b'THE RISK CORNER BY: DAVID ZARUKWHY DONT WE HAVE SEED BIOSIMILARS? W hen a pharmaceutical productgeneric drugs to be introduced. Beforeand research institutes, the present seed goes off-patent, within days thethen, the markets were controlled by largepatent structure is no longer fit for purpose.market is flooded with biosim- producers who made it very difficult toWhat is needed is a seed patent reform ilars (generics) that bring prices down andintroduce generics. This act created a clearthat will encourage and reward innova-drive opportunities for innovators to enteropportunity for innovators to enter U.S.tive seed research, bring prices down for markets. Why doesnt the same happen formarkets when biosimilars brought pricesold technologies and create certainty in seeds when their patents expire? down post-patent. A lot can be arguedmarkets. Ideally this reform would need The first GM seed patents expired inabout the costs, duration of the drug patentsto reduce the time to market for generic 2014. Around that time, there was talk ofor the time it takes to bring new pharma- seeds, set limits on IP holders using new the floodgates opening with cheaper genericceutical products onto the market, but theredata to extend the data restriction periods seeds bringing cost savings to farmers andwas a clear playing field for all actors.and take into account the variety of NGT creating opportunities for innovative newinnovations.seed developments. There was an AgAccordIt is important in Europe that any set up in the U.S. between a group ofrelaxing of the regulatory process for seed companies, agriculture associations andinnovations in Europe comes with intellec-farm unions to prepare for the anticipated"It is important tual property protections for researchers. post-patent transitions. But 10 years on, theIf the EU does indeed reject the filing of floodgates opened to a drought with verythat any relaxingpatents on gene-edited technologies, as the few generic seeds reaching the market.European Parliament proposed in February Around 90% of U.S. corn acreage is plantedof the regulatory2024, that will just mean large companies with GM seeds, much of that off-patentwill introduce protections by other means today. It is difficult to imagine how thisprocess for seed(data restrictions, longer filing periods and continues without any competition frominnovations inendless litigious processes). This strategy cheaper generic seeds. Why is that? has worked to protect post-patented prod-Are the end consumers, farmers, OKEurope comesucts for more than a decade in the U.S. with continuing to pay high prices forSmaller research companies wont have the older, off-patent technologies?with intellectualsame means to play these games and willWere the myriads of patents (fromlikely not enter the European market. traits to events) so complex as to keeppropertyI dont see the European Parliaments lawyers tying their competition inprotections forcaveat on patent-free research sticking. The knots for the long term?European Council will surely revisit this, Is the cost of obtaining efficiency dataresearchers. and the Parliament has asked for a report by too high, making generic seed pro- June 2025 to assess the effects of patents on duction less attractive?access to seeds. It is inconceivable how this Is the time required to register bio- decision could stick especially given how it similars imposing further weight onconflicts with the EUs commitment to the a less competitive market? European Patent Convention. So, while it All these reasons, contribute to theOne of the challenges for seed inno- was meant as a consolation bone thrown failure of competitors to successfully entervators is that the regulatory hurdles are soto the anti-GM activist community, it is a off-patent seed markets. As plant breedingsevere that it limits authorizations to largeclear indication on the need for patent laws technologies evolve, what is needed is acompanies with the deep pockets to manageto be reformed.reform of seed patent regulations to ensurethe demands of the process. Thus, they onlyPatent reform needs to go back to the that innovators are given opportunities, thefile patents for commodity seeds that willheart of intellectual property rights: to farmers dont over-pay for off-patent seedsprovide a significant return on investmentreward and protect the innovator, create and that markets are open to fair compe- given the cost burdens of putting a modifiedmarket certainty and, within a reasonable tition. seed on the market. Smaller seed companiesduration, encourage new product devel-dont stand a chance under such conditionsopments by allowing competitors to enter SEED PATENT REFORM and continue to be excluded from marketsmature markets. Present seed patent laws In 1984, the introduction of the Hatch- via post-patent barriers. With the oppor- do not allow for this. The absence of patents Waxman Act in the U.S. reformed thetunities of gene editing creating innovativewill not make the situation any better or pharmaceutical patent process to allowopportunities for seed solutions from SMEsmake markets more accessible. 12ISEED WORLD EUROPEISEEDWORLD.COM/EUROPE'