Diagnostic Processes and Patent Eligibility

EMD Millipore Corporation Vs Assistant Controller of Patents and Designs – Case Summary

Fact

The appellant, EMD Millipore Corporation, a U.S.-based corporation, filed a patent application bearing No. 1026/DEL/2012 in India on 3rd April 2012 titled “Devices and Methods for Infrared (IR) Based Quantitation of Biomolecules.” The invention concerns a method for the quantitative analysis of biomolecules in various types of samples, including human plasma, food, cosmetics, and environmental samples using infrared spectroscopy.

The appellant claimed priority from a U.S. patent application and amended the claims multiple times during prosecution, finally seeking patent protection for a technical innovation. The key object of the invention was to improve efficiency in IR spectroscopic analysis by reducing repeated calibration and enabling reuse of calibration data.

Despite amendments to overcome objections, the Assistant Controller of Patents and Designs refused the application by order dated 18th February 2021 on the ground that the claims fall under the non-patentable subject matter exclusion of Section 3(i) of the Indian Patents Act, 1970, which excludes diagnostic processes from patentability.

Procedural Detail

The appellant challenged the refusal under Section 117A of the Patents Act before the High Court of Delhi. The appeal proceeded through multiple hearings from 2021 onwards. The court sought additional reports from the patent office concerning the novelty and inventive step of the claims.

A significant issue considered was the correct interpretation and scope of the exclusion clause under Section 3(i) of the Act, which bars patentability of diagnostic methods. The court appointed an Amicus Curiae to assist with submissions on complexity related to the interpretation of Section 3(i).

The matter involved detailed examination of foreign jurisprudence, including decisions from the European Patent Office (EPO) on exclusions for diagnostic methods. Judgment was reserved in December 2024 and pronounced in October 2025.

Dispute

The fundamental dispute centered on whether the subject invention qualifies as a diagnostic process excluded from patentability under Section 3(i) of the Patents Act or whether it qualifies as a patentable technical method.

• The appellant contended that the invention was an innovative technical process improving IR spectroscopic quantitation applicable across industries and should not be barred.
• The respondent argued that the invention was a diagnostic method within the scope of Section 3(i) and thus non-patentable, emphasizing that the exclusion applies broadly to diagnostic methods regardless of their in vivo or in vitro nature.

Issues surrounding the legislative history of Section 3(i), international obligations under TRIPS, and Indian patent policy balancing innovation and public health were also debated.

Detailed Reasoning

The court undertook a comprehensive examination of the legal framework, including Indian patent law, legislative history, and international precedents.

Analysis of Section 3(i)

The court noted that Section 3(i) of the Patents Act excludes:

“Any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products.”

The appellate court analyzed the corresponding provisions in foreign jurisdictions such as:

• The UK’s Patents Act 1977
• Article 53(c) EPC 2000
• Jurisprudence from the EPO’s Enlarged Board of Appeal (notably Case G 000104)

The court emphasized that diagnostic methods excluded under these laws are typically multistep processes involving:

1. Examination
2. Data gathering
3. Comparison
4. Symptom detection
5. Clinical decision-making practiced directly on the human or animal body

Clarifications by the Court

It was clarified that the exclusion’s purpose was to free medical practitioners from patent constraints when applying core diagnostic procedures requiring professional judgment and bearing health risks.

However, patentability is not barred for diagnostic tools, instruments, or technical processes that do not themselves constitute a diagnostic method practiced on the living body.

Examination of the Appellant’s Invention

The court thoroughly examined the appellant’s patent claims and specifications, observing that the invention was directed to an in vitro technical process using infrared spectroscopy for biomolecular quantitation on samples including cosmetics, food, water, and fuels.

Conclusion

The court concluded the invention did not involve any step constituting diagnosis for curative purposes or clinical decision-making performed on or practiced on a human or animal body.

The method improved the technical aspect of IR spectroscopic measurement rather than the intellectual exercise of diagnosis itself. Furthermore, the court noted that the patent had been granted in jurisdictions including the United States and Europe, where comparable exclusions exist, supporting its patentability.

The role and intent of Section 3(i) were revisited in light of legislative history and international trade commitments under TRIPS. The court held that the section was intended to exclude medical procedures requiring practitioner skill and direct interaction with the patient, but not to bar patents on inventions involving technical methods or devices that facilitate analysis or diagnostics without constituting a disallowed diagnostic method.

Amendment of Claims

The court also discussed the permissibility of claim amendments during appeals under Section 59 of the Act, confirming that amendments clarifying or narrowing claims within the original disclosure are allowed. The appellant’s amendments were found to be within permissible limits and did not expand the scope of the invention.

Decision

The appeal was allowed. The impugned order refusing the patent application was set aside, as the claimed invention does not fall within the exclusion of Section 3(i) of the Patents Act.

The court directed the patent office to proceed with the grant of the patent to the appellant after completion of formalities. The exclusion applies narrowly to core diagnostic processes practiced on the human or animal body and does not extend to technical innovations or in vitro processes.

The appellant’s method for IR-based quantitation of biomolecules therefore qualifies for patent protection.

The court relied heavily on the Enlarged Board of Appeal, EPO decision G 000104, setting out the multi-step definitional framework for diagnostic methods and the distinction between in vivo diagnostic processes and technical methods or tools.

In sum, the judgment clearly elucidates the boundary between non-patentable diagnostic processes and patentable technical innovations, guiding future patent prosecution in medical technology fields in India.

Case Summary

Disclaimer

The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.

Written By

Advocate Ajay Amitabh Suman, IP Adjutor (Patent and Trademark Attorney), High Court of Delhi