Patents · October 19, 2026
Can You Patent Gene Editing, Cell Therapy, or Biotech Innovations in the US? A Guide for Irvine, CA Innovators
Yes, you can patent many gene editing, cell therapy, and other biotech innovations in the United States, but biotech patent eligibility excludes natural products, laws of nature, and abstract ideas under 35 U.S.C. 101. Engineered molecules, modified cells, and specific treatment methods often qualify, while claims must also meet enablement and written description rules. Learn more about patent protection or our Irvine patent law services.
What Is Biotech Patent Eligibility Under 35 U.S.C. 101?
Biotech patent eligibility is the threshold question of whether an invention falls within the categories Congress allows to be patented under 35 U.S.C. 101: processes, machines, manufactures, and compositions of matter. Courts have long excluded laws of nature, natural phenomena, and abstract ideas from that list. The USPTO applies these limits through Section 2106 of the Manual of Patent Examining Procedure, which examiners use for every application. For life sciences, the key question is often whether a claimed molecule, cell, or method is markedly different from something found in nature, or whether it adds enough to a natural correlation to be more than the correlation itself. Eligibility is separate from novelty and nonobviousness, so an invention can be new and still be ineligible. Careful claim drafting can often frame a discovery as an eligible application.
Can You Patent Genes or DNA After the Myriad Decision?
You cannot patent a naturally occurring DNA sequence simply because you isolated it, but you can often patent synthetic DNA, such as complementary DNA, that does not exist in nature. That was the holding of Association for Molecular Pathology v. Myriad Genetics, decided unanimously by the Supreme Court in 2013. The Court found that isolating the BRCA1 and BRCA2 genes did not create something new, while cDNA, which omits the non-coding regions of the natural gene, was eligible. The decision did not address methods of using genetic knowledge or applications of the sequences. Under MPEP 2106, examiners compare a nature-based product with its natural counterpart and look for markedly different structure, function, or other properties. Engineered guide RNAs, modified proteins, and new vectors are often drafted to show those differences.
How Do the Mayo and Alice Tests Apply to Biotech and Diagnostic Claims?
The Mayo and Alice decisions created a two-step test: first, ask whether a claim is directed to a law of nature, natural phenomenon, or abstract idea, and second, ask whether the claim adds an inventive concept that amounts to significantly more. In Mayo v. Prometheus (2012), the Supreme Court invalidated claims on adjusting a drug dose based on metabolite levels because the steps were routine. Alice v. CLS Bank (2014) applied the same framework to software. Diagnostic claims that simply measure a biomarker and draw a conclusion remain difficult to patent. Claims that require a specific treatment step, a new laboratory technique, or a new composition generally fare better. Biotech teams in software-heavy fields, such as bioinformatics or AI-driven drug discovery, should plan claims around concrete technical improvements rather than data analysis alone.
Can You Patent CRISPR Gene Editing Tools and Methods?
Yes, engineered CRISPR systems and gene editing methods can be patented, and thousands of related patents and applications exist. The most widely reported dispute is between the University of California and the Broad Institute over priority for single-guide CRISPR-Cas9 editing in eukaryotic cells. In May 2025, the Federal Circuit vacated an earlier Patent Trial and Appeal Board decision and remanded it because the Board applied the wrong conception standard. In March 2026, the Board again ruled that the Broad Institute has priority over the University of California for that invention. Commercial products still move forward under licenses. On December 8, 2023, the FDA approved Casgevy, the first approved therapy using CRISPR/Cas9, for patients 12 and older with sickle cell disease. For gene editing developers, careful prior art review and claim strategy matter more than ever.
Can Cell Therapies Like CAR-T Be Patented?
Yes, engineered cell therapies can be patented when the claimed cells or methods differ markedly from natural cells and the application adequately describes them. In Diamond v. Chakrabarty (1980), the Supreme Court held that a genetically engineered bacterium was eligible. By contrast, in In re Roslin Institute (2014), the Federal Circuit held that a cloned sheep identical to its donor was not eligible. Written description is often the bigger risk. In Juno Therapeutics v. Kite Pharma (2021), the Federal Circuit invalidated CAR-T claims and erased a judgment of about $1.2 billion because the patent did not adequately describe the broad class of binding domains claimed. Cell therapy portfolios often include several claim types.
- Engineered cells with specific genetic modifications
- Chimeric antigen receptor constructs and vectors
- Manufacturing and expansion processes
- Methods of treating a defined patient population
- Dosing regimens and combination therapies
How Did Amgen v. Sanofi Change Genus Claims for California Biotech Companies?
Amgen v. Sanofi, decided unanimously by the Supreme Court in May 2023, made broad functional genus claims harder to sustain because the specification must enable the full scope of what is claimed. Amgen claimed all antibodies that bind a target on PCSK9 and block it, but disclosed only some examples, and the Court held that leaving scientists to trial and error was not enough. For California biotech companies working on antibodies, gene editing tools, or cell therapies, this means drafting should include representative species, structural features tied to function, and data supporting the range claimed. Narrower claim tiers can protect a lead candidate even if broad claims face challenge. This also affects cost, which we discuss in our guide to biotech patent attorney cost.
Where Can You Get Help With Biotech Patent Eligibility in Irvine, CA?
You can get help with biotech patent eligibility from mjIP, an intellectual property law firm in Irvine, CA, that has worked with biotech, pharmaceutical, and supplement innovators since 2010. Founding attorney Mandana Jafarinejad, Esq., is a USPTO-registered patent attorney with a biology degree and in-house experience at a Fortune 500 pharmaceutical company in Orange County, which supports clear communication with examiners about the science. The firm serves Irvine, Orange County, San Diego, and the Bay Area. Review our Irvine patent law services, then contact us to schedule a free consultation, or call (949) 833-7125. This article is general information, not legal advice, and reading it does not create an attorney-client relationship.
Common Questions
Frequently Asked Questions About Biotech Patent Eligibility in Irvine, CA
Yes. Many CRISPR systems, guide RNA designs, and editing methods are covered by issued patents and pending applications held by universities and companies. Priority for single-guide CRISPR-Cas9 editing in eukaryotic cells has been disputed between the University of California and the Broad Institute, and in March 2026 the Patent Trial and Appeal Board again ruled for the Broad Institute.
Casgevy was the first FDA-approved therapy to use CRISPR/Cas9 genome editing. The FDA approved it on December 8, 2023, for patients 12 and older with sickle cell disease and recurrent vaso-occlusive crises. FDA approval and patent rights are separate, so an approved therapy can rely on licensed patents owned by others.
No. Under Association for Molecular Pathology v. Myriad Genetics (2013), isolating a naturally occurring DNA segment does not make it patent eligible. Synthetic DNA such as cDNA, engineered sequences, and specific methods of using genetic information may still qualify, depending on how the claims are written and what the specification discloses about their structure and use.
Some are, but many face eligibility rejections. After Mayo v. Prometheus (2012), claims that only detect a natural biomarker and draw a conclusion are often treated as laws of nature. Claims that add a specific treatment step, a new assay technique, or new reagents tend to have a stronger chance of approval.
A human cell modified in a way that gives it markedly different characteristics from natural cells may be eligible, such as an engineered CAR-T cell. Federal law separately bars patents on claims directed to or encompassing a human organism. Strong applications also need a detailed description that supports the full scope of the cells claimed.
Enablement means the patent must teach skilled scientists how to make and use the full scope of the claimed invention without undue experimentation. In Amgen v. Sanofi (2023), the Supreme Court confirmed that broad genus claims fail when the specification leaves the public to trial and error. Biotech drafting therefore relies on examples, data, and structure.