Ipr In Trips-Compliant Digital Health Ip Frameworks.

07 Feb 2026 --
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1. Introduction: IPR and Digital Health under TRIPS

Digital health includes telemedicine, AI-based diagnostics, wearable health devices, health apps, and electronic health records. Protecting innovation in this area requires a careful balance:

IPR Protection: Encourages innovation in digital health technologies.

TRIPS Compliance: Ensures that IP protection standards comply with international norms (as defined by the WTO under the TRIPS Agreement).

Key points under TRIPS relevant to digital health:

Patents: Art. 27–34 — inventions must be patentable if new, involve an inventive step, and are industrially applicable.

Copyright: Software for health apps and AI diagnostics falls under copyright protection.

Trade Secrets: Algorithms, data analytics methods, and patient databases can be protected as confidential information.

Compulsory Licensing: TRIPS allows exceptions to patents for public health needs (Art. 31).

In the context of digital health, countries have been navigating how to patent AI algorithms, software, and medical devices while respecting TRIPS.

2. Case Law Analysis

Here, I’ll discuss five landmark cases that shape IP frameworks in digital health.

Case 1: Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) – USA

Facts:
Prometheus had patented a method to optimize drug dosage based on metabolite levels in the patient’s blood. Mayo Collaborative challenged the patent as it covered a natural law.

Issue:
Can a medical diagnostic method that uses natural correlations be patented?

Decision:
The Supreme Court invalidated the patent, holding that natural laws cannot be patented merely by applying standard methods.

Relevance to Digital Health:

In AI diagnostics and health algorithms, merely analyzing patient data to identify correlations cannot be patented unless it involves significant innovation beyond a natural law.

TRIPS-compliance implies countries should allow patents for true inventions but not for abstract ideas or discoveries.

Case 2: Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014) – USA

Facts:
Alice Corp. claimed a patent on a computerized system for mitigating financial risk. The technology was a software-based business method.

Issue:
Are software-implemented inventions patentable?

Decision:
The Supreme Court held that abstract ideas implemented on a computer are not patentable unless they involve an inventive concept beyond the abstract idea.

Relevance to Digital Health:

Most digital health software and AI algorithms must demonstrate technical innovation beyond routine computer implementation.

Helps TRIPS-compliant frameworks define what health software can be patented.

Case 3: Bayer Corporation v. Union of India, 2012 (India)

Facts:
Bayer challenged the Indian Patent Office’s rejection of its patent application for an oncology drug, citing Section 3(d) of the Indian Patents Act, which prevents patenting of new forms of known substances without enhanced efficacy.

Issue:
Can incremental innovations in pharmaceuticals/digital health devices be patented?

Decision:
The Indian Supreme Court upheld Section 3(d), emphasizing that patents must demonstrate significant innovation, not just minor modifications.

Relevance to Digital Health:

In digital health, upgrades to existing AI models or health apps must show significant improvement, not just a new version.

TRIPS-compliant countries can use flexibilities for public health while granting IP rights.

Case 4: European Patent Office (EPO) – T 1173/97 (IBM), 2000

Facts:
IBM applied for a patent for a computerized method of data processing. The European Patent Office challenged it as a "program for a computer" under EPC exclusions.

Decision:
Patent granted because the method solved a technical problem and had a technical effect.

Relevance to Digital Health:

AI-based diagnostics and health data processing can be patented if they solve technical problems in healthcare (e.g., faster diagnosis, reduced errors).

EPO approach aligns with TRIPS by granting patents for inventions with industrial application, not mere abstract algorithms.

Case 5: Novartis AG v. Union of India, 2013 (India)

Facts:
Novartis applied for a patent on its cancer drug Glivec, which India denied under Section 3(d).

Decision:
The Supreme Court denied the patent, emphasizing enhanced efficacy requirement.

Relevance to Digital Health:

Reinforces the principle that TRIPS allows countries to define patentability standards, especially to balance public health.

For digital health, governments can prevent patent monopolies on AI tools while protecting true innovation.

Case 6 (Optional Bonus): Mayo v. Prometheus Combined With CLS Alice Principles in AI Health Diagnostics

Courts globally are moving toward restricting patents on algorithms that merely predict health outcomes without inventive application.

This creates a TRIPS-compliant digital health IP framework where:

Software and algorithms are patentable only if inventive.

Data analytics and AI can also rely on trade secret protection if patenting is denied.

3. Key Takeaways for a TRIPS-Compliant Digital Health IP Framework

Patent Eligibility:

Must involve inventive step and technical effect (cases: Mayo, Alice, IBM).

Cannot patent natural laws, abstract ideas, or routine algorithms.

Software and AI Protection:

Patentable if applied to technical problems in health.

Otherwise, rely on copyright and trade secrets.

Public Health Safeguards:

TRIPS flexibilities (compulsory licensing, exceptions) allow governments to ensure access to critical digital health tools.

Indian cases (Bayer, Novartis) show public health considerations can override patent monopolies.

Global Harmonization:

EPO and US approaches differ slightly, but TRIPS sets minimum standards, allowing countries to adapt IP laws for digital health.

Summary Table of Cases

Case	Jurisdiction	Key Issue	Digital Health Relevance
Mayo v. Prometheus	USA	Patentability of natural laws	AI diagnostics must show innovation beyond correlation
Alice v. CLS Bank	USA	Software patentability	Health software patents require inventive concept
Bayer v. India	India	Incremental innovation	Upgraded digital health apps need real efficacy improvement
IBM T 1173/97	EPO	Software patentability	Technical solutions in health AI can be patented
Novartis v. India	India	TRIPS flexibilities & public health	Public health can limit monopolies on critical drugs/tech