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130 nature nanotechnology | VOL 2 | MARCH 2007 | www.nature.com/naturenanotechnology

From the lab to the market

Patents are a double-edged sword — they are essential for the commercialization of new technologies, but flaws in the system also create challenges for universities and smaller companies. On the upside, patents protect ideas and intellectual property (IP), drive innovation and create new industries. On the downside, however, they can favour the creation of monopolies and also result in time-consuming and costly litigation. As the majority of nanotechnology innovation occurs in universities, patents need to bridge the gap between the specific focus of the actual research and the potential applications in the real world, balancing the needs of research institutes — which have limited funds to spend on filing patents — and the monetary returns of commercialization. Implementing a strategy for patents will not eliminate all the challenges posed by the IP system, but it will reduce the risk (see flow chart; Fig. 1).

Patents alone, however, are not enough — it is also important to have ‘freedom to operate’, which means that your new product or process does not infringe on any other patents1. Strategies for obtaining freedom to operate include purchasing or licensing existing patents, cross-licensing (each company giving the other access to the IP they require), and ‘inventing around’ the patents (which I will return to below). However, it is important to realize that the sheer number of patents that are being filed and granted at different patent offices around the world means that you can never be 100% sure that you have freedom to operate. One can only be prudent, perform reasonable due diligence, mitigate the risk and become comfortable with the decisions necessary to move forward.

So what can be patented? It is unlikely that the actual physical phenomena occurring at the nanoscale are patentable. However, in the language of lawyers, the tangible use or embodiment of a physical phenomenon can be. In practice this means that ‘composition of matter’ (that is,

the chemical structure of a material2), fabrication techniques and specifi c applications can be patented. Within the fi eld of quantum dots and nanocrystals3, for instance, there are patents covering all these areas, and companies that actively acquire licenses can control certain commercial applications that rely on quantum dots and nanocrystals. Indeed, their many potential medical applications have resulted in tortuous disputes about patents, and in smaller companies being taken over by larger rivals. Th is has been avoided in some cases, however, with cross-licensing deals. Another approach is to develop a diff erent solution to the problem. For example, as an alternative to using quantum dots and nanocrystals, the US company Keystone Nano use nanoporous ceramics loaded with fl uorescent dyes for diagnostic applications4 (Fig. 2).

The flow chart shows the process I use to translate lab results into commercial products. The first step is to describe the functional requirements of the specific application. The next step is to prioritize these requirements. This focuses attention on the areas where development is needed and also, crucially, identifies the key criteria that need to be covered by the IP. Once functional requirements and their prioritization are understood, the controlled chaos of the brainstorming process can begin. The overall aim is to generate new ideas and then funnel them into the kernels of new inventions. When seemingly insurmountable IP issues arise, brainstorming can often identify ways to overcome these barriers. The intellectual creativity that occurs at the beginning of the process is crucial to its success and should focus on composition of matter and application. Having a composition of matter patent creates strong protection as the rights to the relevant IP must be acquired for the material to be used in other applications, so this is the most strategic approach. It is always advisable to consult a patent lawyer before submitting a patent application, but this

Patent protection and freedom to operate are essential for the commercialization of nanotechnology. Michael Helmus offers a step-by-step guide on how to deal with intellectual property.

Define functional requirements

Prioritize functional requirements

BrainstormingCapture strategically important IP by filing invention records and patent applications based on brainstorming and a review of existing literature and patents. This will establish the initial value of the technologies and products that will enable investment and future commercial and business strategies.

Test proof-of-concept

Refine the design and fabrication processesReview the IP with respect to freedom to operate. This may lead to new inventions, as well as demonstrating the need to license additional technology to allow commercialization to proceed.

Model prototype components and test feasibility

Further refine the design and fabrication processesThis will initiate a new IP review addressing new inventionsrelated to fabrication processes, freedom to operate and licensing of additional IP.

Review functional requirements

Perform FMEA (Failure Modes and Effects Analysis)

Finalize design

Model and test components and deviceAs the final design is completed a final IP review begins to ensure that: all inventions have been captured; decisions have been made on trade secrets versus patenting; and anyadditional IP needed to enable commercialization has been licensed.

Commercial Release

Figure 1 This fl ow chart highlights the major actions and decisions related to patents and IP that are involved in taking an invention from the lab to the market. This approach is based on my experiences of brainstorming sessions at the management consultants, Arthur D. Little, in the mid-1980s. These sessions were similar in many ways to the scenes in the movie Apollo 13 in which the engineers brainstorm solutions to the loss of oxygen in the command module.

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nature nanotechnology | VOL 2 | MARCH 2007 | www.nature.com/naturenanotechnology 131

is particularly true when trying to ‘invent around’ existing IP.

Th e beginning of the inventive process is peculiar and depends on the individuals involved. One of my inventions, for instance, is a medical implant with an average surface charge density that was inspired by miniaturized submarines that travel through blood vessels and traverse across cell membranes by modifying the surface charge distribution on the hull in Isaac Asmiov’s novel Fantastic Voyage II. My invention uses electrodes fabricated from micro- and nanoelectromechanical systems attached to medical devices, which, on coming into contact with blood, modify the surface charge of the device and hence control its biological response (for example, to make it thromboresistant). Full details are available in US patent application number 20060089709. Although this technology is not in production, it will become part of a strategy to create commercialization barriers for competitive technology.

Once an idea has been distilled, performing the proof-of-concept may reveal new compositions, manufacturing processes and characterization methods that can be patented (as well as demonstrating that the invention actually works as intended). When looking at fabrication and characterization, key decisions on whether to patent or keep the methods as a trade secret need to be made. In a company, trade secrets may be more appropriate, whereas a patent might be the best path to protection in an academic environment. For those that are patented, additional invention documentation

and patent applications should be fi led to take into account potential market applications, processes for manufacture, and composition of matter.

Risks can be reduced by evaluating competitive IP at an early stage, at which point a start-up company can be set up or, alternatively, the technology can be licensed to an existing company. Prior to forming partnerships with other companies it is important to investigate freedom to operate — the more freedom, the more valuable the technology. As with all new technologies, following the proper strategy for IP is essential for the

successful and timely commercialization of new inventions in nanotechnology.

References1. www.wipo.int/sme/en/documents/freedom_to_operate.html2. www.baypatents.com/glossary/default.asp?ID_Glossary=883. www.pfc.org.in/ach/quant.htm4. keystonenano.com/imagingtechnologies.asp

Michael N. Helmus is senior vice president for Biopharma at Advance Nanotech e-mail: michael.helmus@Advancenanotech.com

In Th esis next month:Chris Toumey on privacyand nanotechnology

Figure 2 Keystone Nano makes molecular dots for a variety of imaging applications in medicine.

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