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Pharmacapsules @ Gowlings |
| August 26, 2010 - Volume 9, Number 6 | |
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Natural Health Product Changes
As of August 9, 2010, the NHPD will no longer accept a product licence application (PLA) referring to ingredients that are not listed in the Natural Health Products Ingredient Database (NHPID) or are listed but the use and/or source of the ingredient is different from that listed in the NHPID. Applicants must ensure that both the medicinal and non-medicinal ingredients (NMI) in the product are, in the case of a medicinal ingredient, a NHP substance which meets the definition of an NHP in accordance with Schedules 1 and 2 of the Natural Health Products Regulations (NHP Regulations) and in the case of an NMI, are recognized by the NHPD as an NMI and the use and/or source is acceptable for the NMI before the PLA is submitted. A failure to do so will result in the PLA being rejected. The NHPID lists some ingredients with quantity limits or associated restrictions which must be complied with. In addition the NHPID may also designate certain ingredients as unacceptable for use in NHPs. The listing of an ingredient in the NHPID is not a reflection of safety or efficacy, but rather that the ingredient is one that is acceptable for use in an NHP, in the case of a medicinal ingredient, by meeting the definition contained in the NHP Regulations, and for an NMI, that the ingredient meets the NHPD's definition of an NMI including the purpose and source. If the ingredient to be used is not listed as acceptable in the NHPID, or the applicant's use or source is not one listed on the NHPID, the applicant must send a classification request to the NHPD using a NHPID Issue Form. In the case of a medicinal ingredient, the NHPID Issue Form must be accompanied by evidence that demonstrates that the medicinal ingredient meets the substance definition of an NHP contained in the NHP Regulations. In the case of an NMI, the NHPID Issue form must be accompanied by evidence that demonstrates that the ingredient meets the definition of an NMI with an acceptable non-medicinal purpose and/or source. For information on the NHPID Issue Form or the requirements for listing an ingredient on the NHPID, refer to the Appendix: "Classification of Medicinal Ingredients", Classification of Non-medicinal Ingredients" August 9, 2010, by way of a request to pla.info.dlmm@hc-sc.gc.ca until such time as it is listed on the NHPD website.
Provinces and Territories Discuss Joining Forces to Purchase Drugs at Lower Prices
On August 6, 2010, Canadian Premiers attended their annual Council of the Federation Premiers’ Conference in Winnipeg to discuss a joint alliance among the provinces and territories for purchasing common drugs and medical supplies and equipment for the public sector. By working together, the provinces and territories seek to leverage buying power by having a single entity negotiate drug procurement. The expected cost savings of the combined effort will no doubt have an impact on the profit margins and market shares of pharmaceutical manufacturers. This could place further strain on generic manufacturers in some provinces. Ontario, for example, has recently mandated the reduction of generic drug prices to no more than 25 per cent of the cost of the original brand name medication. British Columbia and Alberta, have also taken steps to reduce their prescription drug costs. The nation-wide move is attributed to rising health-care costs and the growing concern for the future of Canada’s Health Care system. For more information, please see the following link: http://www.theglobeandmail.com/news/politics/provinces-to-team-up-on-drug purchases/article1665258/
Provincial Funding for IVF
Quebec recently became the first the first jurisdiction in North America to offer a government-funded program for in vitro fertilization (IVF). The program will cover up to three IVF cycles and will cost an estimated $80 million over the next few years. While groups representing infertile couples have obviously been very pleased by this decision, it has been criticized by others who point out that Quebec has very poor levels of service for expecting mothers as it is, with a serious shortage of family doctors and gynecologists. In addition, the province is controversially prohibiting patients from paying for the service privately, which has led to further criticism from doctors and operators of IVF clinics. Meanwhile, the UK has cut funding for IVF treatments, putting stricter eligibility criteria in place, a cap of £40, 000 per year and a limit of one IVF cycle down from two. For more information, please see the following link: http://www.vancouversun.com/health/Quebec+cover+vitro+costs+starting+August/3272594/story.html
PMPRB Releases Latest Newsletter
