 |
 |
Pharmacapsules @ Gowlings |
|
| May 8, 2008 - Volume 7, Number 5 | Executive Editor: Jennifer Wilkie, Chantal Saunders | ||
In this issue
Big Pharma Continues to Woo Biotech
Large pharmaceutical companies have continued their pursuit of biotech companies in 2008, maintaining a recent trend of big pharma looking to the biotech sector to find new products and technologies. A number of recent transactions illustrate the activity which is occurring: Takeda Pharmaceutical Company Limited, of Japan, recently announced that it had agreed to purchase Millennium Pharmaceuticals, Inc. for approximately US $8.8 billion. Millennium markets VELCADE® for injection, a novel market leading oncology product. GlaxoSmithKline Plc has signed a deal with Regulus Therapeutics LLC that could be worth up to US $600 million. Regulus, a joint venture between U.S. biotech companies Alnylam Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc., was created to discover, develop and commercialize microRNA therapeutics. The strategic alliance between GSK and Regulus is designed to develop and market new microRNA-targeted treatments for conditions caused by chronic inflammation such as rheumatoid arthritis and inflammatory bowel disease. Merck & Co., Inc. has made very public its intention to try to acquire a biotech company. According to The Wall Street Journal, Merck's CEO has stated that Merck would ideally like to acquire a mid-market company with existing revenue generating products and a research focus complimentary to Merck's research efforts. Last summer, Merck entered into a global collaboration agreement with Ariad Pharmaceuticals, Inc. to jointly develop and commercialize Ariad's novel mTOR inhibitor for use in cancer. Ariad is engaged in the discovery and development of medicines to treat cancer by regulating cell signalling with small molecules. There are just a few recent examples of acquisition activity and strategic joint ventures involving big pharma and biotech companies. The large pharmaceutical companies are looking to fill their product pipelines, particularly as blockbuster drugs come off patent. Biotech companies with innovative and promising products and technologies have become very appealing candidates to help them do so. Notwithstanding the general downturn in acquisition activity due primarily to the ongoing credit crunch, M&A activity in the life sciences sector will likely continue its upward trend. For more information, please see: Splintering Support for the Conservative's Biofuels Program
On April 30, 2008 The Globe and Mail reported that the broad political support for the Government's proposed biofuels program is splintering. Although the Conservative's proposal had initially received support, increasing food costs have caused several opposition MPs to take issue with the Government's Bill C-33, An Act to amend the Canadian Environmental Protection Act, 1999. This Bill will enable the government to regulate renewable content and fossil fuels and mandates the following targets: a 5% renewable content in gasoline by 2010 and a 2% average renewable content in diesel and heating oil by 2012. The Globe and Mail quotes Liberal MP Martin as stating that "Canada should put a moratorium on subsidizing biofuels and should advocate that other Western countries follow suit". NDP MPs also raised issue with the Bill on the basis that supporting biofuels may give rise to a perfect storm resulting in a food catastrophe. In view of these concerns, the Bill has been amended to include a review to be undertaken one year after it comes into force and every two years thereafter on the environmental and economic impacts of the biofuel targets. For more information, please see: Ontario Takes Lead in Global Genetic War with Cancer
On April 29, 2008, ten countries announced a collaborative project called the International Cancer Genome Consortium. The goal of the project, projected to last 10 years, is to find genetic mutations associated with fifty types of cancer. The current member countries are Australia, Canada (represented by Ontario), China, Europe, France, India, Japan, Singapore, the United Kingdom and the United States. Each member country is expected to spend roughly $20-million while collecting samples from 500 patients. In addition to a study on pancreatic cancer, Canada will be storing, collecting, analyzing, and sharing all data. The Ontario Institute for Cancer Research is contributing $30-million and will serve as Secretariat for the project. The Province of Ontario plans to contribute a further $10-million to fund OICR's role. The International Cancer Genome Consortium will amass 25,000 times more genetic data than the International Human Genome Project. For more information, please see: Update on PMPRB Review of Excessive Price Guidelines
In a newsletter released April 30, 2008, the Patented Medicine Prices Review Board (PMPRB) reported on its ongoing review of the Excessive Price Guidelines for patented medicines. This review began two years ago and has been expanded over that time to include most elements of the existing Guidelines and some new issues raised by the PMPRB. The newsletter reports on the Board's response to the 43 submissions it received to a discussion paper issued by the Board on January 31. The Board reported that it intends to move ahead on the following matters, even though the commentary suggests that there was no consensus among stakeholders:
