Analytical characterization, not disease identification
At the intersection of science and law, India's Delhi High Court has intervened to correct a patent examiner who misread both the procedural rules and the molecular science underlying a Norwegian researcher's skin cancer analysis technique. Natalja Eikje's method — using infrared spectroscopy to observe how cancer progresses at the cellular level in laboratory tissue samples — was refused on grounds that were never properly raised against most of its claims, and that mischaracterized analytical research as clinical diagnosis. The ruling reminds us that the boundary between a tool that illuminates disease and one that identifies it is not merely semantic, but carries profound consequences for who may own the instruments of scientific discovery.
- A decade-long patent journey collapsed in April 2024 when an Indian Controller rejected all sixteen of Eikje's claims on a single ground that had only ever been raised against six of them — a procedural overreach the court called a blatant error.
- The Controller's deeper mistake was scientific: treating a laboratory spectral analysis performed on biopsied tissue as though it were a diagnostic test administered to a living patient, erasing the precise legal and biological meaning of 'in vitro.'
- India's Section 3(i) exclusion — which bars diagnostic methods from patentability — became the fault line, forcing the court to draw a sharp distinction between data that characterizes molecular change and a conclusion that identifies disease for treatment.
- The Delhi High Court quashed the refusal entirely, remanding the application for fresh consideration within three months, with a hearing guaranteed and neither the original order nor the court's own observations permitted to color the outcome.
- The ruling now stands as a clarifying precedent for biotech and medical device innovators in India, signaling that analytical research tools generating intermediate scientific data occupy different legal ground than excluded diagnostic methods.
A Norwegian scientist's decade-long effort to patent a skin cancer analysis technique in India has been revived after the Delhi High Court found that the Patent Office had both broken procedural rules and fundamentally misunderstood the science it was evaluating.
Natalja Eikje, whose research spans dermatology and clinical physics, developed a method using Fourier Transform Infrared microspectroscopy to study how skin cancer evolves at the molecular level. Working entirely with biopsied tissue samples in laboratory conditions, her technique analyzes spectral patterns in nucleic acids and proteins across benign, premalignant, and malignant stages. She filed an Indian patent application in 2014 covering sixteen claims — the spectral method itself, the FTIR apparatus, and specific molecular groupings with characteristic spectral signatures.
The Patent Office's first examination report in 2021 raised Section 3(i) objections — the provision excluding diagnostic methods from patentability — but only against the first six claims. Eikje responded with amended claims and written arguments. Then, in April 2024, the Joint Controller rejected all sixteen claims on the same Section 3(i) ground, offering no independent reasoning for why claims seven through sixteen — never challenged on that basis — should also fall.
The Delhi High Court identified this as a double failure. Procedurally, the Controller had no authority to reject claims that had never been objected to in the examination report; doing so without any stated basis vitiated the entire order. Substantively, the Controller had misread the invention itself, treating an explicitly in vitro laboratory method as though it were a clinical diagnostic process performed on patients — a reading that directly contradicted the claims' own language.
The court drew a firm legal line: a method excluded under Section 3(i) must inherently identify a disease or condition for potential treatment. Eikje's FTIR technique produces intermediate analytical data about molecular and cellular changes — it characterizes spectral patterns, it does not deliver a diagnosis. Conflating analytical characterization with clinical diagnosis, the court held, was legally untenable.
The application has been remanded for fresh consideration within three months, with a guaranteed hearing and a clean slate. For India's biotech and medical device sector, the ruling establishes that the distinction between a research tool and a diagnostic method is not a technicality — it is the boundary between what can and cannot be owned.
A Norwegian researcher's patent application for a skin cancer analysis method has been given a second chance after India's Delhi High Court found that a government patent examiner had fundamentally misunderstood the science—and broken procedural rules in the process.
Natalja Eikje, a scientist whose career has spanned dermatology, clinical physics, and physiological biophysics, developed a technique using Fourier Transform Infrared microspectroscopy to study how skin cancer progresses at the molecular level. The method analyzes spectral patterns in biopsied tissue samples, observing how nucleic acids and proteins behave across benign, premalignant, and malignant stages. She filed an Indian patent application in August 2014 covering sixteen claims: six describing the spectral analysis method itself, four covering the FTIR apparatus, and six more covering groups of nucleic acids and proteins with specific spectral characteristics.
