- In Life Sciences
- 1 March 2018
Recent Australian Patent Office Decisions
By Alison McMillan PhD
The Tasmanian licit opium poppy industry provides about 50% of the world’s Narcotic Raw Material (NRM). The industry is worth about $290 million to Tasmania.
The Tasmanian poppy industry is controlled by three companies, SunPharma, India’s largest pharmaceutical company, Tasmanian Alkaloids Pty Ltd (Tas Alkaloids) owned by SK Capital, a US private equity company, and TPI Enterprise Limited (TPI), the smallest and only Australian company.
NRM contains a number of alkaloids including morphine in a major amount and codeine in a minor amount. NRM is processed to extract alkaloids for use in the manufacture of pain relief formulations. Codeine is the most widely used pain killer in the world. In order to meet the worldwide demand for codeine, codeine is manufactured from extracted morphine.
Production of a poppy plant variant that can produce high levels of codeine at the expense of morphine would reduce the costs of producing codeine. The commercial advantages would be significant and development of such an improved poppy plant has long been a goal of the licit poppy industry. (A low morphine poppy plant would be of little use in the illicit poppy industry in which morphine is used to manufacture heroine).
Tas Alkaloids developed such an improved poppy plant and filed patent applications around the world. The Australian patent application was accepted on 11 June 2009. Both SunPharma and TPI filed notices of opposition to the grant of a patent at the Australian Patent Office. The main ground of opposition was that the invention was obvious and thus not patentable. It was argued that the steps taken by Tas Alkaloids to produce the improved poppy plant would have been mere routine for a plant biologist. All parties led considerable evidence from a number of highly experienced experts in the field.
The Patent Office recently issued its decisions for both oppositions on 31 January 2018. The Patent Office accepted Tas Alkaloids’ position that the invention was not obvious and both oppositions were dismissed.
The opponents have three weeks to appeal the respective Patent Office decisions in the Federal Court.
The licit poppy industry in Tasmania is of significant commercial importance to Tasmania and is unique in terms of the highly restrictive regulations (requiring United Nations permission to grow the plants) and is controlled by only three companies. For one company to have exclusive and enforceable patent rights for the improved high codeine poppy plant could have significant effects on the industry.
Given the commercial importance of this new poppy, an appeal by one or both of the opponents would be expected. We will be watching further developments with interest.