On February 7, 2024, the Delhi High Court issued a significant judgment in patent law, delivered by Justices Yashwant Varma and Dharmesh Sharma. This 188-page decision overturned a previous single-judge ruling, broadening the interpretation of product-by-process claims. The Division Bench underscored that patent protection should focus on the product’s novelty and inventiveness rather than the specific manufacturing process used.
Case Background
The court heard appeals from Vifor International against several pharmaceutical companies, including Corona Remedies and MSN Laboratories. Vifor sought an interim injunction to prevent alleged infringements of its patent related to Ferric Carboxymaltose (FCM), a novel iron carbohydrate complex patent (IN’536) filed on May 24, 2005, and granted on June 25, 2008, expiring on October 20, 2023. Vifor’s patent was primarily defined by the manufacturing process, a necessity due to the complexity of the product.
Vifor argued that its patent should cover all products exhibiting the claimed characteristics, irrespective of the manufacturing method. The opposing pharmaceutical companies contended that product-by-process claims are inherently restrictive and their products were made using different processes, thus not infringing Vifor’s patent.
Legal Issues Explored
The case tackled critical questions: Does a product-by-process claim protect a product regardless of its manufacturing method, or is it confined to products made through the disclosed process? How should courts assess whether a competing product infringes such a claim when alternative manufacturing methods are used?
Product-by-Process Claims: Legal Context
Product-by-process claims in patents define a product primarily through its manufacturing process. They are crucial in fields like pharmaceuticals, where describing the product structurally is challenging. Although recognized by jurisdictions such as the European Patent Office (EPO), these claims are enforceable only when the product itself is novel, irrespective of the process. Under the Indian Patents Act, Section 48 grants patentees exclusive rights over their inventions, but the protection scope for product-by-process claims is narrower, limited to products derived from the patented process.
Comparative Perspectives
In the European Patent Convention (EPC), product-by-process claims are valid if the product meets novelty and inventive step requirements, independent of the process. UK cases like Catnic Components v Hill & Smith Ltd and Hospira UK Ltd v Novartis AG stress purposive construction of claims. In the US, such claims require patentees to prove the accused product is indistinguishable from the claimed invention.
Court’s Analysis and Observations
The Division Bench recognized product-by-process claims as a hybrid, bridging product and process patents. The court critiqued the single-judge’s restrictive interpretation, affirming that these claims extend beyond products made through the disclosed process. Emphasizing Section 48(a), the court asserted that such claims protect the product itself, provided it is novel and inventive, rather than confining them to process claims under Section 48(b).
Key Takeaways from the Judgment
Product-by-process claims combine product and process patent features, invoked when a product’s structure alone doesn’t suffice to establish novelty. Global guidelines acknowledge the necessity of these claims for structurally indefinable products. The court emphasized that novelty must focus on the product, not its manufacturing process. During patent evaluation, process terms are disregarded to assess whether the product itself is novel and inventive.
More Read
The judgment clarified that the inventive product must be assessed independently of the process, even in infringement disputes. The scope of protection extends only to products described in the claims and not to similar products unless derived from the specified process.
Implications
This landmark ruling represents a transformative shift in Indian patent law’s approach to product-by-process claims. The court decisively rejected the narrow interpretation confining these claims to specific manufacturing processes. Instead, it aligned with global principles, acknowledging that patent protection extends to the product itself, given it is novel and inventive, regardless of its production process.
The decision is particularly impactful for the pharmaceutical industry, where complex products rely on process descriptions to articulate novel attributes. By broadening the interpretation of product-by-process claims, the court has laid the foundation for a more inclusive and equitable patent regime, aligning Indian patent law with global standards and promoting innovation.
