Recent
medical and biotechnological advances have enhanced innovation that has greatly
improved public healthcare. Research regulation ensures medical products have
undergone the necessary tests prior to marketing for public use. Regulation is
also vital to protect the interests of inventors and industry.
Patent
protection forms part of the research regulation system. The UK Patent Act of
1977 grants the inventor exclusivity over a new medical product for a limited
period of time. The patent holder is normally in a position to gain
financially, by setting a higher than competitive price to recover the costs of
innovation.
Policies
for patent applications have been influenced by the advancement of medical research.
The diversity of biological innovations over the past decade have seen more areas
of science now patentable e.g. within the fields of biotechnology and genetics.
Research into new biotechnology materials such as graphene, saw a total of 8416 published patent applications in the
UK by February 2013.
Increased
patent protection in medical research also has its disadvantages as patents can
harm competition within the healthcare market, making it more costly for public
services like the National Healthcare Service (NHS) to benefit from the latest
healthcare development.
This
article will explore; the reasons for patent protection and why it is
increasingly seen as a pivotal part of the innovation process, the main policy
issues of patents and an overview on the recent progress of patent policies in
research regulation.
The
importance of patent protection
Appropriate
regulation of science patents is seen by pharmaceutical companies, governments
and inventors as crucial to stimulating research, leading to new products that
can improve healthcare. The financial rewards associated with a successfully
registered patent is an incentive for researchers and companies to take the
necessary risks, through financial investments, to develop novel medicines and
implement new solutions into tackling life-threatening diseases.
Expired
patents can lead to a significant reduction in loss revenues for the patent
holder when generic competition becomes available. This was demonstrated by Eli
Lilly & Company whose 66% decline in revenues during the final quarter of
2001, was the result of an expired patent on their drug Prozac in 2001.
Patents can provide economic stability for inventors, academic institutions and
industry. Therefore, it is important for inventors, pharmaceutical companies and
institutions to protect new ideas, methods and medical products within the public domain.
Main
policy issues with patents protection
One
of the main policy issues in patent protection is the need for an inventor to
have their patent validated within each European country. Currently, there is no single universal patent application that covers
the 25 countries in the European Union. At present different requirements apply to each European country,
for example; the patent proprietor may have to pay fees to the national patent
office, comply with various requirements and provide a patent document in the
official language of the State. Specific requirements, laws and
regulations by governments are considered costly and time-consuming as the
inventor, small and large companies comply with the policies of each country.
This can impede the public release of novel products in some European countries.
The filing of patent protection by individual countries poses
further issues, namely the huge backlog of patents being processed. It
is estimated that there are 4 million patents waiting to be processed worldwide.
According to Cancer Research UK, guidelines on new medicines should be released
within six months of licensing. For new cancer medicines this regulatory
process is three times longer, delaying the availability of new drugs to NHS
patients.
Regulations
and governance for different areas of medical research in the UK e.g. research
ethics in clinical trials, is monitored by the Health Research Authority
(established in 2010). The primary role
of the HRA is to oversee research regulation and provide a single point of
contact for researchers and the public. Similarly, the EU has recently
approved two new regulations to create an organisation that will oversee a
single patent application process for all EU countries. This
will significantly reduce costs and time-consuming paperwork for the patent
proprietors wanting to do business in Europe, whilst providing a set of
consistent requirements across all EU states.
Major
scientific developments have led to a change in patent policies over the past
decades. New types of inventions in software, genetics and business models are
now deemed patentable. Patent protection is necessary as it provides the
incentive for the innovation of new medical products. Currently a simplified
patent system within the EU is under development. This will provide greater
understanding of patent policies for governments, public and industry experts
alike. In turn this ought to give inventors the initiative to continue to
develop new effective medicines.
Uybach
