Amgen Inc vs The Assistant Controller of Patents

Amgen Inc vs The Assistant Controller of Patents

#### Case Title, Order Date, Case Number, Neutral Citation, Name of Court, and Judge

The case titled *Amgen Inc vs The Assistant Controller of Patents* was decided on 22 August 2025, with case number CMA (PT) No. 28 of 2023, neutral citation 2025:MHC:2096, by the High Court of Judicature at Madras, presided over by Judge Senthilkumar Ramamoorthy.

#### Facts

Amgen Inc., a company based in the United States, filed a patent application (No. 5857/CHENP/2008) with the Indian Patent Office for a lyophilized therapeutic peptibody formulation, specifically romiplostim, marketed as Nplate. This formulation involves adding specific excipients in precise concentrations to enhance the stability and therapeutic efficacy of the peptibody, a synthetic peptide fused with the Fc region of a human immunoglobulin antibody (IgG) to address rapid clearance issues in the human body. The application was filed to protect a formulation designed to treat conditions like immune thrombocytopenic purpura (ITP) by stimulating platelet production through a thrombopoietin receptor agonist (TPO-RA).

Following the filing, the first respondent (Assistant Controller of Patents) issued a First Examination Report (FER) on 20 July 2013, raising objections under Sections 3(d), 3(e), and 10(4) of the Patents Act, 1970, and citing a lack of inventive step based on prior arts (D1 to D6). The appellant responded partially on 16 December 2013 and fully on 25 July 2014, followed by written submissions after a hearing notice on 27 April 2016. Subsequently, the second respondent (Intas Pharmaceuticals Limited) filed a pre-grant opposition on 18 July 2016, alleging obviousness, non-inventiveness, and insufficient description under Sections 25(1)(e), (f), and (g). After hearings and further submissions, the patent application was rejected by order dated 31 March 2023, prompting this appeal.

#### Dispute

The central dispute revolves around the patentability of Amgen Inc.'s lyophilized peptibody formulation under the Patents Act, 1970. The Assistant Controller rejected the application, asserting that claims 1-13 fell within the exclusions of Section 3(d) (mere use of a known process), Section 3(e) (mere admixture resulting in no synergistic effect), and lacked an inventive step under Section 2(1)(ja), with additional issues under Section 10(4) for insufficient description. Intas Pharmaceuticals supported this rejection, arguing the invention was obvious and not novel. Amgen Inc. contested these findings, arguing that the formulation involved a novel process and demonstrated enhanced therapeutic efficacy, justifying patent protection. The key contention was whether the lyophilization process and excipient combination constituted a patentable invention or merely an obvious extension of known techniques.

#### Reasoning

Justice Senthilkumar Ramamoorthy provided a detailed scientific background to contextualize the invention, explaining biologics, peptibodies, lyophilization, and the role of excipients like cryoprotectants and lyoprotectants. The court analyzed the impugned order's reasoning and the appellant's arguments:

1. **Section 3(d) Analysis**: The court examined whether the invention constituted the "mere use of a known process." The appellant argued that the specific combination of excipients and the lyophilization process tailored for romiplostim was not a known process, citing enhanced stability and efficacy. The court noted that the Controller must provide reasoned justification for invoking Section 3(d)'s last limb, which the impugned order lacked, as it did not adequately compare the claimed process with prior art to establish it as "known."

2. **Section 3(e) Consideration**: This section excludes patentability if a composition is a mere admixture without a synergistic effect. The appellant contended that the excipients' specific concentrations produced a unique stabilizing effect beyond the sum of their parts. The court found the Controller's rejection under Section 3(e) insufficiently substantiated, as no detailed analysis of synergy was provided.

3. **Inventive Step (Section 2(1)(ja))**: The court assessed whether the invention would be obvious to a person skilled in the art (PSITA) based on prior arts D1 to D6. The appellant highlighted the novelty of grafting the peptide onto the Fc region and the optimized lyophilization process. The court observed that the impugned order did not sufficiently demonstrate obviousness, particularly given the specific therapeutic context and stability improvements.

4. **Section 10(4) Compliance**: The rejection for insufficient description was challenged, with the appellant arguing that the specification adequately disclosed the invention. The court found the Controller's reasoning unclear and inadequately supported.

The court emphasized that patent rejection requires robust evidence and reasoning, especially under Section 3(d)'s stringent criteria, and criticized the lack of detailed comparison with prior art in the impugned order.

#### Decision

The High Court allowed the appeal, setting aside the impugned order dated 31 March 2023. The court directed the Assistant Controller to reconsider Patent Application No. 5857/CHENP/2008 on its merits, providing the appellant a reasonable opportunity to amend claims if necessary. A reasoned decision was mandated within four months from the receipt of the court's order, with no costs awarded. This decision remands the case for a fresh evaluation, ensuring compliance with the Patents Act's requirements and natural justice principles.

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Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi