On February 7, 2024, the Delhi High Court, through a 188-page judgment by Justices Yashwant Varma and Dharmesh Sharma, overturned a restrictive interpretation of product-by-process claims. The Division Bench ruled that patent protection for such claims extends to the product itself, provided it is novel and inventive, regardless of the manufacturing process.

Background:
Vifor International Ltd. held Patent No. IN'536 for Ferric Carboxymaltose (FCM), a novel water-soluble iron carbohydrate complex with unique molecular properties. The company alleged infringement by pharmaceutical companies, including Corona Remedies Pvt. Ltd. and MSN Laboratories Pvt. Ltd., and sought an interim injunction.

Refusal of Injunction by Single Judge resulted in filing of this Appeal

The Single Judge denied the injunction, reasoning that product-by-process patents protect only products made using the specified process. Since the defendants used a different process, the judge ruled there was no infringement.

Brief Facts of the Case:

Patent Case Summary

1. Patent Details:
   • Application No.: 947/KOLNP/2005
   • Filed: May 24, 2005
   • Granted: June 25, 2008
   • Expired: October 20, 2023
2. Product Description: FCM is described as a water-soluble iron carbohydrate complex, used to treat iron deficiency. The product is characterized by specific molecular weight parameters and a unique production process involving maltodextrins oxidized using an aqueous hypochlorite solution.
3. Claims: The appellant argued that the patent included a product claim with process descriptions, whereas the respondents contended it was a process-limited claim.

Issues Involved in the Case:

• Scope of Product-by-Process Claims: Does a product-by-process claim protect the product regardless of how it is manufactured, or is its scope limited to products made through the disclosed process?
• Infringement Analysis: How should courts evaluate whether a competing product infringes a product-by-process claim, especially when alternative manufacturing methods are used?

Submissions of the Parties

Appellants (Vifor International Ltd.):

• Asserted that FCM is a novel product and the process terms in the claims are merely illustrative.
• Highlighted that the product has been granted patents in 57 jurisdictions without challenge.
• Emphasized that FCM's uniqueness is acknowledged globally, including an INN assignment by WHO.
• Cited international jurisprudence supporting broader interpretation of "product-by-process" claims.

Respondents (Corona Remedies Pvt. Ltd.):

• Contended that the claims are limited to the process described, making the patent a "product-by-process" claim.
• Asserted that their product does not use the same process as described in IN'536, hence no infringement.
• Argued that the product was already known in prior art, making the patent invalid for lack of novelty.

Reasoning and Analysis by the Court

Definition and Purpose:

A product-by-process claim bridges the gap between product and process patents. It is used when a novel product cannot be adequately described by its structure alone, necessitating reference to its manufacturing process.

Key Principles:

1. Novelty of the Product: A product-by-process claim is valid only if the product itself is novel and inventive, irrespective of the process described. Merely describing a new process does not make the product novel.
2. Patentability and Infringement: The same criteria of novelty and inventiveness apply during patent grant and infringement analysis. Claims should not be treated differently for validity and infringement purposes.
3. Global Standards: Guidelines from patent offices (e.g., IPO, EPO, USPTO) and international jurisprudence emphasize that novelty must be assessed by disregarding process terms and focusing on the product's unique attributes.
4. Product is the Main Focus while Process is Supplementary in Nature:

Product-by-process claims fundamentally protect a novel product, with process terms serving as an explanatory tool. The focus remains on the product's uniqueness, ensuring consistent evaluation across patentability and infringement.

Decision:
The Hon'ble Division Bench allowed the appeal filed by Vifor International Ltd. and overturned the restrictive interpretation of product-by-process claims adopted by the Single Judge and held that product-by-process claims protect the product itself, provided it is novel and inventive, irrespective of the specific manufacturing process described in the patent. 

Conclusion:
This broader interpretation ensures that the essence of the invention—the novel and inventive product—is safeguarded, rather than limiting protection to the process by which it is made. This case underscores the complexities of interpreting product-by-process claims under Indian patent law. 

Case Title: Vifor International Ltd. & Anr. vs. Corona Remedies Pvt. Ltd. & Anr.
Case No.:FAO(OS)(COMM) 160/2023 & CM APPL. 39197/2023
Neutral Citation:2024:DHC:878:DB
Date of Order: February 7, 2024
Court:High Court of Delhi at New Delhi
Bench:Hon'ble Mr. Justice Yashwant Varma and Hon'ble Mr. Justice Dharmesh Sharma

Disclaimer:
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Written By: Advocate Ajay Amitabh Suman, IP Adjutor - Patent and Trademark Attorney
Email: ajayamitabhsuman@gmail.com, Ph no: 9990389539