key: cord-0009138-4nvdvkcl
authors: Gold, E Richard
title: SARS genome patent: symptom or disease?
date: 2003-06-14
journal: Lancet
DOI: 10.1016/s0140-6736(03)13674-4
sha: bac6d05b2d2471c465a09ee1b79196d7609183cc
doc_id: 9138
cord_uid: 4nvdvkcl

nan

US$10 000 per country to not only prevent others from patenting the genome but also to obtain the exclusive right to use and sell molecular forms of the genome.

It is this fact, that publishing the genome is not sufficient, that points to the need to adjust the patent system. For there are good reasons why the CDC and the BCCA actually prefer the patent option. First, this option provides them with more leverage in dealing with the University of Hong Kong's Versitech Ltd, which has also applied for a patent. Second, and more importantly, publishing is not enough for the two agencies to prevent others from patenting the SARS genome given their goal of preserving the public domain.

Even if nobody else could patent the genome, others could patent various uses of and products that interact with the SARS genome, thus removing these uses and products from the public domain. With a patent, the CDC and BCCA can indirectly control this activity, because they will be able to impose conditions-such as making these uses and products easily available-on anyone needing access to the genome in the course of their work. They thus can use the patent system to serve the public good. 2 One could argue that the CDC's and BCCA's use of the patents actually demonstrates that the patent system is working well. What this argument ignores is that, as genomic patents increase in number, it will become prohibitively expensive for public organisations to afford not only the expense of patenting genomes and DNA sequences, but also the significant costs of entering into licences and administering those licences. Expecting nonprofit organisations to obtain patents on all their genomic inventions is not a sustainable solution to maintaining an open and free public domain.

The goal of the patent system is to serve the public good, here by not only encouraging biomedical research but also providing access to the results of that research. 3 Giving exclusive rights to inventors is simply the means through which the system reaches this goal but is not the goal itself. Thus, if we keep our eye on the target of our efforts, we soon realise that the system as currently constructed fails to meet its own objectives. As the CDC's and BCCA's efforts illustrate, researchers are concerned that patents held in private hands will decrease research, particularly for the development of clinical applications such as genetic tests. Whilst empirical data are not yet conclusive, 4,5 researchers are feeling threatened by the current system. Health-care administrators have also voiced concern that the patent system limits access to biomedical advances. 6, 7 Whatever the empirical data eventually demonstrate, there is an emerging crisis of confidence in the patent system that is in itself serious.

Several proposals have been made to adjust the patent system to better serve the public good. These proposals include the drafting of licensing guidelines to ensure access to genomic developments, 8 introducing compulsory licensing provisions, 9 better defining the experimental-use exception in countries without a clear exception (eg, the USA and Canada), 9 and introducing a morality clause linked to the manner in which genomic and genetic innovations are commercialised. 10 It is unlikely that any one option will work alone. For example, industry will probably only follow licensing guidelines if governments make it clear that they are prepared to grant compulsory licences if these guidelines are not implemented.

Fundamentally we must remember that the people who need to make these decisions are not the patent experts but the legislatures. Defining the public good is no more the role of patent agents or the courts than it is the role of air-traffic controllers to tell us where to go on holiday. In each case, the experts can tell us where it is safe to land, but cannot tell The prevalence of obesity in the USA has increased from around 15% before 1980 to 30% in 1999-2002. 12 Operations for severe obesity are doubling yearly in frequency and are estimated to be over 100 000 in the USA in 2003. Operations that produce malabsorption have the potential to cause, for example, protein malnutrition, iron-deficiency anaemia, metabolic bone disease, stomal ulcers, duodenal ulcers. Until more is known about the magnitude of these lifelong complications, we should consider a decrease in the use of operations that cause malabsorption and an increase in the use of pure restriction operations. 13 Laproscopic operations can be performed with minimum discomfort for the patient, which makes obesity surgery more attractive for the patient. This in turn increases the demand for surgical treatment. Avoiding a long incision is serendipitous in that the patient is avoiding the lifelong risk of giant hernia, the complication that started gastric reduction operations for treatment of morbid obesity. In addition to straining public-health administrations, severe acute respiratory syndrome (SARS) is testing out the patent system. Recent news 1 that researchers in the USA, Canada, and Hong Kong have applied for patents covering the SARS genome illustrates how the patent system is still not yet ready for the breakout of genomic patent claims. In particular, the news demonstrates that the patent system needs to be adjusted-not discarded-by governments to better reach the goal of that system: the attainment of the public good. It may seem odd that two non-profit organisations, the US Centers for Disease Control and Prevention (CDC) and the British Columbia Cancer Agency (BCCA), would bother patenting the SARS genome, because both want the genome to remain in the public domain, free to all researchers. As an alternative, these agencies could have published the genome, thus preventing others from being able to patent it. Instead they will eventually spend about us where we want to land. Determining our goals and ensuring that they are met is why developed countries have opted for democratic governments. Let us use them.

