Patent protection in research regulation

 

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