in not likely to be sought by the inventor, as a new
chemical entity is often the invention that needs
protection and such an invention necessarily must
be publicly divulged. Two types of pharmaceutical
inventions, however, are often kept as trade secrets:
manufacturing process improvements and screen-
ing assays.
48.2 Short history of patents
Patents are not a new concept. They were granted at
least as far back asancient Greece andBabylon. Nor
are they the product of only one form of govern-
ment. Essentially every country has some form of
patent protection, albeit not necessarily as strong as
that in the United States and the other industrialized
countries. Patent laws have long existed even in the
noncapitalist systems, such as the former USSR.
That intellectual property is a highly valued concept
that can be no better demonstrated than by the
observation that there are only two rights (Patents
andCopyrights)which arespecificallymentionedin
the US Constitution. (The much-praised Bill of
Rights was a group of 10 amendments added to
the basic document.) Section 8, para 8 reads:
To promote the progress of science and the useful arts
by securing for limited times to authors and inventors
the exclusive rights to their respective writings and
discoveries.Limitations on patent rights. Patents, however,
are not free of their detractors. As they are a form of
monopoly and because monopolies have been sub-
ject to abuse (e.g. granting the king’s cousin a
monopoly on the local water well), anti-monopoly
laws (e.g. restraint of trade, anti-trust, etc.) exist
which can be used to limit a patentee’s rights.
Another limitation on patent rights is simply
prohibiting the grant of patents on certain types
of inventions, typically based on ethical or eco-
nomic considerations. There are arguments against
‘patenting life’, as a result of which some types of
biotechnology inventions are unpatentable in many
countries. Among these can be included patenting
transgenic animals, pieces of the human genome
and, of course, human clones. Many countries
prohibit methods of treating humans. Another,
older, prohibition is that against granting patents
to pharmaceuticalsper se. Although their numbers
are diminishing, many countries have allowed
only limited patent protection on pharmaceuticals.
Typically what can be patented in these countries is
a process to synthesize the compounds but not on
the compoundsper se. These, so called, ‘process
countries’ are mostly nonindustrialized. They have
argued that they would be at an economic disad-
vantage if they were to grant compoundper se
protection because they do not have the in-house
infrastructure to invent/patent such compounds
themselves. All such patents would be granted to
foreign, international pharmaceutical houses, as a
consequence of which, moneys would always be
flowing out of these countries to pay for vital phar-
maceutical drugs. Many ‘process’ countries have
already amended or have agreed to amend their
laws to include compoundper seprotection. The
subtleties of these ethical and economic debates are
beyond the scope of this discussion.48.3 Patent protection
Fundamental patent rights. A patent is a monopoly
for a period of time (20 years) which gives the
patenteethe right to exclude othersfrom making,
using, selling or offering to sell the patented inven-
tion. Patents are limited geographically, tempo-
rally and by the rights of others. Because others
may have superior rights, a patent never gives the
patentee a right to practice the invention. This is a
basic concept which is often unappreciated by the
non-practitioner.
Patent licensing. Thus, the oft-heard, ‘We just
licensed in the right to make Compound X’, when a
patent license has been negotiated, is legally incor-
rect. It would imply that the right conveyed by the
license is actually greater than that possessed by
the licensor. However, the licensor doesnothave
the right to make Compound X, only the right to
deny that right to others. What is generally con-
veyed by a patent license, and depending on the
wording thereof, is (1) protection from a patent
infringement suit by the licensor or (2) the right
to sue others for patent infringement.48.3 PATENT PROTECTION 621