On December 27, 2020, Congress signed the Consolidated Appropriations Act, 2021, into law. The omnibus act includes new legislation affecting patent, copyright and trademark law. A brief summary of key provisions is provided below.Patents – Section 325 Biological Product Patent Transparency
42 USC § 262(k) was amended to require that the US Food and Drug Administration (FDA) provide the public with more information about patented biological products. Within six months, the FDA must make the following information available to the public on its Database of Licensed Biological Products or “Purple Book,” and it must update the list every 30 days:
- A list of each biological product, by nonproprietary name, for which a biologics license is in effect
- The license date and application number
- The license and marketing status (as available)
- Exclusivity periods
The amendment requires that the holders of a license to market a biologic drug now disclose all patents believed to be covering that drug. The new law is designed to prevent errors that could delay biosimilars from coming to the market.Copyrights – The CASE Act of 2020
The Consolidated Appropriations Act incorporates the Copyright Alternative in Small-Claims Enforcement (CASE) Act of 2020, as well as legislation designed to increase criminal penalties for the unauthorized digital streaming of copyright-protected content. The CASE Act includes revisions to the Copyright Act, 17 USC §§ 101 et seq., with the goal of creating a new venue for copyright owners to enforce their rights instead of having to file an action in federal court.
The Copyright Claims Board
The CASE Act established the Copyright Claims Board (a small claims court), which is designed to serve as an alternative forum where parties may voluntarily seek to resolve certain copyright claims regarding any category of copyrighted work. A party may opt out upon being served with a claim, choosing instead to resolve the dispute in federal court. A party to a proceeding before the Board may, but is not required to, be represented by a lawyer. A party may also be represented by a law student who is qualified under applicable law, and who provides such representation on a pro bono basis. The Board consists of three copyright claims officers who may conduct individualized proceedings to resolve disputes and must issue written decisions setting forth their factual findings and legal conclusions.
The Board must follow the law in the federal jurisdiction in which the action could have been brought if filed in federal court. Because jurisdictional conflicts may arise where a dispute may have been brought in multiple jurisdictions, the CASE Act provides that the Board may apply the law of the jurisdiction that the Board determines has the most significant ties to the parties and the conduct at issue.
Although formal motion practice is not permitted, discovery is allowed on a limited basis, including requests for documents, written interrogatories and written requests for admission. The Board may consider evidence, documentary and (non-expert) testimony, without the application of formal [...]