and over-breadth. The Court rejected the allegations of invalidity as well as Apotex' allegation of non-infringement of its product, APO-latanoprost.
The decision highlights the importance of determining correctly what is the inventive concept of a particular patent. This is necessary because it primarily determines the proper approach to take with many of the allegations such as anticipation, obviousness and utility. In this decision, the Court held that Apotex had based its allegations on a premise which the Court did not agree was sound. The Court therefore concluded that arguments made by Apotex founded on this premise could not have succeeded.
Of particular interest in this case was two creative arguments raised by Apotex in relation to the allegation of anticipation. However, both arguments failed to convince the Judge. The first was to suggest that Pfizer's inclusion of a particular patent (which was cited by Apotex in the NOA as prior art) on the Form IV Patent List was an admission by Pfizer that the prior art disclosed a substance which anticipated the patent at issue. In dismissing the submission, the Court noted that there is no jurisprudence in support of what Apotex was seeking. The second argument was to try to persuade the Judge that the patent at issue was a selection patent over a particular piece of prior art. This ground, if accepted by the Judge, would have allowed Apotex additional arguments in support of its anticipation allegations. However, the Judge declined to make such a finding because, primarily, Apotex had not alleged such a ground in its NOA.
For more information, please see the following link:
http://decisions.fct-cf.gc.ca/en/2010/2010fc447/2010fc447.html
AstraZeneca v Novopharm, motion to adduce video-recordings of cross-examinations of expert witnesses in a PMNOC Regulations case, rosuvastatin, March 11, 2010
AstraZeneca brought a motion seeking an order that video-recordings of cross-examinations of expert witnesses in the proceedings be filed as part of the Application Record and available at the hearing. Novopharm did not object to the recordings being made but objected to them being filed with the Court. In short, AstraZeneca's submissions were that the video-recordings were superior when compared to a paper transcript and would enable the Court to better understand the scientific evidence of the expert witnesses and also enable the Court to assign the proper weight to the particular evidence given. The Judge declined to grant the motion as AstraZeneca had failed to convince him that anything other than the usual approach in PMNOC proceedings, where the application is determined upon the written record, was necessary. The Judge was of the view that the written record was an adequate basis and the presentation of the evidence by any other means (such as video-recordings) was unnecessary.
For more information, please see the following link:
http://decisions.fct-cf.gc.ca/en/2010/2010fc276/2010fc276.html
Apotex v Sanofi, case management directions on the late disclosure of documents or information, clopidogrel, April 30, 2010
Prior to a case management conference within a streamlined case, the Prothonotary ordered the parties to make submissions at the conference on the question of whether a date should be set after which the parties required either consent of the other party or leave of the Court to serve a supplementary affidavit of documents or a corrected or completed information in answer to a discovery question. Counsel for Sanofi agreed to the measure, but Apotex objected saying it was unnecessary and if a dispute arose it could be settled at trial.
The Prothonotary acknowledged that late disclosure of documents or information can often prejudice the other party and although the Federal Court Rules were designed to prohibit "trial by ambush" the late disclosure of documents or information could effectively achieve the same result. She then explained that the usual remedy in a situation like that was sometimes inadequate - the receiving party wishing to object to the late disclosure of documents or information was often required to do so at trial. The result of this was that – if justice between the parties required the late evidence to be accepted – often the trial would have to be adjourned to allow for further discoveries or additional expert reports.
The Prothonotary made an order setting deadlines after which the parties required either consent of the other party or leave of the Court to serve a supplementary affidavit of documents or a corrected or completed information in answer to a discovery question. Her stated objective was to ensure, as far as possible, that disputes as to the disclosure of documents or information would be dealt with in a timely fashion. Her intention was to promote early identification and disposition of issues of admissibility related to late disclosure. This would free up trial time and possibly avoid adjournments.
In choosing an applicable date, the Prothonotary elected for a date that would roughly coincide with the date on which the last of the rebuttal expert reports would be served and filed. She reasoned her choice by explaining that by this date the parties should know with great precision on what documents and information they might wish to rely on at trial and so fully appreciate the consequences of any incomplete and inaccurate disclosures they might have made.
For more information, please see the following link:
http://decisions.fct-cf.gc.ca/en/2010/2010fc481/2010fc481.html
Celgene Corporation v Canada (AG), Supreme Court of Canada grants leave to appeal, Thalomid, April 22, 2010
The Supreme Court of Canada has granted Celgene Corporation's application for leave to appeal the decision of a majority of the Federal Court of Appeal regarding the jurisdiction of the Patented Medicine Prices Review Board.
