Abstract
The patent system plays a pivotal role in many industries. Perhaps the
pharmaceutical industry places most reliance on the protection afforded by
patents. The uncertainty, complexity and high costs of identifying new
pharmaceutical products and bringing these to market has always provided, and
continues to provide, motivation to pharmaceutical companies to protect the
results of their research and development (R&D). The scale of patenting
activity in the pharmaceutical sector and the importance of developing and
providing improved standards of medicinal products as part of healthcare are
reflected in the patent system itself. Many patent laws contain provisions
explicitly addressing problems and issues that arise from the healthcare
industry. Examples include patenting further medical indications of known
pharmaceutically active compounds and the unique extension of patent terms
available by way of supplementary protection certificates (SPCs).
The growing body of international case-law and judgments relating to
pharmaceutical patents reflects the current high levels of activity in
enforcing these patents and the efforts being made to push at the boundaries
of patent law by creative pharmaceutical companies and their patent attorneys.
the cases before the European Court of Justice (ECJ) relating to the free
movement and parallel importation of pharmaceuticals between EU Member States
are just an example of this creativity. Few would disagree that these cases
were fundamental in defining the doctrine of exhaustion of rights now
enshrined in European Community law.
The subject of patent law in general and its commercial applications is a
fascinating topic, more so when focusing on the peculiarities of
pharmaceutical patents and the related laws and legislation. This report will
examine the fundamental aspects of patent law in Europe and worldwide,
relating legislation and the commercial applications and implications of
patents in the pharmaceutical sector. It will give the reader an understanding
not only of the basics of patent law, in general and as it relates to
pharmaceuticals, but also the relationship between patents and the commercial
realities of doing business in the pharmaceutical sector. It will also help
the reader to stop thinking of patents as perhaps a complicated legal entity
and understand how to relate to patents as valuable business assets - in some
cases the most valuable assets can a company can own.
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