The January discussion paper had also identified a number of regulatory and guideline options to address the issues arising from the Federal Court of Canada decision in LEO Pharma (Dovobet) regarding the reporting of rebates for purposes of calculating the average price of a medicine. Although members of the pharmaceutical industry and some provincial drug benefit plans supported an option to clarify that benefits to third party payers should not be reported, the Board stated that it wishes to give further consideration to this proposal as it does not take the option of regulatory amendments lightly. Similarly, it will defer any decision on guideline options relating to changes in its Consumer Price Index methodology pending further work on the other guidelines issues so that all options can be considered in a more comprehensive manner. Reports of Working Groups on Therapeutic Improvement and International Therapeutic Class Comparison were received by the Board and are now available on its website. A Working Group on Price Tests began meeting during April. The Board has stated that it is committed to complete its guidelines review by the fall of 2008 and to this end, will issue a Stakeholder Communiqué later this spring and will provide a further opportunity for consultation with stakeholders during the summer on a comprehensive package of proposed changes to the guidelines. For a copy of the PMPRB's April 2008 NEWSletter, please visit: Proposed Amendments to the Patented Medicines (Notice of Compliance) Regulations
The Canadian Government published proposed amendments to the Patented Medicines (Notice of Compliance) Regulations ("Regulations") in the Canada Gazette, Part I, on April 26, 2008. The stated purpose of the proposed amendments is to reinforce the predictability, stability and consistency of Canada's intellectual property regime for pharmaceuticals. The proposed amendments were necessary to address the Federal Court of Appeal's ruling in Ratiopharm Inc. v. Wyeth and Wyeth Canada, 2007 FCA 264. In that decision, the Court heard an appeal from a motion to dismiss a prohibition application. The Court considered a patent list that had been submitted prior to June 17, 2006, and held that there was a requirement for a "certain link" between the invention of the patent, the change to the drug effected by the SNDS, and the NOC against which the patent was listed. This interpretation brought the Regulations that applied to a patent on a patent list that was submitted before June 17, 2006, closer to the Regulations that apply to a patent on a patent list that was submitted on or after June 17, 2006. However, when the Regulations were amended in October 5, 2006, there was a clear transitional provision that provided that any patent on a patent list that was submitted prior to June 17, 2006, was to be "grandfathered" in the sense that they would remain subject to the listing requirements as they were interpreted and applied before June 17, 2006. This provision was implemented to minimize market disruption. However, as a result of the Ratiopharm Inc. v. Wyeth and Wyeth Canada decision, disruption certainly resulted and the Government reacted by introducing these new proposed amendments. In the Regulatory Impact Analysis Statement ("RIAS") that accompanies these proposed amendments, the Government acknowledges that Court of Appeal explicitly reversed "its own previous ruling that a patent containing a claim for the medicine in a drug is listed generally against the drug, rather than against the specific submission for a NOC upon which the list is based." The Government has therefore published a number of proposals, including the following:
There is also a proposed amendment to section 6 of the Regulations that would prevent parties from moving to have a prohibition application dismissed on the grounds that a grandfathered patent does not meet the listing requirements under the old Regulations. However, another proposed amendment would prevent this amendment to section 6 from applying to any motion that was brought before April 26, 2008. Therefore, while the Government's stated intention is also to close down further litigation, that intention may still be difficult to achieve. These proposed amendments may change once again by the time they are published and brought into force, so all interested parties will no doubt watch for their publication in the near future, and innovative companies are encouraged to take stock of any patents that have been de-listed to ensure any steps to have them re-listed are addressed in an expeditious manner after the final form of the amendments is revealed. For more information, please see: Major Recruitment Effort at FDA
The Food and Drug Administration (FDA) has launched a substantial recruitment effort in light of an upcoming major expansion. The FDA plans to hire more than 1, 300 biologists, chemists, pharmacologists and other staff by October 2008. The expansion comes in part due to growing pressure from Congress to improve operations and an attempt to alleviate the pressure on current staff. More than 600 of the new positions are being funded by recently authorized higher industry fees. More than 700 additional hires will fill current vacancies; many of which will work in the areas of drug reviews and post-approval monitoring of side-effects. Others will be involved in food and import safety and inspections. Filling the positions could pose a challenge as the recruitment and retention of specialized scientists has proven to be a problem in the past. For more information, please see: Recent Cases Shire & Cephalon v. Apotex; NOC proceeding on the merits; April 25, 2008; modafinil The Court dismissed the application on the basis that the allegation that the patent was invalid due to anticipation, obviousness