Patent Disclosure Process
This page describes a proposed process for domain committees and their secretaries to follow to ensure adherence to IHE's patent disclosure policy.
1) IHE's Principles of Governance include an intellectual property policy that defines a duty to disclose certain known patents or patent applications. This obligation applies to patents or applications that involve "Necessary Claims," meaning that in developing a system compliant with some IHE Technical Framework document (including Supplements), an implementer would necessarily infringe upon that patent.
2) Every domain committee member serves as a representative of an IHE Member Organization. In applying for membership, these organizations have all agreed to abide by the Principles of Governance, including specifically the intellectual property policy and the patent disclosure obligation. It is the duty of the domain Secretary to maintain committee rosters for that domain and to ensure that all committee members are in fact authorized representatives of IHE Member Organizations. The list of organizations is published at http://www.ihe.net/governance/member_organizations.cfm. Membership applications and the Principles of Governance document are linked at http://www.ihe.net/governance/index.cfm.
3) The domain committee Secretary is responsible for reminding committee members of the patent disclosure policy in writing (via email) and orally at face-to-face meetings (using the presentation slides provided below) at key milestones throughout the development process of Technical Framework documents, including:
- When a call is issued for new Profile Proposals
- When draft Profile Proposals are being selected for Supplement Development
- When Supplements are being prepared for publication for Public Comment
- When Supplements are being prepared for publication for Trial Implementation
- When Supplements are being advanced to Final Text for incorporation into Technical Framework volumes
The duty to disclose applies both to Profiles under development and to those already published. In the case of new Profiles, the mandated timing for disclosure is prior to their publication for Public Comment. Committee members are responsible for promptly disclosing patent claims relating to already published Profiles whenever they become aware of such claims.
4) In cases where an IHE Member Organization asserts a patent claim as being necessarily infringed by implementers of systems compliant with an IHE Technical Framework document, its committee representatives will be responsible for formally disclosing any such patent claim. If allegations regarding assertion of claims pertaining to previously undisclosed patents by an IHE Member Organization reach the Secretary of an IHE Domain or the Secretary of the IHE International Board, the Secretary will request that the Member Organization in question make a formal patent claim disclosure and submit a letter of assurance (using the form provided below) specifying the scope of the asserted claim and associated licensing terms. Refusal to formally disclose a patent claim, while asserting claims of necessary infringement by implementers of systems compliant with IHE Technical Framework documents, may be grounds for expulsion of an IHE Member Organization.
5) The Principles of Governance stipulate that disclosed patents must be made available by license to other IHE Member Organizations under reasonable and non-discriminatory terms, including a condition of reciprocity.
Related Materials
- Draft Disclosure Posting Form
- Patent Disclosure Announcement Slides
- Letter of Assurance Form
- Add link to introductory paragraphs