The Madras High Court in the recent case of Hygieia, Inc. (hereafter referred to as “Hygieia”) v. Assistant Controller of Patents and Designs (hereafter referred to as the “Controller”) set aside a refusal order after noting that the Controller had not adequately considered the amended claims and their compliance with the original application before refusing Hygieia’s patent application.
Background
Hygieia filed a PCT national phase application before the Indian patent office on December 23, 2013, with a total of 22 claims. The application was titled “Systems, Methods, and Devices for Achieving Glycemic Balance,” and allotted patent application number 10225/CHENP/2013.
A first examination report (FER) was issued by the Controller of Patents and Designs on 6th March 2018 alleging that Hygieia’s application lacked inventive step under Section 2(1)(ja) based on two prior art references. The Controller also raised an objection to the patentability of the invention under Sections 3(i), 3(d), and 3(k) of the Patents Act (hereafter referred to as “Act”). Hygieia responded to the objections in the FER by submitting an amended set of 24 claims on December 5, 2018, primarily aligning the claims of its Indian application with that of the U.S. counterpart. In the amendments, Hygieia introduced a second independent claim designated as Claim No.10.
Upon review of the response, the Controller issued a hearing notice on August 26, 2019, maintaining all the objections in the FER while adding a new objection under Section 59 of the Act. Post-hearing, the Controller issued a refusal order with an observation the amendments were not in compliance with section 59. The controller reasoned that the original claims of Hygieia’s Application pertained solely to a defined method or process, but the amended claims shifted the scope to an apparatus or device. This change from a process to a product was beyond the scope of the existing claims and therefore liable to be refused.
In the refusal order, the Controller further stated that the amendments claimed in claims 1 to 24 were not clear as to whether they constituted a disclaimer, correction, or explanation.
Court’s analysis:
The Court referred to the judgment of the Delhi High Court in the case of Allergan Inc. vs. The Controller of Patents and held them crucial for resolving the current case.
The key issue in the present matter was whether Hygieia could be barred from seeking a patent in respect of the product i.e., apparatus, merely because the original application, as filed by the Appellant, sought a patent for the method (but not for the apparatus) in which said apparatus was to be used even if the apparatus, was disclosed in the complete specification.
The Court observed that it is only after the filing of an international application, that an applicant can proceed to file national phase applications in the countries designated during the international phase. Since each country operates under its patent laws, this results in varying regimes, therefore, it would be impractical or unrealistic to expect that the claims in the original PCT application, as filed (in this case, in the US), would be patentable in every designated country.
This court noted that this was the precise situation in the present case. The method claim for treating a patient’s diabetes was patentable in the US and was, indeed, granted a US patent. In India, however, such a method claim was not patentable under Section 3(i). It was for this reason that the Appellant had opted to amend its method claim into a product claim.
Relying on the principles laid down in landmark judgments such as those of Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries Ltd., Arnold v. Bradbury, Merck Sharp & Dohme Corporation v. Glenmark Pharmaceuticals and Parkinson v. Simon, the court observed that claims should be interpreted in a manner so as to give them a meaningful effect. The specification and the claims must be considered together and interpreted in conjunction.
Conclusion
The court concluded by holding that separating claims from their accompanying specifications is against the fundamental principles of patent law and is a situation that the Court must consciously avoid. The Application was remanded for de novo consideration with the directions that the application be re-examined by a different controller who would then be required to dispose of the application within a strict time frame of six months.
Authored by Dr. Vasundhara Paliwal, Patents Team, BananaIP Counsels.
Citation: Hygieia, Inc. v. Assistant Controller of Patents and Designs, (T)CMA(PT) No. 153 of 2023 ( H.C. Madras March 12, 2024). Available at: https://indiankanoon.org/doc/64571465/, Last Visited on: 13/07/2024.
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