Product-by-process claim lesson in appeal judgment

In commercial litigation, including patent dispute, judicial decisions mostly decide the rights and interests of parties, quantify damages, and that’s about it. Rarely in commercial law litigation are issues heard and decided not just for the sake of parties, but also for setting the law right.

The Division Bench of Delhi High Court passed one such landmark decision on 7 February 2024, in a batch of three appeals filed by the Swiss pharmaceutical company Vifor. The court was tasked with judging whether a patent having “product-by-process” claims conferred a monopoly on the product, or only the process used to attain it.

Background

The appeals were filed against a decision of a single judge, dated 24 July 2023, in three patent infringement suits filed by Vifor against entities concerning manufacture or sale of Ferric Carboxylatose (FCM), an iron carbohydrate complex used for intravenous treatment of iron deficiency anemia.

Vifor’s patent had a product-by-process claim relating to FCM valid until 20 October 2023, and asserted infringement against three entities.

The defendants admitted making FCM but argued that their manufacturing process was different; and that a product-by-process patent was essentially a process patent, and nothing else.

The single judge agreed and dismissed Vifor’s application, conceding that iron carbohydrate complexes were known in the prior art, so the inventive step of the patent lay in the process of making FCM. The Judge also held that novelty of FCM may have been relevant for determining novelty but was irrelevant for infringement.

The appeals

Appeal hearings commenced in September 2023 and as the patent was expiring, what hung in the balance for Vifor was therefore not the fate of the three underlying suits, but 20 lawsuits filed against a host of defendants. While interim injunction was now fait accompli, Vifor’s right to claim damages or deposits now rested on the Division Bench’s stand.

Recognising the important issue “has directly arisen for consideration before a court in India for the first time”, the Division Bench said its decision “would have wide ramifications on how such claims are construed by courts in pending and future litigation”.

The decision

The Division Bench summarised its findings into 29 lucid propositions (cardinal principles) of law. In short:

1. A product-by-process claim is not limited to the process used to attain the product.
2. There is a distinction between a product “obtained by” and “obtainable by” a process.
3. Infringement of a product-by-process patent – where the product is “obtainable by” a process – has to be tested on the basis of the product in question, and not limited to the process used in the claim.
4. The single judge erred in relying on the UK decision in Hospira UK. This is because Hospira dealt with a patent having a product “obtained by” a process, a claim necessarily limited to the process.
5. Double Standard Approach: If a product is novel and inventive, satisfying patentability criteria, there is no justification to disregard its novelty and inventiveness in an infringement scenario. Sections 107 and 64 of the Patents Act, 1970, buttress this point.
6. The position taken by the US decision of Abbott Laboratories (holding process features as limiting the product-by-process claim) has not been accepted in any other jurisdiction. Even the Japanese Supreme Court, in 2012 (Ju) 1204, Minshu Vol.69 No.4, did not accept that process terms are limiting or that they remove the focus from the inventive product itself, and rejected the “double standard” approach with respect to tests for patentability and infringement.
7. Merely because a patentee chooses to describe a product in its claims by referencing a process for obtaining it does not mean that the monopoly resides in the process.
8. Such claims are drafted in those situations where the product is novel, and cannot be fully described by its structure. Thus, the patentee must rely on the process features. This is the rule of necessity.

Conclusion

This short article does not even begin to do justice to the eloquence and the depth that the Division Bench’s decision attains. Although the conclusion is clear, the way to get there was anything but.

Every patent law practitioner and student should be encouraged to read this decision; it is a welcome journey into claim construction, statutory interpretation, and also interpreting foreign decisions in the context of legislative intent of an Indian statute.

Pravin Anand is a managing partner, Vaishali Mittal is a partner and Siddhant Chamola is a managing associate at Anand and Anand.