7. Patents for Methods of Medical Treatment of Humans
What Is a Method of Medical Treatment of Humans?
210. The term "method of medical treatment of humans" covers methods of treating human illness. These may include such things as surgical procedures, such as a method of doing heart surgery, or drug treatment regimes, such as treating a medical condition by taking a particular drug or combination of drugs. It does not include such things as pharmaceuticals or surgical apparatus that may be used in a method of treatment.
Why Are Methods of Medical Treatment an Issue?
211. Currently, methods of medical treatment of humans are not patentable in New Zealand. Most other countries do not allow such methods to be patented either. The New Zealand Court of Appeal has held that any change in this policy should be made by Parliament, not the Courts, given the commercial, economic, ethical and social implications involved. Despite this, there have been several challenges to the current policy of refusing patent protection to methods of medical treatment. As the Courts have made it clear that the issue is one that must be dealt with by Parliament, the current review of the Patents Act 1953 provides a good opportunity to discuss the issue. Whatever the outcome, the result will be greater certainty for all concerned.
What Is the Situation in New Zealand?
212. The definition of invention in s2 of the Patents Act 195348 does not specifically exclude methods of medical treatment of humans from patentability. The definition of invention in the Patents Act 1953 is the same as that in the United Kingdom Patents Act 1949 (now repealed). Decisions49 of the United Kingdom courts, interpreting this definition, established that a method of medical treatment of human beings to prevent or cure disease is not a "manner of manufacture". On the basis of these decisions, patents for methods of medical treatment of humans have been refused by IPONZ. These decisions were followed by the New Zealand Court of Appeal50 which held that a method of treatment of human illness or disease did not qualify for the granting of a patent. In this decision all three judges agreed not only that such a method should not be granted a patent, but also that any change in this policy was a matter for the legislature, not the courts, to decide.
213. More recently, the New Zealand Court of Appeal has held51 that methods of medical treatment can no longer be treated as not being an invention. The Court also held that if methods of medical treatment were to be excluded from patentability, it must be on moral or policy grounds, but did not go so far as to say that patents must be granted for such methods. The earlier decision, that a change in policy relating to the patenting of methods of medical treatment of humans was a matter for the legislature, was not challenged. IPONZ has continued to refuse patent claims to methods of medical treatment.
214. Although methods of medical treatment of humans are not patentable in New Zealand, not all methods involving medical treatment are excluded. Previous United Kingdom court decisions have attempted to draw a line between what is and is not an unpatentable method of medical treatment. The line is somewhat arbitrary, but essentially, methods of medical treatment of humans are excluded only where the treatment is for an illness, or to relieve pain and suffering. Methods of treatment of humans that have been held to be patentable include the following (the list is not exhaustive):
- The human is not ill, i.e. is not actually suffering from a disease, for example cosmetic surgery;
- The human is suffering from a condition which is part of a continuum from one extreme to another, in which variation from an arbitrary norm is regarded as being an illness, e.g. baldness, infertility, obesity;
- Elective treatments for conditions which are not in themselves illness, e.g. contraceptive methods or reducing the desire to smoke;
- Diagnostic testing which does not require surgery, or treatment of conditions which do not actually require treatment of the human, e.g. killing bacteria on the skin;
- Treatment of minor conditions where the active ingredient is incorporated into an over-the-counter product.
Second Medical Use
215. The ban on the patentability of methods of medical treatment has caused problems where a known substance already used to treat a particular medical condition is found to be useful in treating some other medical condition, this second use having been previously unrecognised. An example of this would be the discovery that aspirin was useful in reducing the risk of heart attacks. Because the substance is not new, it cannot be patented (it may have already been patented). If methods of medical treatment cannot be patented, then the second use cannot be patented either, as the only novelty is in the use to which the substance is put. This leaves the discoverer of the second medical use with no patent protection, even though the costs of investigating the second medical use may be high. Without patent protection, there may be little incentive to investigate the properties of existing pharmaceuticals to determine if they have other, previously unknown, medical uses.
