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June 24, 2009 - Volume 8, Number 8 | |
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PMPRB Releases Revised Compendium of Policies, Guidelines and Procedures
The Patented Medicine Prices Review Board released its Revised Compendium of Policies, Guidelines and Procedure on June 9, 2009. The Board largely adopted the proposals set out in the consultation document released in March 2009. New changes in the final version of the Guidelines include a list of publically available price sources, revisions to the Board's mandate and a modification to one of the price tests. The revised Guidelines will come into effect on January 1, 2010. For more information, please see:
"Federal Conservative "BioCaucus" - An Excellent Step
The federal Conservative Party announced recently that a group of MPs, including the Minister of Industry, Tony Clement, have formed a "BioCaucus" to promote the opportunities and benefits of biotechnology in Canada. The BioCaucus will address the health, social and environmental benefits of biotechnology and advocate for the development of research and educational facilities to attract new investment to enable Canada to continue as a leader in the development of new technologies. We understand that the federal Liberal Party has formed a similar caucus having biotechnology as its priority. The formation of these sorts of focused groups of key influencers recognizes the importance of biotechnology to the growth of Canada's knowledge-based economy. Hopefully, it will stimulate other important constituencies at the federal, provincial and municipal levels to enhance their efforts to create similar focus groups which can be effective facilitators for dialogue around the key challenges which confront Canada's biotechnology sector and the design and implementation of innovative strategies and solutions to address these issues. Effective communication and collaboration among all key stakeholders in the biotechnology sector - within government, academia and the private sector - needs to be a priority and put at the top of everyone's agenda. The creation of these sorts of BioCaucuses by political parties sends a strong signal and is a welcome development. It is an important step in the right direction towards putting sufficient resources and effort into realizing the enormous potential that the Canadian biotechnology industry offers." For more information, please see:
Canada Losing Biotechnology Companies and Employees
Recently, Public Policy Forum, an independent organization that promotes policy choices in Canada, convened a roundtable discussion on the future of biotechnology in Canada. During the meeting BIOTECanada launched its blueprint for Canada to become the world's leading bio-economy. The roundtable highlighted that biotechnology is an important part of Canada's economy. In 2007-2008 biotechnology represented 6.4% of Canada's gross domestic product outpacing the automotive and aerospace sectors. Despite the importance of biotechnology to Canada's future, Canada's support for bio-based industries is slipping. This coupled with the global recession means that Canada is losing companies and people to other countries. In May alone, it was estimated that the Canadian biotech-industry work force was cut by 8%. The roundtable suggested several ways of preventing the loss of biotechnology companies and people including providing short term financial support to enable biotechnology companies to weather the current global recession. For more information, please see:
FTC Report on Follow-on Biologics
Earlier this month, U.S. lawmakers debated the key issue of the exclusivity period afforded to biologic drugs - those drugs manufactured using living tissue and micro-organisms. The hearing was called to discuss a Federal Trade Commission (FTC) report "Follow-on Biologic Competition" released on June 10, 2009. The FTC report summarized conclusions following public roundtables and comments, and suggested that competition for follow-on biologics (FOBs) would be lower than for regular generic drugs because of the substantial regulatory and manufacturing costs for FOB approval, lack of automatic substitution with the innovator product, concerns regarding safety and efficacy, and various existing innovator marketing strategies. The FTC had concluded that the 12- to 14-year regulatory exclusivity period was too long to promote innovation because of anticipated retention of market share even upon FOB entry, and suggested a 180-day exclusivity period for a first generic akin to the Hatch-Waxman model. An important aspect of the debate was the ability of biotechnology companies to recoup their costs, with some challenging the industry claim that the 12- to 14- year exclusivity period was required. Others were disappointed by the failure of the committee to bring in scientific experts on issues of safety and efficacy. Based on the FTC's report, only drugs with an excess of $250 million of annual sales would attract FOB competition, with only two or three generic entrants. The full FTC report can be found at:
Recent Cases
