We present to you the excerpts from the talk delivered by Prof.Graham Dutfield,Leeds University,UK on traditional medicines and patents.We thank Prajna R.Mahapatra,a third year student of NUJS Kolkata and an enthusiastic member of IPTLS for her painstaking efforts in preparing this note. Our podcast friendly readers (listeners actually) can also access the podcast here.
Speaking at the a talk titled “From Traditional Medicines to Modern Drugs: Do Patents Protect Inventions and Promote Piracy?” as a part of the I(P)DEATE Series, presented by the NUJS IP Chair and IPTLS,at NUJS, Kolkata, Professor Graham Dutfield of Leeds University, UK principally highlighted two questions: (a) Is traditional knowledge (TK) important in drug discovery within the context of modern pharmaceuticals?; and, (b) Does patent law help drug companies claim possession of TK? Deviating from common responses of absolute affirmation or complete denial in response to the first question, Prof. Dutfield suggested that TK is still important but the degree of importance remains disputed. He also acknowledged that although the potential of TK still remains unexplored, its realization still remains a Herculean task. Drawing from the above assertions, it seems likely that often scholars and academicians overestimate or underestimate the value of TK.
Elaborating on the reasons for underestimating the value of TK, Prof. Dutfield mentioned that the number of new drugs entering the market today is less than the numbers in earlier days as new chemical entities continue to be hard to come across. Consequently, scientists are looking again at “old” chemicals to see whether they have further useful properties. This has happened with Aspirin and methylene blue. Given their greater age, one can expect several at least of these to have origins in traditional or pre-industrial societies. Further, while the industry often cites 10-12 years as the average time it takes to turn a drug discovery into a commercial product, the real figure may be a great deal longer if we go back to the true origin, which can be far more distant than many would suppose. Following TK leads is a complicated process that may sometimes yield useful results only after years and years of gruelling research. For example, there may be a stark difference between the modern use of the drug and the original TK lead i.e., the former may be completely different from the latter leading one to lose track of where the initial lead came from. As a result, the “learning trail” from the initial find to a product or class of products can become hard if not impossible to trace. Besides, sometimes, it is just too early to tell how fruitful the research is i.e., an immediate result may not arise from the same; however, this does not necessarily leads one to the conclusion that the purported TK lead is useless or that TK with no obvious commercial application today will not have one many years into the future.
Prof. Dutfield subsequently threw light on the reasons why the importance of TK is likely to be overestimated. Firstly, he felt that since TK was important in the past, it was obvious for many people to simply assume that it will remain important in the future as well. Secondly, he specifically cited how certain scholars have pointed out that some ‘biopiracy’ scares have attracted more attention than is warranted. He cited the example of unwarranted sensationalism and the hype created by NGOs and the media regarding the ill-effects of what may otherwise be considered a normal business practice. Lastly, Prof. Dutfield suggested that there is a tendency of some people to romanticize about indigenous people and their right over TK.
On the question of the link between TK and drug discovery, Prof. Dutfield cited very interesting statistics highlighting the fact that almost 74 percent of modern drugs derived from medicinal plants have the same or related use in traditional medicine. The real question is whether such indications make TK more important in future drug discovery. Prof. Dutfield suggested that TK should provide lessons for the future. The most important example in this context is that of aspirin. Aspirin has been known to mankind for the last 7000 years. Its benefits as an analgesic and an anti-inflammatory agent were known in ancient Greece and Rome Europe was quinine, which was difficult to obtain. Tracing the history of aspirin and quinine can be quite illuminating for gauging the importance of TK for future drugs. Similarly, tracing the history of the use of Curare which is a common name for a South American arrow poison can throw up interesting trivia as to its transient effect on respiration and also its use as a muscle relaxant in surgery.
Prof. Dutfield also discussed the question of how TK could form the basic subject matter of a patented invention. He pointed out that there are four different ways to answer this question. First, looking at the claim for patent as an ‘inventive step’ beyond the TK, there is nothing wrong with patenting it. Second, the patent can be granted in error when the patent examiners possibly do not have access to all the prior art and hence, mistakenly grant a patent. It is noteworthy that the Indian government has sought to avoid this problem by establishing and maintaining a Traditional Knowledge Digital Library (TKDL). Third, a patent can be granted to the invention despite its similarity to the TK due to lack of documentation of the TK. And, finally, sometimes, patent law may arguably give rights to those who can translate ritual knowledge into the language of science whether or not such a translation requires much inventive input or actually creates any new thing. Prof. Dutfield seems to be extremely critical of this approach and suggested that surely, a mere translation should not be enough to get a patent but that perhaps in some jurisdictions it is sufficient.
Prof. Dutfield then initiated an insightful discussion on the 1996, House of Lords decision in Merrell Dow v. Norton ([1996] R.P.C. 76 (H.L.).The instant case concerned terfenadine, an anti-histamine drug for which the pharmaceutical company, Merrell Dow Pharmaceuticals obtained a patent and subsequently, on its expiry, other pharmaceutical companies proceeded to make and market terfenadine products. After conducting research on the transformed chemical (in this case, the acid metabolite) that is actually instrumental in having the therapeutic effect, Merrel Dow obtained a patent on the transformed chemical. The claim made by Merrell Dow, however, was that other pharmaceutical companies cannot supply terfenadine to the public without infringing the patent held for the acid metabolite since this involves knowingly supplying consumers with the means for putting the invention into effect. The claim was that commercial supplying of terfenadine is an infringement of the patent held for the acid metabolite under the UK Patents Act, 1977. Lord Hoffman’s judgment in this context was of utmost importance as he drew an analogy between the case at hand and the Amazonian Indian who unknowingly uses quinine to treat malaria. Lord Hoffman opined that the Amazonian Indian who treats himself with powdered cinchona bark for fever is using quinine, even if he thinks that the reason why the treatment is effective is that the tree is favored by the Gods. In other words, the teachings of his traditional medicine contain enough information to enable him to do exactly what a scientist in the forest would have done if he wanted to treat a fever but had no supplies of quinine sulphate. In conclusion, Prof. Dutfield’s interpretation of Lord Hoffman’s laudatory stand on the issue was that one can patent something that is old and previously used and /or available to the public if it was not known about under any enabling form of description; otherwise, one cannot do so. Patent law does not have its own specialized epistemology.
The seminar ended with a discussion on various burning issues on TK and patents such as how many jurisdictions of the world may not accept Lord Hoffman’s view. The larger question that followed the debate was that even if Lord Hoffman’s view is accepted, does that automatically ensure that TK is safe and is there such a thing as ‘bio-piracy’ anyway? During the discussion, Prof. Dutfield notably raised the significant question of Intellectual Property linked with Human Rights. Symbolic patent protection may not have any industrial value though it has local value. TK is worth protecting mostly as it is important for the local people.
The seminar was thought provoking on several counts and we wholeheartedly thank Prof. Graham for the insights offered.
