The Calcutta HC in West Bengal Chemical Industries Limited v. M/s. GTZ (India) Pvt. Ltd., decided on 25 June, refused to grant injunction relief to the Patentee since it could not make out a prima facie case and did not satisfy the balance of convenience. Besides from being short on reasoning (only 3.5 page devoted to analysis out of 23 pages), I argue that the Court fails to distinguish between product, process and product by process patent. Due to this unclarity, the Court fails to make relevant inquiries while deciding whether a prima facie case was made out, which is one of the factors to be determined before granting an interim injunction.
Arguments
The Calcutta High Court was deciding an injunction suit, filed to restrain the Respondent from (i) exploiting the Patented product and (ii) using the process protected by the Patent and commercially exploiting the product ‘directly obtained’ from the process.
The present suit involved two patents- IN370845 and IN434424.
IN’845, in its specification, provides an “improved and cost-effective” process for the preparation of ‘pure’ ferric carboxymaltose (FCM) which could be used to prepare medication without requiring further purification. The process, as opposed to prior practice, used citric acid for oxidization to prepare FCM.
IN’424, on the other hand, is a modification of 370845, which provides an ‘advanced process’ for the synthesis of better soluble FCM. The improved FCM, as a result of the advanced process, provides “desired molecular weight, polydispersity index and good solubility for treatment of iron deficiency.”
The Patentee, in their submission, argued that the Patent protection extended to both the product as well as the process used to obtain that product i.e. product by process patent. According to them, the Respondent was manufacturing and commercially exploiting, both FCM (IN’845) and improved FCM (IN’424), using the process protected under both patents. As a result, it had incurred a “huge loss of two crores and above.”
The Respondent, on the other hand, assailed the validity of both the Patents. On IN’845, they submitted that it does not extend protection to the product “Ferric Carboxymaltose” per se since it relates to the process for preparation of FC. It was further argued that FC is not a ‘novel’ product but is a known compound. On IN’424, it repeated that FCM was a known substance which was not novel (since no improved efficacy is adduced). Also, the only improvement in this patent (over IN’845) was the oxidisation of maltodextrin using Ozone gas instead of citric acid which was ‘devoid of uniqueness.’
(Not) Working the Patent
Since this was a suit for injunction, the Court had to consider three factors- (i) Is prima facie a case made out against the Respondent; (ii) In whose favour does the Balance of Convivence lie; and (iii) would irreparable damage be caused to the Patentee in case relief is denied.
On the prima facie factor, the Court notes, in Para 39, that the Patentee does not have any right over FCM composition per se “which is known in every respect and has nothing to do with the patent protection.” Therefore, it held that there was no ‘product’ patent u/s. 48(a) of the Patents Act. As regards process, it noted, in Para 37, that there was no material or record of a scientist or technical expert which indicates that there was an “identity of the process used.” (here, the Court relied on FDC Limited judgement by MHC)
On the balance of convenience, although the Court does not provide any reasons, it seems the Court was swayed by the Form 27 (statement of working of patents) submissions relating to the Patent. In Para 35, the Court records that for FY 2020-21 and 2022-23, the patent was not worked by Patentee in India owing to ‘ongoing market strategy.’ The Respondent, on the other hand, had just entered into the Pharma Industry and was manufacturing and commercially exploiting FCM. Therefore, the Respondent would suffer higher inconvenience or injury if the injunction was granted as compared to the Patentee in case the relief of injunction is denied.
To flag, the Patentee had submitted that it had suffered more than two crores (‘2 crores’) due to the infringing activities of the Respondent. The Court, however, does not give any weight to this.
On irreparable damage, the Court does not provide any reasons. It simply notes in Para 41 that “As regard irreparable damage… (which is) to be made (out) by the petitioner for grant of interim injunction, in my opinion, the plaintiff has failed.” One can only speculate whether this finding is due to the non-working of the Patent.
What is a Product? What is Process?: Learning from Vifor
The Judgement, in my opinion, is short on reasoning.. Apart from that, most of the judgement is an extraction of submissions, claims of the respective patents, sections of the Patent Act and relevant Judgements. At one point, it wrongly extracts the claims for IN’424 and puts it below IN’845!
However, let me discuss the legal quarrel I have with this Judgement.