In a decision dated December 23, 2009, the Court of Appeal overturned the decision of the Trial Judge and restored the decision of the PMPRB providing jurisdiction to the PMPRB over medicines imported under a Special Access Programme authorisation issued by Health Canada. The Court of Appeal held that the only question before the Board was whether the medicine was being "sold in any market in Canada" within the meaning of paragraph 80(1)(b) of the Patent Act. If it was, the Board could require the patentee to provide pricing information about the medicine and make a remedial order regarding the pricing.
The Court of Appeal concluded that the phrase should not be interpreted with reference to common law commercial principles for determining the location of a sale (such principles would find that the sale of Thalomid occurred in New Jersey), as the price regulation provisions of the Patent Act are for the protection of consumers. The Court of Appeal looked at the purpose of the legislation and held that it is part of a regulatory scheme administered by a specialized tribunal to prevent the abuse of the market power created by a patent through the charging of excessive prices for medicines used to treat patients in Canada. Thus, the Court of Appeal agreed with the PMPRB's interpretation of the phrase "sold in any market in Canada" as enabling the Board to oversee the prices of medicines in Canada either generally or in specific markets, including purchasers receiving medicines through the Special Access Programme. The Court of Appeal held that the location of the market is determinative (i.e. Canada) rather than the location of the sale itself (i.e. New Jersey).
In his dissent, Justice Ryer found that the majority had improperly emphasised the location of the market rather than the location of the sale of the medicine, effectively rewriting "sold in any market in Canada" as "sold into any market in Canada". He went on to hold that as Thalomid was sold by Celgene Corporation in New Jersey directly to physicians in Canada, its sale would not come under the pricing controls of the Board.
For more information, please see the following link:
http://scc.lexum.umontreal.ca/en/news_release/2010/10-04-22.3a/10-04-22.3a.html
Sanofi v ratiopharm, PMNOC Regulations decision, irbesartan, March 5, 2010
Sanofi sought an order prohibiting the granting of a NOC to ratiopharm. There were two patents in issue but Apotex accepted that a NOC could not issue until one of the patents expired in March 2011. With respect to the remaining patent, the Judge held that Apotex' allegation s of invalidity and non-infringement were justified.
Several claims were in issue in the case. Claim 1, upon which a number of the claims were dependant, was for a pharmaceutical composition with a given dissolution profile. Sanofi argued that the required dissolution profile was a limitation on the formulation whereas Apotex argued that it was a promise of performance. In the end, the Judge decided that distinguishing between the two was not necessary as the allegation of invalidity was justified on either interpretation. Given the overlap of evidence and arguments in the case, the Judge declined to assess the numerous grounds of invalidity independently (in "watertight compartments") and instead preferred the "seamless garment of law" approach adopted by Justice Harrington in an earlier case. The allegation of invalidity was found justified on the grounds of being obvious to try, because of the breadth of the claims and lack of utility or sound prediction.
In considering the allegation of non-infringement, the Judge had to consider whether a particular excipient (the name of which was redacted for confidentiality) in ratiopharm's formulation was a diluent. This issue arose because the excipient used by Apotex was multi-functional within the formulation. The Judge held that in circumstances like this it is appropriate to ascribe to the excipient its primary role within the formulation. In doing so, he concluded it was not a diluent and therefore the allegation of non-infringement of Apotex's formulation was justified.
For more information, please see the following link:
http://decisions.fct-cf.gc.ca/en/2010/2010fc230/2010fc230.html
Merck v. Pharmascience, PMNOC Regulations decision, finasteride, May 11, 2010
The Court, in a lengthy decision, dismissed an application for prohibition in respect of the drug finasteride, wherein allegations of invalidity had been raised, including grounds of double-patenting, novelty and obviousness. One claim of the patent was at issue. This claim was written in the Swiss style format and thus the Court devoted many pages to discussion of the history of patent construction, method of medical treatment claims and Swiss style claims and whether they fall within the PMNOC Regulations. The judge ultimately found that the allegations of invalidity were justified with respect to novelty and double-patenting, but not with respect to obviousness.
For more information, please see the following link:
http://decisions.fct-cf.gc.ca/en/2010/2010fc510/2010fc510.html
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