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February 28, 2008 - Volume 7, Number 3 | |
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Canadian 2007 Venture Capital Performance
Canada's Venture Capital and Private Equity Association (CVCA) and Thompson Financial recently announced that venture capital investment in Canada increased 21% to $2.1 billion in 2007. However, more than 80% of the growth resulted from a significant increase in investment by U.S. venture capital firms in Canadian companies. U.S. firms represented more than 40% of total Canadian venture capital investment in 2007 and more than 50% of investment in Ontario. Biopharmaceutical and other life science investments increased 23% in 2007 to $633 million, compared to $514 million in 2006. Investments were made in 70 life sciences companies over the course of the year. The CVCA also reported that Canadian venture capital firms saw a significant decline in fundraising in 2007. Canadian venture capital firms raised only $1.19 billion, a drop from the $1.64 billion raised in 2006 and the 5th year out of the past 6 that fundraising has declined. In contrast to the Canadian situation, according to The MoneyTree™ Report by PricewaterhouseCoopers and the National Venture Capital Association based on data from Thompson Financial, venture capitalists invested U.S.$29.4 billion in U.S. companies in 2007, an 11% increase over 2006 and the highest investment total since 2001. The life sciences sector set an all time record for venture capital investing with U.S.$9.1 billion in 862 deals, compared to U.S $7.6 billion in 786 deals in 2006. More significantly, U.S. venture capital funds raised U.S.$34.7 billion in 2007. While this is only slightly more than the amount raised in 2006, it represents the highest level of fundraising seen since 2001. In summary, the 2007 results reveal that the Canadian venture capital industry continues to struggle to overcome the sluggishness exhibited since the technology bubble burst in 2001. Instead, venture capital investment growth in Canada is being driven primarily by U.S. funds extending into, and taking advantage of the available opportunities in, Canada. For more information, please see: Product Monographs Now Available on Health Canada Website
By notice dated February 5, 2008, Health Canada has indicated that effective immediately Product Monographs are available from the Health Canada website as part of the information made available from the Drug Product Data Base. This step follows Health Canada's notice in September 2007 indicating that it had planned to host product monographs. For more information, please see: Release of Final Special Access Programme (SAP) Guidance Document
By notice dated January 30, 2008, the Therapeutic Products Directorate (TPD) and the Special Access Programme (SAP) published a final Guidance Document for the industry. The document is a revised version of the draft published for consultation in January 2007. As stated in the notice, the document provides guidance on access to unauthorized drugs through the SAP and clarifies the mandate, intent and scope of the program. Further, the process for requesting a drug through SAP is outlined. For more information, please see: Proposals for the Approval of Generic Biologics Under Consideration
The budget proposed by President George W. Bush on February 4, 2008 included a new authority to approve generic biologics. On February 7, 2008, John Dingell, House Energy and Commerce Committee Chairman, indicated that he was not yet satisfied with any of the legislative proposals put forward to date. In an interview for the Reuters Regulation Summit, he stated "nobody has told me yet that they have something that would really satisfy me. As to, first of all protecting the consumer and assuring that in fact this was identical with the way [the brand name biologic] worked in the body." Three areas which will have to be addressed in any proposal include the (i) market exclusivity to be afforded to the innovative biologics, (ii) the size of the studies necessary to obtain approval, and (iii) interchangeability. For more information, please see: Next Phase in Electronic Review of Drug Submissions
By notice dated February 25, 2008, Health Canada has provided a revision to the Draft Guidance for Industry on Electronic Review Documents submitted as part of the preparation of a new drug submission. The document defines the electronic file requirements and provides guidance on the structure, content and format of electronic information to be included with submissions in the CTD format. This is the latest phase in this project that Health Canada is developing as a phased migration from the current paper-based and proprietary standards to the ICHe CTD specification. Submissions currently in preparation may continue to follow the Health Canada Guidance Documents in effect prior to the date of the release of this notice. However, effective April 1, 2008, all subsequent submissions should be compiled using the most recent revisions to the guidance documents. For more information, please see: Recent Cases Apotex v. Eli Lilly; Appeal