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Pharmacapsules @ Gowlings |
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| April 21, 2008 - Volume 7, Number 4 | Executive Editor: Jennifer Wilkie, Chantal Saunders | ||
In this issue
PMPRB Departs from its Guidelines in Determining Price in Recent Decision
In a significant decision dated April 10, 2008, a Hearing Panel of the Patented Medicine Prices Review Board (PMPRB) has ruled that it is not appropriate to apply the PMPRB's Excessive Price Guidelines to assess the pricing of once-daily drugs used to treat attention deficit hyperactivity disorder (ADHD). The PMPRB Guidelines currently establish categories of new medicines that include, among other things, drugs that provide moderate, little or no improvement, and drugs that provide a substantial improvement over existing medications. In the decision, the panel concluded that Adderall XR falls midway between moderate improvement and substantial improvement, thus constituting "a fourth category that, on the findings of this panel, is unique to once-daily medicines for ADHD." A detailed discussion of this decision can be found in the Drug Pricing & Reimbursement Newsletter dated April 15, 2008. For more information, please see: Canada Remains Cost Competitive Leader
KPMG has released the latest edition of its "Competitive Alternatives" publication. This study provides a very thorough comparison of international business locations. Its primary focus is business cost, measuring the combined impact of a variety of significant cost components. The basis of the comparison is the after-tax cost of start-up and operation over a 10 year planning horizon. While many complain that Canada's taxes and social programs make it relatively unattractive to business investment, the KPMG study reveals that Canada is the lowest cost country within the G7, maintaining the leading competitive position it has held for the past few years. On the other hand, the most notable recent cost trend has been the weakening of the U.S. dollar. As a result, the United States has experienced the greatest gain in cost competitiveness within the G7 over the past 2 years. The U.S. is now just slightly more expensive than Canada as a place to do business. On a more positive note, the study shows that, in the past 2 years, Canada has increased its cost competitiveness lead over the European G7 countries. According to the KPMG study, Canada has its strongest results in the research and development sector, including, in particular, biomedical R&D in the biotechnology sector, due in large part to Canadian tax treatment afforded R&D costs. For further information and access to the KPMG study, go to: Manitoba to Halt Internet Drug Trade
The Manitoba Pharmaceutical Association has decided to cease licensing the province's internet pharmacies. The change comes amid concerns over the ability of regulators to oversee the activities of Internet pharmacies, which conduct their business primarily with customers outside of Canada. The move is scheduled to take effect at the end of June this year. For more information, please see: PMPRB Issues Notice of Hearing - Apotex Inc.
The Patented Medicine Prices Review Board (PMPRB) has issued a Notice of Hearing into certain allegations against Apotex Inc. This is the first proceeding commenced by the Board against a generic drug manufacturer. The notice addresses allegations by the Board Staff that Apotex has failed to file information with the Board concerning patented medicines and has failed to file information on total sales and expenditures on research and development which is used by the Board to calculate a patentee's R&D-to-sales ratio. No date has been set for the hearing. For more information, please see: New Bill Allows Government to Monitor Drugs After They Have Been Approved
The Conservative Government has recently tabled new legislation in the House of Commons, which is intended to protect consumers from unsafe products, tainted food and drugs. The proposed legislation will allow the Minister of Health to pull products off the shelf including toys, tainted food and contaminated drugs. The "Consumer Product Safety Act" will allow the federal government to order mandatory recalls of products and includes a new power for the Health Minister to disclose confidential business information without the company's consent if there is a serious and imminent health risk. Included among the proposed amendments is mandatory adverse drug reporting requiring hospitals to report when patients have a negative reaction to drugs. Currently in Canada there is no such reporting system in place. The legislation also includes a new monitoring system to track drugs after they have been approved for sale in Canada. Called a "life-cycle approach," drug companies will now have to continue to file data regarding the safety of pharmaceuticals after they've been approved for sale. For more information, please see: Nanotechnology and Other Scientific Studies Central to India's Future In a recent speech in Toronto at the Canada India Foundation awards, the former President of India, Dr. Abdul Kalam, indicated that the promise for India's future is in nanotechnology, stem-cell research, and other scientific studies. Dr. Kalam noted that the "potential uses are endless" for nanotechnology and, for example, that it may be particularly useful in purifying water, which is of key importance in a country where half the population does not have access to clean drinking water. Dr. Kalam noted that such areas of technology will help boost India's gross domestic product (GDP) which will in turn, together with government funding and partnerships between the private and public sectors, allow further research to continue. In all, if the GDP continues to grow along the path it is currently on, it will allow India to become a developed nation by 2020 and that India is currently on track to meet the goals that Dr. Kalam set out in his 1998 book Vision 2020. For more information, please see: The Future of Vaccines
