On April 17, 2019, Senators Chris Coons and Thom Tillis, and Representatives Doug Collins, Hank Johnson, and Steve Stivers unveiled a framework to reform 35 U.S.C. §101. Section 101 of the Patent Act currently makes patentable “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Although the statute is relatively permissive, courts have limited patentable subject matter beyond the statutory mandate by creating judicial exceptions. Under these exceptions as articulated in Alice Corp. v. CLS Bank International, “[l]aws of nature, natural phenomena, and abstract ideas are not patentable.” The proposed framework seeks to address these exceptions to patent eligible subject matter through statute versus an ever-growing list of case law.
Under the lawmakers’ proposed framework, reformed Section 101 would:
- Keep existing statutory categories of process, machine, manufacture, or composition of matter, or any useful improvement thereof.
- Eliminate, within the eligibility requirement, that any invention or discovery be both “new and useful.” Instead, simply require that the invention meet existing statutory utility requirements.
- Define, in a closed list, exclusive categories of statutory subject matter which alone should not be eligible for patent protection. The sole list of exclusions might include the following categories, for example:
- Fundamental scientific principles
- Products that exist solely and exclusively in nature
- Pure mathematical formulas
- Economic or commercial principles
- Mental activities
- Create a “practical application” test to ensure that the statutorily ineligible subject matter is construed narrowly.
- Ensure that simply reciting generic technical language or generic functional language does not salvage an otherwise ineligible claim.
- Statutorily abrogate judicially created exceptions to patent eligible subject matter in favor of exclusive statutory categories of ineligible subject matter.
- Make clear that eligibility is determined by considering each and every element of the claim as a whole and without regard to considerations properly addressed by 35 U.S.C. §§102, 103, and 112.
The bipartisan proposed patent reform is intended to promote innovation, with particular attention to inventions in the life sciences. According to Senator Coons, “U.S. patent law [currently] discourages innovation in some of the most critical areas of technology, including artificial intelligence, medical diagnostics, and personalized medicine.” “[L]eaders in the fields of biologics research and diagnostics will deliver the cures of tomorrow,” Representative Stivers added, “only…if we can protect those innovations with the patent protection that rewards the risks and investment necessary to discover the next great idea.” Legislators Coons, Tillis, Collins, Johnson, and Stivers are now soliciting feedback on the proposal and encourage stakeholders to email IntellectualProperty@tillis.senate.gov.
Gibbons will continue to monitor proposed changes to 35 U.S.C. §101, particularly as they affect life science companies.