WIPO Budapest Treaty Access During Pendency: Expert-Only Rules and National Variations

TL;DR
During the pendency of a patent application relying on a Budapest Treaty deposit, access to the deposited biological material is typically restricted to independent experts designated by the applicant or required by the examining office, or to persons who have the applicant's authorization. The exact access rules vary by contracting state. Restricted access can make it difficult for third parties to design around or challenge the patent until the material becomes publicly available after grant or publication. See our WIPO Budapest Treaty biotech deposits guide by the PatentPaper research team for deposit requirements and our WIPO Budapest access rules guide by the PatentPaper research team for post-grant access.

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. The goal is to balance the applicant's interest in maintaining confidentiality during prosecution with the public's interest in access for legitimate purposes.

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 and the undertaking was signed.

National Variations in Access Rules

The US generally makes the deposit available upon issuance of the patent, with expert-only access during pendency in some cases. The EPO makes the deposit 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. Japan, Korea, and other contracting states have their own variations. 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. This can be an advantage for the applicant (delaying design-arounds or challenges) but a disadvantage for the public (delaying access for legitimate research or design-around purposes). Licensees may negotiate for earlier access or for the right to designate experts to obtain the material during pendency for specific purposes.

Strategic Considerations for Applicants and Third Parties

Applicants should be aware of the access rules in key jurisdictions and should plan their prosecution and licensing strategies accordingly. If restricted access is important, the applicant should choose an IDA and draft the specification to take advantage of expert-only access rules. Third parties seeking access should request samples promptly after publication or grant (when access becomes available in most jurisdictions) 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.

Practical Tips for Managing Access During Pendency

Applicants should: (1) check the access rules for each relevant jurisdiction before filing; (2) choose an IDA with clear access procedures; (3) document any expert designations or authorizations; (4) respond promptly to legitimate access requests; and (5) consider the competitive implications of restricted vs public access. Third parties should: (1) monitor publication and grant dates; (2) request access promptly when it becomes available; (3) be prepared to sign required undertakings; and (4) petition for relief if access is improperly denied.

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 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 during pendency?

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 the applicant block access even if the rules allow it?

Generally no. If the rules allow access (for example, to a properly designated independent expert), the applicant cannot block it. The applicant can, however, impose reasonable conditions (such as undertakings) consistent with the rules.

Can I challenge a denial of access during pendency?

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. Applicants and third parties must consult the specific rules of each relevant jurisdiction.

Which PatentPaper resources cover biotech deposits and access rules?

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