Can I patent a medical procedure?

Can I Patent a Medical Procedure?

Medical professionals, researchers, and healthcare companies often develop innovative procedures that advance patient care. When substantial resources are invested in developing these methods, questions naturally arise about securing intellectual property protection through patents.

Medical Procedure Patents: Legal Framework

Basic Patent Requirements

Like all inventions, medical procedures must meet standard patentability criteria:

• Novelty - The procedure must be new and not previously disclosed
• Non-obviousness - The procedure must not be obvious to someone skilled in medical practice
• Utility - The procedure must serve a useful purpose
• Patent-eligible subject matter - The procedure must qualify under legal definitions of patentable inventions

The United States Patent and Trademark Office (USPTO) evaluates these requirements during the patent examination process.

Special Considerations for Medical Procedures

Medical procedures occupy a unique position in patent law due to their direct impact on healthcare delivery and ethical considerations:

• Medical procedures technically qualify as patent-eligible subject matter
• However, special statutory provisions limit enforcement against medical practitioners
• International approaches to medical procedure patents vary significantly
• Ethical debates continue regarding the appropriateness of such patents

The landscape for medical procedure patents has evolved considerably in recent decades, shaped by legislation, court decisions, and professional medical ethics guidelines.

The Physician's Immunity Provision

Section 287(c) Limitations

In 1996, the U.S. Congress enacted a significant amendment to patent law affecting medical procedures. Under 35 U.S.C. § 287(c):

• Patent holders cannot enforce medical procedure patents against medical practitioners
• The immunity applies to "medical activity" performed by licensed healthcare providers
• The protection extends to related healthcare entities for the practitioners' activities
• This immunity does not apply to procedures using patented products or biotechnology

This provision effectively creates a limited statutory exemption from infringement liability for medical professionals, though the patents themselves remain valid.

Scope of Protected Activities

The immunity provision specifically defines "medical activity" as:

• The performance of a medical or surgical procedure
• On a human body or human embryo
• By a licensed medical practitioner
• Where the patent claims the method directly

American Medical Association has supported these limitations, citing concerns about patient access and the free exchange of medical knowledge.

What Can Be Patented in Medical Practice

Medical Devices and Products

While practitioner immunity exists for procedures, no similar restriction applies to:

• Medical devices (A61B)
• Surgical instruments (A61B17)
• Diagnostic equipment (A61B5)
• Pharmaceutical compositions (A61K)
• Therapeutic products (A61P)

Medtronic holds numerous patents on medical devices and the procedures for using those devices, with full enforcement rights against competitors.

Biotechnology Procedures

Certain medical procedures remain fully enforceable, including those involving:

• Gene editing techniques
• Cell modification procedures
• Tissue engineering methods
• Laboratory testing processes

Myriad Genetics previously held patents on genetic testing methods, though some were later invalidated on other grounds in the landmark Association for Molecular Pathology v. Myriad Genetics Supreme Court case.

Diagnostic Methods

Diagnostic method patents face additional challenges:

• Must involve more than observing natural correlations
• Should include novel technical steps beyond mental processes
• Often require tying to specific apparatus or transformations
• Face heightened scrutiny under Mayo Collaborative Services v. Prometheus Laboratories, Inc.

Roche Diagnostics focuses its patent strategy on diagnostic devices and test kits rather than pure diagnostic methods due to these challenges.

International Perspectives

European Approach

The European Patent Convention takes a different approach from the U.S.:

• Article 53(c) explicitly excludes "methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body" from patentability
• This prohibition is absolute rather than an enforcement limitation
• However, products for use in these methods remain patentable
• "Swiss-type" claims (new use of known compounds) offer alternative protection

The European approach reflects a fundamental policy decision that medical procedures should remain in the public domain.

Other International Approaches

Medical procedure patent policies vary globally:

• Japan - Allows medical procedure patents with some restrictions
• Canada - Similar to Europe, excludes medical procedures from patentability
• Australia - Permits medical method patents with fewer restrictions than the U.S.
• India - Specifically excludes medical methods from patentability under Section 3(i) of the Patents Act

These variations create complex considerations for global healthcare innovators seeking international protection.

Strategic Considerations for Medical Innovators

Alternative Protection Strategies

Given the limitations on medical procedure patents, inventors should consider alternative approaches:

• Focus patent claims on associated devices or compositions
• Consider trade secret protection for procedures not readily reverse-engineered
• Develop complementary technologies with stronger patent positions
• Create comprehensive intellectual property portfolios with multiple protection layers

Johnson & Johnson employs a multi-layered approach, patenting devices, pharmaceuticals, and systems related to surgical procedures.

Ethical and Practical Considerations

Beyond legal considerations, medical innovators should weigh:

• Potential impact on healthcare costs and access
• Professional medical society positions on procedure patents
• Public perception and potential backlash
• Academic and research community norms

Many healthcare organizations, including the World Medical Association, have expressed concerns about medical procedure patents potentially restricting patient access to care.

Questions about Medical Procedure Patents

How Do I Determine If My Medical Innovation Is a "Procedure" Affected by Immunity Provisions?

