Patents, the charter & a healthy dose of rights in wrongs: the poison is the elixir for life, liberty & security of the person.

• Author: Amani, Bita
• Position: Canada

What is it about our political process that enables legislatures and governments to ignore the most fundamental interests of significant segments of society with impunity? (1)

1. INTRODUCTION

   There are some 3,000-4,000 hereditary diseases related to errors in our genetic code including cystic fibrosis, muscular dystrophy, diabetes and various forms of cancer (breast, stomach, colorectal etc). (2) The Canadian Breast Cancer Foundation estimates that 22,200 women will have been diagnosed with breast cancer in 2006 and 5,300 will die; of the 160 estimated new cases of breast cancer in men, 45 are expected to die. (3) Breast Cancer is a disease that disproportionately affects women, predominately those between the ages of 50-69. (4) Although breast cancer is the most frequently diagnosed cancer among Canadian women, it is also one of the most treatable; deaths could be reduced by one quarter if 70% of women in this age group receive routine clinical breast exams and biannual screening. (5)

   Predictive genetic screening for cancer related genes is an effective and integral part of using new technology to battle cancer. Both the BRCA1 and BRCA2 genes have been linked with the propensity to develop breast and ovarian cancer while HMPPC has been associated with colorectal cancer. The American firm of Myriad Genetic Laboratories Inc. (Myriad), which holds the patents over both the above genes and their diagnostic testing, sought to enforce their exclusive rights in Canada by threatening litigation with cease and desist letters sent to the governments of British Columbia and Ontario in 2001.

   For cancer patients and their political supporters, the exclusive right to control access and set the price for something which already exists as a product of nature makes gene patenting reprehensible and simply wrong. Ontario's then Premier, Mike Harris, refused to back down in response to Myriad's legal threats, saying in a speech to the Ontario Advisory Committee on Predictive Genetic Technology (6) that Canada needs to amend its laws to prevent privatization of human genes and that "[u]like new drugs, genes aren't invented--they are discovered. They have always existed." Additionally, Mike Harris urged that:

   [t]he benefits of a world-wide effort such as the human genome project should not be the property of a handful of people or of companies. Our genetic heritage belongs to everyone. We must share its benefits fairly. We must do what we can to make genetic tests and therapies affordable and accessible ... [i]f we have the ability to save a life, we have a responsibility to do so. (7) Tony Clement, Provincial Minister of Health at the time, consistently defended the position of the Ontario government for its continued diagnostic screening of BRCA1 and 2 despite criticism by industry that this constituted an uncompensated public taking. (8) Clement remained ever mindful of the limited resources and duty of his government to respond to the health needs of its constituents. Ontario continued its testing of Canadian patients in the public health system at approximately one-fifth of the cost without licence. (9) Since then, the Canadian Cancer Society (CCS) has taken the position that it opposes the exclusive rights of gene patent holders if they are used to interfere with an individual's health, impede the development of new knowledge, or restrict Canadian women's access to cancer-related genomie testing. (10)

   While the governments in this case displayed an atypical preference for individual health rights by prioritizing the delivery of public health over private proprietary claims in the field of cancer genomics, nothing today bars the issuing of new gene patents nor is there any comprehensive policy for their regulation. (11) In fact, the Canadian Patent Office (CPO) (12) has long been granting patents on genes from a variety of species, proteins, and micro-organisms without public scrutiny, participatory debate, or attention to the need for cross-policy co-ordination. As the ensuing discussion will show, the validity of gene patents is increasingly at issue within patent law for failure to meet established legislative and doctrinal requirements. As DNA provides genetic information, it has been argued that granting patents for the discovery of genes based on their isolation or purification is actually an inappropriate private taking from the information commons. (13) The Commissioner of Patents nevertheless continues to grant these patents pursuant to his authority under the Canadian Patent Act (CPA). (14) This article addresses potential public authority liability for the granting of gene patents.

