2. Patentable Subject Matter

Patents / Biotechnology / US Biotechnology Practice

The United States Patent statute provides that utility patents may be granted for the invention of "any new and useful process, machine, manufacture or composition of matter or any new useful improvement thereof". [8] It is specifically provided that the term "invention" includes a discovery and that the term "process" means "process, art or method and includes a new use of a known process, machine, manufacture, composition of matter or material." [9]

This broad statutory definition of subject matter has enabled the United States to take a lead in widening the scope of subject matter for which patent protection may be obtained. The Supreme Court has noted the breadth of this language in Diamond v. Chakrabarty, [10] a case relating to bacteria that had been genetically modified to enable them to digest oil and so be of use in environmental protection against oil spills, in the following words:

In choosing such expansive terms as "manufacture" and "composition of matter" modified by the comprehensive "any", Congress plainly contemplated that the patent laws would be given wide scope.

The relevant legislative history also supports a broad construction. ... The Committee Reports accompanying the 1952 Act inform us that Congress intended statutory subject matter to "include anything under the sun that is made by man" ... This is not to suggest that Section 101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable. Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law E = mc ²; nor could Newton have patented the law of gravity. Such discoveries are 'manifestations of ... nature, free to all men and reserved exclusively to none'.

Today the breadth of these words has been taken to heart by the Court of Appeals for the Federal Circuit so that the restrictions on patentability are effectively limited to abstract ideas, physical phenomena and laws of nature.

Although some nineteenth century cases confined the scope of composition of matter patents claiming new chemical compounds to such compounds when produced by a defined process, since at least 1902, it has been clear that such a claim covers the compound irrespective of its means of production. [11] Purified natural products have been held to be patentable in cases where it was not obvious that one would have wished to purify the naturally occurring material. [12] In recent years the focus in such cases has been much more on whether what is claimed is new (i.e. different from what existed in nature) than on whether it constituted a "composition of matter". [13]

Unlike many other countries, therapeutic methods of treating humans are patentable in the United States, although there are now restrictions on obtaining remedies in respect of inventions that are surgical techniques. [14]

The rationale of the Chakrabarty case that anything under the sun that is new and man made may be patentable has been extended to plant seeds and plant cell culture lines notwithstanding the fact that special protection for plants is possible by means of plant patents or under the Plant Varieties Protection Act. [15]

In line with this rationale, the Patent Office has announced that in principle genetically modified non-human animals are patentable and has issued a patent on the so-called Harvard mouse (a mouse genetically modified so as to be susceptible to cancer and, thus, facilitate medical research in this field). The Patent Office announcement in this matter was challenged in the case of Animal Legal Defense Fund v. Quigg [16] on the ground that the USPTO had not complied with the necessary formal procedures for a rule making. The challenge was rejected by the Court on the ground that no new rule had been made and the announcement was merely an "interpretation" of prior court decisions.

The effect of this broad definition of patentable subject matter is that, in the pharmaceutical and biotechnology fields, as long as the claimed invention is new, useful and not obvious and that the specification contains a proper written description that describes the best mode for putting the invention into practice that is known to the applicant and provides proper enablement to put the invention into practice, one can claim the following:

1) New chemical entities, including new intermediates and in appropriate cases new salts, enantiomers and polymorphs.
2) Methods of making new compounds.
3) Methods of treatment, diagnosis etc using new compounds.
4) New methods of making both old and new compounds.
5) New compositions, possibly containing known compounds but in different dosage amounts or forms.
5) New methods of treatment, diagnosis etc. using old or new compounds.
6) New methods of modulating biochemical processes which are carried out in a human, animal or plant.
7) New kits for example containing a new combination of materials or of materials and equipment used for diagnosis or treatment.
8) Newly identified DNA as long as it is claimed in a form which differs from that in which it occurs naturally (that is to say it is claimed in purified or isolated form). Newly created DNA is treated as a new chemical compound.
9) New organisms and parts of organisms such as seeds, for example those containing modified DNA.
10) New vaccines.
11) New vectors, such as plasmids, new hybridomas and new antibodies.
12) New research techniques and in some cases at least the products obtained from using these techniques. [17]

Additionally recent case law has much expanded the types of computer related invention that can be patented. This has some significance in the biotechnology and pharmaceutical areas since it means that one can patent for example software for modeling molecular shapes such as the shape of receptor sites and predicting the type of molecule that lay bind to such receptors. It may also be possible to patent novel compounds discovered by use of such models. [18] The Patent Office now even accepts as a potentially patentable “manufacture” a signal on a carrier wave carrying such a computer program and possibly even data carried on such a signal meets the utility requirements set out below. [19]

It is worth noting that the Court of Appeals for the Federal Circuit, although it has been subject to criticism for doing so, applied the case law developed in dealing with chemical inventions to the new realm of biotechnology.

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