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Absolute patent protection of naturally occurring substances

The patent system has been developed to reward inventors for their invention, and publication thereof, with a temporary monopoly on the commercialization of their invention.

The reward was deemed appropriate compensation for the inventors’ efforts and contribution made to the human knowledge base.

In the old days, when the inventions mainly related to products such as mechanical devices or processes how to make something, this reward system worked effectively. Difficulties started when patentability of chemical compounds was considered. From a historical viewpoint, patentability of chemical compounds was initially denied in many jurisdictions; it was only possible to claim the process of making such a compound. At the time, this did not pose too much of a problem, because the patent laws generally held that the protection of a patent claim directed to a process also extended to the product directly obtained from such a process. Hence, when the process was a method for making a chemical compound, the compound itself was also protected. With this system, the reward for the inventor finding a new chemical compound would still be warranted.

Yet, it formed a deviation from the reward theory, since by only claiming the process of making a compound, the inventor could also get protection for the compound for whatever application it was used, even if the inventor had not thought of or did not claim such a use. If the chemical compound per se was already known, only a new process for making such a compound could be patented. The protection conferred to such a claim only covered chemical compounds that were made by that new process.

Further, a new method for using a chemical compound, or, to put it more simply, a new use of a chemical compound remained patentable, even if the chemical compound itself was known and possibly patented by the process of making it. In the case that a patent was issued on (the process of making) a new compound, a new patented use would yield a dependent patent position. The new use of the compound could not be commercialized without a licence under the general process patent, and the holder of the general process patent would be inhibited from the commercializing of the compound for the new use. Yet, this system was thought to provide a justified balance between the contribution of the inventor and the monopoly that was granted. And, more importantly, in practice it seemed to work.

The ban on claiming a chemical compound has been lifted in many jurisdictions over the last century, with the argument made that a claim on a (new) chemical compound would not alter the protection awarded to the inventor for a process for making that (new) chemical compound. In the UK the new patent law of 1949 enabled chemical compound protection per se, Germany followed in 1968 and a Europe-wide acceptance of chemical compound claims occurred with the start of the European patent system as laid down in the European Patent Convention (EPC) 1973.These claims are now accepted world-wide in accordance with the TRIPs agreement. In point of fact, Lord Kitchin recently confirmed in the case Generics UK Ltd & Ors v. Lundbeck A.S ([2007] EWHC 1040 (Pat)) that the invention of a new chemical compound and a way to make it would be entitled to such a protection per se.

Major problem
The effect of this so-called ‘absolute’ patent protection for chemical compounds did not alter the situation with respect to dependent patents on new uses of the compound. However, during this change in European patent law, it soon became apparent that patentability of chemical compounds per se caused a major problem in the pharmaceutical field. This problem was created by the fact that on socio-ethical grounds patentability of methods for medical treatment was denied under the EPC and also in most of the important European national patent laws. In such a case, when a new pharmaceutical use was found for a chemical compound that was already known, it was impossible to claim the compound because of lack of novelty, and it was impossible to claim the new pharmaceutical use because of the lack of patentability of medical treatments. This problem was solved by the fiction that chemical compounds for which a (new) pharmaceutical use was found would be considered novel. Thus, a claim like “Compound X for use in medical treatment” was deemed allowable because it was fictitiously deemed to be novel. Such a claim is known as a ‘first medical use claim”.

From the early days of the EPC, this statutory exception did not extend to inventions involving a second or further novel medical indication for compound X. This raised a problem when not only the compound was already known, but also at least one medical use thereof was known. The artificial solution for this problem was found by claiming such a new pharmaceutical use through what is commonly referred to as the Swiss-type claim: “Use of compound X for the manufacture of a medicament for treating disease Y”. The recent decision G 2/08 by the Enlarged Board of Appeal of the European Patent Office found that, because of the recent changes in the EPC, these Swiss-type claims are no longer necessary as they can be replaced by a purpose-bound so-called second medical use claim: “Compound X for use in treatment of disease Y”. The protection of this type of claim only extends to the specifically mentioned treatment.

In view of this development, one can observe a backshift in the scope of protection to that which more closely follows the original goal of the patent system: a temporary monopoly for the contribution of the inventor. With the second medical use claim, the inventor only contributed to the art in that compound X could be used in the treatment of a disease Y, and this is exactly the scope of protection of the claim. However, the first medical use claim still occupies a middle position between absolute protection and purpose-bound protection. It does not protect all uses of compound X per se, but it protects more than a single use: all pharmaceutical uses of compound X are covered, whether they formed part of the invention or not.

The question now is how this relates to compounds that are already present in nature. Again looking at the history of patent law in this respect, it seems that here both novelty and scope of protection are the key themes. This problem was already recognized early last century with the UK Patent Act of 1949 containing the provision:

“4(7) Where a complete specification claims a new substance, the claim shall be construed as not extending to that substance when found in nature.”

From this, it can be learnt that it was considered possible to patent naturally occurring substances, but that the scope of protection should not extend to comprise embodiments that were present in nature. Basically, the UK Patent Office held that naturally occurring products when they were in their isolated or purified form for the first time, were patentable. A similar approach was taken by the US courts (253 F.2d 156, 4th Cir. 1958) when deciding on the patentability of purified vitamin B12. In this last decision, however, it was stated that the claim could not cover the fully purified or isolated product, since the claim was directed to an extract with vitamin B12 having a maximum activity which was less than that of the fully purified product.