   The BRCA1/2 controversy raises important considerations of distributive justice, legal ethics, economics, human rights, social costs related to the patenting of genes, the unintended consequences of legislative inertia, and the need for governmental accountability. Literature dealing with patents and human rights tends to reflect the hegemony of trade and proprietary values by disproportionately focusing on the economic costs of infringement under domestic patent laws and the larger cost of state non-compliance with trade-related patent rights under the World Trade Organization's (WTO) Trade Related Aspects of Intellectual Property Agreement (TRIPS). (15)

   Neither property nor health rights are expressly protected under the Canadian Constitution. Proposed public liability for the breach of an individual's right to health under the Canadian Charter of Rights and Freedoms (16) is, however, a much needed countervailing consideration against the threat of trade sanctions and would help ensure greater domestic accountability over the grant of gene patents which are presumptively valid (17) state granted monopolies that confer enforceable "exclusive" rights for the patent holder (patentee) for twenty years. Constitutional accountability, which has the potential to achieve positive health outcomes, should not be ignored.

   This article fills the scholarly aperture by canvassing the other costs for noncompliance associated with the international human right obligation of health where gene patents are concerned. It does so by engaging in a Charter analysis informed by the Supreme Court of Canada (SCC) decision in Jacques Chaoulli and George Zeliotis v. Quebec (Attorney General). (18) Doctor Jacques Chaoulli and Mr. George Zeliotis challenged Quebec's legislation restricting the ability of Quebeckers to purchase private health care, in order to avoid the long waiting lists in the public system, Zeliotis had suffered a number of health problems which were exacerbated by delays in the public health care system. It has been reported that the waiting list for hip replacement surgery is two years and for radiation therapy after breast-conserving surgery, sixteen weeks. (19) Dr. Chaoulli was a practicing physician whose efforts to get a licence for private operations had met with consistent opposition. The Court of Appeal unanimously upheld the trial judge's finding championed, for the most part, by government experts tauting the propriety of Canadian wait times and the efficacy of the Canadian public health system. They concluded that the contested legislation did not violate either the Federal or Quebec Charters. The Supreme Court of Canada had a different perspective on the matter.

   Only seven of nine members of the SCC sat for the appeal and, in a 4:3 split, the majority held that the contested legislation was impermissibly offensive to the individual rights and freedoms of Quebeckers and reversed the finding of the lower courts. Three of the majority justices, McLachlin C.J.C., and Major and Bastarache JJ., found that the prohibition violated s. 7 of the Charter and could not be justified as a reasonable limit under s. 1. The fourth justice, Deschamps J., found that as the prohibition violated the broader language of the Quebec Charter it did not require further consideration under the narrower provision of rights in the Canadian Charter. (20) The three judges forming the dissent, Binnie, LeBel, and Fish JJ., found that s. 7 was not violated and that the case pertained to the allocation of resources which is a policy issue more appropriately dealt with by the capable hands of democratically elected representatives than by judges. (21)

   I argue that the recent judgment in Chaoulli can be analyzed broadly as the start of a constitutionalized right to health within an emerging public law action for regulatory negligence. Interpreted against a backdrop of "constitutional tort" jurisprudence, public sector liability may now be expanded to account for failure to protect individual health from unjustified state intrusion, whether that intrusion is from a faulty "operational" measure in applying the statutory standards for patentability set out in the CPA or a faulty "policy" decision by CPO in treating genetic sequences to be patentable subject matter a priori. Constitutional remedies could include a declaration (including invalidation of gene patents and a call for a moratorium), monetary damages, injunctive relief and other possibilities available under the Charter for failure to regulate public health in a manner consistent with Canada's obligations under international human rights instruments and now consitutionalized by Chaoulli.

   2. OVERVIEW

   The remainder of this article is divided into three parts. Part 1 provides a basic primer on patent law and considers traditional private law remedies for public sector liability in order to determine whether a private action in tort could be made against the government for the issue of gene patents. After identifying the limitations of a private law approach, Part 1 also considers the possibility of public law proceedings for regulatory negligence under the Charter and compares this with pursuing invalidity under patent law. Finally, Part 1 will also establish that the Charter applies to the impugned...