The Chinese University of Hong Kong and SEQUENOM, INC. (“Appellants”) contested the denial of their patent application 4812/CHENP/2012 by the Assistant Controller of Patents and Designs (“Respondent”) at the Patent Office in Chennai. Their proposed method, "Fetal Genomic Analysis from a Maternal Biological Sample," was developed through a collaboration between the two appellants, with its claims reduced from 44 to 12 post-discussions with the Patent Office. The respondent contended that this method could identify genetic irregularities in a fetus, categorizing it as diagnostic and thus non-patentable under Section 3(i) of the Patents Act, 1970.
The appellants refuted this, maintaining their method only identifies the fetal fraction in a maternal sample and is not intrinsically diagnostic. Highlighting inconsistencies, they noted how some in vitro methods received patents while others did not. Furthermore, the invention disclosed in the patent application is centered on the examination of nucleic acid molecules in a biological sample collected from a pregnant woman. Its objective was to identify the fetal fraction within the sample. This fetal fraction played a crucial role in subsequent testing to diagnose chromosomal aberrations. Notably, the invention itself did not engage in the direct diagnosis of diseases or conditions. Rather, it offered a valuable indicator, known as the fetal fraction, instrumental for subsequent diagnostic processes.
The Hon’ble Madras High Court emphasized that a process's 'diagnostic' classification is based on its inherent capability to detect diseases, irrespective of its label. Drawing on the TRIPS Agreement and recent Patent Office guidelines, the court indicated the potential patentability of in vitro diagnostic methods and elaborated on the nature of diagnosis.
In conclusion, the Hon’ble Court distinguished between screening and diagnostic tests, establishing that the appellants’ method, though related, was not explicitly diagnostic, rendering objections on Section 3(i) grounds invalid. The Hon’ble judge acknowledged the inconsistencies in patent decisions and underlined the importance of spurring diagnostic tech innovations. The judge also suggested refining Section 3(i) while highlighting potential measures for treatments and leaving the final decision on such amendments to the competent authorities.
The Chinese University of Hong Kong and SEQUENOM, INC. vs. The Assistant Controller of Patents & Designs [CMA (PT) No.14 of 2023]