Naturally occurring substances
Currently, it is widely accepted that naturally occurring substances, when provided in isolated or purified form, i.e. no longer in their original natural environment, are patentable. In the US patent practice one is obliged to claim the naturally occurring substance in its isolated form. However, recent case law in the UK (Monsanto Technology LLC v. Cargill PLC, [2007] EWHC 2257 (Pat)) and the Netherlands (Monsanto-Cefetra, First instance court, The Hague, 19 September 2008) has ruled that the word ‘isolated’ in the claim also limits the scope of protection: an isolated DNA sequence appeared only protected if not linked to other DNA sequences, even in recombinant way.

When it comes to the process of isolation or purification of naturally occurring substances, a similarity can be seen with the process of synthesizing a chemical compound. Thus, it would only seem justified that if the same patentability requirements also applied in this case, a similar scope of protection would result. This was also the issue in the early patents in this field, which predominantly related to insulin, vitamins, hormones and the like. It can be argued that the act of purification or isolation would result in a rewardable contribution to the art. This reasoning still applies nowadays for – mostly novel – compounds isolated from plants or other organisms. Many pharmaceutical compounds find their origin in nature (salicylic acid, atropine, penicillin, taxol) and isolating them has certainly contributed to the human knowledge base.

However, in the last decades another form of (patent on) biological compounds is emerging where the invention does not so much reside in the purification or isolation of the compound, but in determining the function of the already known compound. Indeed, this relates to DNA sequences, such as genes and proteins. While the whole human genome now is known with respect to the individual genes contained therein, this does not mean that human DNA sequences are no longer patentable because they are all known in their ‘isolated’ form. It is still possible to define ‘new’ sequences from the non-coding DNA or to find still unknown (‘new‘) sequences defined by variations (polymorphisms) between individuals. And, of course, next to human genetic information there is still a wealth of naturally occurring substances (genes and proteins) in other animals, plants and micro-organisms that have yet to be unravelled.

Public concern
Next to patent arguments, there is also an increasing public concern which should be taken into account. This public concern has culminated recently in the cases in Europe, the USA and Australia against the BRCA patents of Myriad. In Europe, the oppositions that have been filed against the Myriad patents resulted in such strong limitations of the patents (on sheer patentability grounds) that they are no longer a public concern. However, in the USA the District Court of Southern New York (in AMP v. USPTO) has ruled that the DNA claims in the Myriad patents were invalid because "DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature … [its] existence in an “isolated” form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes." Therefore, it was concluded that "the patents at issue directed to “isolated DNA” containing sequences found in nature are deemed unpatentable subject matter." This decision coincides with the perception of many people, since the distinction between known DNA and novel DNA (in its isolated form) is not commonly understood. Further, as follows from the arguments above, patenting of DNA conflicts with the reward theory since the only contribution of the inventor is finding a use or application of the DNA.

The question now is whether the current view on patentability of naturally occurring substances such as DNA and the scope of such patents should be altered. A first decision on this has been provided by the European Court of Justice (ECJ) in the case Monsanto Technology LLC v. Cefetra B.V. ( (C-428/08, dated 6 July 2010). In this case the European Court of Justice had to study the ‘conflict’ between the common provisions of the patent law, which provided for an absolute protection, and the provision of the European Directive on the patentability of biotechnological inventions (Directive 98/44/EC). In their decision, the court mentioned that according to the Directive 98/44/EC, a single DNA fragment where no indication for a function is given does not contain technical information and hence does not form a patentable invention.

Thus, the court came to the conclusion that since the patentability of DNA is purpose-bound, the scope of protection of a claim on a DNA construct was also purpose-bound: “Now the Directive does not provide protection for a patented DNA sequence which can not exert its function, the provision as explained does not allow the legislator to provide absolute protection to a patented DNA sequence as such, irrespective if this exerts its function in the material in which it is present”. This means that any other use of a patented genetic sequence would be free from infringement. From the definition in the Directive 98/44/EC of ‘biological material’, it is to be understood that the same reasoning would apply to any material that is reproducible in a biological system.

Although a purpose-bound protection for naturally occurring substances seems justified in view of the reward theory, there are still some considerations to make. First of all, should there be a difference between biological material and non-biological material? For instance, if a new chemical compound, e.g. a mineral, is found in nature and the inventor provides, next to a useful application of that compound, also a method for synthesizing or purifying the compound, would it then not be justified to allow the inventor absolute protection for this compound?

Secondly, imagine that an inventor improves upon a naturally occurring substance. For instance, if a biological material (a protein such as an enzyme) is altered such that an improved function would be available (higher yield of the enzymatic reaction, less toxic side effects, and the like), it can be argued that such an altered compound is no longer ‘a naturally occurring” substance. According to the above system, absolute protection would then again be justified. Would that change, if after filing of the patent application, it appears that such an altered molecule can actually be found in nature? According to the reward theory, the inventor was the first to provide the compound and to describe how to make it, and should therefore be entitled to absolute protection.

And, of course, there is the argument that a naturally occurring substance is also a chemical substance, although this aspect is often neglected when biological materials such as DNA are considered. And why should there be a distinction between a laboratory made chemical molecule and one isolated from a source in nature?

Gene claims may in due course require a different approach. However, since they represent only one species of chemical compound, this approach should not be extended to cover the group as a whole.

Considering current public concern, any future decision to change the patent law on this topic will most likely be based on political arguments, rather than any real need of change from a patent perspective.