Contents
- Health Minister Urged To Take Action Against Cross-Border Drug Trade
- Court Finds Enantiomer Patent Valid
- Public Involvement In Drug Safety Hearings
- Quebec Class Action Against Generic Drug Manufacturers
- U.S. FDA Issues Final Guidances On Risk Management Of Drugs And Biologics
- WTO, Trips Amendment Deadline Missed
- Court Finds Notice Of Allegation Insufficient
Health Minister Urged To Take Action Against Cross-Border Drug Trade
The Canadian Medical Association, the Canadian Medical Protective Association, the Canadian Pharmacists Association, the Federation of Medical Regulatory Authorities of Canada and the National Association of Pharmacy Regulatory Authorities issued a joint press release stating that they have met with Health Minister Ujjal Dosanjh: "to explore solutions to the concerns raised by the cross-border exports of prescription drugs including the potential effect on the security and availability of affordable drugs for Canadians."
In the press release, the President of the Canadian Medical Association urged the Government to work with the provinces to develop a comprehensive program to monitor Canada's drug supply. The President of the Canadian Pharmacists Association also noted that while Health Canada has a role to play in addressing the issue, the exportation of prescription drugs from Canada is "fundamentally a trade issue".
The health bodies informed the Minister of the various policies and agreements that they have developed to govern the practices of physicians and pharmacists as they relate to the cross-border trade. The groups emphasized that they "have clearly and repeatedly stated that aspects of the practice are unethical and not part of either sound pharmacy or medical practice, which is founded on the sanctity of the patient-practitioner relationship."
The press release quotes the following response from the Health Minister: "It is encouraging to see that the national advocacy and regulatory bodies of the medical and pharmacy professions have come together on this issue...I am working hard with my Cabinet colleagues to take steps to protect the Canadian drug pricing regime and supply, as well as ensure that safe and ethical practices are maintained."
Media reports regarding the press release note that the provinces and the federal Department of International Trade may have to be involved to ensure that Health Canada's policies address the issue. The reports also note that regulators will require assistance in enforcing laws that are adopted to criminalize the cross-border trade.
For more information, please see:
http://www.pharmacists.ca/content/media/newsroom/news_releases/release_d
etail.cfm?release_id=120
http://chealth.canoe.ca/channel_health_news_detail.asp?channel_id=131&me
nu_item_id=4&news_id=13973
Court Finds Enantiomer Patent Valid
In a recent case, the Federal Court issued an order of prohibition for a patent claiming an enantiomer, thereby preventing the generic manufacturer from obtaining marketing approval until the patent expires.
The generic company argued that the patent was invalid for obviousness, anticipation and double-patenting. The Court disagreed and upheld the patent's validity on all fronts.
In considering whether the patent was invalid for anticipation, the Court used the test for anticipation adopted by the Supreme Court of Canada, namely, that a prior publication must contain a clear direction such that "in every case and without the possibility of error" a skilled person would be led to the claimed invention. The skilled person must be able to arrive at the impugned compound the first time he or she tries and every time thereafter. A claim to a specific chemical compound cannot be anticipated by a prior art reference, which only teaches a broad genus of compounds.
The Court then assessed obviousness as of the date of the invention. Again, the Court looked to teachings from the Supreme Court and the Court of Appeal and held that suggestions and signposts in the prior art are not enough. In order for an invention to be obvious, a skilled person must have known before trying that they could achieve the desired result.
Finally, the Court assessed the issue of double-patenting and held that the allegation of double-patenting added nothing to the argument of obviousness or anticipation. Furthermore, as one patent claimed a genus, and the other claimed a species, the claims were not coterminous. Thus there was no same invention double-patenting.
The full text of this decision can be found at:
http://decisions.fct-cf.gc.ca/fct/2005/2005fc390.shtml
Public Involvement In Drug Safety Hearings
Health Minister Ujjal Dosanjh is asking the Standing Committee on Health to hold public hearings on the issue of making the federal system of approving prescription drugs more transparent and improving warnings about post-marketing adverse events. The review follows the highly publicized withdrawal of an arthritis drug from the market after studies found an increased risk of heart attacks among its users and users of other similar drugs. In his letter to the Chair of the Standing Committee, Dosanjh emphasized that, "Canada must have a system that will make post-market information, including adverse events, more accessible publicly and result in greater safety for potential users of new drugs." Dosanjh requested that the Standing Committee make formal recommendations to the Government on the public availability of post-market drug information.
