WIPO Budapest Treaty Access Rules: Restrictions During Pendency and After Grant

TL;DR
Under the Budapest Treaty, access to deposited biological material is restricted during the pendency of the patent application to independent experts or persons authorized by the applicant or the examining office. After grant (or in some jurisdictions after publication), the material generally becomes available to the public, subject to any restrictions imposed by the depository or national law. The exact access rules vary by contracting state and can significantly affect the ability of third parties to design around or challenge the patent. See our WIPO Budapest Treaty biotech deposits guide by the PatentPaper research team for deposit requirements and our CRISPR gene editing patents guide by the PatentPaper research team for thicket and licensing issues around deposited materials.

Access During Pendency: Independent Experts and Authorized Persons

During the pendency of the patent application, access is typically limited to independent experts designated by the applicant or required by the examining office, or to persons who have the applicant's authorization. The exact rules vary by jurisdiction. Some countries require the requester to sign an undertaking that the sample will be used only for the purpose of the patent proceedings and will not be distributed to third parties.

Example: In a 2023 EPO opposition involving a deposited cell line, the opponent requested access during the opposition proceedings. The EPO required the opponent to designate an independent expert who signed an undertaking limiting use to the opposition and prohibiting further distribution. The patentee could not block access once the expert was properly designated.

Access After Grant or Publication: Public Availability and Restrictions

After the patent grants (or in some jurisdictions after publication of the application), the deposited material generally becomes available to any person who requests it, subject to any restrictions imposed by the depository or national law. Some countries allow the applicant to impose limited restrictions (for example, requiring the requester to agree not to distribute the material or to use it only for non-commercial research) even after grant. Complete secrecy after grant is generally not permitted if the deposit was necessary for enablement.

National Variations and Strategic Implications

The US, EPO, Japan, Korea, and China all recognize Budapest Treaty deposits but have different access rules. The US generally makes the deposit available upon issuance of the patent. The EPO makes it available upon publication of the application or grant, with expert-only access during pendency. China has its own rules that may require additional documentation or undertakings. Applicants should choose an IDA and draft the specification with the access rules of key jurisdictions in mind.

Effect on Design-Arounds, Challenges and Licensing

Restricted access during pendency can make it difficult for third parties to design around or challenge the patent until the material becomes available. Once the material is publicly available, third parties can obtain it for research, design-around, or validity testing. Licensees may negotiate for earlier access or for the right to designate experts to obtain the material during pendency for specific purposes.

Practical Tips for Depositors and Third Parties Seeking Access

Depositors should choose an IDA with clear access procedures and should document the exact characteristics of the deposited material at the time of deposit. Third parties seeking access should request samples promptly after publication or grant and be prepared to sign any required undertakings. If access is denied or delayed, the requester can petition the relevant patent office or depository for relief.

FAQ

When does the deposited material become publicly available?

It depends on the jurisdiction. In the US, generally upon issuance of the patent. In the EPO, upon publication of the application or grant, with expert-only access during pendency. Other contracting states have their own rules. The specification and the depository's access policy should be consulted.

Can the applicant block access even after the patent grants?

Some jurisdictions allow limited restrictions (for example, requiring the requester to agree not to distribute the material or to use it only for research). Complete secrecy after grant is generally not permitted if the deposit was necessary for enablement.

Can I get access during pendency if I am not a party to the patent proceedings?

Generally no. Access during pendency is limited to independent experts or persons authorized by the applicant or the examining office. Third parties who are not involved in the proceedings usually must wait until the material becomes publicly available.

What undertakings are typically required to obtain a sample?

Common undertakings include: using the sample only for the purpose stated in the request; not distributing the sample to third parties; and, in some cases, not using the sample for commercial purposes until the patent expires or a license is obtained.

Can I challenge a denial of access?

Yes. The requester can petition the relevant patent office or the depository for relief. In some cases, the patent office can order the applicant to authorize access or can designate an independent expert to receive the sample on behalf of the requester.

Does the Budapest Treaty require all contracting states to have the same access rules?

No. The Treaty sets minimum standards but allows contracting states to adopt their own access rules, including restrictions during pendency and after grant. Applicants and third parties must consult the specific rules of each relevant jurisdiction.

Which PatentPaper resources cover biotech deposits and enablement?

Our WIPO Budapest Treaty biotech deposits and biotech enablement post-Ariad articles by the PatentPaper research team provide detailed analysis of deposit requirements, access rules, and enablement issues in biotech patenting.