Celgene v. Canada; judicial review of a PMPRB decision; 2009 FC 271; thalidomide; March 17, 2009 Celgene is the current owner of several patents relating to thalidomide. It does not have full market authorization from Health Canada to market or sell the product in Canada. However, Celgene's Thalomid thalidomide product is approved for market in Canada by way of the Special Access Program (SAP). Under the SAP, a Canadian doctor makes a request to Health Canada for authorization to treat a patient with Thalomid. When that authorization is granted, Celgene in the United States packages the product and ships it free-on-board directly to the medical practitioner in Canada. An invoice is sent instructing that payment is to be made in U.S. dollars and couriered to Celgene in the U.S. No Canadian taxes are paid on the transactions and all shipments from the U.S. have U.S. packaging and labelling. The drug is never redistributed in Canada and all unused portions are to be returned to Celgene. The PMPRB asserted jurisdiction over these sales. The Board found that the locus of the sale was a commercial choice and not determinative of its jurisdiction. The Board reasoned that it was not Parliament's intention to leave medicine purchasers who are in Canada without the price protection of the Board. Upon review, the Court held that the Board does not have the jurisdiction to regulate these sales. The Patent Act serves a public policy function but functions within a commercial reality. A market in the commercial sense cannot exist without a buyer and a seller. Thus, for the market to exist in Canada, the purchase and sale must both be in Canada. Furthermore, there was no evidence that an object of the Patent Act is to provide jurisdiction over sales of medicines outside of Canada. Thus, the Court held that the Board's opinion was without basis in law. A textual, contextual, and purposive analysis of section 80(1)(b) of the Patent Act does not support the Board's opinion of its own jurisdiction. Thalomid is sold to Canadians but the medicine is not sold in any market in Canada. Thus, these sales are not within the jurisdiction of the Board. The full text of the decision can be found at: Pfizer v. Novopharm; 55.2 decision; 2009 FC 638; sildenafil; June 18, 2009 The Federal Court granted prohibition in respect of a patent claiming the use of sildenafil for the treatment of erectile dysfunction by oral administration. The patent had previously been challenged by another generic company, with an allegation that the patent was invalid for obviousness, anticipation and failure to meet the requirements of the legislation. The Trial Division in that previous case granted prohibition, which was upheld by the Court of Appeal. In this case, Novopharm also alleged the patent was invalid for obviousness. The Court considered Novopharm's evidence and found that Justice Mosley's previous conclusions on obviousness were comprehensive and that the Novopharm allegation was unjustified. The Court found the allegation of inutility to be not justified, holding that there is no requirement in patent law that evidence of utility must be included in the patent. It is sufficient that the patent states that the invention has been demonstrated to be useful and that the patent holder can show evidence of demonstrated utility if validity is challenged. Further, a study demonstrating utility does not need to meet the standards required for regulatory approval. The Court did not consider sound prediction on the basis that utility had been demonstrated. The Court also refused to invalidate the whole patent on the basis of inoperability of certain compounds. It applied s.58 of the Patent Act and found that inoperative species do not affect the validity of other claims where the compound works as promised. The Court also found the allegation of insufficiency not to be justified, holding that an insufficiency attack will only succeed where a person skilled in the art could not put the invention into practice. The patent contained a statement that one of the especially preferred compounds induced penile erection in impotent males. However, this compound was not explicitly identified in the patent. There were only 9 compounds in the list of those especially preferred. Furthermore, the importance and value of the patent should not be invalidated by such an objection 13 years after the patent was laid open for public inspection. The credibility of the sufficiency allegation was undermined by its timing. The Court accepted expert evidence that the skilled reader would know that one of the two single compounds claimed in claim 6 or 7 were one of those compounds that worked. Thus, the allegation based on insufficiency is unjustified. However, the Court made a number of obiter statements inviting the Court of Appeal to comment on this reasoning. The full text of the decision can be found at: sanofi-aventis v. Laboratoire Riva; appeal of an application to quash an NOC; 2009 FCA 169; ramipril; May 26, 2009 The Court of Appeal upheld the decision of the Trial Division refusing to quash the decision of the Minister of Health to issue a Notice of Compliance. The underlying decision is summarized here. Pharmascience was prohibited from bringing its generic ramipril product to market under the NOC Regulations. Riva cross-referenced Pharmascience's submission. However, after the Pharmascience proceeding, another generic company was successful in alleging the invalidity of the patent at issue. Thus, Riva was able to follow that Notice of Allegation and obtain an NOC. sanofi sought to quash that NOC on the basis of the cross-reference. The Court of Appeal found that Riva's ANDS was not so linked to that of Pharmascience that the Pharmascience Prohibition Order should also bar Riva. Furthermore, the Court of Appeal held that Riva did not circumvent the NOC Regulations as it was required to engage them with a Notice of Allegation. Thus, Riva should not be prohibited from coming to market. The full text of the decision can be found at: The full text of the Trial Division decision can be found at: |
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