For more information, please see:
http://www.thestar.com
http://www.hc-sc.gc.ca/english/media/minister/letter1.html
Quebec Class Action Against Generic Drug Manufacturers
In February 2003, a motion for authorization to institute a class action against generic manufacturers of pharmaceuticals was filed in Quebec Superior Court by consumers. The generic manufacturers were alleged to have granted rebates, discounts or other illegal advantages to pharmacists. According to the class of consumers, this behaviour resulted in an increase in the price consumers pay for drugs.
The class requested that the Quebec Superior Court render a preliminary decision as to whether certain rules of the new Codes of Civil Procedure (C.C.P.) governing motions to authorize class action, were consistent with the Quebec Charter of Human Rights and Freedoms. The Superior Court decided not to address this issue, deferring its ruling until after the motions for authorization were heard.
On August 30, 2004, leave to appeal to the Court of Appeal was granted. The issue before the Court stems from the 2003 amendment to the procedure to institute a class action in Quebec which abolished the need to file an Affidavit in support of the Motion, the rights for respondents to cross examine the petitioner and the right for respondents to file a written contestation. The generic manufacturers argued that they will not receive a fair hearing in accordance with the Quebec Charter of Human Rights and Freedoms, which states that all parties have a right to a "fair" hearing in accordance with the principles of fundamental justice. The Court of Appeal of Quebec heard the appeal in early March of this year. A decision is expected in June of this year.
U.S. FDA Issues Final Guidances On Risk Management Of Drugs And Biologics
The U.S. Food and Drug Administration (FDA) recently issued three final guidances based on draft guidances published in May 2004. The final guidances are directed at improving the assessment and monitoring of risks associated with drugs and biological products in clinical development and general use.
The first of the final guidances relates to premarket risk assessment and focuses on considerations for the stages of clinical development of products. It builds on a number of existing FDA and ICH guidances related to preapproval safety assessments.
The second guidance deals with the development and use of risk minimization action plans. It includes a call for broader input from patients, health care professionals and the public when recommendations are made on whether to initiate, revise or end risk minimization interventions.
The third final guidance, addressing heightened postmarketing vigilance, recommends reporting and analytical practices for monitoring the safety concerns and risk of medical products in general use.
For more information, please see:
http://www.fda.gov/bbs/topics/news/2005/NEW01169.html
http://www.fda.gov/cder/guidance/6357fnl.htm
http://www.fda.gov/cder/guidance/6358fnl.htm
http://www.fda.gov/cder/guidance/6359OCC.htm
WTO, Trips Amendment Deadline Missed
Members of the World Trade Organization (WTO) failed to meet a March 31 deadline to make permanent an agreement on access to generic drugs that was reached in August, 2003. The agreement, which permits a temporary waiver of certain obligations under the WTO Agreement on Trade Related Intellectual Property Rights (TRIPS), remains valid pending a permanent amendment.
The temporary waiver permits countries to issue compulsory licences to manufacturers to produce generic drugs to be exported to developing and least developed countries in need of medicines to address public health crises. Developing countries say the 2003 agreement is too restrictive, which may explain why they have not yet used it to obtain medicines. The African Union described the waiver as an interim solution that "can be terminated at any time" and argued that the waiver "can pose problems and obstacles to the realization of the goal of access to affordable medicines".
For more information, please see:
http://news.yahoo.com/news?tmpl=story&cid=1508&u=/afp/20050331/hl_afp/wt
ohealthpharmatrade&printer=1
Court Finds Notice Of Allegation Insufficient
In a recent decision, the Federal Court found for the innovator and issued an order of prohibition. The Court dismissed claims of double patenting raised by the generic manufacturer who was seeking to come to market with a generic version of the innovator's drug.
One patent in issue concerned the use of the medicine for a particular indication. The generic company simply alleged it was not seeking marketing approval for the particular indication covered by the patent. The Court held that the generic product would provide a therapeutic effect equivalent to the innovator product, no matter what indication the drug is used to treat. The Court held that the Notice of Allegation (NOA) amounted to a bald assertion of non-infringement. The active steps that the generic company will take to restrict the marketing of its drug ought to have been in the NOA. As a result, the NOA was deficient and not a NOA as contemplated by the Regulations.
A second patent in issue claimed a genus of compounds. Due to circumstances beyond the control of the innovator, that patent did not issue until 20 years after it was filed. However, the species patent — a subset of the genus patent — issued earlier in time. The generic company tried to argue that the genus patent was invalid due to double-patenting of the species patent. The Court held that there was no "evergreening" and that the claims of the species patent were not obvious, as of the date of invention of the genus patent claims covering the active ingredient. Also, the species patent was patentably distinct from the genus patent.
The full text of this decision can be found at:
http://decisions.fct-cf.gc.ca/fct/2005/2005fc340.shtml
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