September 02, 2020
Agricultural Biotech Patent Watch
Agricultural Biotech Patent Watch
Author(s): Nicole D. Kling, Ph.D.
In our last issue, we looked at trends in patent application filings in the biocontrol/biopesticide/biostimulant space. We found that from 2015 to 2019, certain jurisdictions remained of steady interest to patent filers, while other jurisdictions appeared to see significant changes in the numbers of filings. We spoke with IP attorneys in Europe and Canada, the two leading non-U.S. jurisdictions, about what forces are driving filing decisions and general IP strategies in those locations.
Our last issue of Patent Plantings found that Europe is the most popular jurisdiction for biocontrol/biopesticide/biostimulant patent filers outside of the U.S. In our survey period in 2019, if a patent family had any filings outside of the U.S., there was an 88% chance that those filings included a filing at the European Patent Office (EPO). For patents awarded in the U.S. during the same period, if they were part of an international patent family, there was a 91% chance that the family included an EPO application. These numbers are significantly higher than those for any other jurisdiction.
Efficiency of EPO filings
An EPO filing can be attractive because of its multi-national nature. Ellie Purnell of HGF Ltd. notes:
In Europe, filings in the biocontrol/biostimulant/biopesticide area have been consistent over the past few years. As for other areas of technology, this is likely to be because the patent system in Europe represents relatively good value. The single central prosecution of one patent application can allow an applicant to obtain a bundle of national patents in the European countries of his choice all with the same claim scope, without having to individually prosecute separate patent applications in each country.
An active push away from traditional pesticides
As health and environmental concerns with 20th century agricultural practices rise, various regulations, incentives, and market pressures are combining to drive considerable interest in the biocontrol/biostimulant/biopesticide space. Ellie further explained:
Relative to traditional pesticides, biological pest management is also easier to implement in Europe as there are strict regulations in place around the use of synthetic crop protection chemicals to protect the environment. These regulations may be more stringent than other areas of the developing world. This is combined with a general drive towards more eco-friendly organic farming methods led by government incentives and more conscious consumers.
Anna Gregson, Craig Titmus, and Mike Stott of Mathys & Squire LLP agreed that the increasingly challenging environment for traditional chemical pesticides is likely driving interest into the biopesticide space:
The European biopesticides market has been growing steadily in recent years. The regulatory environment is becoming increasingly strict for traditional chemical pesticides. These regulatory conditions, together with increased consumer awareness and demand for sustainable agricultural practices, are likely driving the continued trend for filing patent applications for biopesticides at the European Patent Office (EPO).
The explicit aim of the EU’s regulatory framework relating to pesticides is to reduce the use of and the risks inherent to the application of pesticides. To achieve this aim, the EU’s regulatory framework for the approval and registration of pesticides is by many benchmarks the strongest in the world. This framework (based in Directive 128/09 and supplemented by Regulation 1107/09 (which sets harmonised maximum pesticide residue levels in food and feed) and Regulation 1107/09 (concerning placement of plant protection products on the market) uses a risk-based approval approach and places strict evidentiary burdens on pesticides before they can be placed on the EU market. The framework includes some of the strongest limits on chemical pesticidal residues in food and feed out of any jurisdiction in the world, and determines environmental liability based on the “polluter-pays” principle.
Set in this context, it is not surprising that pesticide manufacturers and growers in the EU continue to look for alternatives to chemical pesticides, and that this is reflected in the continued trend for biopesticide filings at the EPO.
Looking forward, the Mathys & Squire team expected the governmental forces driving interest in biopesticides to increase:
Currently fewer biopesticides are registered in the EU than other jurisdictions due to the complexity of the registration process, which also requires a risk-based approach for biopesticides as well as for traditional chemical pesticides. However, in August 2017 new “basic substance” and “low risk substance” categories were introduced. Many biopesticides, including microbial pesticides and semiochemicals (e.g., pheromones) are assessed for compliance with low-risk criteria. This allows for a reduced dossier to be submitted, and for existing scientific literature to be used in the dossier. In addition, the assessment period for low-risk products is reduced to 120 days, low-risk products are approved for 15 years (rather than the 10 years for standard products), and lower fees are payable. We therefore expect the number of approved biopesticides to increase in the future.