216. In the European Community, where methods of medical treatment are also unpatentable, the "Swiss type" claim was devised to enable second medical uses to obtain some patent protection. "Swiss type" claims are patent claims52 of the form:
the use of [known compounds] for the production of pharmaceutical compositions for the treatment of [a particular medical condition]
The term "Swiss-type" comes from a 1984 decision of the Swiss Intellectual Property Office to allow claims in this form. IPONZ now allows "Swiss-type" claims. This practice was upheld in the Court of Appeal Decision in Pharmaceutical Management Agency v The Commissioner of Patents and Others (CA56/99).
Medical Treatment Patents in Other Countries
Australia
217. The Australian Patents Act 1990 does not specifically exclude methods of medical treatment of humans from patentability. The definition of invention in the 1990 Act53 (and in the now repealed 1952 Act) contains wording similar to that in the New Zealand Patents Act 1953. Despite this, in 1994, the Australian Federal Court ruled54 that methods of medical treatment were patentable in Australia. The Court reasoned that since the Australian Parliament had not specifically excluded medical treatment when it passed the 1990 Act, Parliament did not intend that such methods should remain unpatentable.
European Community
218. Article 52(1) of the EPC states that "European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step." Paragraph 4 of Article 52 states that:
Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of paragraph 1. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods.
219. Methods of medical treatment are therefore not eligible for the grant of European patents. All states that are parties to the EPC55 have implemented the EPC as part of their national patent legislation.
United States
220. The United States Patents Act does not exclude methods of medical treatment of humans from patentability. Such methods may be granted a patent in the United States. From July 1996 newly issued medical process patents56 are, however, no longer enforceable against medical professionals who infringe while performing a medical or surgical procedure57. This exemption from infringement proceedings only applies to surgical or medical procedures, and not methods of treatment using pharmaceutical compositions.
International Agreements
221. Article 27.3 of the TRIPS Agreement allows member countries to exclude from patentability "diagnostic, therapeutic and surgical methods for the treatment of humans or animals." Most countries exclude methods of medical treatment of humans from patentability.
What Should New Zealand's Policy on Patents for Medical Treatment Methods Be?
222. In considering what policy New Zealand should adopt, there appear to be just three basic options:
- Maintain the status quo;
- Allow methods of medical treatment to be patented;
- Allow methods of medical treatment to be patented, but provide that medical practitioners who use a patented method without the patent owner's permission would be exempt from infringement proceedings.
223. In deciding what policy New Zealand should adopt with regard to methods of medical treatment, it will be necessary to weigh up the costs and benefits to New Zealand of each of the options identified above. In the discussion that follows, the possible costs and benefits of each option are set out, although no attempt is made to quantify them.
Option i): Continue to Refuse to Grant Patents for Methods of Medical Treatment of Humans
224. If New Zealand continues to refuse to grant patents for methods of medical treatment, the main benefit is likely to be that the medical profession will continue to have free access to new medical procedures. The potential costs of license fees and patent litigation will be avoided. The ethical problems that might arise where doctors had a financial interest in particular procedures would also be avoided.
225. It is not clear that there would be any disadvantage to New Zealand in continuing to refuse to grant patents for methods of medical treatment of humans. There appears to be no empirical evidence to suggest that this acts as a disincentive to medical research in New Zealand (or anywhere else). One possible problem might be that owners of medical treatment patents overseas may try to prevent the use of their methods in New Zealand if they cannot be patented here. It is, however, difficult to see how this could be achieved without keeping details of the method secret. This would not be possible though, if the method had already been patented in another country. In any case, there is no evidence that New Zealanders' access to new methods of medical treatment has been restricted by the current ban on the patenting of such methods.
226. A possible disadvantage of maintaining the current position on patents for methods of medical treatment is that it would place New Zealand's patent regime out of step with that of Australia, which allows such patents. Does this cause any problems for businesses in the two countries? Most patents granted in Australia and New Zealand are granted to owners who are not resident in either country. Few, if any, local businesses may be affected by the differences in patent law on this issue.
Option ii): Allow Patents to Be Granted for Methods of Medical Treatment of Humans
227. Those in favour of the grant of patents for methods of medical treatment argue that the reasons for granting patents in the first place - to encourage innovation and to provide an opportunity to benefit from effort and investment in research and development - apply equally to medical treatment as to anything else. If patents are not granted for methods of medical treatment, it is argued, inventors or businesses may be unwilling to invest in research and development.