In a recent article, the future of vaccines is highlighted, in particular, the upturn of vaccines in view of work being done in the areas of biotechnology and molecular genetic technology. The benefits of such technology may be great for long term health needs, but the reality of health care cost constraints on governments may seriously dampen sustained growth of vaccine markets. Steps need to be taken to prevent cost pressures from stamping out an important part of long term health care planning. For more information, please see: Recent Cases Solvay v. Apotex; 55.2 Proceeding; March 6, 2008; pantoprazole, application for prohibition dismissed The Court dismissed the application on the basis that Altana had not proven that the allegation of non-infringement was not justified. Two patents were at issue. One patent claimed novel pharmaceutical compositions combining pantoprazole with a helicobacter-inhibiting antimicrobial agent and the use of such combinations. The second patent claimed formulations of pantoprazole and their uses. With respect to the first patent, the Court found that Apotex planned to market its tablets as a monotherapy and not as an infringing combination therapy. The Court further held that Altana was not otherwise able to show a link between Apotex' actions and its proposed Product Monograph, and the direct infringement that the Court was asked to assume. Thus, the allegation of non-infringement with respect to the combination therapy patent was found to be justified. The dispute with respect to the formulation patent centred on whether pantoprazole would be simultaneously resistant and not resistant to gastric juice, a claimed element. Apotex put forward its master formulation, and evidence from its experts commenting on that master formulation. No samples were part of the case. The Court found that Altana had not established that the NOA was insufficient, and had only raised a vague theoretical doubt as to non-infringement. The Court went on to determine that therefore there was no need to come to a conclusion on the allegations regarding invalidity. The Court's decision in this regard centred on the fact that its comments would be obiter in this case in view of its finding on the allegation of non-infringement but would be used to bind any other current applications involving Altana and another generic company, even if the evidentiary record was different. Finally, the Court also found that it has no jurisdiction to consider issues of eligibility for listing in a hearing on the merits of a 55.2 proceeding. However it did make a number of obiter comments regarding this issue. Such issues must be decided as part of s.6(5) motion. The full text of this decision can be found at: Nycomed v. Novopharm; s.6(5) Motion; 55.2 Proceeding; February 6, 2008; pantoprazole The Court dismissed the application for an order of prohibition on the basis that the patent was not eligible for listing. The Court held that the patent related to new formulations, not new uses. The submission against which the patent had been listed related to new issues, which were disclosed or claimed in the '697 Patent and did not form part of the patented invention disclosed by the '697 Patent. The fact that the words "for the use of inhibiting H+K+-ATPase" are tagged on to the dependent claims does not lead to the conclusion that the invention includes the use of the disclosed formulation. That use was already known as of the priority date, and adding a known use to the claims does not add anything to the invention claimed. The full text of the decision can be found at: Bayer Healthcare v. Sandoz; An Appeal of Judicial Review of a Decision of the Minister; January 23, 2008; drug: ciprofloxacin Bayer challenged the Minister's decision to issue a NOC to Sandoz in respect of vials of ciprofloxacin. The Court of Appeal upheld the decision of the Federal Court to dismiss the application with costs. At the time Sandoz's NOC was issued, Bayer had withdrawn its similar product from the Canadian market. Thus, Sandoz's NOC was on the basis of establishing pharmaceutical equivalents of its product to an innovator product in an equivalent jurisdiction. However, Sandoz's ANDS continued to include reference to Bayer's product in Canada. The Federal Court found that Sandoz did not compare its product to Bayer's for the purpose of showing bioequivalence. The comparison was only for the establishment of a safe limit of a certain impurity. Thus, the Judge made no palpable and overriding error, and his decision was upheld. The full text of the decision can be found at: Nycomed v. Genpharm; s.6(5) Motion; 55.2 Proceeding; March 10, 2008; pantoprazole The second person brought a motion to dismiss the proceeding on the basis that the two patents were ineligible for listing and that in addition, it would be abusive to proceed in respect of the second patent. The Court partially dismissed the proceeding on the basis that the first patent was not eligible for listing, the second patent was eligible for listing and that the proceeding could proceed to hearing on the merits with respect to a second patent. Under section 6(5)(a) of the Regulations, the Court held that the patented invention was a new use of the medicine. However, the submission for a NOC against which the patent was listed related to a combination therapy. Thus, the Court held that the patent was not properly listed against that submission. The second patented invention comprised novel pharmaceutical compositions to treat certain diseases, and included combinations of pantoprazole and another anti-microbial agent. This patent was found to be properly listed against the NOC for combination therapy. The Court went on to dismiss the second part of the motion in respect of the second patent, holding that the standard is very high for a NOC proceeding under the Regulations to be dismissed under section 6(5)(b). These motions are not intended to provide a second opportunity to argue the merits of the case. Substantive arguments regarding validity and infringement are properly raised at the prohibition proceeding and not on motions such as these, except in the clearest of cases. The full text of the decision can be found at: Sanofi v. Riva; 55.2 Proceeding; March 4, 2008; ramipril The Court dismissed an application for an order of prohibition based on non-infringement. The patents at issue relate to the use of the medicine for the management of patients at increased risk of cardiovascular events. The parties agreed there would be no direct infringement. The Court assumed that a patient taking Riva-ramipril for the management of their increased risk of cardiovascular events infringes the patent at