Patenting to promote innovation

 Patents and intellectual property are a vital, if potentially complex, part of life sciences research today. Patrick Andersson, Senior Patent Examiner and Patent Expert at the Swedish Patent and Registration Office (Patent-och registreringsverket; PRV), is one of a team of around 15 specialists in life sciences that asses patents and support companies and individuals through the process.

PRV grants patents and registers trademarks and designs, and is an International Searching Authority (ISA) and International Preliminary Examining Authority (IPEA) authority under the Patent Cooperation Treaty (PCT).

Beginning the process

The process of patenting begins earlier than many researchers think, even before the first day at the laboratory bench.

“Researchers working in life sciences need to have an eye on intellectual property, even before they begin the research. They need to conduct a thorough search and analyse the IP from two perspectives to find a direction for their research – to find out what is patentable, and to find freedom to operate and not infringe others’ work,” says Andersson.

What can be patented?

To be patentable, an invention (a product or a technology) must be novel – it must not be known or described anywhere in the world. It must also be inventive and non-obvious, and not a logical development of something already known. It also has to have industrial applicability. Patenting an invention based on a discovery in life sciences is harder than one in the automotive industry, for example – the patent office needs more information on what the discovery is for, and what it can do. 

“Mere discoveries cannot be patented, however it is possible to patent isolated proteins, DNA and microorganisms, if these have not been described previously, provided that they have a practical use. While this is controversial, it can stimulate researchers to find new discoveries, make them known to other researchers and put them into use for the benefit of the public,” says Andersson. 

In the early days, it was hard to sequence DNA, and the authorities granted patents for sequences such as those for growth hormone in all organisms. Now that sequencing DNA is easier, particularly following the publication of the Human Genome Project data, the hurdle for ‘inventive’ is much higher, and the patent office requires a more defined use for the DNA.

“Many products or technologies have applications for a number of diseases, and small companies can only focus on one – we would recommend that they patent for use in all possible disease areas, and then the company can license out any areas outside their main research field,” says Andersson.

After the application goes in

It takes 24 to 36 months for PRV to approve a life sciences (pharmaceuticals, biotechnology, food technology and medical technology) patent in Sweden. The process has speeded up, and now around 80% are approved within 24 months, which, according to Andersson is fast compared with most other patent offices. 

The percentage of approved patents in life sciences between 2005 and 2009 is around 10% (see Table 1). This is much lower than the Swedish Patent Office percentage overall, which is around 50%. The increased speed of approval and the catch up of a backlog may explain the increased numbers in 2010 and 2011.

Table 1: Life sciences patent applications in Sweden

“Within the life sciences, many applicants file a first priority application in Sweden, followed by a PCT application and a continuation in regional phase at the European Patent Office, which can give protection in all 38 member countries of the EPC (European Patent Convention). If this latter application is approved, it covers Sweden, so the first national application is often withdrawn prior to publication,” says Andersson. “The advantage of filing first in Sweden is that this gives applicants an early analysis of the patentability before considering how to proceed internationally, and also the applications in life science are usually made in English with an option to receive the report in English, which will help with international applications.”

The perils and pitfalls 

The process of patent applications can appear daunting, especially for individuals and small biotech companies, and there are a number of perils and pitfalls. The timing of a patent is not easy – enough research must have been completed so that there is something to put in the application, but it is also important to patent early.

“Life sciences companies make two key mistakes when they are filing patents, particularly if they do so without the support of a patent agent. This is to claim a very narrow patent just on what they have achieved, so that competitors can invent around the patent, or to claim too much – they try to patent the world. It is possible to make a broad application and then file a more narrow application later,” says Andersson, “but the risk is coming up against your own initial patent application. It’s also hard to insert new things into an existing patent. Doing as much research as possible upfront can help to avoid some of these issues, and using a patent agent can help smooth the process, as they ask the right questions and talk the same language as patent examiners. It’s important to know what has been patented in the past and what competitors are doing – as well as reading the journals, researchers need to keep up to date with published patents as well. Researchers must also be aware of the issues of disseminating too much information before they put in a patent application, for example in presentations at conferences. 

Intellectual property is vital

Intellectual property is an important business tool, as it attracts investment, and income from out-licensed projects will go towards development costs of projects that remain in-house. Patents are also an asset as part of a company’s exit strategy, and it’s a process that’s vital to get right.