and inutility was justified. The Court found that the patent was anticipated despite the fact that the alleged anticipatory document did not state the purpose to which the particles of medicine are to be used nor did it disclose a pharmaceutical composition as claimed in the patent. The Court rejected these arguments on the basis that the prior document did disclose a composition said to be useful in therapeutics and that the use of active ingredient was well known. Thus, it appears that the Court is broadening the test for anticipation to allow for the use of knowledge outside of the alleged anticipatory document. In its obviousness analysis, the Court held that one should look at whether there was an inventive step or skill required to arrive at the patent. If such a step is lacking, the Court held there is no valid invention regardless of whether the category is anticipation or obviousness. The Court held that the allegation of invalidity due to the patent being a mere discovery should not be distinguished from an allegation of invalidity due to anticipation or obviousness. It refused to create a new category of invalidity. Regarding utility, the Court held that the patent provided for dosing in the same range as the prior art. The Court held that no "demonstrable safety "innovation" has been shown." Thus the patent was also found to be invalid for inutility. The full text of the decision can be found at: Eli Lilly v. Novopharm; s.6(5)(b) Regulations; Interlocutory Motion; April 18, 2008; raloxifene The Court refused to grant the generic company's motion to dismiss the proceeding relating to one patent for abuse of process. Lilly had been unsuccessful in obtaining a prohibition order relating to the same patent with a different generic company. Before the timeframe for appealing that decision had expired, Novopharm brought a motion to dismiss the within proceeding on the basis of abuse of process, due to the Court's previous decision relating to the same patent. In the interim, Lilly appealed the first decision. Thus, the Court on this motion found that Lilly was not improperly attempting to re-litigate the results of the other proceeding and thus, this proceeding was not an abuse of process. Rather, it was an appropriate exercise of the process provided under the Regulations and consistent with Lilly's rights of appeal in the other proceeding. The full text of the decision can be found at: Apotex v. Canada (Minister of Health) & Servier; Judicial Review of Decision of Minister of Health; April 14, 2008; perindopril In this proceeding, Apotex sought approval for its perindopril products on the basis of a bioavailability comparison to only the 8mg strength of the innovator's drug. It argued that comparisons could then be drawn to the 2 and 4mg strengths on the basis of Health Canada's Proportional Formulations Policy. Due to an unexplained omission, one of the patents on the patent list had not been listed against the 8mg strength of the innovator's tablets. However, the patent was listed against the other two strengths. The Minister decided that Apotex must address the listed patent under the Regulations and Apotex sought judicial review of that decision. The Court found that the Minister's decision was correct. The Court found that the generic company had confused the obligations for bioequivalence with the obligations under the Regulations and the Food and Drug Regulations to make a comparison to the Canadian Reference Product. The Canadian Reference Product is the pharmaceutical equivalent of the product that the generic is seeking to market. Thus, the need to make this comparison for the purposes of the Regulations cannot be overcome by the Minister's Proportional Formulations Policy. Such a result is consistent with the policy of the Regulations. In addition, after commencing this judicial review proceeding, Apotex sent a Notice of Allegation to the innovator in respect of the very patent at issue. Thus, the innovator brought a motion to dismiss the within application as moot. The Court held that it was not prepared to dismiss the application on the grounds put forward in the motion. However, the Court also held that it did not wish to "encourage this kind of multifarious proceedings which consumes the time and resources of the Court and the parties." Thus, the motion was dismissed without costs because the serious issue was raised due to Apotex' action in pursuing multiple remedies concurrently. The full text of the decision can be found at: Mayne v. Aventis; Motion to Set Aside Order of Prohibition; January 15, 2008 The Court of Appeal granted an appeal from an order of prohibition, the decision of the Trial Division granting the order of prohibition was set aside, and the application for a prohibition was dismissed. The patent that was the subject of the prohibition proceeding had subsequently been delisted by the Minister by the time the appeal was before the Court of Appeal. Mayne brought a motion seeking to set aside the order of the Trial Division as there was no longer any basis for the order now that the patent was not on the Patent Register. Aventis responded that the patent was still valid and infringed, and that the order of prohibition should therefore stand. The Court held that the proper remedy for Aventis is by way of infringement action; it cannot have the benefit of a remedy under the Regulations when there is no basis for the remedy in that the patent is not listed on the Patent Register and therefore the Regulations are not triggered. The full text of the decision can be found at: |
|||||||||||
|
|||||||||||
|
|||||||||||