Centre for Intellectual Property Policy, Faculty of Law, McGill University, Montreal, Quebec, Canada H3A 1W9 (e-mail: Richard.Gold2@McGill.ca) entries during a 30 min lunch on day 3, who would know? Stone and colleagues used "instrumented" diary binders with covert light sensors and miniature electronics to check when entries were made. Their electronics "indicated that actual compliance was only 11%", although the participants returned "diary cards corresponding to 90%" of requested entries. Unfortunately, the electronics only noted when corners were being cut, not why.

Education is one way to improve behaviour. It is not entirely effective, at least not professional schooling: medical students did not even return all experimental equipment in a compliance exercise. Kastrissios et al 2 studied 36 student volunteers, assigning them to a 2-week regimen of either twice or thrice daily ingestion of a medication proxy (breath mints). Caps on electronic pill-bottles recorded removal of medication. Five students did not hand back their electronic bottles, and the overall adherence to medication was 71%.

Audit and punish is the old fallback for reducing bad behaviour; in truth, it does not work very well. Auditing taken to its logical conclusion means videotape, a popular medium for monitoring human behaviour. Clinicians and researchers alike could document everything with videotape recordings. Such tapes could show that patients were appropriately evaluated, warned of risks, treated, and reevaluated. If any inconsistencies surfaced, reporters could request tapes, search for incriminating frames, and broadcast them with the evening news like scenes from a bank robbery.

Public punishment has long been a crowd pleaser. Graft and misappropriations remain grist for news media despite fines and jail terms. Still, Stone and others propose electronic audits for patients (by pocket computer or datalogging chip). Disease arranges its own punishment for poor compliance-eg, glaucoma and blindness. Despite warnings, 42% of glaucoma patients became blind in one eye through non-compliance, and remained non-compliant with medication to save their good eye. 16 Non-compliance was the third most common cause of renal transplant rejection according to Didlake et al. 17 Maybe education, auditing, and punishment fall short because non-compliance is not simply bad behaviour. People make unintended mistakes. 18 Efforts are underway to eliminate them. 19 Even good intentions can be misguided. One of our loved ones suffered recurrent cystitis while fighting breast cancer. Antibiotics worked well. On her fifth episode, she decided to treat immediately and call her doctor later: she had bottles of antibiotic ready. Asked how she had antibiotics already, she explained that happily her physician always prescribed a 7-day supply, although her symptoms disappeared after only 1 or 2 days. What about taking a full 7-day course as prescribed, she was asked? "You have to hoard any extra pills possible since cystitis inevitably recurs", was her reply.

Clearly it is time for a paradigm shift. Tarzan could critique current medical practice simply by aping "Me doctor, you patient, take pill". Others would more tactfully point to a chasm between medicine as it should be and medicine as it is. Some focus on patients' non-compliance; they advocate various corrective approaches already discussed. Some focus on physicians' errors; they usually advocate emulating the aviation industry, a triumph of reliability over complexity. Some focus on institutional misbehaviour; they usually advocate stricter regulations. But is it not time to take a broader view, as when The Lancet commented that "[all] human endeavours, they are imperfect"? 13 An understatement. Bluntly, we are very human physicians in corruptible institutions treating fallible patients. Everyone takes shortcuts. This is the ragged edge of medicine in the 21st century. 

Patients lie, or at least research participants do, according to a recent paper by Arthur Stone and colleagues. 1 Their patients faked entries in medication logs, as did others that tried to beat electronic monitors. 2, 3 This finding goes a bit beyond polite white lies. 4 But, were these patients less scrupulous than those clinicians who faked clinical charges 5 or the researchers 6-8 and corporations 9,10 who faked study results? Breast Cancer Relief, 11,12 Werner Bezwoda, 8 and Roger Poisson 13,14 provoked public reaction for their failures to handle moneys responsibly, report honestly, or follow protocols precisely. Bad behaviour is evident up and down the medical food chain.

Concern about medical non-compliance focuses too narrowly on patients and their bad behaviour. Physicians' prescriptions often fail to comply with practice guidelines. Non-compliance by physicians and patients is just one facet of each person's attitudes and responses, partly adapted to medical demands, yet fundamentally the same attitudes and responses triggered by various social prescriptions: pay taxes, take care while driving, take time with kinsmen, take work seriously, take pills as directed. Society may have expectations for physicians and patients, 15 but do we really believe that people behave completely differently in their medical roles? People cut corners on their taxes; people skip protocol steps; people skip medicine doses. People cut corners, although they know they ought not, especially if they see no direct harm to any specific individual or themselves.

Stone and colleagues 1 found that a patient's clinical diary might describe symptoms at breakfast, lunch, and dinner for a 3-day period as required, say, for a gastrointestinal drug trial. However, a if a participant had actually made all nine

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