Home > Topics > Patents and Patenting: Balancing Protection with the Public Domain > Deposit of Biological Materials in Support of a U.S. Patent Application > Editor's Summary, Implications and Best Practices

The rules governing biological deposits in support of a patent application can cure potentially fatal patent defects. They can also provide flexibility for both patent applications and for patents issued over or dependent upon biological materials.

A biological deposit is not a requirement per se, but under U.S. patent law it can satisfy three main requirements. It can also be used to satisfy:

• the enablement requirement, enabling one skilled in the art to make and use the invention.
• the written description requirement, describing the claimed invention in sufficient detail such that one skilled in the art would reasonably conclude that the applicant was in possession of the claimed invention at the time of filing.
• the best mode requirement, disclosing the best mode of carrying out an invention in sufficient detail to allow one of ordinary skill in the art to practice it.

A deposit is not strictly necessary for any of these requirements, but it may be required when words cannot explain how to make and use the invention. A biological deposit can also potentially broaden the scope of claims in the event of litigation.

Biological materials that can be deposited include those capable of direct or indirect self-replication (such as bacteria, fungi, eukaryotic cells and lines, hybridomas, plasmids, plant tissues, and seeds) and other non-living material (such as viruses, vectors, cell organelles) existing in, and reproducible from, a living cell.

If only starting materials are readily available, then the specification should provide sufficient guidance on making or isolating the biological material necessary for practicing the invention, without undue experimentation; otherwise, a deposit of biological material is mandatory. Undue experimentation is decided under a standard of reasonableness; it is not merely a quantitative determination. Generally, there is no undue experimentation where time-consuming experiments are merely routine, such as a reliable screening test performed on a large number of samples.

While a deposit can be made at any time during the pendency of a U.S. application, those seeking foreign rights are advised to deposit before filing any priority application, as many foreign jurisdictions—including Australia, Canada, China, and Europe—require a deposit to be made before the filing date of the priority application.

The Budapest Treaty governs international recognition of biological deposits in support of patents. Signatory countries (64 as of 2006), which includes the U.S., are required to recognize a biological deposit made in any of the 37 depository institution approved by WIPO. A patent applicant can be deposited at any of the 35 International Depositary Authorities (IDAs) recognized by WIPO.

During an application’s pendency, a deposit incorporated into a patent application specification need not be available to the public, but it should be available to the PTO. After issuance of a patent, deposited biological material that is incorporated into the specification should be freely available to the public. However, the patent owner can be further protected by collecting information about who receives such deposits. The deposit of biological material in a recognized depository does not grant a license, either express or implied, to infringe the patent supported by the deposit. Likewise, neither does the release of deposited material from the depository to third parties.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policymakers

• Under U.S. patent law, a deposit of biological materials can help to support patents where the subject matter consists of or is derived from biological materials.
• The Budapest Treaty governs patent-related deposits of biological materials at thirty-seven International Depositary Authorities (IDA) recognized by the WIPO. Signatory countries of the Budapest Treaty (64 as of 2006) are required to recognize a biological deposit made in any WIPO approved depository, no matter the location.
• Under U.S. patent law, after issuance of a patent, deposited biological material that is incorporated into the specification by accession number should be made freely available to the public.

For Senior Management (university president, R&D manager, etc)

• The rules governing biological deposits in support of a patent application provide a means of curing potentially fatal patent defects as well as providing flexibility in patent applications and even issued patents. Encourage staff, scientists and technology transfer officers to understand these rules.
• Biological deposit is not a requirement per se. However, a deposit may be necessary when words cannot explain how to make and use the invention. Of course, an applicant may reference a deposit even when not required. Helping the technology transfer office to establish a protocol for making deposits will be of value, especially as patents dealing with biological subject matter are filed and prosecuted.

For Scientists

• Biological materials, obtained from your research program, that can be deposited include those capable of direct or indirect self-replication (such as bacteria, fungi, eukaryotic cells and lines, hybridomas, plasmids, plant tissues, and seeds) and other non-living material (such as viruses, vectors, cell organelles) existing in, and reproducible from, a living cell.
• Understand and recognize that your institution’s technology transfer office may require you to prepare biological materials for deposit, pending a patent application for an invention arising from you program. Understand your duties and responsibilities in implementing such deposits. The success of the patent application may very well depend on such a deposit.
• During pendency of a patent application in the U.S., a deposit incorporated into the application’s specification need not be available to the public, but should be available to the U.S. Patent and Trademark Office (PTO). After issuance of a patent, deposited biological material that is incorporated into the specification should be freely available to the public.

For Technology Transfer Officers

• Under U.S. patent law a biological deposit can satisfy the enablement, the written description, and the best mode requirements.
• While a deposit can be made at any time during the pendency of a U.S. application, those seeking foreign rights are advised to deposit before filing any priority application, as many foreign jurisdictions—including Australia, Canada, China, and Europe—require a deposit to be made before the filing date of the priority application.
• It is important to know what the options are for the deposit of biological materials. A patent applicant can deposit in any of the 37 International Depositary Authorities (IDAs) recognized by WIPO. The Budapest Treaty governs international recognition of biological deposits in support of patents. Signatory countries (64 as of 2006), which include the U.S., are required to recognize a biological deposit made in any of the 37 approved depository institutions.
• In the U.S., during pendency of a patent application, a deposit incorporated into the application’s specification need not be available to the public, but should be available to the U.S. Patent and Trademark Office (PTO). After issuance of a patent, deposited biological material that is incorporated into the specification should be freely available to the public.
• The deposit of biological material in a recognized depository or the release of deposited material from the depository to others does not grant a license, either express or implied, to infringe the patent.
• An example of fees is $2500 for a patent-related deposit at the American Type Culture Collection (ATCC). This includes viability testing, a deposit certificate, 30 years of storage, release of samples according to deposit rules, quarterly informing report of distribution of released materials, and regulatory compliance reviews.
• The deposit of biological material in a recognized depository or the release of deposited material from the depository to others does not grant a license, either express or implied, to infringe the patent.