Composition of matter claims

Carbide s patent department had reservations because in their experience, composition of matter claims had to be drawn very narrowly to be valid and as such were frequently easy to circumvent. We convinced them that the unique properties that make A and X useful are singular results of their specific chemical composition and the arrangement of atoms in the crystal lattice of the zeolites. To our knowledge, the use of powder x-ray data as a finger print to uniquely identify a specific crystal structure was a new concept in patent protection. 

Composition-of-matter claims can include claims to small organic compounds that may be useful as drug candidates as well as claims to more complex biomolecules. For example, a composition-of-matter claim may encompass claims to proteins, plasmids, pieces of DNA or RNA, and pharmacological receptors. 

The second type of method-of-use claims relates to methods of using the invention. In terms of pharmaceuticals, method-of-use claims typically relate to the use of a particular drug in the treatment of specific diseases or conditions. FDA approval of a new drug is linked to specific therapeutic uses, and therefore these types of method claims provide important protection for the innovator. These claims are important because they provide patent protection that is in addition to any composition-of-matter claims that may be applicable. Method-of-treatment claims are particularly important for compounds that are already subject to composition-of-matter claims or for which composition-of-matter claims are not available. For example, an inventor may discover that a previously known compound possesses unreported and unexpected antiinflammatory properties. The inventor may not obtain composition-of-matter protection for the compound itself because the compound is contained in the literature and therefore does not meet the novelty requirement for patentability. However, the inventor may instead obtain a method-of-use claim based on the unexpected anti-inflammatory properties because a compound s unexpected properties may be enough to support patentability. 

Composition of Matter Ciaims. Prior art compounds that are structurally similar to the claimed compound or drug may render the claimed compound obvious and therefore unpatentable. But [a]n assumed similarity based on a comparison of formulae must give way to evidence that the assumption is erroneous" (128). Recently, the Court of Appeals for the Federal Circuit reaffirmed this standard for prima facie obviousness as applied to composition of matter claims ... 

Under the current system, an applicant may question whether even to file such divisional applications. If broad and adequate protection can be provided in the parent case, it appears that divisional applications may not be necessary. For example, if broad composition of matter claims can be obtained in the parent application, method of use claims presented in a divisional application may offer little additional protection and offer no additional patent term extension. Little additional protection is provided because the broad composition of matter claims will cover all uses of the compound, including a new use. In the event, however, that the composition of matter claims are later found to be invalid or unenforceable, the method of use claims could prove to be valid and enforceable. Thus, there are strong arguments that such divisional applications should be filed even under the current system. 

Rnd the composition-of-matter claims, which usually open the section. 

Rnd the broadest generic claim, which ordinarily contains a general formula and begins the set of composition-of-matter claims. 

On February 28,1978, A. W. Anderson and G. S. Stamatoff received US. Patent 4,076,698. It was assigned to DuPont de Nemours and Company and provided DuPont the composition of matter on ethylene/1-olefin copolymers in which the 1-olefin contained 5 to 18 carbons. The original patent was filed on January 4, 1957. After a series of court proceedings that took place in the early 1980s, the court awarded DuPont the composition of matter claim on these copolymers. Hence, any polyethylene producer that offered ethylene/1-hexene or ethylene 1-octene copolymers from approximately 1978-1995 was obligated to pay DuPont a royalty. The copolymers produced by Anderson and coworkers were prepared with the solution... 

The foregoing reaction scheme had been described in a patent issued in 1934 to Clemmensen (9), who prepared certain organic esters of thiophosphoric acid embodying both aromatic and aliphatic radicals. These esters are claimed as new compositions of matter useful as fire retardants. Parathion itself is not specifically described in the patent. 

The first lawyer assigned to molecular sieves planned to base protection on the process of manufacture. Since we could not possibly cover all practical methods of making A and X, we asked for composition of matter coverage, with process claims only to protect our actual manufacturing methods, and broad use claims covering as many applications as possible, so as to minimize the possibility of restrictive use claims by others. 

Information on United States patents related to the drug or drug product is to be included in the NDA. The relevant types of patents are the composition-of-matter patent for the API, patents related to the formulation or composition of the drug product, and use patents that are applicable to the clinical indications claimed in the NDA. Process patents for any of the manufacturing processes used for the API or drug product need not be included. The applicant must certify the validity of each patent listed in the NDA. The proper wording for these certifications is in the regulations (21 CFR Part 314). 

However, prior knowledge or use in this country, by even a single person other than the applicant for patent, may completely destroy any claim of novelty, according to our law. However, there are recognized exceptions to this rule, particularly where the prior use was merely experimental or where the use had been abandoned or forgotten. The latter doctrine—forgotten or lost art—is applicable primarily to arts or processes, because of the intangible nature thereof, but the doctrine is inapplicable to machines, manufactures, or compositions of matter, which still exist in their entireties, since they can be identified and analyzed if necessary. 

Chemicals are classified as compositions of matter from a patent statute viewpoint. A claim on a composition protects the inventor without regard to the use of the product. Where a new use is found for an old chemical, if the new use incorporates a change in the physical form or packaging, sometimes product claims can be obtained. More commonly, the new discovery must be claimed as a method of using. Examples are given to illustrate the type of wording which has met acceptance in the Patent Office. No matter how worded, the legal requirements for patentability, particularly unobviousness, must be met. 

There can easily be argument as to whether a claim to this type of invention should be classed as a composition of matter or a manufacture, as the claim has certain of the attributes of each. 

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. 

Of course, the discovery of a new quality of an old product does not make the product itself patentable, but invention may be claimed in a new process of using the product—for example, in applying it to vegetation as an insecticide or in a new composition of matter involving its admixture with a carrier which makes it suitable for the novel purpose 11). 

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. 

Patentable subject matter is ... any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof Patent laws provide that patents may be granted only for inventions that are deemed to be new and useful. These requirements exclude pharmaceutical inventions that have not been shown to be reasonably safe and effective and chemical compounds that have no use except as intermediates for additional research. However, some special considerations have traditionally been applied in the case of chemical compounds, particularly those possessing therapeutic or pharmacological activity. A compound that is useful as an intermediate for the manufacture of a pharmacologically active compound may be claimed and afforded patent protection because it satisfies the utility requirement and is considered to be useful. Further, a compound need not show therapeutic utility in humans to meet the utility requirement of patentability pharmacological activity in animals or in vitro activity is considered sufficient in some cases. If the patent application purports to claim the use of a compound for the treatment of humans, the inventor must show that the compoimd is both safe and effective in humans. 

Compound claims directed toward the drug compound generally afford the broadest scope of patent protection against competitors. However, no single type of claim can afford the best patent protection. The best protection against competitors includes a portfolio of patents, each of which is directed toward a different aspect of the drug. For example, an inventor may obtain a patent for composition of matter that covers the chemical compound itself, another for its... 

You cannot get a patent for an idea or mere suggestion. Patents are granted to people who (claim to) "invent or discover any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof," to quote the essence of the U.S. statute governing patents. Complete and enabling disclosure is also required. 

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