The Drug development process - Pharmaceutical Biotechnology: Concepts and Aapplications - page 71

Table 4.1 Some products of nature that are generally patentable under US
patent law. Additional patenting criteria (e.g. utility) must also be met. For many
products, the patent will include details of the process used to purify the product.
However, 'process' patents can be fi led, as can 'use' patents. Refer to text for
further details
A pure microbial culture
Isolated viruses
Specifi c purifi ed proteins (e.g. EPO)
Purifi ed nucleic acid sequences (including isolated genes, plasmids, etc.)
Other purifi ed biomolecules (e.g. antibiotics, vitamins, etc.)
production (fermentation) and purifi cation protocol allowed production of pure, crystalline vitamin
B 12 which could be used clinically. On this basis, a product patent was granted in the USA.
Using the same logic, the PTO has granted patents, for example, for pure cultures of spe-
cifi c microorganisms and for medically important proteins (e.g. Factor VIII purifi ed from blood
(Chapter 12) and EPO purifi ed from urine (Chapter 10)).
Rapid technological advances in the biological sciences raises complex patenting issues, and
patenting law as applied to modern biotechnology is still evolving.
In the late 1980s, the PTO confi rmed they would consider issuing patents for non-human mul-
ticellular organisms, including animals. The fi rst transgenic animal was patented in 1988 by Har-
vard University. The 'Harvard mouse' carried a gene that made it more susceptible to cancer and,
hence, more sensitive in detecting possible carcinogens.
Another area of biotechnology patent law relates to the patenting of genes and DNA sequences.
Thus far, patents have been issued for some human genes, largely on the basis of the use of their
cloned products (e.g. EPO and tPA). A consensus has emerged that patent protection should only
be considered for nucleotide sequences that can be used for specifi c purposes, e.g. for a sequence
that can serve as a diagnostic marker or that codes for a protein product of medical value. This
appears to be a reasonably approach, as it balances issues of public interest with encouraging in-
novation in the area.
The issue of patenting genetic material or transgenic plants/animals remains a contentious one.
The debate is not confi ned to technical and legal argument: ethical and political issues, including
public opinion, also impinge on the decision-making process. The increasing technical complexity
and sophistication of the biological principles/processes upon which biotechnological innovations
are based also render resolution of legal patenting issues more diffi cult.
A major step in clarifying European Union (EU)-wide law with regard to patenting in biotech-
nology stems from the introduction of the 1998 European Patent Directive. This directive (EU
law) confi rms that biological material (e.g. specifi c cells, proteins, genes, nucleotide sequences,
antibiotics, etc.) that previously existed in nature are potentially patentable. However, in order ac-
tually to be patentable, they must (a) be isolated /purifi ed from their natural environment and/or be
produced via a technical process (e.g. rDNA technology in the case of recombinant proteins) and
(b) they must conform to the general patentability principles regarding novelty, non-obviousness,
utility and suffi ciency of disclosure. The 'utility' condition, therefore, in effect prevents patenting
of gene/genome sequences of unknown function. The directive also prohibits the possibility of