A new golden age for natural products
Natural products – chemical compounds produced by living organisms – are ubiquitous in our daily lives and fundamental to the modern life-sciences economy. From beauty products, to health supplements, to cancer therapeutics, the science behind natural products is developing rapidly, and we are reaping their benefits now more than ever. In fact, 2015 was heralded as ushering in “a new golden age of natural products” with the Nobel Peace Prize in Physiology / Medicine being awarded to Campbell, Omura, and Tu for their discovery of a pair of natural products that have revolutionized the treatment of devastating parasite-borne diseases.1 Unfortunately, while the science behind natural-product-related innovations has never been more advanced, the intellectual property policy surrounding natural-product-related inventions is growing increasingly unclear and has the potential to stifle innovation – at least in the United States.
Patent eligibility for natural-product-related inventions – United States post 2014
Like any sector of the innovation economy, the life-sciences industry relies on sound patent policy to incentivize research and development. Unfortunately, the new golden age for natural products is contemporaneous with a series of policy changes at the United States Patent and Trademark Office (USPTO) that severely restrict the types of natural-product-related inventions that are considered patent eligible. Briefly stated, in March 2014 (on the heels of a United States Supreme Court ruling on Myriad Genetics2), the USPTO issued a controversial Guidance that expanded their set of judicial exceptions (types of non-patentable subject matter) to include the broad term “natural products”.3 According to the March 2014 Guidance, if a claim recites or involves a natural product, then the claim must recite something “significantly different” than the product itself. The Guidance resulted a sharp rise in eligibility objections and outcries from the life-sciences community. Since then, the USPTO has issued an interim guidance and a number of updates (20144, 20155, 20166) on their position. Among other changes, the “significantly different” requirement has been replaced with a “markedly different” requirement in view of further rulings from the United States courts. The interim guidance and updates provide details on the USPTO’s interpretation of the scope of these phrases with a series of examples that are widely discussed and debated. For the current discussion, suffice it to say that the often arduous and technically-challenging process of isolating and purifying a natural product does not meet either threshold. Amidst this golden age for natural products, the United States can be a challenging jurisdiction for life-science innovators.
In Canada, patent-eligibility is codified by the definition of “invention” set out in section 2 of the Canadian Patent Act. In short, “any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter” may meet the Canadian requirement for patent eligibility. Canadian courts and the Canadian Intellectual Property Office (CIPO) have generally interpreted these categories expansively and delineated judicial exceptions clearly. In contrast to the USPTO, CIPO does not characterize natural-product-related inventions as judicial exceptions. Accordingly, while natural products and their properties are more likely to have been publically disclosed – such as to destroy novelty (and thereby bar patentability) – natural products are not distinguished from other compositions of matter for the purposes of section 2 of the Canadian Patent Act. As such, the current standards applied to natural- product-related inventions in Canada are similar to those applied in the United States prior to 2014. In this golden age for natural products, Canada remains a friendly jurisdiction for life-science innovators.
Developing a coherent prosecution strategy to navigate differing patent-eligibility rules between Canada and the United States can be complex and often requires the preparation of jurisdiction-specific claim sets and remarks.