The Calcutta High Court in West Bengal Chemical Industries Limited v GTZ (India) Private Limited and Ors recently dealt with an application by WBCIL for an interim injunction to prevent infringement of its patents IN370845 and IN434424.
WBCIL held patent IN370845, relating to ferric carboxymaltose, and an improvement patent IN434424 that claimed fewer side effects with greater cost-effectiveness. Both were product-by-process patents for iron replacement therapy asserting low toxicity compared to similar treatments. WBCIL claimed that the pharmaceutical composition of its patent formula was novel.
In December 2022, WBCIL learned that GTZ had published a brochure referring to their similar products. At the same time, an ex-employee of WBCIL approached a company with whom WBCIL had a long business relationship offering to sell these therapeutics. WBCIL then demanded the respondents stop infringing their patents. GTZ accepted that it manufactured various products including ferric carboxymaltose but denied it had infringed WBCIL’s patents.
The plaintiff applied to the court for an interim injunction against the respondents, arguing the respondents had used a process to make ferric carboxymaltose that infringed its patents. It claimed the unauthorised manufacture and commercialisation of the infringing product had caused it significant loss.
In rebuttal, the respondents submitted their analysis of patent IN370845 showed it to be frivolous. Indeed, the invention had been granted without the assessor and the Patent Office applying their minds to the requirements for issuing patents.
They argued that patent IN370845 did not protect the product ferric carboxymaltose by itself. They argued that the preparation was a well-known therapeutic made by many companies, such as Dr Reddy’s Laboratories, Global Calcium, Weefsel Pharma, Trumac Health Care, Kavya Pharma and Medzeel Life Sciences.
The respondents contended that the claims in both patents involved no inventive step, as the claimed invention was publicly known or publicly used in India or was published in India or elsewhere. They also argued that the complete specification of both patents did not sufficiently and fairly describe the invention and the method by which it was to be carried out. The claims of both patents fell into the product-by-process category. The product had to be novel and inventive itself, irrespective of the novelty or invention of the process by which it was made. Further, the claims were non-patentable under sections 3(e) and 3(d) of the Patents Act, 1970.
Patent IN434424 was also challenged for not being a valid improvement. The only difference between the two patents was that oxidation of maltodextrin was carried out by using citric acid in IN370845 and in IN434424 by ozone gas, a well-known colourable imitation.
The court found that WBCIL produced and offered for sale generic ferric carboxymaltose, a product known in every respect and which had nothing to do with patent protection. It had been assigned a United States Chemical Abstracts Service (CAS) number. Further, WBCIL had stated in a working statement for the financial year 2020-2021 that the patented invention had not yielded sufficient research results to scale it into commercial development. For the financial year 2022-2023, WBCIL said the product was not working because of its ongoing marketing strategy.
The court found that the plaintiff had not produced any material from any scientist or technical expert who had tested the products of both parties and identified the processes used. In rejecting the application, the court held that WBCIL had no rights over ferric carboxymaltose itself and could only enforce its rights under section 48(a). WBCIL had failed to make out any case for the grant of an interim injunction, let alone passing the test of balance of convenience and irreparable loss.
This judgment establishes that the grant of a patent gives a patent holder no absolute right to enforce ancillary protection. The patent must be strong, not just a paper patent unable to withstand revocation in the courts. Innovators will be more cautious when drafting and making patent applications. The court reiterated that in cases of product-by-process claims, products must satisfy the requirement of novelty as well as of inventive steps.
