The Delhi High Court in the case Vifor (International) Limited And Anr. v. MSN Laboratories Pvt Ltd Anr. and other connected matters observed and has ruled the product-by-process claim under the Patents Act would necessarily have to be examined on the anvil of a ‘new and unobvious product’, which being irrespective of the applicant having chosen to describe the invention by referring to a process of manufacture.
The Division bench comprising of Justice Yashwant Varma and Justice Dharmesh Sharma in the case observed and has stated that the mere adoption of the product-by-process format would not result in a novel product being downgraded to Section 48(b) of the Act and it would inevitably have to be tested on principles enshrined in Section 48(a) of the Act.
Therefore, the Section 48 of the Patents Act deals with rights of patentees and it has been stated under section 48(a) that where the subject matter of the patent is a product, the patentee will have the exclusive right to prevent third parties from making, using, offering for sale, selling or importing that product in India. Thus, the Section 48(b) confers similar right on a patentee where the subject matter of the patent is a process.
The court in the case stated that the mere usage of process terms cannot be accepted as limiting nor is there any justifiable rationale to accept the advocated distinction between validity and infringement and if the rule of necessity were to compel the applicant to submit an application embodying a product-by-process claim, thus, there would appear to be no justification to stultify the extent of protection.
The bench in the case obserevd and has stated that the product-by-process claim would have to meet the test of pertaining to a novel and inventive product as opposed to a process.
Adding to it, the court stated that it will thus be wholly incorrect to abridge or truncate a product-by-process claim to fall within the ambit of Section 48(b) of the Patents Act.
The court stated that as long as the product-by-process claim pertains to a product which is novel and inventive and unknown in the prior art it would remain a product which would fall within the ambit of Section of 48(a) of the Act.
The bench in the case also observed that as long as a product-by-process claim pertains to a product which is novel and has no parallel in the prior art and the mere fact that the patentee chooses to describe the invention more exhaustively by reference to process terms, thus, the said tests should remain unchanged.
The court in the case observed that the guidelines as well as the judgments rendered in the context of product-by-process claims speak in unison when they state that for assessing novelty one must disregard the process terms and discern whether the product possesses novelty. Therefore, this court is reminded that a product is not rendered novel merely by virtue of the fact that it is produced by a new process. Further, the court stated that the product-by-process claim is an amalgam which ‘straddles’ the otherwise recognised distinction between products and process patents per se.
The court stated product-by-process patent is founded on a claim relating to a novel product whose unique attributes are sought to be explained by reference to its manufacturing process.
In the present case, the court was dealing with the appeal moved by Vifor (International) Limited wherein it challenged the order of single judge passed in July last year refusing interim relief in its patent infringement case against various entities including Dr. Reddy’s Laboratories.
The court observed that Vifor’s patent was titled ‘Water Soluble Iron Carbohydrate Complex and a Process for Producing Water Soluble Iron Carbohydrate Complex’, IN’536.
The court observed that the bench headed by Single Judge clearly erred in appreciating the scope of product-by-process claims and manifestly erred in propounding the theory of distinct principles being applicable to infringement actions.
The court while considering the facts and circumstances of the case observed and has left it open to Vifor to press its claim for deposit of percentage of sales at the appropriate stage and subject to further orders passed in the pending suits.
Accordingly, the bench allowed the appeal and has set aside the judgement of single judge.
The counsel, Senior Advocates Neeraj Kishan Kaul and Sandeep Sethi with Advocates Pravin Anand, Vaishali Mittal, Rohin Koolwal, Hersh Desai, Ira Mahajan, Pritha Suri and Siddhant Chamola appeared for the Appellant. The counsel, Advocates G. Nataraj, Shashikant Yadav, Rahul B., Advs; Senior Advocate Chander M. Lall with Advocates Kunal Vajani, Kunal Mimani, Shubhang Tandon and Prashant Alai represented the intervener, BDR Pharmaceuticals Pvt. Ltd.