228. As noted earlier, there appears to be no empirical data to support this argument. In any case, financial rewards may not be the only incentives to innovation in the field of medical treatment, particularly where the innovator is a doctor or other medical practitioner. Rewards such as prestige, peer recognition, and respect by society may be other drivers of innovation. Some doctors may be motivated to develop new medical treatments by the need to improve the health or quality of life of their patients rather than by any desire for personal advancement.
229. The development of new methods of medical treatment, particularly surgical methods, may be much cheaper than the cost of, say, developing a new drug. This may reduce the need for an exclusive right to provide an opportunity for the inventor of the new method to recover the development costs.
230. Another argument in favour of granting patents to methods of medical treatment is one of consistency: that is, why should methods for the treatment of disease be singled out for exclusion from patent protection? What logical justification is there for saying that methods that produce that produce a cosmetic or functional result are patentable, while those that produce a curative result are not? Why should substances and devices used in medical treatment be patentable, while methods for their use are not? Against this, it could be argued that the matter is one of public policy. That is, the question of whether methods of medical treatment of humans should be patentable or not should be decided by considering what is in the best interests of society as a whole.
231. Most developed countries have placed some restrictions on the patenting of methods of medical treatment of humans. The lack of patents to methods of medical treatment does not seem to have slowed the advances in medical technology that have taken place in the last 30 years.
232. The one area where the granting of patents may have a positive effect is in the field of second medical use. Investigating a second or subsequent medical use of a known compound is likely to involve considerable investment. In such a case, the availability of patent protection may be necessary to provide an incentive for research. The allowance of "Swiss-type" claims (see above) is a way of providing this incentive without the potential disadvantages of allowing claims to methods of medical treatment.
233. One of the main disadvantages of granting patents for methods of medical treatment would the likely increases in the costs of healthcare. Doctors and other health providers may face increased costs for patent licenses, and may also have to take into account the cost of patent infringement litigation. These extra costs would add to the costs of the health system. Most New Zealand patents are granted to overseas owners, and this is also likely to be the case for medical treatment patents. As a result, most of the revenue generated by these patents will flow offshore.
234. Another possible disadvantage is that access to medical procedures such as surgical methods may be restricted if such procedures are patented. Doctors, health providers and patients may be unwilling or unable to pay the license fees demanded by patent owners. Patent owners may also restrict the number of licenses that they are willing to grant. If licenses are restricted, then some patients may find that they have a reduced choice of doctor or surgeon. In some cases, patients may be denied access to a particular method because they are unable to find a doctor who is licensed to perform it.
235. The granting of patents to methods of medical treatment may raise ethical problems. Doctors who have a financial interest in a patented method of treatment may use that method, or refer patients to doctors who use that method in preference to others, even though that method may not be the most appropriate for that particular patient. On the other hand, doctors who are unable, or unwilling, to obtain a license to use a patented method may use some other method, even though this may not be as appropriate for the patient as the patented method.
236. Allowing patents to methods of medical treatment may stifle the sharing of information between physicians, which may actually slow down the rate of innovation. Doctors and medical researchers may be unwilling to share information, because this may jeopardise their chances of getting a patent. Although it is a requirement of the patents system that there be full disclosure of the invention, this information cannot readily be used until the patent has expired.
Option iii): Allow Patents for Methods of Medical Treatment, but Exempt Medical Practitioners from Infringement
237. The only country that has adopted this approach is the United States. As noted earlier, the United States Patents Act exempts medical practitioners from infringement proceedings if they infringe while performing an medical or surgical procedure. The provision of this exemption was in response to an attempt by an ophthalmic surgeon who had taken out a patent to a particular method of cataract surgery to sue another surgeon for patent infringement.58
238. The possibility of exempting medical practitioners from infringement proceedings has also been suggested in a recent decision of the New Zealand Court of Appeal59, where it was stated in paragraph 65:
Bearing in mind the rationale for the method of treatment exception permitted under TRIPS, Art 27:3, - that there should be no interference with the medical practitioner's diagnosis and treatment of patients - perhaps the logical approach would be to permit claims to extend to the method of treatment using the compound or composition, but to require from the patentee a disclaimer of any right to sue the practitioner.
