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April 7, 2009 - Volume 8, Number 4 | |
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Health Canada Releases Guidance Documents for Subsequent Entry Biologics
Health Canada recently released its new guidance document for Subsequent-Entry Biologics (SEBs). In addition, a final guidance document was released for Data Protection under the Food and Drug Regulations, as well as proposed amendments to the guidance documents under the Data Protection Regulations and the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) to reflect the new SEB guidelines. The Data Protection Regulations and the PM(NOC) Regulations are critical aspects of the SEB regulatory system both for existing biologic therapies and for IP strategies on biotechnology products going forward in Canada. The guidance documents define an SEB as a biologic drug that would enter the market subsequent to, and 'similar' to an innovator product authorized for sale in Canada. The new regulations apply to all biologic drug submissions where the sponsor seeks authorization for sale based on demonstrated similarity to a biologic drug that was authorized for sale in Canada and relies, in part, on prior information regarding the authorized innovative biologic drug in order to present a reduced clinical and non-clinical package as part of the submission. The policy statements included in the new guidance document specifically state that SEBs are not "generic biologics" and many characteristics associated with the authorization process and marketed use for generic pharmaceutical drugs do not apply. Authorization of an SEB is not a declaration of pharmaceutical and/or therapeutic equivalence to the reference biologic drug. An SEB will only be authorized if a submission demonstrates similarity based on a direct or indirect comparison to such an authorized innovative biologic drug. The concept of what an indirect comparison may constitute will no doubt create discussion amongst sponsors looking for approval of SEBs. The basis for a product being authorized as an SEB hinges on the ability to demonstrate similarity to a suitable reference biologic drug. In order to provide flexibility to sponsors, Health Canada has provided a mechanism to be used in appropriate and special circumstances, to permit the use of a reference biologic drug that is not authorized for sale in Canada which can still be used in the demonstration of similarity between the SEB and the product authorized for sale in Canada. However, where a non-Canadian reference product is used, the submission must explicitly and clearly explain the link between the reference product and the product authorized for sale in Canada. If a non-Canadian reference biologic product is considered, the new guidance documents state that non-Canadian product should be widely marketed in a jurisdiction that formally adopts International Conference on Harmonization (ICH) guidelines and has regulatory standards and principles for evaluation of medicines, post-market surveillance activities, and approaches to comparability that are similar to Canada. Finally, in order for a sponsor to sufficiently explain the link between the non-Canadian reference biologic drug and the version of the product authorized for use in Canada, it must document in its submission that the non-Canadian reference biologic drug is marketed by the same innovator company or corporate entity which is approved to market the medicinal ingredient in the same dosage form in Canada, or that it is marketed through a licensing arrangement with the innovator company or corporate entity which currently markets the version of the product approved in Canada. Once a notice of compliance (NOC) is granted, the SEB is a new biologic drug and regulated like any other new biologic drug. Therefore, an SEB cannot be used as a reference biologic drug. Detailed and comprehensive product characterization will need to be provided by a sponsor in order to demonstrate similarity. The following additional criteria will be used to determine the scope of eligible products:
In addition to the requirements which need to be included in the chemistry and manufacturing (C&M) data package for an SEB the regulations also set out the amount and type of data required to demonstrate similarity with the reference biologic drug, including extensive side-by-side characterization of the SEB and the chosen reference biologic drug. A number of quality considerations and characterizations of physical properties for submissions are also outlined in the new guidance documents. For more information, please see:
Natural Health Products Directorate Releases New Policy on the Interface of Food and Natural Health Products
