[Guest Post] Enablement, Commercial Availability, and the Durability of Agro-Biotech Patents: Lessons from Inari v. Corteva

[Jocelyn Bosse]

[Guest Post] Enablement, Commercial Availability, and the Durability of Agro-Biotech Patents: Lessons from Inari v. Corteva

 Jocelyn Bosse Thursday, December 18, 2025 - agriculture, biotechnology, corn, patents, plant varieties, United States

The IPKat has received and is pleased to host the following guest post by Katfriends Giulia Tatangelo, Valentina Predazzi, and Federico Caruso (SIB LEX). They discuss a decision that emerged against the backdrop of a larger ongoing dispute in the USA, concerning both utility patents and plant variety protection certificates, between Inari and Corteva (the latter of which is the successor in title to IP rights obtained by Pioneer Hi-Bred). The dispute has raised many difficult questions about the deposit of biological material, and in this case, we see how it affects the assessment of enablement under patent law.

Here's what Giulia, Valentina, and Federico have to say:

"In patent law, agricultural biotechnology often occupies an uncomfortable space. It is a field defined by living materials, long development timelines, and peculiar commercial implications. The recent Patent Trial and Appeal Board (PTAB) decision in Inari Agriculture, Inc. v. Corteva Agriscience LLC (IPR2024-01014) focuses on these tensions.

In the decision at issue, the PTAB rejected all novelty and obviousness challenges brought by Inari Agriculture against Corteva’s insect-resistant corn patent (U.S. Patent No. 8,901,378, herein the ‘378 patent). The case turned on whether a transgenic plant event generated through a random integration process was sufficiently enabled without a biological deposit, and whether commercial availability of the germplasm could satisfy the enablement requirement for priority purposes.

While the decision resolves a specific inter partes review, its broader significance lies in the manner in which the PTAB addressed enablement and prior art in the context of biological inventions, including commercial availability. Notably, no equivalent dispute has arisen in Europe, despite the corresponding European patent’s grant in 2015 (EP1620571B1).

Image by Abdulhakeem Samae via Pixabay.

Background of the Dispute

The ’378 patent protects a specific transgenic corn event, designated TC1507, obtained through particle bombardment and characterized by the stable integration of a defined DNA construct conferring insect resistance and herbicide tolerance. In particular, the construct includes an expression cassette encoding the Cry1F protein derived from Bacillus thuringiensis, which provides resistance against insect pests. 

Inari petitioned for inter partes review asserting anticipation and obviousness based exclusively on Barbour (US 2006/0037095). The petitioner’s challenge turned entirely on priority: because the TC1507 event resulted from a random integration process, Inari argued that the priority application claimed for ‘378, dated April 30, 2004 (hereinafter the “2004 Application” which in turn claimed a priority, based on a provisional application dated 2003) failed to enable reproduction of the specific event absent access to the biological material itself. On that basis, Barbour, published in February 2006, was the first application disclosing ‘378 subject matter. Consequently, if the relevant priority was not that dated April 30, 2004, Barbour could have amounted to a destructive prior-art.

Enablement as the battleground

In particular, Inari argued that the priority application (the 2004 Application) failed the enablement requirement of 35 U.S.C. §112 because the TC1507 event was created through particle bombardment, resulting in random genomic integration. According to this argument, the event could not be reproduced from the written description alone and therefore required a deposit of biological material. No such deposit was made.

At the institution stage, the Board agreed that the written disclosure of the 2004 Application, considered in isolation, did not enable a skilled person to recreate the TC1507 event as of its filing date. 

Commercial Availability and Practical Enablement

Enablement doctrine has long recognized that inventions involving living materials do not always lend themselves to complete written description. Case law and USPTO guidelines have therefore developed exceptions, most notably through the deposit system, to ensure that the public ultimately receives meaningful access to the invention in exchange for the patent grant.

What makes Inari v. Corteva noteworthy is the way in which the Board framed enablement in light of the practical availability of the claimed biological material. During proceedings, the focus shifted from theoretical reproducibility based solely on the written disclosure to whether the TC1507 event was, in practice, accessible to the public. The evidentiary record showed that TC1507 corn had been commercially cultivated beginning in 2003 and that harvested grain expressing the TC1507 event was sold as a commodity without contractual restrictions. As a result, a person of ordinary skill in the art could obtain the germplasm through ordinary commercial channels and, using known screening and detection methods, including those disclosed in Barbour itself, identify and possess the claimed invention.

On that basis, the PTAB concluded that enablement turns on whether the public is assured access to the invention by the time the patent issue. Because the TC1507 event was “known and readily available” well before  ’378 grant, the absence of a germplasm deposit did not exclude enablement.

The PTAB found that enablement requirement aims to ensure that, upon issuance of the patent, the public can practice the invention. In the agricultural biotechnology context, enablement might be satisfied by commercial distribution, making biological material effectively accessible. In this sense, the Board recognized that deposits are unnecessary where biological materials are already publicly available and unlikely to disappear during the patent term. 

Priority, prior art and a strategic reversal

Once enablement was established, the priority determination led to the rejection of all Inari’s assertions. 
Because Barbour was the published version of the same disclosure and the claims were entitled to the 2004 priority date, Barbour could not qualify as prior art. Consequently, all novelty and obviousness challenges necessarily failed. In other words, since the evidence submitted by Inari showed that TC1507 was available before the filing of ‘378 - and protected by the priority chain dating back 2003 as observed before – Barbour was not the prior art with respect to TC1507.

In any case, in the concurring opinion of the Administrative Patent Judge, it has been observed that Inari did not satisfy the burden of proof with respect of the allegedly relevant commercialization of TC1507 in 2003.

This aspect of the decision underscores that prior art analysis in biotechnology is often inseparable from priority entitlement and enablement. Publication dates alone are mere dates. Instead, courts and offices must examine whether an earlier application truly supports the latter claims.

The concurring opinion reinforced this conclusion by turning Inari’s own arguments against Barbour itself. Inari had asserted that commercially harvested corn expressing TC1507 was widely available without contractual restrictions as early as the 2003 growing season. Those same facts, the concurring judge reasoned, supported a finding that the invention was enabled through commercial availability, eliminating the asserted reference as prior art altogether.

Conclusion 

In Inari v. Corteva, the PTAB’s approach confirms in agricultural biotechnology is not merely about claiming molecular constructs but about safeguarding the specific events that deliver commercial performance. 

Timing and width of commercialization, and licensing may later influence enablement and priority analyses. At the same time, the case serves as a caution against oversimplifying enablement challenges in biological fields, recognizing that written disclosure does not necessarily work for complex biological systems in the same way as it does for other inventions; consequently, the standard for enablement must adapt to the unique realities of biological availability and the practical accessibility of germplasm."

 

DO YOU WANT TO REUSE THE IPKAT CONTENT? PLEASE REFER TO OUR 'POLICIES' SECTION. IF YOU HAVE ANY QUERIES OR REQUESTS FOR PERMISSION, PLEASE GET IN TOUCH WITH THE IPKAT TEAM.

 

https://ipkitten.blogspot.com/2025/12/guest-post-enablement-commercial.html