Patent claims natural products

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. 

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. 

Since patent examiners on their own initiative cannot recommend to extend the scope of the proposed patent claims, it is probably best to reach for a maximum in the patent application and revise the claims according to the objections from a patent office. However, it is useless to go too far, e.g. by extending patent claims to mere principles, products of nature or undisclosed analogous subjects as well as to known and obvious things. 

A variety of fully synthetic analogues of pseudomonic A were also prepared. The pharmaceutical industry had already published a series of patent applications claiming antibacterial analogues of the natural product in which the "right-hand" (ester) side-chain had been modified, and we found that some of these also had herbicidal activity. But we focused our attention on the synthesis of analogues in which the left-hand (epoxide) side-chain of the natural product had been modified. This side-chain contains four of the eight chiral centres of the natural product, so there appeared to be good scope for simplification. 

Several natural D-lactic acid producing bacterial species exist Sporolactobacillus inulinus, Sporolactobacillus laevolacticus (previously Bacillus laevolacticus), and Lactobacillus delbrueckii are among these bacteria [29, 42, 43]. Also, patents have been filed claiming the production of D-lactic acid by a genetically modified microorganism. Several different species such as Kluyveromyces and Escherichia coli have been claimed so far [44, 45]. 

It has been shown that natural rubber and MA reactions are best run in the presence of compounds such as 2,6-di-ter/-butyl-p-cresol, 6-phenyl-2,2,4-trimethyl-1,2-dihydroquinoline, and -dicarbonyl compounds as antioxidants.Both for the mass and solution production procedures at 180°C, these reagents inhibit crosslinking. Recent patents claim that triazine derivatives, such as 2,4,6-trichloro-5-triazine, and phosphorus compounds, such as trioctadecylphosphite, are also very effective for preventing crosslinking during treatment of liquid rubbers with MA. 

The term purified distinguishes the enzyme from the product as it exists in nature. In an attempt to distinguish the claimed enzyme from enzymes which were known before the patent was filed, the enzyme is defined as having certain characteristics i.e. DNA polymerase activity, thermostability and a molecular weight within a specified range. 

Can you understand why the acknowledged presence of L-arterenol (norepinephrine) in the human body did not anticipate (render not novel) any of the three listed claims If not, remember that anticipation requires that each and every limitation of the claim must be met. Note especially the requirement of each claim that requires the substances be in crystalline and substantially pure form. Products of nature are not patentable subject matter per se, but here the inventors provided the compounds in a form that they did not naturally exist in (crystalline and substantially pure). 

There are numerous decisions that hold product claims to chemical compounds as compositions of matter to be valid within the meaning of the patent statutes. With few exceptions there are no specific references to the rule that products of nature are unpatentable. The statements in the decisions are in sharp contrast with the thought that the rule was at all applicable. For example in the Kuehmsted case (tf), the pure chemical compound known generally as aspirin was held to be patentable because of its new utility. The court held that whatever may have been its antecedents chemically, aspirin in pure form was a new thing. The formerly known crude material was legally a different material in that it had no utility as a medicinal. The court held that aspirin was an article of manufacture within the meaning of the patent law. 

In spite of some unfortunate statements, as in the tungsten case, the law never intended a rule which would declare otherwise patentable compositions of matter to be unpatentable merely because their creation might be conceived to be the handiwork of nature rather than of man. The courts merely desired in the principle-of-nature cases to force the inventor to claim only the tangible manifestations of his contribution. As to those cases where products have been declared unpatentable, the courts may be said to have been looking primarily to the test as to the presence or absence of novelty or invention. 

Specifically, a new composition of matter (NCM) or new chemical compound prepared by synthetic methods is the primary area of interest. They may be made using synthetic methods or are isolated from natural sources such as plant or oceanic material or from fermentation broths. At times, a compound is known in an impure state that is unusable as a pharmaceutical product. If it is obtained in a purified state and meets the requirements of patentability, it can be claimed as a compound of a defined purity. 

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