On July 30, 2010, the PMPRB released its latest newsletter. The Newsletter, inter alia, provides a summary of its 2009 Annual Report, which was tabled before the Government on June 16, 2010, and a summary of the status of Board proceedings. It should be noted that a number of the outstanding Board proceedings involve generic patentees who have failed to file. Additionally, of note is that the Board’s redetermination of certain issues ordered by the Federal Court late last year in the Copaxone case has been set down for October 4-5, 2010 (see our previous newsletter discussing this decision here) Further, it is noted that the Celegene case for which leave was accepted by the Supreme Court of Canada has been set down to be heard by the country’s top court on November 10, 2010 (see our previous newsletters discussing the trial decision here and court of appeal decision here.). For more information, please see the PMPRB Newsletter:
Recent Cases
Pfizer v ratiopharm, appeal of decision on invalidity, amlodipine besylate, July 29, 2010 In the Federal Court, Pfizer’s patent for amlodipine besylate was held invalid on numerous grounds, including obviousness. Pfizer appealed and the Federal Court of Appeal (“FCA”) dismissed the appeal. Pfizer had previously developed a maleate salt of amlodipine but it discovered this salt demonstrated processing disadvantages. Pfizer then made and analysed - via a salt screening process - a number of other salts of amlodipine and decided to proceed with and patent the besylate salt. This salt form was eventually sold under the brand name NORVASC. The trial judge held that a salt screen selection process was routine work for the person skilled in the art at the time and held that the result of the salt screening was predictable or obvious to try. Furthermore, the judge held that the skilled person would be motivated to test the besylate salt as this had already been shown to offer advantages over other salts in terms of stability. In dismissing the appeal, the FCA held that the trial judge had provided detailed, cogent and articulate reasons to support his judgment and that Pfizer had failed to demonstrate any palpable or overriding errors. The full text of the decision can be found at: http://decisions.fca-caf.gc.ca/en/2010/2010fca204/2010fca204.html Purdue Pharma v Minister of Health, judicial review of decision of Office of Patented Medicines and Liaison (“OPML”), TARGIN, July 8, 2010 Purdue filed a New Drug Submission (“NDS”) as part of its application for a notice of compliance (“NOC”) to market and sell the drug TARGIN in Canada. Purdue received a NOC in December 2009. Along with its NDS, Purdue applied to list one of its patents (the ‘738 Patent) pursuant to section 4 of the PMNOC Regulations in relation to TARGIN. In June 2009, the OPML advised Purdue that the ‘738 Patent was not eligible for listing on the Patent Register in relation to TARGIN. This was because to be eligible for listing on the Patent Register under s. 4(2)(c) of the Regulations, a patent must contain a claim to the formulation that contains all the medicinal ingredients that are included in the formulation that was approved through the issuance of the NOC. The Federal Court dismissed the application for judicial review. The judge held that the approved dosage form of TARGIN is a delivery system for administering a formulation containing two medicinal ingredients, namely, oxycodone and naloxone. The judge also held that the dosage form claimed in the ‘738 patent is a delivery system for administering a formulation containing oxycodone as the sole medicinal ingredient and that naloxone, for the purposes of the Regulations, is not within the scope of the claim. Thus, the judge held that because the dosage form claimed in the ‘738 Patent and the dosage form that was approved by the NOC issued in respect of TARGIN are delivery systems for administering two different formulations, this fell outside of s. 4(2)(c) which plainly requires the claimed dosage form and the approved dosage form to be the same. To be eligible for listing under s. 4(2)(c) in relation to TARGIN, the dosage form claimed in the ‘738 Patent must include within its scope both of the medicinal ingredients included in the approved dosage form of TARGIN. Purdue has appealed this decision. The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2010/2010fc738/2010fc738.html Sandoz Canada v Abbott Laboratories, appeal and cross-appeal of PMNOC decision, clarithromycin extended-release, June 22, 2010 Sandoz served a notice of allegation (“NOA”) upon Abbott and filed an Abbreviated New Drug Submission (“ANDS”) with respect to clarithromycin extended-release. The ANDS compared Sandoz’s product with BIAXIN XL marketed in Canada by Abbott. The NOA addressed four patents but only three were relevant to the appeal. The judge had held the allegations of invalidity contained in the NOA to be unjustified with respect to Abbott’s ‘266 patent and issued an order prohibiting the Minister of Health from issuing a Notice of Compliance (“NOC”) to Sandoz until expiry of the ‘266 patent. The ‘266 patent protects an extended release formulation of clarithromycin. Sandoz had argued that a prior patent application disclosed an extended release formulation of azithromycin; a drug similar to clarithromycin. Sandoz submitted that as the formulation of the disclosed azithromycin product was almost identical to the formulation of the ‘266 patent (except, of course, for the different active ingredients) the skilled person would have considered it obvious to substitute clarithromycin