Part I: Diagnostic method patents in India

In March 2023, the Delhi High Court will consider two significant rejections by the Patent Office (PTO) that will determine the fate of diagnostic method patents in India. The PTO recently rejected EMD Millipore’s patent application involving IR based spectroscopy and Sequenom’s patent application involving non-invasive prenatal genetic diagnostics on the grounds that both inventions were not patent eligible under Section 3(i) of the Patents Act, 1970.  This provision excludes diagnostic processes from patent protection. Both rejections have been challenged before the Delhi High Court. The court has appointed Adarsh Ramanujan as amicus curiae. Adarsh has blogged for us several times in the past here.

As with other provisions of the Patents Act, Section 3 is a useful ‘policy lever’ and courts can use it to define optimal intellectual property norms for low-middle-income countries like India. On one hand, patent protection can incentivise innovation in this sector which can lead to faster, improved and more accurate diagnosis. On the other hand, patent protection can raise concerns for research, health care delivery and affordable access to diagnostics tests for patients.

Historical reasons for inclusion of ‘diagnostic processes’ in Section 3(i), its scope and extent are unclear. Further, there have been no significant cases that have considered the scope and extent of this provision. The absence of both historical context and precedent gives the court considerable room for active judicial review. It remains to be seen whether the court will deploy judicial review in ways that make it tougher to obtain such patents or in ways that make it easier. For now, here is the lay of the 3(i) land (over Part I and Part II):

The diagnostic patent applications at issue

EMD Millipore’s patent application for ‘devices and methods for infrared (IR) based quantitation of biomolecules’ (no. 1026/DEL/2012):  IR spectroscopy is an analytical method used in research for analysing biomolecules such as nucleic acids, proteins, lipids, endotoxins etc. in a biological sample such as blood, plasma serum and urine. This method detects molecular differences between normal and diseased tissues based on vibrational signatures which can be used to diagnose diseases such as cancer.

EMD’s invention claims to be an improvement over prior art as it requires lesser time and lesser sample volume for quantification of biomolecules. Users do not need to generate calibration curves each time and the calibrant does not need to be the same molecule as the analyte being quantitated.

Before the PTO, EMD argued that its invention does not disclose any process of treatment of human beings or animals. Rather, the invention is a purely technical method of quantitation of one or more biomolecules in a sample. However, the PTO was of the view that the invention was essentially a diagnostic process and merely characterising the invention as a purely technical method of quantitation did not take away from its true characteristic of being a diagnostic process. The PTO held that the nature and final outcome of the method was to provide information of diagnostic value making the invention non-patentable under Section 3(i).

Sequenom’s patent application for ‘processes and compositions for methylation-based enrichment of fetal nucleic acid from a maternal sample useful for non invasive prenatal diagnoses’ (patent application no. 3139/DELNP/2012): This invention involves a test, performed on samples taken from pregnant women, to check for foetal abnormalities. The pregnant woman’s blood, tissue, amniotic fluid are used for such testing.

Sequenom made formalistic arguments, relying on differences between ‘screening tests’ and ‘diagnostic tests’, to defend its application. Sequenom argued that until the foetus is born, there can be no ‘diagnosis’ and the test being performed is merely a ‘screening’ test to check whether there is a possibility of the foetus suffering from any abnormalities. The PTO, however, held that any testing of a pregnant woman’s blood, tissue or other biological sample qualifies as a ‘pre-natal diagnostic test’ under the Pre- Conception and Pre-Natal Diagnostic Techniques Act, 1994 and is clearly a diagnostic process that is not patentable under Section 3(i).

It is pertinent to note that Sequenom’s patent was confirmed in Australia but held invalid in the US (here).

Part II will analyse the contours of section 3(i) and also highlight policy considerations to be kept in mind before an appropriate legal test for diagnostic method patents is formulated.

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