Steven Zuccarelli is a J.D. Candidate at Osgoode Hall Law School
On 28 October 2010, IP Osgoode hosted Professor Graham Dutfield of the University of Leeds School of Law, who discussed research that demonstrates how the development and commercialization of hormones as pharmaceuticals represents an example of how IP policy, scientific developments, and the business of pharmaceuticals come together to shape the future of an industry. Professor Dutfield’s work specifically shows how the skills and tools developed by the pharmaceutical industry during the rise of hormone research from the 1930s to the 1960s continue to be used today.
To understand the role that hormones play in the current state of the life sciences industry, Professor Dutfield highlights the key distinctions that hormones have in relation to more traditionally conventional synthesized chemicals. Hormones represent a class of chemical signaling molecules manufactured in living organisms, like humans, by cells or glands. Examples of hormones include adrenaline and insulin. Unlike completely synthesized chemicals, commercially available hormones often represent purified or isolated examples of naturally occurring chemicals, and because of their natural sources, pose challenges in terms of what the distinction is between what is patentable versus not patentable. However, as Dutfield demonstrates, at the approximate time of the initial wave of commercialization of the hormone as a treatment for disease in the 1930’s to 1950’s, both the U.S and Germany (then the worldwide leader in the commercial pharmaceutical industry) demonstrated a willingness to allow the patenting of hormones, and therefore a general desire to allow isolated and purified biological products to become proprietary. This has set the tone for patent policy that is evident even today.
Dutfield’s use of adrenaline and insulin as case studies highlights the effect of the willingness of patent offices to grant patents for naturally occurring chemicals, in the context of a still evolving scientific understanding of the hormones.. For example, a subsequent adrenaline product to market signaled that the originally patented product, patented by Jokichi Takamine, was in fact an impure concoction of multiple chemicals, and therefore did not represent the pure “adrenaline” that was the subject of the patent. With the chemical identity of the commercial product often unknown, patents were therefore increasingly granted based on the clinical function, or alternatively the isolation or purification process of the substance, rather than its structure or identity. This represented a shift in patenting principles that has persisted even to today, according to Dutfield. Also interesting during this period was that companies were increasingly looking at the patent filings of their competitors in multiple jurisdictions, not only gaining an understanding of what their rivals were doing, but also to garner information that may help with filling the gaps in their own patent filings.
Hormones in the life sciences sphere are worth investigating, as they posed issues for science, business and patent policy during the infancy of the pharmaceutical industry’s development, and therefore had a great role to play in forming a framework for strategy that is employed by the industry now. For scientists, the challenges came from the isolation and purification techniques that were involved in obtaining a viable product, along with having to relate the hormones to a clinical and therapeutic function to obtain a patent. For businesses, obtaining patents strategically to block competition, and the use of rival patents to obtain insights into new techniques and therapeutics refined skills that are extensively used even now.
As Dutfield noted at the end of his discussion:
“During the five decades covered in our account, patent legislation changed quite little – but it did not really need to. The jurisprudence tended to be quite favourable for those seeking patent rights in this field, and that was enough. Courts were susceptible to broadly similar life-is-chemical analogies. We are living with that legacy today. In this era of international competition, what did change was patent management strategy, which became global, much more sophisticated and at times quite aggressive. Competition was intense, but collaboration was not uncommon either.”
Full video coverage of Professor Dutfield’s talk, including the question and answer period, can be accessed on IP Osgoode’s Events Archive page.