for azithromycin . The judge disagreed and Sandoz appealed. The Federal Court of Appeal dismissed Sandoz’ appeal and highlighted, from the evidence, a number of differences between clarithromycin and azithromycin that it said did not make substitution obvious. The judge had held that the allegation of invalidity for double patenting in respect of Abbott’s ‘395 patent was justified, notwithstanding that Abbott had dedicated its conflicting patent (‘541 patent) to the public. The dedication had been made by Abbott after the NOA had been served but before the prohibition hearing. The judge held that had the dedication been executed prior to the service of the NOA, Sandoz would have had no ground for alleging double patenting in respect of the ‘395 patent. Abbott cross-appealed this decision alleging, in part, that the proper date for considering the justification of allegations in a NOA is the date of the hearing not the date of the NOA. The FCA referred to various earlier cases (including one, Merck, from the Supreme Court of Canada) and allowed the cross-appeal. The FCA held that the judge had erred and should have considered the status of the ‘541 patent at the date of the hearing - and by then it had been dedicated to the public. So at the hearing the ‘541 patent was to have been read as if its claims had never issued and, as such, had the judge taken cognizance of the dedication she would have concluded that the allegation of double patenting was unjustified. The full text of the decision can be found at: http://decisions.fca-caf.gc.ca/en/2010/2010fca168/2010fca168.html Novo Nordisk v. Cobalt Pharmaceuticals, s. 55.2 proceeding, repaglinide, Aug. 3, 2010 Cobalt served a NOA with respect to repaglinide, the S enantiomer of a previously disclosed racemic compound (the “388 compound”), alleging invalidity of the '851 patent on grounds of anticipation, obviousness and s. 53(1). The Court dismissed the application of Novo Nordisk, finding the allegation of invalidity for obviousness was justified. The '851 patent disclosed that the S enantiomer had suprising pharmacokinetic properties over the R enantiomer and the racemic compound. Cobalt argued that the suprising allegedly advantageous properties constituted an express promise and should be read into the claims covering the S enantiomer compound. The Court disagreed that these advantageous properties should be read into the compound claims, but did note that as these properties are inherent to the compound, they will be taken into account when considering anticipation and obviousness. For anticipation, the Court found that there was no enabling disclosure in either the ’398 patent or the ’331 patent application that defines in clear terms the nature of the pharmacokinetic advantages allegedly possessed by repaglinide. The mere disclosure of the 388 compound and that enantiomers could be separated in the prior art was not an enabling disclosure of the invention. For obviousness, the court applied the Sanofi test and found the allegation of obviousness justified. In particular, she found that it was known as of the relevant date that the 388 compound had hypoglycemic activity, and that such activity likely resided primarily in one of the enantiomers. Further, it was known at the relevant time that the person skilled in the art would know how to prepare substantially pure enantiomers of racemic compounds such as the 388 compound. While this notional person would not be able to predict what the pharmacokinetic properties of any given enantiomer would be, it was known that the pharmacokinetic properties of enantiomers could differ significantly from the racemate and from each other, and that it was therefore important to test them. Thus, while one could not predict the surprising pharmacokinetic properties identified as advantageous with respect to replaglinide, the court considered that it would be “obvious to try” to a person skilled in the art, by June 1991, it was more or less self-evident that repaglinide’s pharmacokinetic properties could well be very different from those of the (R) enantiomer or the 388 compound. Given that the extent, nature and amount of effort required to make repaglinide in the first place was neither prolonged nor arduous, and the methods used and processes followed to test its pharmacokinetic properties were admittedly routine and that there was motivation to investigate, there existed more than the mere possibility that testing the enantiomers of the 388 compound for their pharmacokinetic properties was something that might be worth trying. The Court addressed the s. 53(1) argument due to its potential impact on costs. The Court rejected Cobalt's allegation under s. 53(1), inter alia, on the basis that the alleged omissions were inadvertent and as Cobalt had not squarely put its allegations of omissions to the inventors whom they cross-examined. Further, with respect to criticisms raised with the study in the patent, the court held that the standard for patents should not be equated with regulatory standards. For more information, please see the following link: http://decisions.fct-cf.gc.ca/en/2010/2010fc746/2010fc746.html |
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