Biological Deposits: Strategic Considerations

• Published date: 17 March 2022
• Subject Matter: Intellectual Property, Patent, Trade Secrets
• Law Firm: J A Kemp LLP
• Author: Mr Andrew Bentham, Ian MacLeod, Kapil Tuladhar and Pamela Tuxworth

Introduction

It is a fundamental requirement of patent law that, in exchange for a monopoly right, a patent must disclose the claimed invention in sufficient detail to allow a person skilled in the relevant technical field to reproduce the invention. This requirement is known as sufficiency of disclosure in European practice and enablement in the US. Therefore, a biological deposit is often made, usually with an International Depositary Authority (IDA) under the Budapest Treaty, to ensure that subject matter relating to biological material that is not publically available and/or which cannot be adequately described by other means, is sufficiently disclosed. The sufficiency/enablement requirement is then satisfied by the depositary institution making samples of the deposit available to third parties on request.

This briefing focusses on strategic aspects relating to biological deposits, including how it might be possible to remedy a deficiencies relating to biological deposits. A complementary briefing sets out what a biological deposit is, why a biological deposit may be needed and basic requirements for making a biological deposit.

Are there any disadvantages to making a biological deposit?

It is common to think about biological deposits in the context of the benefit they offer to the applicant, i.e. ensuring that an invention is sufficiently disclosed to the public where this might not otherwise be possible. However, the consequence that is sometimes overlooked is that a Budapest Treaty-compliant biological deposit will generally eventually become physically available to third parties on request, usually once the patent application has been published¹. Therefore, where the public availability of a biological deposit represents an unacceptable disadvantage to a potential applicant, it may be preferable to keep specific biological material confidential and control access to the physical resource instead. In other words, a potential applicant may choose to protect a specific biological resource as a trade secret and/or through contracts such as materials transfer agreements (MTAs), rather than through the patent system.

Trade secrecy of course comes with risks that control of the trade secret may break down, so the balance has to be carefully weighed. However, it is not a given that patent protection is always the best route to follow in the case of a very valuable biological resource. Also, where the deposit merely exemplifies a broader principle underlying the invention, it may not always be necessary to make a biological deposit for patent purposes, as the requirement is that the invention be reproducible, not the exact material that any given deposit would represent. For example, if the invention lies in a given mutation and that mutation is documented and can be reliably made again, it may not be necessary to deposit germplasm that embodies it, whereas such a deposit could give competitors an advantage in trying to copy the invention.

Put another way, making a biological deposit for patent purposes can be thought of as a gamble. If the applicant wins and the patent is granted, they obtain the powerful time-limited monopoly right of a patent. However, if the applicant loses (i.e. is unable to obtain and maintain a patent), then assuming that publication of the patent application has occurred², the public can benefit from the invention when it might have otherwise stayed confidential. Similarly, the biological resource is publicly available after patent expiry whereas a trade secret is potentially indefinite, and if there are several deposits in a specification but not all of them are eventually covered in the granted claims, the un-claimed ones are also available without the restraint that the granted claims place on the claimed ones³. Although this principle applies to the patent process more generally, the applicant's loss is potentially greater where biological deposits are involved because third parties can obtain physical samples of the biological deposit, rather than having to re-develop the deposited biological material based on the written teaching of a patent document⁴.

Can these disadvantages be mitigated?

To an extent, an applicant can mitigate the risk of such a loss at the EPO by making use of the "expert solution" provision⁵. This means that, as long as the necessary formal requirements are met, a biological...