In an enchantment introduced by Vifor, a Delhi Excessive Courtroom division bench has issued a landmark judgment that clarifies the anomaly of evaluation and scope of product-by-process claims and infringement thereof.
On 7 February 2024 the bench held that patent safety awarded from product-by-process claims would lengthen to the product whatever the course of used for its manufacture, supplied that the product itself is novel and ingenious (FAO (OS)(COMM) 159-161/2023).
Accordingly, the bench allowed Vifor’s appeals and put aside the only choose’s order denying Vifor an interim injunction in opposition to MSN Laboratories, Dr Reddy’s Laboratories and Corona Treatments, that are all distinguished generics producers in India.
Case background
Product-by-process claims are a subspecies of product claims. They’re utilized in instances the place a novel and ingenious product can’t be described by its traits alone and course of phrases are required to correctly describe it. Whereas the claimed subject material remains to be novel and ingenious, it’s described by the technique of a course of which will have been used to make the product.
Vifor filed three separate fits in search of interim injunctions to stop the defendants from infringing its patent titled “Water Soluble Iron Carbohydrate Complicated and a Course of for Producing Water Soluble Iron Carbohydrate Complicated” (221536). This patent pertains to ferric carboxymaltose (FCM), which is used for intravenous therapy of iron-deficiency anaemia.
Vifor asserted that declare 1 of the patent was a product declare for FCM, and that the method parts used to explain the tip product didn’t prohibit its rights to the method itself. In different phrases, declare 1 was set out within the product-by-process format.
The defendants contended that Vifor’s patent rights had been restricted to the particular course of described within the claims; since they used totally different processes to supply FCM, they maintained that their actions weren’t infringing.
The only choose had refused to grant Vifor an interim injunction in its 24 July 2023 ruling, holding that the product-by-process declare was basically a course of declare and that the defendants’ processes didn’t infringe Vifor’s go well with patent.
Aggrieved, Vifor challenged this choice by submitting an enchantment earlier than a division bench of the Delhi Excessive Courtroom.
The bench’s ruling
The appellate bench supplied an in depth judgment that clearly outlined the authorized place on product-by-process claims.
Product-by-process claims
A product-by-process declare straddles the boundaries between product and course of patents. As such a patent is based on a declare referring to a novel product that can’t be totally described by its construction, the applicant is compelled to discuss with the manufacturing course of with the intention to describe its invention.
Product-by-process claims don’t relate to merchandise which might be rendered novel merely as a result of they’ve been produced by a brand new course of; if novelty was claimed solely in respect of a course of, these merchandise could be handled and granted as course of patents.
Any reference to course of phrases in product-by-process claims solely aids in explaining the novel attributes of a brand new product, unknown within the prior artwork.
Underneath the rule of necessity, patent registries and courts around the globe acknowledge and settle for the potential for structurally undefinable merchandise.
Patentability have to be examined and evaluated independently of the allocation of a global non-proprietary identify to a chemical formulation.
Dichotomy between product and course of
The dichotomy between a product and a course of doesn’t function in a vacuum: it’s liable to exterior affect.
Dissimilar or double requirements on the grant stage
Separate yardsticks of novelty can’t be utilized when deciding whether or not to grant a patent and subsequent infringement, because the declare language is identical in each situations. If a patent is accepted to be novel and ingenious on the grant stage, then there isn’t a justification for disregarding its novelty and inventiveness when inspecting infringement claims. This is able to quantity to propagating a double customary, which is an unjust and untenable method.
Distinction between ‘obtainable by’ and ‘obtained by’
In its declare, Vifor used the phrases “obtainable by” to convey the method by which the claimed product might be manufactured or produced. Nevertheless, as established, the method itself needn’t be the ingenious factor of a patent. The courtroom clarified that use of the time period ‘obtainable by’ corresponds to Part 48(a) of the Patents Act 1970, which grants a patentee the unique proper to stop third events from misusing its product patent.
Against this, claims that includes the phrases ‘obtained by’ point out a direct hyperlink between the product and the method, and this expression quantities to course of patent infringement beneath Part 48(b) of the act.
To find out whether or not safety extends to the product, the declare language and specification must be examined case by case, and a product-by-process declare must pertain to a novel and ingenious product, versus a course of.
Errors within the single choose’s ruling
The bench held that, because the novelty of FCM seems to have been uncontested, the only choose essentially erred in understanding product-by-process claims as being restricted to a product obtained by a particular course of.
Key takeaways
The division bench’s choice offers much-needed readability on the evaluation of product-by-process claims and infringement of such patents – a difficulty that, till now, had not been decisively elucidated in Indian patent jurisprudence.
Whereas the choice might not technically be binding for the ultimate adjudication of any of the FCM patent infringement fits, it clearly outlines the authorized place relating to product-by-process claims, which is according to international benchmarks. Additional, whereas Vifor was not granted an interim injunction as its FCM patent had expired in October 2023, the courtroom – in a really encouraging transfer – granted Vifor the freedom to press its declare for deposit of share of gross sales made by the infringers within the respective fits.
