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2018 Farm Bill: Proposed Regulations for Comment

July 18, 2019
Post by Heidi S. Nebel

The United States Department of Agriculture (USDA) has published proposed regulations for comment to enact the 2018 Farm Bill, Public Law No: 115-334, Sec. 10108. As one may recall, the bill amended the United States Plant Variety Protection (PVP) Act to add asexually propagated plants as a potential PVP certificate option.

As a USDA PVP Board Member, I was privy to these proposed regulations and was able to provide my own input earlier this year along with the rest of my Board Members. There are several significant concerns that interested parties may want to review and comment upon.

Highlights of the changes in the proposed rule:

1. Addition and adjustment throughout the regulations to reflect the addition of asexually reproduced plants.

2. Streamlining of the fee structure to include the certificate issuance fee as part of the initial filing fee (refunds will be made for withdrawal or abandonment of the application).

3. Germplasm deposit of asexually reproduced material is proposed.

This deposit section is designed to parallel the seed deposit requirements for sexually reproduced plants. The provisions provide for lyophilized tissue culture deposit for an additional $3,000 per application. This raises the fees for a PVP for asexually reproduced plants to over $8,000. At this cost, one may want to consider a utility filing with its broader protection. While there will still be a deposit for a utility patent, plant patents (35 U.S.C. Section 161) do not require a deposit, only a color picture of the asexually reproduced variety.

Additional concerns relate to what is considered “propagating material” for an asexually reproduced plant, as well as the exciting prospect of providing protection for tuber-propagated plants (which are excluded from the Plant Patent Act).

If you are interested in reviewing the proposed regulations and/or providing comments, please go to https://www.federalregister.gov/ and search for FR Notice: AMS-ST-19-0004. Comments can be submitted from this website.

For more information on this topic, contact Intellectual Property Attorney, Managing Member, and Chair of the Biotechnology & Chemical Practice Group, Heidi S. Nebel, by calling our office at (515) 288-3667.


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