of 55.2 Decision; February 4, 2008; olanzapine The Court of Appeal upheld a prohibition order. The issue before the Court was whether the applications judge erred in law in that the issue of sufficiency of disclosure was not before her since it had not been raised in the notice of allegation. The generic company argued on appeal that the issue of sufficiency of disclosure arose as a result of the innovator having characterized the patent at issue as a valid selection patent and in the notice of application and thus the applications judge ought to have addressed the issue. The Court of Appeal dismissed the appeal, upholding the decision of the applications judge who held that sufficiency of the disclosure is a stand alone ground that ought to have been raised in the notice of allegation. The full text of this decision can be found at: Ab Hassle v. Apotex; Motion for Reconsideration of a Final Judgment; 55.2 Proceeding; February 13, 2008; omeprazole The generic company brought a motion asking the Court to reconsider its decision in two proceedings where prohibition was granted and affirmed by the Federal Court of Appeal. The basis for the motion was a decision in a subsequent proceeding, which was also affirmed on appeal. The Court denied the motion. Apotex argued that the Court's analysis of its product in the second proceeding was a substantive finding that Apotex' omeprazole tablets do not contain a sub-coat. Thus that finding should be applied to the sub-coat patents that were the subject of the earlier proceedings. As a result, Apotex argued that the Court should overturn the prohibition orders in the earlier proceedings. The Court held that there is no precedent to re-open a prohibition order because evidence adjudicated in another case relating to another patent appears to be more favourable than the evidence that was or could have been adduced by that party in the earlier case or could have been considered if the party had framed its notice of allegation properly. The Court also found that subsequent judgment in another proceeding is rarely a circumstance that would permit the re-opening of a judgment in an earlier proceeding. If the subsequent judgment results in a change in law, the Court will not re-open an earlier judgment. When the subsequent event is a change in circumstances, the Court is reluctant to speculate as to what may have happened in the earlier event. Finally, the comments of the Court with regard to the content of Apotex' product were obiter to the principal finding. The Court found that in the first of the earlier proceedings, Apotex did not put together a sufficient allegation to put the question of non-infringement into play. In the second proceeding, Apotex failed to persuade the Court that its conduct in the first proceeding did not preclude it from making such allegations. Thus, Apotex is now trying to do what it did not do in the first proceeding and could not do in the second. Thus, the determinations of the Court in the third proceeding do not constitute new matter. 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: Sanofi v. Riva; Motion to Strike; 55.2 Proceeding; January 31, 2008; ramipril The Court overturned a decision of a Prothonotary to strike an application. Riva had cross-referenced the submission of Pharmascience in respect of the ramipril products. Pharmascience had been prohibited by the Courts from coming to market until after patent expiry. Riva was successful in its 55.2 proceeding. The Minister made a decision not to grant an NOC due to the prohibition order against Pharmascience. Riva started a judicial review proceeding against the Minister. However, discussions continued between the parties and the Minister reversed his earlier decision and issued an NOC to Riva. Sanofi-Aventis commended an application seeking to challenge the position taken by the Minister by reversing its earlier position that Riva should be prevented from obtaining an NOC until Pharmascience had obtained its own NOC. Riva successfully brought a motion to strike the application. On appeal, the Court found that it was not clear and beyond doubt that Sanofi had no standing to bring the application. Furthermore, a motion to strike the application is not the stage at which it should be decided whether a "decision" so as to come under the scope of s. 18.1 of the Federal Courts Act exists. These are matters which should be left to the applications judge. The full text of the decision can be found at: Upcoming Conferences April 9-11, 2008: Ottawa Gowlings is sponsoring a litigation workshop and two-day conference on Life Cycle Management issues, April 9 through 11, in Ottawa, in conjunction with the Canadian Institute. Gowlings Partners Jane Clark and Martin Mason will lead the litigation workshop on patent and PMPRB litigation. Gowlings Partner Adrienne Blanchard and Janssen-Ortho's Lesia Babiak will chair the conference. Gowlings Partner Mary Thomson will speak on class action litigation, while Partner Dale Hill will speak on international tax issues such as transfer pricing. For more information, please see: |
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