Large-scale scientific experiments and the need for more exemptions like the Hatch-Waxman exception in Patent Law

Oceanography is a fascinating field of study, encompassing knowledge from a variety of scientific and engineering disciplines.  Notable pioneering efforts in oceanography have been recognized from countries across the globe although tribute must be given to the great Jacques Cousteau for the popularization of oceanography in the eyes of the general public.  His books, films, and conservation efforts have revealed the wonders of the oceans for countless children and adults alike.

In the 1980s, John Martin’s seminal work out of Woods Hole Oceanographic Institute fueled the idea of seeding algal blooms with iron, aka iron fertilization, into becoming a feasible solution to the issue of rising atmospheric carbon dioxide (CO2) levels.  The results of his studies on mapping the oceanic distribution of nutrients essential for algal proliferation confirmed the presence of large regions that are low in iron levels with respect to macronutrients such as nitrate, phosphate, and silicate.   Such regions are found in the subarctic North Pacific, equatorial Pacific, and Southern Oceans, and described as iron-limited, with regards to biological productivity, as the pelagic macronutrient concentrations in these regions are similar to those found in coastal waters but iron levels are significantly lower.   Oceanographers have labeled these areas as High-Nutrient Low Chlorophyll (HNLC) regions, due to the unusually low algal populations in spite of the abundance of macronutrients.

            These findings sparked the idea of iron fertilization: by artificially enriching the HNLC regions with iron, algal blooms may be initiated, drawing down atmospheric CO2 through the surface boundary layer of the ocean where photosynthetic algae amass.  The carbon from the CO2 is incorporated into the algal biomass and ultimately the algae die and sink to the ocean bottom, essentially sequestering carbon into the ocean sediment.  Several expeditions took place between 1995-2012, in an international effort to test this hypothesis.  Each experiment involved dumping tons of iron, often in the form of iron sulfate, into a patch of an HNLC region and monitoring biological activity, nutrient levels, CO2 levels, etc. 

            An interesting consequence of undertaking of such large-scale experiments has been a commercial interest in developing iron fertilization into a viable solution to climate change.  A number of start-ups have patented various aspects of iron fertilization including methods for introducing iron to ocean waters (US6056919, US6200530), apparatuses for iron release (US20130006445, US20110282773) and processes for monitoring the effects of enriching ocean waters with iron (WO2016090478). 

            The results of the iron fertilization experiments have generated inconclusive results.  There have been no definitive correlations between increased algal biomass and atmospheric CO2 levels.  Furthermore, initiating algal blooms may result in disruptions between the careful balances within trophic ladders such as relationships between types of algae and the organisms that eat them, oxygen levels in the surface layer, biogeochemical cycles in marine systems, as well as elevated levels of algal byproducts including nitrous oxide, a potent greenhouse gas.  In short, altering one factor in the marine environment could unknowingly trigger a plethora of undesirable consequences that could be disastrous.  Preventing others from experimenting with such iron fertilization techniques (such as through patent protection), further studies to better understand potential effects cannot be conducted using those particular techniques at the specific location.  As each marine ecosystem is intricate and unique, it is difficult to fully understand the highly dependent web of relationships between flora, fauna, and chemical makeup of the local waters without prior careful monitoring and analysis by scientists and engineers.

            While US patent law provides a research exemption with respect to drug development through the Hatch-Waxman exemption (as confirmed by the Supreme Court in the 2005 Merck v. Integra case), it does not expressly provide a statutory exception for oceanic research. 

            While the protection of intellectual property is important and may be an invaluable factor in implementing technological advances, when it comes to processes established by nature, we are often still neophytes.  Hopefully, the realization that natural processes are far more complex than realized will eventually bring about the additional of statutory updates enabling research to continue unobstructed with regard to our oceans. 

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