issue. The Court also assumed that a prescribing physician or a dispensing pharmacist could be found to have induced that infringement. However, the Court found that infringement by patients, physicians and pharmacists is not contemplated by s. 5(1) of the Regulations. Sanofi-Aventis can educate physicians and pharmacists as to the existence and breadth of its patent rights and demand that those rights be respected. However, unless Riva participates by inducing infringement, the remedy is not to prohibit the Minister from allowing the generic into the market place. The Court commented that infringement by inducement can be established by inferences reasonably drawn in the Product Monograph or from evidence relating to the dosage form of the generic product, its labelling or its marketing. In this case, the totality of the evidence was not conclusive to establish infringement or infringement by inducement on the part of Riva. The full text of the decision can be found at: AB Hassle v. Apotex; Appeal from Interlocutory Motion for Mootness; March 4, 2008; omeprazole After being unsuccessful in a proceeding under the Regulations for an order of prohibition, the generic company started an impeachment action in respect of the same patent. While the action was pending, the patent expired. The patentee moved to have the action dismissed as moot. By this decision, the Court of Appeal granted the appeal and dismissed the proceeding as moot. The generic argued that the proceeding should proceed because if it was successful in this proceeding and another action involving another patent, it would be moving to overturn the corresponding prohibition orders and thus commence a proceeding under section 8 of the Regulations. However, at this time, there were no other live proceedings that would be impacted by the Court allowing this action to proceed. The Court also highlighted that the concern for judicial economy also strongly militates against allowing this action to proceed. The Court commented that infringement by inducement can be established by inferences reasonably drawn in the Product Monograph or from evidence relating to the dosage form of the generic product, its labelling or its marketing. In this case, the totality of the evidence was not conclusive to establish infringement or infringement by inducement on the part of Riva. The full text of the decision can be found at: Les Laboratoires Servier v. Apotex; Interlocutory Motion to Quash Subpoena; March 7, 2008; perindopril Motions were brought to quash seven subpoenas that required five lawyers, a patent agent and an administrative assistant to attend at trial to testify and produce certain documents. The Court quashed 6 subpoenas, and let the final one stand, but only on a limited basis. The subpoenas were related to three issues in the case: inventorship, conspiracy and a correction to a claim. The Court held that each of the proposed witnesses might reasonably be supposed to have information relating to the case. However, the subpoenas, as they related to inventorship and the conspiracy allegations, were so broad as to amount to a fishing expedition. With respect to the correction allegation, the Court had no evidence of the roles that the individuals who had been subpoenaed played other than a general statement of their duties at the time. The Court also held that there was insufficient evidence to demonstrate that Apotex' allegations of conspiracy were made honestly and with sufficient probability of their truth to overcome the privilege that applies. Thus, the only part of one subpoena that was not quashed related to the correction allegation. This was not privileged as it arose in the context of the proposed witness' capacity as a patent agent. The full text of the decision can be found at: Sanofi-Aventis et al. v. Apotex; Interlocutory Motion for Relief from the Implied Undertaking; March 7, 2008; ramipril Apotex sought relief from the implied undertaking to use information learned on discovery of Schering and Sanofi in one proceeding in another proceeding, involving a different party, Servier. The Court refused to grant relief from the implied undertaking except in the limited case of one set of documents, that had been publicly available, were not confidential, but could not be obtained from any other source. With respect to the remainder of the documents sought, the Court held that, as the parties were not the same in both proceedings, there would be prejudice to Servier, as it would be unable to review the entire discovery record in the ramipril case to determine if there was anything to help it respond to the documents adduced by Apotex. Furthermore, Apotex could have sought access to these documents through a number of other methods, and did not. The full text of the decision can be found at: Schering-Plough v. Pharmascience; Interlocutory motion on the 55.2 decision; March 18, 2008; desloratadine The Court granted Pharmascience's motion to strike Sepracor's Notice of Appearance in this proceeding. Sepracor was named as a Respondent Patentee and filed a Notice of Appearance that stated that it would participate in the proceeding. The Court held that Sepracor was properly named as a Respondent. However, the Court also found that a Respondent may not modify the Notice of Appearance prescribed in the rules. Thus, the Notice of Appearance was struck. The full text of the decision can be found at: Pfizer v. Ranbaxy; An Appeal of a 55.2 decision, March 20, 2008; atorvastatin The Court granted the appeal and issued an order of prohibition. Specifically, the Court overturned the trial division's finding with respect to insufficiency. The Court confirmed that the Supreme Court in Consolboard and Pioneer Hi Bred set out the test for the scope and purpose of subsection 27(3) of the Patent Act. The Court also confirmed that there is not a higher level of disclosure required in selection patents. The Court held that a patent must disclose the invention and how it is made. A selection patent should also disclose the advantages that underlie the selection. However, one cannot attack a selection patent on the basis that there is no data to support the advantages. The Court also confirmed that the patent is not invalid for double patenting or anticipation. The full text of the decision can be found at: |
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