The saga of how to regulate food like NHPs continues. The Natural Health Products Directorate and the Food Directorate, have come out with another policy, entitled "Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats which attempts to provide more certainty to industry in understanding how Health Canada will classify products in food format1, i.e. food or an NHP. The Food-NHP Classicisation Committee (F-NCC), will adjudicate and classify products in food format based on 4 criteria: Product Composition; The policy does not indicate which if any of the criteria have priority over any other criteria and whether the decision will be based on a majority of the four criteria favouring one classification over the other. In addition, the criteria below appear to be best directed to black and white situations, which for the most part is not the case. As such it is suggested that the decision will continue to be resolved on a case by case basis, with little predictability in outcome. Product Composition When a product or ingredient is present solely to provide nourishment, nutrition or hydration or to satisfy hunger, thirst or a desire for taste, texture or flavour (food attributes) then such criteria are indicative that the product or ingredient is a food. Conversely a product that is or has an added ingredient that has no known food purpose, the ingredient has been added for its therapeutic use, then the ingredient or food is likely to be classified as an NHP. Product Representation A product that might for composition or other reasons be classified as a food may nonetheless be an NHP if it represented or sold as a product having therapeutic uses. Claims that provide for a therapeutic use not based on the use of the product as a food, suggests the product is an NHP. Product Format Products sold in a manner that lends itself to dosing, i.e. sold in single dose units for measured amounts, is an indication that product is an NHP. Public Perception and History of Use. If a product has a historical pattern of use as a food or if public perception is that the product is a food, then these are indications that the product is to be classed as a food. This latter criteria appears to be a general catch all, that if desired, would allow the F-NCC to classify a product in a food format as a food. In summary, keep in mind the policy does not provide any guidance on which if any characteristics play a greater role in the classification process, if the ultimate classification is based on a majority of the forgoing criteria pointing one way or the other and how to apply the criteria in situations where the facts are not black and white. While the policy may shed additional light on the classification process in certain cases, unpredictability will remain. For more information, please see: 1. A product is 'in food format" if it is sold in a format and serving size consistent with food use. Examples include chewing gum, hard candies, candy bars, tea, juices and beverage. It is interesting to note that the policy does not address the numerous drug products sold in food format, i.e. chocolate chews, popsicle and fruit juice.
PMPRB Releases Revised Draft Excessive Price Guidelines
On March 26, 2009, the Patented Medicine Prices Review Board (PMPRB), Canada's federal price control body, released a revised draft Excessive Price Guidelines document for comment. This marks the latest in a series of consultation documents released by the PMPRB over the past few years as it has embarked on its plan to overhaul the Guidelines. While comments will be received until April 27, 2009, the PMPRB has indicated that it considers the new Guidelines in nearly final form. For more details, please see:
Recession's Toll On Public And Private-Sector R&D Spending
Along with many industry sectors, the recession is taking a toll on Canada's research industry, particularly the biotechnology industry. A survey of more than 250 biotechnology companies conducted by BIOTECanada illustrates the state of the industry. For example, last year, research capital raised by biotechnology companies fell 41 percent as compared to the year before. This credit crunch is not isolated to the biotechnology industry. Statistics show that this pinch is being felt by industries such as automotive, aerospace, communications and other private-sector research industries. However, amid this negative outlook, there is still a small light at the end of the tunnel. While total research funding is down, the number of companies doing research has doubled (from 10,000 to 20,000) since the 90s. For more information, please see:
Guidance Document: Data Protection Regulations
Health Canada has issued a Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations that outlines how Health Canada will administer the Regulations Amending The Food And Drug Regulations (Data Protection). The guidance applies to pharmaceutical, biological and radiopharmaceutical drugs that receive Notices of Compliance on or after June 17, 2006 (including relevant products for veterinary use but not veterinary biologics). The Guidance Document purports to provide further information as to what is an innovative drug, the scope of data protection for combination drugs, the criteria for the determination of whether pediatric studies will qualify for additional data protection, the applicability of the provisions where the product is withdrawn from the market and the process for assessing whether a drug qualifies for data protection. The Guidance Document is not a legal instrument and does not impose any new obligations regarding data protection. For more information, please see:
