Natural products patentability

Known templates Natural products Patents Agrochemicals... 

In our methodology to search for a new lead, which we call lead generation, three approaches are possible as shown in Figure I. The first is to use the structure of known templates, such as bioactive natural products, patents and commercial agrochemicals. The modification of these structures has resulted in the formation of compounds with desired properties, thus many researchers have... 

Camphor, Cj HjgO, occurs in the wood of the camphor tree Laurus camphora) as dextro-camphor. This is the ordinary camphor of commerce, known as Japan camphor, whilst the less common laevo-camphor is found in the oil of Matricaria parthenium. Camphor can also be obtained by the oxidation of borneol or isoborneol with nitric acid. Camphor may be prepared from turpentine in numerous ways, and there are many patents existing for its artificial preparation. Artificial camphor, however, does not appear to be able to compete commercially with the natural product. Amongst the methods may be enumerated the following —... 

B. M. Malyarchuk, V. Yu. Pavlyuk, F. V. Nijger, B. G. Tarasov, and P. V. Tarabarinov. Composition for plugging flooded porous strata— contains clay, alumina cement, natural zeolite, calcined soda, polyacrylamide, alkyl resorcinol resin, pentaerythritol production waste and natural saline. Patent SU 1776764-A, 1992. 

Exhibit 1.5 provides a brief explanation of patents. Patents are the pillars that support the drug industry. In contrast, traditional medicines, which are mainly derived from natural products of plant or animal origins, are not patentable. This is because traditional medicines consist of a multitude of compounds and it is difficult to establish patent claims based on varying quantities of materials. 

With the ABA, the source country must know in advance how the natural products are to be exploited and the benehts that can be shared. If the CBD is not observed, the natural products can be treated as being poached and the patent based on these products may be invalidated. 

Frenz JL, Kohl AC, Kerr RG. (2004) Marine natural products as therapeutic agents Part 2. Expert Opin Ther Patents 14 17-33. 

The benefits of the DSHEA to the manufacturers of natural products is obvious. They can claim a variety of health benefits for their products in very general terms that may sound to consumers like health claims but usually are not. They also can (although they are unlikely to attempt to) sell products that do not contain the chemicals listed on the label, are not safe for human consumption, or are not effective at treating the conditions for which they are recommended. In some ways, this situation sounds similar to the conditions that existed at the beginning of the 20th century, when the FDA was created to deal with the false and misleading claims of patent medicine suppliers. 

In the USA, purity alone often facilitates patenting of a product of nature (Table 2.3). The PTO recognizes purity as a change in form of the natural material. For example, although vitamin B12 was a known product of nature for many years, it was only available in the form of a crude liver extract, which was of no use therapeutically development of a suitable production (fermentation) and purification protocol allowed production of pure, crystalline vitamin B12 which could be used clinically. On this basis, a product patent was granted in the USA. 

In this chapter we disenss the rationale for patent systems, the nature of patents and the procedures by which they are obtained for biotechnologieal products and processes. Hopefully this chapter will serve to increase patent awareness amongst bioscientists, dispel some common misconceptions and highlight some problems which patenting biotechnological inventions ean pose. 

The variability in composition is because these are natural products and often are not pure extracts of a single chemical. Instead, they often contain multiple chemicals that may contribute to different beneficial or adverse effects. Composition may also vary as a function of what part of the plant is used to make the product (e.g., the root versus the stalk). In contrast to patented medications, there is no requirement to prove safety or efficacy to market it. There is also no requirement to define the basic pharmacology of the product. Hence, there is often little substantive knowledge about the pharmacodynamics or the pharmacokinetics of the compound or constituents. 

Sometimes, a straightforward natural product isolation route, irrespective of bioactivity, is also applied, which results in the isolation of a number of natural compounds small compound library) suitable for undergoing any bioactivity screening. However, the process can be slow, inefficient and labour intensive, and it does not guarantee that a lead from screening would be chemically workable or even patentable. 

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