239. Under this option, patents for methods of medical treatment of humans could not be enforced against medical practitioners. If the patented method was a surgical method, or some other therapy not directly involving the use of drugs, then this could effectively render the patent worthless if the method was one that only medical practitioners were able to carry out.
240. Where the patented method primarily involves the use of pharmaceuticals, rather than a surgical method, then the fact that the method could not be enforced against medical practitioners may not affect the rights of the patent owner very much. Such methods would usually be commercially exploited by the sale of packages containing the drug or drugs involved in the method, together with instructions for their use. Medical practitioners may be unwilling to take the time to buy the pharmaceuticals separately for use in the method.
241. Under this option medical practitioners would not incur the extra costs of license fees or patent litigation. If methods of treatment that primarily involve the use of drugs become patentable, however, then there could be an increase in the cost of such treatments. Other health workers, such as nurses, rescue or first aid workers, or practitioners of alternative medicine could still be liable for infringement if they used patented methods of medical treatment without the permission of the patent owner.
What Does the Medical Profession Think?
242. The views of the medical profession in New Zealand do not appear to have been canvassed on this issue. The American Medical Association (AMA) had this to say on the subject on the subject:60
…medical process patents potentially threaten the integrity of the medical profession.
The AMA expressed the view that the grant of patents for methods of medical treatment could reduce the professionalism of physicians who may put economic goals above those of patient health.
243. The World Medical Association Association Statement on Medical Process Patents61 included the statement:
the patenting of medical procedures poses serious risks to the effective practice of medicine by potentially limiting the availability of new procedures to patients.
In light of this, it would be important to take account of the views of the New Zealand medical profession before making any change to New Zealand's current policy regarding patents for methods of medical treatment of humans.
If the Status Quo Is Retained, How Might It Be Implemented?
244. If it is decided that methods of medical treatment should remain unpatentable in New Zealand, it may be desirable to amend the Patents Act so that these are clearly excluded from patentability. This would result in certainty for patent applicants and the Courts and could significantly reduce future litigation on the subject. To ensure this, any exclusion relating to medical treatment would have to clearly spell out what was meant by "method of medical treatment of humans". What sort of treatment methods would be excluded? Such an exclusion would have to comply with Article 27.3(a) of the TRIPS agreement. Perhaps some or all wording in this article could be adopted to provide for this.
245. Another option would be to leave the current definition of invention in S2 of the Patents Act 1953 unchanged and rely on past Court decisions to maintain the ban. That is, under this option there would be no specific exclusion for methods of medical treatment. There is a risk with this approach. A Court could decide that because Parliament did not provide for a specific exclusion when it had the opportunity to do so, Parliament did not have any particular desire to maintain the ban on patenting of methods of medical treatment of humans. The result would be that IPONZ would be required to grant patents for such methods. As discussed previously, this is essentially what happened in Australia.
Methods of Medical Treatment of Animals
246. The TRIPS agreement allows parties to exclude methods of medical treatment of animals from patent protection. Such methods are currently patentable in New Zealand. The EPC contains an exclusion for these methods. Is there a case for New Zealand to exclude methods of medical treatment of animals from patentability?
Questions
- Should methods of medical treatment of humans remain unpatentable in New Zealand? If not, why not?
- If methods of medical treatment were to become patentable in New Zealand, what benefits would there be for New Zealand? What would be the costs?
- If methods of medical treatment were to become patentable in New Zealand, should such patents be enforceable against medical practitioners?
- If methods of medical treatment of humans were to remain unpatentable, should they be the subject of a specific exclusion the Patents Act? If not, why not?
- If the Patents Act were to contain a specific exclusion for methods of medical treatment of humans, what treatments should be excluded? Should there be a definition of "medical treatment of humans" in the Patents Act, or should the interpretation of this term be left to the courts?
- The TRIPS agreement also allows for methods of medical treatment of animals to be excluded from patentability. These methods are currently patentable in New Zealand. Should such methods be excluded from patentability? If so, why?
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