Patrick Hui is a J.D. candidate at Osgoode Hall and is taking the Patent Law course.

Innovator companies have long founded their business plans on the search for blockbuster drugs. Blockbuster drugs are products that generate more than $1 billion in annual revenue for pharmaceutical companies and are the lifeline of these businesses. By allocating the majority of R&D resources to blockbusters, innovator companies have engaged in a high risk-high reward practice that to date, has largely paid off. However, as many innovator patents near their twenty year expiration date, large pharmaceutical companies are turning to a rapidly developing area of science in nanotechnology that will undoubtedly dominate the pharmaceutical industry for decades to come.

Nanomedicine is defined as a controlled manipulation of particles at the nanoscale level resulting in medical benefits. To pharma companies, it has a wide range of applications including drug delivery, diagnostics, detection, imaging, and devices. Current pharmaceutical and life science operations will continue to benefit from this developing field as it has the potential to increase effectiveness while enhancing drug delivery systems. A simple example of these benefits is the production of an aspirin tablet that works twenty times faster. Similarly, researchers have begun working on treatment approaches using nanoparticles that allow for gene delivery into human cells. As both small and large pharmaceutical companies have started to invest in these areas, a crucial question will be the protection of patent rights in such a rapidly developing and novel field. Vivek Koppikar, a USPTO Examiner, has published his thoughts on the trends and issues that American nanotech patents face.

In his article, he cites both administrative and substantive issues that could arise. Administratively, the USPTO will have to deal with the “patent land grab” phenomenon – that is – the attempt by innovator companies to state patent claims as broad as possible in order to secure the most amount of IP. This phenomenon can be attributed to the need for innovators to showcase their IP in an attempt to sway venture capitalists to invest in such a high-risk field. Moreover, as innovator companies file their claims, the process is further burdened by the USPTO’s historical inability to meet the high-volume demands of competent examiners in a developing area. Taken together, Koppikar argues that USPTO’s inability to adapt to nanotechnology patents will follow the same inefficient cycle it once did when DNA technology was first introduced.

More importantly, Koppikar cites numerous patent issues that relate to size-based patentability. Many breakthroughs at the nanomedicine level are simply compounds or devices that already exist at the relatively larger sized micro scale level. Consequently, it may be argued that nanotech inventions could all be deemed anticipated by their larger-sized counterparts. In accordance with the recently clarified doctrine of anticipation in Apotex Inc. v. Sanofi-Synthelabo, the prior art must enable a person skilled in the art to perform the invention without undue burden. While the idea of creating a nanocompound may come easy to a person skilled in the art, I would contend that the actual process of miniaturization requires extensive work and experimentation and thus would not render nano-patents anticipated.

Koppikar also suggests that overcoming obviousness may be a burden to nano-patents. Paraphrasing Apotex Inc. v. Sanofi-Synthelabo, a patent will be invalidated when a person skilled in the art compares the “state of the art” with the inventive claims and finds it obvious. During the early stages of developing nanotechnology, many claims will be found non-obvious as the state of the art will be in its infancy. However, as more patents are claimed, it will be increasingly difficult to overcome the obviousness burden as the state of the art will be far more knowledgeable and harder to distinguish from inventive claims. This trend illustrates the importance of securing as many patents as possible in the early stages of new and developing technologies.

Lastly, applicants drafting broad claims in an attempt to secure the most IP may have difficulty under s.27(4) of the Patent Act. This provision provides that the specification must end with a claim or claims defining distinctly and in explicit terms the subject-matter of the invention for which an exclusive privilege of property is claimed. Where claims are broad or vague, Courts may invalidate the patent. However, as we have learned in Jansen-Ortho v. Novopharm, Courts are reluctant to invalidate patents where a person skilled in the art could resolve the ambiguity without too much effort.

Several hurdles exist in overcoming size based patentability that will likely be case specific. However, it is undeniable that nanotech patents are a growing trend. It would be wise for innovators to be cognizant of both the administrative and legal issues that could arise when prosecuting patents that will undoubtedly shape our future.

Posted in Cross Border Issues, Patentability, Patents, Pharmaceutical Drugs, Technology