The judgement does not clarify the distinction between ‘product’, ‘process’, and ‘product by process’ patents. As a result, the Court did not ask itself whether the product itself was novel or not, which, as I show later, would have required the Court to undertake an additional inquiry u/s. 48(a) (Product Patent) before deciding whether a prima facie case was made out. The Court confined itself to the comparison of the process for preparation of the products, rather than going into deciding the novelty of the product, which is also protected by a patent-by-process patent.
The Patentee in this case submitted that IN’424 and IN’845 were product-by-process patents. As pointed out here and here, a product by process patent, due to the rule of necessity, is described by reference to the manufacturing process to explain the unique attributes of the Product. Nevertheless, that does not mean that the patent protection is only extendable to the process described. Rather, the protection will also extend to the product as long as it is novel, inventive and unknown in the prior art.
Unfortunately, apart from writing that “section 48(a) relates to…the patent for a product… section 48(b) relates (to) … patent for a process”, there is nothing in the Judgement which explains the scope of product by the process. The Court, even after extracting the conclusion of Vifor, does not tell whether it agrees with the above definition of product by process patents or not.
Was the invention in the above patents ‘novel and inventive and unknown in the prior art’?
A similar set of facts arose in Vifor. There, the patent no. IN’536 was also related to FCM. The Patentee, there also, explained the invention using a description of the manufacturing process. The Patentee had never contended that FCM was a novel product which was not known earlier. Rather, it conceded that FCM, like Iron carbohydrates, were already known. However, using a description of the process of manufacturing, the Patentee claimed that their invention ‘sterilised quickly and was stable at high temperatures’ as compared to prior known FCM. Additionally, the newly ‘obtainable’ FCM had reduced toxicity and prevented anaphylactic shocks, resulting in application at high dosage rates.
The SB of DHC held that although the invention was a ‘product by process’, the protection of the patent only extended to the process used, referring to the scope of claims. The DB, on appeal, rejected this finding. Relying on Guidelines for Examination of Patent Application in the Field of Pharmaceuticals, the DB held that once an invention is accepted as ‘product by process’, the protection would also extend to the product per se. It noted, in Para 171, that “One cannot lose sight of the problems in the prior art which FCM sought to overcome. These are evident from the claims and the specifications which explained the improvements and advantages that FCM had achieved over the prior art.” In that case, none of the respondents had challenged the validity of the patent.
In the present case, the petitioner had claimed that IN’424 and IN’845 are product-by-process patents. Per Vifor, if the invention claimed is a product-by-process, the Court will has to determine if the product is novel and demonstrates inventive step. Although I could not find a scheme for examination of patents in the statute (whether novelty or inventive step has to be tested first), I did find these Guidelines from JPO which tells that the Examiner has to first assess novelty of the invention. If the invention is found to be novel i.e. it is not disclosed in prior art, the Examiner will then determine whether inventive step is satisfied or not. (also see here and here)
Does the Court go into novelty analysis?
The Court simply noted that FCM was “known in every respect…and had a CAS No. which is a universal identifier of known chemical molecules.” Stopping the inquiry at this stage itself, the Court concluded that the Patentee does not have “any right over Ferric Carboxymaltose composition per se.”
The Court does not go into the question of novelty i.e. whether the invention was previously disclosed in prior art or not. The Court missed an opportunity to lay down a standard to assess novelty at a prima facie level, where the Court is not supposed to conduct a mini trial. (refer to this post on prima facie assessment)
The inquiry does not stop at novelty. If found novel, the Court then had to look into the question of inventive step.
If the FCM produced by the process was found to be novel and, given the attributes it had (stable, less toxic etc.), inventive, the Court would have to undertake a separate inquiry i.e. whether the Respondent’s product infringes the Patentee’s product. If found infringing, the prima facie factor would have been decided against the Respondent.
The Court, by not going into the question of novelty, sidestepped a crucial inquiry before concluding that no prima facie case was made out. The prima facie factor could have been decided differently (i) if the patentee’s product was found to be novel as well as inventive, and if, on comparison, (ii) the Respondent’s product was found to be infringing the patentee’s product u/s. 48(a).
It is important to note that the Respondents consisted of former employees of the Patentee’s company, one of whom had worked in the R&D department of the company. Given these circumstances, it was all the more relevant for the Court to be going into these questions.