Legal Battle highlights biological deposit issues in patent law

In September 2023, a significant legal challenge brought by Corteva against Inari Agriculture has thrust the issue of seed deposits into the spotlight, and affords a useful opportunity to remind ourselves on the legal requirements surrounding the deposit of biological material to support a patent application.

Corteva alleges that Inari has infringed its patents by obtaining Corteva’s patented seeds, illegally importing them into Europe, genetically editing the seeds, and seeking patent protection in the US for the modified traits.  Corteva further claims that Inari have used a third party to misappropriate Corteva’s seeds from the America Type Culture Collection (a recognised institute for the deposit of biological material such as seeds and microorganisms).

The role of biological deposits in patent law

Patent law grants a monopoly for an invention in exchange for disclosing the nature of the invention.  For this reason, it is a requirement that an invention is described in a patent application in a manner which enables it to be reproduced.  For some biological inventions, a written description is not enough to allow a third party to reproduce the invention, and access to biological material, such as seeds or microorganisms, may be necessary to satisfy the legal requirement of enablement.

The Bupadest Treaty governs the deposit of such material, allowing for a single biological deposit to be made, which is recognised by other Treaty members through reciprocal arrangements.  Many jurisdictions, including Europe, Japan, and Korea, require that the deposit is made before the filing date.  This requirement ensures that the deposit information is provided in the published patent application, as part of the teaching of how to practice the invention.  In Europe at least, a priority document must contain an enabling disclosure of the invention, making it crucial to include deposit information in the first filing.  In contrast, in the US, a deposit can be filed much later, up to a date which is set in the Notice of Allowance, posing a challenge for US applicants to meet overseas requirements.

Patent applications must include the deposit date and the deposit accession number.  A provisional deposit date and accession number will be provided by a Deposit Authority upon initial receipt of the deposit, but if after testing the sample proves not to be viable and a new sample needs to be supplied, the deposit date may change.  In order to ensure that the correct deposit date and accession number are included in a patent application, starting the deposit process well in advance of a priority filing is advisable to ensure that the viability test can be completed before the filing date,     and that the information in the patent application will be correct.

Third party access to deposits

A key issue in the Corteva v Inari lawsuit pertains to the issue of third party access to the deposited seeds.

Inari has responded to the allegations, by arguing that the patented seeds deposited with the ATCC are available to the public without restriction after a patent grants.  They contend that by depositing the seeds, Corteva authorised their availability and transportation of the seeds for commercial purposes.

Under the Budapest Treaty, an International Deposit Authority is obliged to keep a deposit for the later of 30 years from the initial deposit, or 5 years from the last request for a sample.  During this time, any natural or legal person can request a sample of the deposit, and the International Deposit Authority must furnish it to them provided that they have rights to the sample in accordance with patent law which governs the patent or patent application referring to that sample.

For patent applications before the EPO, access to deposited material can be restricted to a nominated independent expert, provided that a request for restricted access is made within a specified time limit.

However, this restriction expires upon grant, upon which date, if the deposited material falls within the scope of the granted claims it may then be accessed by any third party, but in accordance with patent law it may only be used for experimental purposes only.  Similar provisions apply in the US and Japan.   Inari have defended their use of the seed deposits, stating in a court filing “In exchange for the grant of these patents, Corteva assured the public that the deposits would be available to the public without restriction when the patents issued….Corteva now seeks to renege on that promise.”

Conclusions

The Corteva v Inari case highlights that there may be risks associated with deposit of biological material.   There are particular risks in a situation where a patent has been granted but the deposited material does not fall within the scope of the granted claims.  If an invention can be described in a reproducible manner without the need for a biological deposit, then this may be preferable, provided that the requirements for enablement are clearly met.

This case underscores the complexity of patenting biological material and the critical importance of understanding the requirements of International deposit requirements to safeguard intellectual property.

This article was prepared by Partners Punita Shah and Ellie Purnell