When the Patent Office issued its first examination report in February 2021, it raised objections under several sections of India's Patents Act, but crucially, it objected to only the first six claims on the ground that they fell under Section 3(i)—the provision that bars diagnostic methods from patentability. Eikje responded substantively in August 2021 with amended claims, and submitted additional written arguments in October 2023. Then, in April 2024, the Joint Controller of Patents and Designs rejected the entire application—all sixteen claims—solely on the Section 3(i) diagnostic methods ground. The Controller provided no independent reasoning for rejecting claims seven through sixteen, which had never been challenged on that basis.
Eikje challenged the refusal in the Delhi High Court. The court identified two critical errors. First, it was a procedural violation: the Controller had no authority to reject claims that were never objected to in the examination report. Whatever the merits of the Section 3(i) argument against claims one through six, claims seven through sixteen should have been assessed independently. Rejecting them without any stated basis was, the court said, a blatant error that vitiated the entire order.
Second, and more substantively, the court found that the Controller had misread the nature of the invention itself. The term "in vitro" carries a precise scientific meaning—it refers to work performed outside a living organism, in a controlled laboratory setting, using isolated tissue samples in test tubes or petri dishes. Eikje's claims explicitly confined the method to this in vitro context. Yet the Controller had reasoned as though the method were a diagnostic process performed on patients, a reading that directly contradicted the express scope of the claims.
The court drew a sharp distinction between an analytical research tool and a diagnostic method. A test that qualifies as diagnostic under Section 3(i), the court held, must inherently identify a disease or condition for potential treatment. Eikje's FTIR method did not do that. It produced intermediate analytical findings about spectral patterns in nucleic acids and proteins—data intended to advance scientific understanding of how skin cancer develops at the molecular level. It characterized molecular and cellular changes, but it did not deliver a definitive disease identification. The Controller had conflated analytical characterization with diagnosis, a conflation the court found legally untenable.
The court quashed the refusal and remanded the application to the Controller for fresh consideration within three months, directing that Eikje be given a hearing and that the decision be based on the existing record without being influenced by either the court's observations or the original order. The ruling clarifies that Indian patent authorities must rigorously distinguish between in vitro analytical methods and excluded diagnostic methods—a distinction that carries significant weight for biotech and medical device innovators seeking patent protection in India.
Citas Notables
The Controller had fundamentally misread the in vitro nature of the claimed method and had exceeded the scope of the Section 3(i) objection by rejecting claims that were never challenged.— Delhi High Court, in its judgment
A test qualifying as a diagnostic method under Section 3(i) should inherently identify a disease or condition for potential treatment; the FTIR spectral method provided data about molecular interactions intended to advance scientific understanding, not disease identification.— Delhi High Court, distinguishing analytical from diagnostic methods
La Conversación del Hearth Otra perspectiva de la historia
Why does it matter whether something is called analytical versus diagnostic?
Because India's patent law explicitly bars diagnostic methods from protection. If the examiner can call your work diagnostic, they can refuse your patent. The court is saying that label has to mean something precise—it can't just be applied to any method that touches on disease.
But Eikje's method does relate to cancer. Doesn't that make it diagnostic?
It relates to cancer, yes, but it doesn't diagnose cancer. It studies how cancer develops at the molecular level using isolated tissue samples in a lab. That's research. Diagnosis would be: you take a biopsy from a patient, run it through the method, and get back a determination of whether they have cancer and what stage it's at.
So the Controller thought it was doing that?
Exactly. The Controller read the claims as if they described a clinical test performed on patients. But the claims explicitly say "in vitro"—meaning the whole process happens outside the body, in controlled lab conditions. The Controller just didn't engage with that limitation.
What about the procedural problem the court mentioned?
That's almost separate. The examiner only objected to six of the sixteen claims under the diagnostic methods rule. Then rejected all sixteen on that same ground, with no explanation for why the other ten should be refused. That's not how patent examination works. You have to address each claim.
Does this mean Eikje gets her patent?
Not automatically. The case goes back to the examiner to reconsider. But now the examiner has to actually understand what in vitro means, and has to address each claim on its merits. The court has drawn a line: analytical methods that advance scientific understanding are different from diagnostic methods that identify disease in patients.
What changes for other biotech inventors?
They now have a clearer precedent that in vitro research tools won't automatically fall under the diagnostic exclusion just because they touch on disease. The examiner has to look at what the method actually does—does it identify disease, or does it generate research data? That distinction matters.