Nanotechnology involves materials and devices built on a molecular, or nanometer scale, and crosses many interdisciplinary boundaries including chemistry, physics, electronics, mechanics and biology. Its interdisciplinary nature, as well as its ability to have effects at molecular, cellular and systemic levels make nanotechnology a natural for application in the traditionally interdisciplinary field of medical devices. The newly emerging field of nanomedicine applies nanotechnology to perform highly specific medical intervention at the molecular or cellular level for curing disease or repairing damaged tissues.
The possible applications of nanotechnology to medical devices offer an exciting glimpse into the future. While we're not quite talking about Raquel Welsh navigating the blood vessels in a tiny submarine as envisioned in the classic sci-fi movie adaptation of Isaac Asimov's Fantastic Voyage, we are talking about some equally amazing technologies that have the potential to revolutionize medicine.
Nanomedicine will emerge in the fields of therapeutics, diagnostics, imaging, power systems, tissue engineering, biosensors, implants, and artificial organs to name a few. The lines drawn between biotechnology, pharmaceuticals and medical devices will become even more blurred than they are today. The field should benefit greatly from its share of $3.7 billion in government funding over the next four years under the U.S. National Nanotechnology Initiative, and from the NIH Nanomedicine Roadmap Initiative.
Nanomedicine should be able to take advantage of many of the nanotechnology structures and devices being developed today such as nanocrystals, nanotubes, dendrimers, fullerenes, quantum dots, nanoparticles and nanowires. If you are not familiar with these terms, you will be in the not too distant future.
The future may hold nanoscale medical devices that circulate through the body intelligently identifying and binding with cancer cells for the purpose of releasing a killing toxin directly into them. Nanoscale oxygen compressors and flow regulators will someday deliver oxygen to oxygen-deprived tissues and organs at the cellular level. Nanotube based x-ray sources will greatly reduce the size of medical x-ray devices. Nanorobots will circulate in the bloodstream and perform surgery at the cellular level. Self-assembling nanotubes may form the basis for biocompatible materials suitable for artificial joints. Dendrimers will form the microscopic scaffolding on which artificial organs will be grown. Medical diagnostics will be performed by nanoscale sensors. Nanotech contrast agents will intelligently identify and "light up" diseased tissue in medical imaging systems.
The emerging field of nanomedicine faces the same intellectual property challenges as the general field of nanotechnology faces today. The challenges include obtaining effective patent coverage and developing technology in the face of overly broad patent claims issued to others by the patent office. The U.S. Patent and Trademark Office is the currently unable to effectively deal with the rising number of nanotechnology patent applications that require examination, but is meeting with industry in an effort to resolve the problems.
Just like the problems experienced at the patent office when biotechnology was a newly emerging field, the patent office is ill equipped from a personnel, reference library and logistical standpoint to efficiently provide high quality examination of leading edge nanotechnology inventions at this early stage in the technology's evolution.
The highly interdisciplinary nature of nanotechnology is complicating the effective hiring and training of examiners, who traditionally have focused on single technical areas. The patent office has not yet developed a comprehensive nanotechnology classification system which is critical to the effective examination of applications. To obtain a valid patent, it will be incumbent on the inventor to conduct a very thorough prior art search and provide the examiner with the references needed for an effective examination. In the mean time, before the patent office has developed a sufficient storehouse of nanotech prior art and experience, expect to see some overly broad claims issue that may, at least temporarily, have a chilling effect on the industry.
Aside from examination quality issues, nanomedicine inventions may face an uphill battle at the patent office where the nature of the device is perceived to be a scaled down version of a larger, microscale device. The patent office may argue that the nanotech invention is anticipated or made obvious by the similar microscale device. Reduced size alone may not provide a sufficient basis for patentability unless the reduction in size also alters some physical property of the device in a meaningful way. Inventors should think outside the box when claiming new nanomedicine devices to consider broad and narrow claims, as well as claims to applications of their inventions outside the field of medicine.
The FDA and other government approval processes for nanomedicine devices may become a high hurdle for the industry. There is considerable uncertainty as to what approvals are necessary for nanomaterials. Unresolved health, safety and environmental issue surround the development of nanotechnology generally, and the government is considering ways to regulate the industry as a whole. FDA will be in the forefront of needing to resolve some of these issues in the context of approving medical devices, many of which may not be eligible for 510k approval. Furthermore, the EPA is exploring whether certain nanomaterials would fall under the Toxic Substances Control Act and thereby require EPA review as well.
Nanomedicine offers many opportunities, challenges and unknowns. What is certain, however, is that the practice of medicine as we know it is about to change dramatically.
The content of this update is general in nature and is not intended as legal advice related to individual situations. Counsel should be consulted for specific legal planning and advice.