This streamlined approval process for biopesticides may underlie the continued trend for European patent filings whilst filing numbers decrease in other jurisdictions.
Our last issue also noted that corporate patent applicants were becoming a supermajority of filers by 2019, while academic and governmental applicants were less dominant but still accounted for a significant portion of the filing activity. The team at Mathys & Squire suggests that the unique structural aspects of the biopesticide space may be driving these trends as well:
Given the commercial attractiveness of biopesticides, it is not surprising that the “big hitters” in the traditional/chemical pesticide space, such as Bayer CropScience AG, are diversifying to biopesticides, and that they are responsible for the majority of filings in this sector. Having said that, the reduced time required for the R&D of biopesticides and lower investment costs compared to synthetic chemical pesticides continue to attract start-ups to this space. In addition, many academic institutions have established departments working on agents with the potential to be used as biopesticides, and we continue to see filings from such institutions, and spin-out companies forming to commercialise this research.
A wider look at other numbers
The survey in our last issue of Patent Plantings demonstrated that Canada is one of the most-favored jurisdictions after the EPO, but suggested it may be experiencing a possible decline in recent biocontrol/biostimulant/biopesticide application filings. Emma Saffman of BCF suggests that these numbers be carefully considered in view of the larger trends in agri-tech and agri-food industries in Canada:
According to a study published by the Canadian Intellectual Property Office (CIPO) in 2019, patenting activity in Canada has been relatively steady in recent years in all areas, including agricultural biotech, with the majority of patent applications originating from the United States.
Emma noted that the fish and seafood agri-food sector is of particular economic interest to Canada and has experienced considerable annual growth rates in both economic activity and patent filings. Additionally:
Another growing area to watch in Canada is cannabis, which is positioned to become a driver for agricultural biotech and agri-food patenting in Canada. With cannabis now legal in Canada for both medical and recreational use, investment and innovation in this area have exploded. The CIPO issued 23 patents containing the words “cannabis” or “cannabinoid” in their claims in 2019, a 256% increase from 2014. Although the absolute number of patent applications filed remains fairly low, this number is expected to rise as new cannabis-related applications filed after legalization, almost two years ago, come out of the confidentiality period and are published.
Tools available for Canadian filings
Emma further notes that agri-tech filers may qualify for Canadian programs that are designed to encourage innovation:
Agriculture technology innovators should be aware that many agriculture and plant-related patent applications may be eligible for free expedited examination in Canada under the program for Advanced Examination for Green Technologies. This program encompasses a wide range of patent applications related to green and clean technologies. To enter the program, the Applicant must file a written request for advanced examination for green technologies with a statement that “the application relates to technology that if commercialized would help to resolve or mitigate environmental impacts or to conserve the natural environment or natural resources”. The application must be open to public inspection (laid open or published), but early laying open can be requested if the application is not already open to the public. There is no fee required for requesting advanced examination under the program or for early laying open of the application. Once an application has been accepted into the program, a first office action is usually issued within three months.
To make the most efficient use of intellectual property, it is important to identify and track “push” and “pull” factors that create environments favorable to biocontrol/biostimulant/biopesticide development and use. Consumer-based pressures for more ecologically-sound products, loosening of governmental regulations such as those for Europe’s “low[-]risk” pesticides, or patent office programs such as Canada’s Advanced Examination for Green Technologies can create “pulls” into the biocontrol/biostimulant/biopesticide space. At the same time, increasingly stringent regulations for traditional “chemical pesticides” and similar products combine to push markets and development away from 20th-century technologies and into the next generation of agri-tech. These factors intersect with standard market concerns to guide international IP filing decisions.
The foregoing has been prepared for the general information of clients and friends of the firm. It is not meant to provide legal advice with respect to any specific matter and should not be acted upon without professional counsel. If you have any questions or require any further information regarding these or other related matters, please contact your regular Nixon Peabody LLP representative. This material may be considered advertising under certain rules of professional conduct.
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