Section 104A mandates that for defendants in patent infringement cases, the products must be identical for burden of proof to shift, emphasizing the distinction required for biologics compared to conventional drugs.

JUDGMENT :

AMIT BANSAL, J.

I.A. 5827/2024 (seeking constitution of a confidentiality club)

1. The present suit has been filed inter alia seeking relief of permanent injunction restraining infringement of the following two Indian patents (hereinafter collectively referred to as the ‘suit patents’):

a. Indian patent no. IN 268632 titled as ‘PHARMACEUTICAL FORMULATION COMPRISING HER2 ANTIBODY’ (hereinafter ‘IN’632’) is a product patent which relates to an aqueous pharmaceutical formulation comprising Pertuzumab and excipients such as sucrose, histidine acetate buffer, polysorbate such that the pH of the said formulation is between 5.5-6.5.

b. Indian patent no. IN 464646 titled as ‘PERTUZUMAB VARIANTS AND EVALUATION THEREOF’ (hereinafter ‘IN’646’) is a process patent which relates to the method for making a composition comprising Pertuzumab and one or more variants.

CASE SET UP IN THE PLAINT

2. The case set up by the plaintiffs in the plaint is as follows:

2.1 The plaintiff no.1, a Switzerland based company founded in 1896, is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. The plaintiff no.2, an American corporation founded in 1976, is the world’s first biotechnology company, which was acquired by the plaintiff no.1 in March 2009 as its wholly owned independent subsidiary. The plaintiffs no.1 and 2 are hereinafter collectively referred to as the ‘plaintiffs’.

2.2 As of 2023, the Roche Group, of which the plaintiffs are a part, has a presence in over 100 countries. The Roche Group has invested significantly in the field of research and development and one of the major areas of focus and investment for the Group is treatment of cancer.

2.3 Human epidermal growth factor receptor (HER) are important mediators of cell growth, differentiation and survival and include four distinct members, i.e., HER1, HER2, HER3 and HER4. The overexpression of HER2 gene is a primary cause for breast cancer tumours which is one of the most aggressive forms of cancer.

2.4 Both the suit patents pertain to Pertuzumab, which is a monoclonal antibody (MAb) biologic used to inhibit the dimerization of HER2 cells with other HER receptors, and thus inhibits tumour growth. Pertuzumab is a prescription medicine for treating patients with early-stage breast cancer and metastatic breast cancer and has been approved by regulatory authorities in several countries across the world.

2.5 The bibliographic details of the suit patents are set out below:

a. Suit Patent IN’632

b. Suit Patent IN’646

2.6. IN’632 has 4 claims which are set out in paragraph no.28 of the plaint.IN’646 has 8