Editor: Deborah, please tell us about the specific practice areas of intellectual property in which you participate.
Vernon: My practice has been directed to helping clients assess, build, maintain and enforce their intellectual property, especially in the technology areas of material science, analytical chemistry and mechanical engineering. Prior to entering the practice of law, I studied mechanical engineering as an undergraduate and I obtained a PhD in material science engineering, where I focused on creating composite materials with improved mechanical properties.
Editor: Please describe some of the new areas of biological and chemical research into which your practice takes you, such as nanotechnology, three-dimensional printing technology, and other areas.
Vernon: I would say the two most interesting areas in the last year or two have been in 3-D printing and nanotechnology. 3-D printing is an additive technology in which one is able to make a three-dimensional product, such as a screw, by adding material rather than using a traditional reduction process, like a CNC (milling) process or a grinding-away process. The other interesting area has been nanotechnology. Nanotechnology is the science of materials and structures that have a dimension in the nanometer range (1-1,000 nm) – that is, on the atomic or molecular scale. A fascinating aspect of nanomaterials is that they can have vastly different material properties (e.g., chemical, electrical, mechanical properties) than their larger-scale counterparts. As a result, these materials can be used in applications where their larger-scale counterparts have traditionally not been utilized.
I was fortunate to work in the nanotech field in graduate school. During this time, I investigated and developed methods for forming ceramic composites, which maintain a nanoscale grain size even after sintering. Sintering is the process used to form fully dense ceramic materials. The problem with sintering is that it adds energy to a system, resulting in grain growth of the ceramic materials. In order to maintain the advantageous properties of the nanosized grains, I worked on methods that pinned the ceramic grain boundaries to reduce growth during sintering. The methods I developed not only involved handling of nanosized ceramic particles, but also the deposition of nanofilms into a porous ceramic material to create nanocomposites. I have been able to apply this experience in my IP practice to assist clients in obtaining and assessing IP in the areas of nanolaminates and coatings, nanosized particles and nanostructures, such as carbon nanotubes, nano fluidic devices, which are very small devices which transport fluids, and 3D structures formed from nanomaterials, such as woven nanofibers.
Editor: I understand that some of the components of the new Boeing 787 are examples of nanotechnology.
Vernon: The design objective behind the 787 is that lighter, better-performing materials will reduce the weight of the aircraft, resulting in longer possible flight times and decreased operating costs. Boeing reports that approximately 50 percent of the materials in the 787 are composite materials, and that nanotechnology will play an important role in achieving and exceeding the design objective. (See, http://www.nasc.com/nanometa/Plenary%20Talk%20Chong.pdf). While it is believed that nanocomposite materials are used in the fuselage of the 787, Boeing is investigating applying nanotechnology to reduce costs and increase performance not only in fuselage and aircraft structures, but also within energy, sensor and system controls of the aircraft.
Editor: What products have incorporated nanotechnology? What products are anticipated to incorporate its processes in the future?
Vernon: The products that people are the most familiar with are cosmetic products, such as hair products for thinning hair that deliver nutrients deep into the scalp, and sunscreen, which includes nanosized titanium dioxide and zinc oxide to eliminate the white, pasty look of sunscreens. Sports products, such as fishing rods and tennis rackets, have incorporated a composite of carbon fiber and silica nanoparticles to add strength. Nano products are used in paints and coatings to prevent algae and corrosion on the hulls of boats and to help reduce mold and kill bacteria. We’re seeing nanotechnology used in filters to separate chemicals and in water filtration. The textile industry has also started to use nano coatings to repel water and make fabrics flame resistant. The medical imaging industry is starting to use nanoparticles to tag certain areas of the body, allowing for enhanced MRI imaging. Developing areas include drug delivery, disease detection and therapeutics for oncology. Obviously, those are definitely in the future, but it is the direction of scientific thinking.
Editor: What liabilities can product manufacturers incur who are incorporating nanotechnology into their products? What kinds of health and safety risks are incurred in their manufacture or consumption?
Vernon: There are three different areas that we should think about: the manufacturing process, consumer use and environmental issues. In manufacturing there are potential safety issues with respect to the incorporation or delivery of nanomaterials. For example, inhalation of nanoparticles can cause serious respiratory issues, and contact of some nanoparticles with the skin or eyes may result in irritation. In terms of consumer use, nanomaterials may have different material properties from their larger counterparts. As a result, we are not quite sure how these materials will affect the human body insofar as they might have a higher toxicity level than in their larger counterparts. With respect to an environmental impact, waste or recycled products may lead to the release of nanoparticles into bodies of water or impact wildlife. The National Institute for Occupational Safety and Health has established the Nanotechnology Research Center to develop a strategic direction with respect to occupational safety and nanotechnology. Guidance and publications can be found at http://www.cdc.gov/niosh/topics/nanotech.
Editor: The European Union requires the labeling of foods containing nanomaterials. What has been the position of the Food & Drug Administration and the EPA in the United States about food labeling?
Vernon: So far the FDA has taken the position that just because nanomaterials are smaller, they are not materially different from their larger counterparts, and therefore there have been no labeling requirements on food products. The FDA believes that their current standards for safety assessment are robust and flexible enough to handle a variety of different materials. That being said, the FDA has issued some guidelines for the food and cosmetic industries, but there has not been any requirement for food labeling as of now. The EPA has a nanotechnology division, which is also studying nanomaterials and their impact, but I haven’t seen anything that specifically requires a special registration process for nanomaterials.
Editor: What new regulations regarding nanotech products are expected? Should governmental regulations be adopted to prevent nanoparticles in foods and cosmetics from causing toxicity?
Vernon: The FDA has not telegraphed that any new regulations will be put into place. The agency is currently in the data collection stage to make sure that these materials are being safely delivered to people using current FDA standards – that materials are safe for human consumption or contact with humans. We won’t really understand whether or not regulations will be coming into place until we see data coming out that indicates that there are issues that are directly associated with nanomaterials. Rather than expecting regulations, I would suggest that we examine the data regarding nano products to optimize safe handling and use procedures.
Editor: Have there ever been any cases involving toxicity resulting from nano products?
Vernon: There are current investigations about the toxicity of carbon nano tubes, but the research is in its infancy. There is no evidence to show any potential harm from this technology. Unlike asbestos or silica exposure, the science is not there yet to demonstrate any toxicity link. The general understanding is that it may take decades for any potential harm to manifest. I believe my colleague, Patrick J. Comerford, head of McCarter’s product liability team in Boston, summarizes the situation well by noting that “if any supportable science was available, plaintiff’s bar would have already made this a high-profile target.”
Editor: While some biotech cases have failed the test of patentability before the courts, such as the case of Mayo v. Prometheus, what standard has been set forth for a biotech process to pass the test for patentability?
Vernon: There is no specified bright-line test for determining if a biotech process is patentable. But what the U.S. Patent and Trademark Office has done is to issue some new examination guidelines with respect to the Mayo decision that help examiners figure out whether a biotech process is patent eligible. Specifically, the guidelines look to see if the biotech process (i.e., a process incorporating a law of nature) also includes at least one additional element or step. That additional element needs to be significant and not just a mental or correlation step. If a biotech process patent claim includes this significant additional step, there still needs to be a determination if the process is novel and non-obvious over the prior art. So while this might not be a bright-line test to help us figure out whether a biotech process is patentable, it at least gives us some direction about what the examiners are looking for in the patent claims.
Editor: What effect do you think the new America Invents Act will have in encouraging biotech companies to file early in the first stages of product development? Might that not run the risk that the courts could deny patentability as in the Ariad case where functional results of a process were described rather than the specific invention?
Vernon: The AIA goes into effect next month. What companies, especially biotech companies, need to do is file early. Companies need to submit applications supported by their research to include both a written description and enablement of the invention. Companies will need to be more focused on making sure that they are not only inventing in a timely manner but are also involving their patent counsel in planned and well-thought-out experiments to make sure that the supporting information is available in a timely fashion for patenting.
Editor: Have there been any recent cases relating to biotechnology or nanotechnology that our readers should be informed about?
Vernon: The Supreme Court will hear oral arguments in April in the Myriad case. This case involves the BRCA gene, the breast cancer gene – and the issue is whether isolating a portion of a gene is patentable. While I am not a biotechnologist, I think this case will also impact nanotechnology as a whole. Applying for a patent on a portion of a gene is not too far distant from applying for a patent on a nanoparticle of a material that already exists but which has different properties from the original, larger-counterpart material. Would this nanosize material be patentable? This will be an important case to see what guidance the Supreme Court delivers this coming term.
Editor: Is there anything else you’d like to add?
Vernon: I think the next couple of years for nanotech will be very interesting. As I mentioned, I did my PhD thesis in the nanotechnology area a few years ago. My studies, like those of many other students, were funded in part with government grants. There is a great deal of government money being poured into nanotechnology. In the next ten years we will start seeing more and more of this research being commercialized and adopted into our lives. To keep current of developments, readers can visit www.nano.gov.