In a recent ruling, the Calcutta High Court dismissed an appeal by West Bengal Chemical Industries Limited (hereafter referred to as “WBCIL”) seeking an interim injunction to prevent M/s. GTZ INDIA Pvt. Ltd. and Ors. (hereafter referred to as “GTZ”) from launching Ferric Carboxymaltose, alleging it infringed their patents IN 370845 and IN 434424. This judgment provides clarity on the scope of product-by-process claims under the Indian Patents Act, 1970 and the tests to be applied during their examination and enforcement. The case also highlights the necessity of expert testimony in establishing infringement.
Background/Facts
The patents in question, IN 370845 and IN 434424, are product-by-process patents owned by WBCIL, covering Ferric Carboxymaltose and its enhanced formulation, used for intravenous treatment of iron deficiency with reduced toxicity. IN 370845, titled “Improved process for preparation of Ferric Carboxymaltose,” was granted for a process of preparing Ferric Carboxymaltose, and IN 434424, titled “Improved Ferric Carboxymaltose with less side-effects obtained cost-effectively,” represents an improved version of the initial invention aimed at reducing side effects cost-effectively.
In December 2022, GTZ released a brochure featuring their product, closely resembling Ferric Carboxymaltose, prompting WBCIL to issue a legal notice to GTZ to cease allegedly infringing activities. WBCIL alleged that GTZ had used processes outlined in their patents, IN 370845 and IN 434424, for preparing Ferric Carboxymaltose. In their reply, GTZ denied all assertions. They acknowledged their involvement in manufacturing and trading Ferric Carboxymaltose-based products, asserting their lawful right to do so despite not being the patent holders.
In response, WBCIL filed an infringement lawsuit against GTZ and some former employees now associated with GTZ, alleging that GTZ’s process for preparing Ferric Carboxymaltose infringes on their patents IN 370845 and IN 434424. WBCIL claimed exclusive rights over both the product and processes associated with the pharmaceutical composition comprising 90% Ferric Carboxymaltose having a molecular weight of 82 kDa with iron content of 34.55%, and less than 10% of Ferric Carboxymaltose components having a molecular weight below 10000 Da. They also sought interim relief to compensate for their losses, citing significant financial impacts due to the unauthorized manufacture and commercialization of the infringing product.
Submissions by GTZ India Pvt. Ltd.
GTZ disputed the validity of the suit patents, arguing that they lack novelty, inventive step, and that the complete specifications of both patents do not sufficiently and fairly describe the invention, rendering them invalid.
To support their case, GTZ argued that Ferric Carboxymaltose is a known product, manufactured and sold as an API or injectable formulation by several companies. They contended that IN 370845 pertains to the process of preparing Ferric Carboxymaltose, a known iron complex with a ferric hydroxide core stabilized by a carbohydrate shell, and does not protect the product “Ferric Carboxymaltose” per se. Additionally, they claimed that the complete specifications of both patents do not sufficiently and fairly describe the invention or the method by which it is to be performed.
GTZ further contended that the claims of the patents, particularly claim 4 of IN 370845, which involves a “product-by-process” claim, are not supported by the specifications. They argued that product-by-process claims must demonstrate the novelty and inventive step of the product, independent of the process. They also asserted that the claims are not patentable under Section 3(e) and Section 3(d) of the Patents Act, 1970, as they do not disclose any improved efficacy of the claimed composition over the known Ferric Carboxymaltose.
GTZ also contested the patent’s validity based on prior art references and suggested that the patents did not meet the necessary criteria of novelty or inventive step required under the Patents Act, of 1970. They referenced a 2015 article detailing iron absorption in milk formulas stabilized with maltodextrin and citric acid, which predates the patents and describes similar processes. They also noted that the reaction of ferric chloride with sodium hydroxide to produce ferric hydroxide is a basic chemical reaction known to elementary chemistry students, and that the selection of citric acid as a cross-linking agent for maltodextrin is devoid of any uniqueness.
Consequently, GTZ initiated a petition for revocation against patents IN 370845 and IN 434424.
Court’s Observations
The Court primarily relied on a recent landmark decision of the division bench of Delhi High Court in the case of Vifor (International) Ltd. and Ors. vs J.B. Chemicals and Pharmaceuticals Limited to pronounce its decision. Citing the judgment, the Court reasserted that a product-by-process claim pertains to a novel and inventive product that is defined by its manufacturing process, especially when the product’s unique attributes cannot be fully described by its structure alone. Such claims focus on the product’s novelty, not merely the process, and should be treated as product patent under Section 48(a) rather than process patent under Section 48(b). Process features should not limit the scope of these claims during infringement cases. Challenges to the validity of a product-by-process patent can focus on the product’s novelty, independent of the process terms. Therefore, product-by-process claims must be evaluated based on the novel product itself, not downgraded by the process description.
The Court noted that WBCIL has been purportedly producing and selling generic Ferric Carboxymaltose, a compound identified by its CAS number 9007-72-1, according to the data from the National Library of Medicines data. The Court also highlighted that the statutory declarations under Section 146 of the Patents Act, 1970, and Rule 131 under Form 27 for the fiscal years 2020-2021 and 2022-2023 indicated that the patented invention had not been worked in India on a commercial scale.
The Court ruled that WBCIL had no rights over the Ferric Carboxymaltose composition per se, rendering Section 48(a) inapplicable. The Court also stressed the need for clear evidence of infringement and noted that WBCIL has not produced any materials on record of any scientist or any technical expert who tested the products in question to arrive at an independent finding regarding the identity of the processes used.
Conclusion
The Court found no prima facie case for an interim injunction and denied it citing the petitioner’s failure to provide expert opinion to support their claims. This decision underscores the pivotal role that expert testimony plays in patent infringement cases, especially when dealing with a well-established chemical compound like the one in question.
Authored by Dr. Neetha Mohan, Patents Team, BananaIP Counsels
Citation: West Bengal Chemical Industries Limited vs M/s. GTZ (INDIA) Pvt. Ltd. & Ors., Calcutta High Court, 25th June, 2024, CS-COM 513 of 2024. Available on https://indiankanoon.org/doc/147642971/
Disclaimer
The case note/s in this blog post have been written by IP Attorneys at BananaIP Counsels based on their review and understanding of the Judgments. It may be noted that other IP attorneys and experts in the field may have different opinions about the cases or arrive at different conclusions therefrom. It is advisable to read the Judgments before making any decisions based on the case notes.
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