Background:
The petitioner, in this case, holds patents that protect their inventions related to Ferric Carboxymaltose (FCM), an iron replacement therapy. The patents in question are IN370845, granted for a process of preparing Ferric Carboxymaltose, and IN434424, an improved version of the initial invention aimed at reducing side effects cost-effectively. Despite these protections, the petitioner alleges that the respondent has infringed on these patents by adopting a similar process for the preparation of FCM, which is claimed to be both dishonest and a direct violation of the petitioner's intellectual property rights. The Court declined the relief of interim injunction to the petitioner on the ground of inter alia lack Expert Opinion Comparing Defendant's Product with Patent.

Case Details:
The petitioner's invention, protected under patent No. IN370845, is a method for preparing Ferric Carboxymaltose. The petitioner also applied for and was granted a new patent, No. 434424, on June 13, 2023, for an improved version of FCM that purportedly has fewer side effects and is more cost-effective. The advantages of these inventions, as claimed by the petitioner, include lower toxicity compared to other iron replacement therapies.

The infringement suit was filed on the grounds that the respondents had adopted a process for preparing Ferric Carboxymaltose and its improved version, which is identical to the petitioner's patented process, thus violating patents IN370845 and IN434424.

Respondent's Contention:
The respondent contended that Ferric Carboxymaltose (FCM) is not a novel product. They argued that FCM is a known iron complex, consisting of a ferric hydroxide core stabilized by a carbohydrate shell, and that this has been unequivocally acknowledged by the petitioner in their written submission dated June 16, 2021. The respondent further argued that any product claim based on Ferric Carboxymaltose lacks novelty, as it is a known compound, and therefore, the petitioner cannot claim any patent right or monopoly over it.

Court's Observations:
The Hon'ble Court evaluated both of the plaintiff's patents. The first patent, IN370845, relates to an improved process for preparing Ferric Carboxymaltose. The second patent, IN434424, pertains to an improved version of FCM with reduced side effects, obtained cost-effectively.

The Court observed that the petitioners are purportedly producing and selling generic Ferric Carboxymaltose, a compound that is well-known and identifiable by its CAS number 9007-72-1, as disclosed by the National Library of Medicines data. The petitioner's statutory declarations under Section 146 of the Patents Act, 1970, and Rule 131 under Form 27 for the financial year 2020-2021 stated that the patented invention had not been worked for further research and development to scale it commercially. Similarly, for the financial year 2022-2023, it was not worked due to an "ongoing marketing strategy."

Lack of Expert Testimony:
A critical point in the court's decision was the lack of expert opinion comparing the defendant's product with the patented inventions. "The petitioner did not produce any evidence from a scientist or technical expert to demonstrate that the defendant's process was identical to or infringed upon the patented process. This absence of expert testimony significantly weakened the petitioner's case."

Legal Analysis:
The crux of the issue lies in the absence of expert evidence. Patent infringement cases often hinge on detailed technical comparisons between the patented invention and the alleged infringing product. Without expert testimony, it is challenging to establish that the defendant's process infringes on the patented process, particularly when the product in question is a known compound like Ferric Carboxymaltose.

The petitioner's failure to provide scientific evidence or a technical expert's opinion to substantiate their claims left the court with insufficient grounds to grant an interim injunction. The court's decision underscores the importance of expert analysis in patent infringement cases, especially when the product involved is a known chemical compound with established characteristics.

Conclusion:
The case highlights a fundamental aspect of patent law: the necessity of expert testimony in establishing infringement. The court's ruling emphasizes that without detailed, expert-driven comparisons, claims of patent infringement, particularly involving known compounds, are likely to falter. The petitioner's inability to provide such evidence led to the dismissal of their request for an interim injunction, underscoring the critical role of expert opinion in patent litigation.

The lack of expert opinion comparing the defendant's product with the patented invention was a decisive factor in this case. It serves as a reminder of the rigorous standards required to prove patent infringement and the essential role of technical expertise in supporting such claims.

Case Citation: West Bengal Chemical Industries Vs Gtz India Pvt Ltd. :25.06.2024: CS-COM 513 of 2024 : Calcutta High Court: Krishna Rao, H.J.

Disclaimer:
The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.

Written By: Advocate Ajay Amitabh Suman, IP Adjutor - Patent and Trademark Attorney
Email: [email protected], Ph no: 9990389539