U.S. President Obama Appoints Commissioner of the FDA and Creates a New Food Safety Working Group
In his March 14, 2009 weekly address, President Obama announced appointments to the FDA and the creation of a new Food Safety Group. Dr. Margaret Hamburg was appointed as the Commissioner of the FDA and Dr. Joshua Sharfstein was appointed the Principal Deputy Commissioner. Dr. Hamburg has previously served as the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Service, Commissioner of Health for the City of New York and Assistant Director of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. Dr. Sharfstein is the Commissioner of Health for the City of Baltimore. During this address the President also announced the creation of a new Food Safety Working Group which will advise on how food safety laws can be updated and better enforced. The text of the President's remarks is available at:
Recent Cases
Bristol-Myers Squibb v. Apotex; 55.2 Decision on the Merits; 2009 FC 137; cefepime; February 10, 2009 The Court refused to grant prohibition on the basis that Apotex' allegation in respect of invalidity for obviousness was justified. The patent related to a polymorph of cefepime. The Court considered the Supreme Court's tests for anticipation and obviousness pursuant to the new tests articulated by the Supreme Court in Sanofi. After considering the evidence of the parties on anticipation, the Court found that the evidence was contradictory and leads to an inconclusive result. As Apotex bears the burden, on a balance of probabilities, the Court concluded that the patent was not anticipated. However, the Court found that the essential elements of the patent were more or less self-evident having regard to the state of the art. Thus, the allegation of obviousness was justified. Of note, a disclaimer was filed before the commencement of this application but after the NOA was received. The Court held that this disclaimer could not be considered in the context of the proceeding. The Court fixed the date of the NOA as the proper date to construe the claims of the patent at issue. Thus, neither party could rely on the disclaimer to its benefit in the proceeding. The full text of the decision can be found at: Lundbeck v. Cobalt, Genpharm and Apotex; Merits of 55.2 Decisions; 2009 FC 146; escitalopram; February 25, 2009 The Court granted prohibition in respect of each of the proceedings against each defendant. The patent at issue related to an enantiomer of citalopram. The generic companies alleged anticipation, obviousness, ambiguity, a lack of sound prediction, inutility and insufficiency. All allegations were found to be not justified. The Court held that the patent at issue was not a selection patent as it did not have surprising activity over the genus. The Court then considered the law of Sanofi and found that the patent was neither anticipated nor obvious. However, the Court indicated that if it was wrong in deciding that the '452 patent is not a selection patent, it was an invalid selection patent. The full text of the decision can be found at: Pfizer v. Apotex; Interlocutory Decision; s.6(7) of the PM(NOC) Regulations; 2009 FC 226; amlodipine; March 4, 2009 The Court upheld the decision of the Prothonotary refusing further production of ANDS documents. The first patent at issue related to the besylate salt of the product and Apotex' allegation was that its product would not contain that particular salt, nor would the salt be used in the manufacturing process. The second patent related to an enantiomer of amlodipine and Apotex' allegation was that it was not infringing as it was using the racemate. Prior to the motion, Apotex had voluntarily disclosed large portions of its ANDS. The Prothonotary found these portions to be sufficient. The Court held that the issue to be determined by the judge is whether the process Apotex states it will use would infringe, not whether some other process would infringe. Thus, as the process documents Apotex states it is using have been disclosed, it cannot be said that the further documents requested are relevant. The full text of the decision can be found at: Abbott v. Sandoz; Appeal of 55.2 Decision; clarithromycin; 2009 FCA 94; March 20, 2009 The Court of Appeal dismissed the innovator's appeal regarding a finding that the allegation of invalidity was justified. The Court below had found that Sandoz' allegations as to anticipation were justified. The Court had construed the claim to not include the special advantages of Form I clarithromycin as essential elements. The Court of Appeal reviewed this construction and found it correct in law. Further, since the claim of the patent at issue covers any amount of Form I, even when mixed with other form, and since the experts agreed that at least a small amount of Form I would be made when following the teachings of the prior art, the prior art anticipated the patent at issue. The full text of the decision can be found at: |
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