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The Pune-based Serum Institute of India (SII) has received a patent approval from the Indian Patent Office for its application for improved process for production of monoclonal antibody for rabies vaccine with improved potency in a review petition, after it was rejected through an order on July 27, 2021.
The company filed a patent application on September 26, 2015, for improved feeding strategies and purification processes for monoclonal antibody production, for an invention which provides a method for manufacturing a rabies monoclonal antibody (HuMab 17C7).
According to the complete specification filed by the company with the patent office, the method using optimal cell line, cell culture conditions, and purification process results in low osmolality, minimum secondary metabolites like ammonia and lactate, enhanced cell growth and productivity, minimum aggregation or degradation of monoclonal antibody during purification, thereby improving potency of monoclonal antibody (HuMab 17C7) at least four fold as compared to human rabies immunoglobulin (hRIG).
“The improved potency for Rabies monoclonal antibody is retained for extended periods at storage at 2-8 °C, 25 °C, and 40 °C,” said the company filing. The claims submitted by the company in September, 2015, claimed that the monomeric monoclonal antibody is stable for 36 months at 2-8 degree Celsius with retention of at least 85 per cent potency, and for at least six months at 25 degree Celsius with retention of at least 85 per cent potency and for at least six months at 40 degree Celsius of at least 85 per cent potency.
The application was taken up for hearing on July 5, 2021 and the patent official observed in an order refusing the application, that the company has submitted amended claims, which did not fall wholly within the scope of the claims of the specification before the amendment.
The company has added a step in the amendment and the patent official observed that it is not backed by the specifications filed at the time of initial filings. It also observed lack of clarity and conciseness and insufficient disclosure in the amended filings.
The patent office, in the order in July, 2021, concluded that the instant application does not comply with the requirements of sections 10 (4) (a), (c), 10 (5) and 59 (1) of the Patents Act, 1970 (as amended).
Section 10 (4)(a) mandates that every complete specification shall fully and particularly describe the invention and its operation or use and the method by which it is to be performed. Section 10 (4)(c) adds that the complete specification shall end with a claim or claims defining the scope of the invention for which protection is claimed. Section 10(5) mandates that the claim or claims of a complete specification shall relate to a single invention, or to a group of inventions linked so as to form a single inventive concept, shall be clear and succinct and shall be fairly based on the matter disclosed in the specification.
Section 59 (1) on amendment of application or specification stipulates that no amendment of an application for a patent or a complete specification or any document relating thereto shall be made except by way of disclaimer, correction or explanation, and no amendment thereof shall be allowed, except for the purpose of incorporation of actual fact, and no amendment of a complete specification shall be allowed, the effect of which would be that the specification as amended would claim or describe matter not in substance disclosed or shown in the specification before the amendment, or that any claim of the specification as amended would not fall wholly within the scope of a claim of the specification before the amendment.
Following this, the company submitted a review petition on August 27, 2021 made required amendments and made necessary clarifications during a hearing held later. Taking the amended claims on record in view of providing natural justice to the applicant company, the Assistant Controller of Patents and Designs, on October 10, 2022, issued an order observing that the grounds on which the application was refused do not exist.
“Therefore, Form 24 (review petition) filed by the applicant is allowed and the decision issued under Section 15 on July 27, 2021 is treated as withdrawn,” said the order, granting the patent to the application with the amended claims.
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