Determining whether your medical innovation falls under the immunity provisions requires careful analysis of both the innovation itself and the statutory language. The key question is whether your invention constitutes a "medical or surgical procedure on a body." Generally, methods directly performed on patients by physicians or other licensed medical practitioners during treatment fall within immunity provisions. This includes surgical techniques, therapeutic methods, and clinical procedures. However, your innovation likely falls outside these provisions if it: (1) involves a patented drug, device, or biotechnology product; (2) occurs primarily in laboratory settings rather than on patients; (3) can be performed by non-medical personnel; or (4) represents a business method related to healthcare delivery rather than direct patient treatment. The line becomes particularly blurry for minimally invasive procedures using specialized equipment. In these cases, courts typically examine whether the innovation primarily resides in the method itself or in the enabling technology. Consulting a patent attorney experienced in medical technology is essential, as they can analyze relevant case law and USPTO examination history for similar innovations to determine your specific situation.

What Parts of My Medical Innovation Should I Focus on Patenting?

When developing a patent strategy for medical innovations, focus on patentable elements that maintain enforceability and maximize value. Prioritize patenting specialized devices, instruments, or equipment used in your procedure—these remain fully enforceable against competitors even when the procedure itself falls under physician immunity provisions. For diagnostic innovations, emphasize novel reagents, test kits, or specialized apparatus rather than the analytical or interpretive steps. If your innovation involves treatment methods, consider drafting claims covering the composition of therapeutic agents or their specific formulations for particular applications. For procedural innovations, identify whether any steps occur outside direct physician-patient interaction, such as sample preparation techniques, data processing methods, or pre-treatment protocols, as these may remain enforceable. When the innovation involves software or AI components, focus on specific technical implementations rather than abstract diagnostic correlations. This layered approach creates a protective ecosystem around your core innovation, even if some aspects face enforcement limitations. Remember to align your patent strategy with your commercialization plans—patents on supporting technologies often provide more effective market exclusivity than procedure patents alone.

How Do Medical Procedure Patent Restrictions Vary Internationally?

Medical procedure patentability varies significantly across major jurisdictions, requiring a territory-specific strategy. The United States grants medical procedure patents but limits enforcement against medical practitioners under 35 U.S.C. § 287(c), essentially creating a statutory license for physicians while maintaining enforceability against commercial competitors. Europe, under Article 53(c) of the European Patent Convention, expressly excludes methods of treatment and diagnosis practiced on humans from patentability, though products for use in these methods remain patentable. Japan allows medical procedure patents but provides limitations on enforcement similar to the U.S. approach. Canada generally excludes medical methods from patentability following the Europe model. Australia permits medical method patents with relatively few restrictions, offering broader protection. China theoretically excludes treatment methods but often grants patents for specifically defined procedural techniques. India explicitly prohibits medical method patents under Section 3(i) of its Patents Act. These variations necessitate jurisdiction-specific claim strategies—for example, in Europe, consider "product for use" claims or focus on devices rather than methods, while in the U.S., draft claims to maintain enforceability against commercial entities. For global protection, develop a tiered strategy prioritizing key markets with favorable laws and your primary commercialization targets.

What's the Relationship Between Medical Procedure Patents and Standard of Care?

The relationship between patented medical procedures and the standard of care creates complex ethical and legal considerations. When a patented procedure becomes the recognized standard of care, tensions arise between intellectual property rights and physicians' obligations to provide optimal treatment. The physician immunity provision in U.S. law (35 U.S.C. § 287(c)) specifically addresses this concern by preventing enforcement against medical practitioners performing patented procedures, ensuring doctors can implement best practices without infringement liability. However, the patent holder can still enforce rights against hospitals, manufacturers, or other commercial entities that promote or systematize the procedure. This creates potential upstream effects on healthcare costs and access. Medical specialty societies and ethics boards generally discourage patents that might restrict standard-of-care implementation, and physicians have professional obligations to share advances that benefit patients. From a strategic perspective, patents on procedures likely to become standard of care often deliver limited financial returns due to enforcement restrictions, while generating potential backlash from the medical community. Consider instead patenting enabling technologies, devices, or composition elements that support the procedure while allowing the core medical technique to be widely adopted.

How Have Recent Court Decisions Affected Medical Procedure Patentability?

Recent Supreme Court decisions have significantly narrowed the scope of patentable subject matter for medical procedures, particularly for diagnostic methods. The Mayo Collaborative Services v. Prometheus Laboratories (2012) decision invalidated patents on methods of optimizing drug dosages based on metabolite measurements, establishing that correlations between biomarkers and treatment outcomes represent unpatentable natural laws unless the application includes "significantly more" than the natural law itself. The Association for Molecular Pathology v. Myriad Genetics (2013) decision, while focused on gene patents, reinforced that merely discovering natural phenomena without significant additional innovation falls outside patentable subject matter. In Alice Corp. v. CLS Bank (2014), the Court established a two-part test for patent eligibility that has been applied to medical methods, requiring that claims directed to abstract ideas or natural phenomena include an "inventive concept" beyond conventional steps. Lower courts have subsequently invalidated numerous diagnostic method patents. This jurisprudential trend has shifted medical innovation patenting toward: (1) novel technical implementations rather than the underlying biological correlations; (2) treatment methods rather than diagnostic methods; and (3) systems and devices rather than pure methods. Patent applications now require careful drafting to emphasize technical improvements beyond natural phenomena, with detailed implementations that transform abstract principles into specific applications.