Section 3(i) of Patents Act does not exclude infrared-based biomolecule detection: Delhi High Court

Section 3(i) of Patents Act does not exclude infrared-based biomolecule detection: Delhi High Court

The method does not constitute a diagnostic method, the Court ruled and permitted the patent to proceed for grant.

The Delhi High Court has held that a method for detecting biomolecules using infrared light is not excluded under Section 3(i) of the Patents Act in the case of EMD Millipore Corporation vs Assistant Controller of Patents and Designs. The method does not constitute a diagnostic method, the Court ruled and permitted the patent to proceed for grant. The right of the applicant to revert to an earlier set of claims and amend claims during appeal was also upheld by the Court as they fell within the scope of Section 59.

An Indian patent application was filed by EMD Millipore Corporation for a method using infrared spectroscopy to detect biomolecules in liquids such as blood, urine, or saliva. The Controller of Patents refused the application on the grounds that the claimed method was a diagnostic method excluded under Section 3(i) of the Patents Act. The applicant appealed to the Delhi High Court and sought to revert to an earlier set of claims while also amending them during the appeal proceedings.

EMD Millipore Corporation submitted that the invention is an analytical tool using infrared spectroscopy and not a diagnostic method; the method can be applied to environmental and industrial samples, not just human fluids; and no diagnosis or medical decision-making is involved. EMD requested to revert to an earlier claim set and amend the claims during appeal. The Patent Office argued that detection of biomolecules in bodily fluids amounts to diagnosis, which is excluded under Section 3(i). It opposed the request to revert to earlier claims and objected to amendments filed during appeal, citing non-compliance with Section 59.

Section 3(i) excludes methods of diagnosis for treatment, the court observed. The invention involves a process for detecting biomolecules using infrared radiation but does not involve interpreting the results or diagnosing a disease, the court noted. The claims do not involve any deductive or clinical steps typically associated with diagnosis, the court said. The court referred to international standards, including the EPO’s G 1/04 decision, and concluded that the invention stops at data acquisition and does not involve attributing meaning to the data. The presence of biological samples alone is not sufficient to classify the invention as a method of diagnosis under Section 3(i), the court stated.

The court held that amendments to claims can be made during an appeal under Section 59, provided they do not introduce new matter.

The court recognised the right of an applicant to revert to a previously examined claim set during appeal. It held that there is no restriction under the Patents Act that prohibits reversion to an earlier claim set, especially when the same was on record before the Patent Office.

The invention is not excluded under Section 3(i) of the Patents Act, the court held. It permitted the applicant to revert to an earlier set of claims filed in 2017. Amendments during appeal are permissible if they comply with Section 59, the court held. It directed that the patent application be taken forward for grant.