Clearing the Air around Product-By-Process Patent: Visor Limited V. Msn Ltd & Another

29th March, 2024 - 10:18 am Categories: Legal Case 0 Comments

INTRODUCTION

In a recent case before the honorable Delhi High Court, the question regarding the implications of patentability in the case of the product-by-process was delved into. The major aspect of the judgment revolved around two major questions. Firstly, whether the product-by-process patent claim can be read in seclusion under Article 48 (b) of the Patents Act 1970, disregarding the subclause (a) of Article 48. Secondly, whether a different theory applies in case of infringement actions, on a product-by-process claim than in cases of validity claims.

CASE BEFORE THE SINGLE BENCH OF THE HIGH COURT

Appellant: The case named Vifor (International) Limited and Another v. MSN Laboratories Private Limited and Others came before the high court as an appeal moved by the former party (the appellant) challenging an order passed by a single judge bench last year. The prior judgment refused to grant interim relief to Vifor Limited in its patent infringement case against various entities including MSN laboratories. In the appeal, Vifor had contended its rights over IN’536 which is primarily a drug, Ferric carboxymaltose (FCM), used to treat anemia caused by iron deficiency. Vifor claimed that their patent protects the whole product per se irrespective of the process used to manufacture the same product. In the patent claim of IN’536, Vifor has also mentioned the process of the product which it claimed to be “only an aid” in describing the final product to be patented. Vifor, therefore claimed that the patent includes and extends to all the processes resulting in the production of FCM and also that the patent is a product claim rather than a product-by-process one and therefore the respondents have infringed its patent right by manufacturing FCM in whichever process they did.

Respondent: The respondents claimed before the single-judge bench that Vifor has mentioned IN’536 as a product claim, however has also specified the process through which the product is to be obtained, i.e., through the oxidation of maltodextrin using aqueous hypochlorite. The respondent argued that the mentioned process constituted an “essential determinant” of FCM in Vifor’s patent claim and therefore, cannot claim infringement in case of the distinct process employed to produce FCM as it is essentially a product-by-process patent and not a product patent. Also, Vifor’s claim would render the manufacturing of the product, FCM restricted by monopoly, the respondents urged before the court.

Court’s observation: In its observation, the court held that Vifor’s contention of patentability on the whole of the product resides on a fallacious point as the extent of rights and protection granted through the patent cannot extend beyond the disclosure of the invention in the patent claim. The court therefore rejected the contention of the appellant that the process mentioned in the patent claim was not specific. The court held where the patent claim has mentioned a particular process to manufacture the end product, it cannot claim infringement when another process (with the distinct agent) is involved to manufacture the same product and therefore also cannot claim the patent on the product as the mention of process specifies the patent collectively as a product-by-process.

APPEAL: CORRECTING THE FALLACIES AROUND PRODUCT-BY-PROCESS PATENT

The two-judge bench of the Delhi High Court recorded their statement in the appeal case brought forward by Vifor. In the observation by the court, the judges were primarily concerned with two fallacious and inconsistent observations made by the single-judge bench. The court in the appeal, however, concurred with the observation made by the single judge bench to conclude the patent of IN’560 as a product-by-process claim and not a product patent per se as the claims mentioned in the patent include the specification of the process through which the product has been manufactured.

However, the court in the appeal took down the fallacies in the former judgment by the single bench on two major grounds.

Firstly, the court held that under 48 (b) of the Indian Patents Act, 1970, the patent although mentioned as the product-by-process, it however does not mean that the patent can be allowed only concerning a novel process without taking into account the “novelty” of the product. The court contended that it is not always possible that a particular novel product can be specifically and necessarily described by its composition and structure. That makes the requirement of product-by-process patent claims decisive. The court further stressed that the case of product-by-process claim “owes their genesis to cases where new products could not be fully described by their structure compelling the patent applicant to rely upon and refer to the process feature”.

Through the observation made by the court in the present appeal, it became evident that although section 48(b) mentions the process patent, however, the grant of process patent can only be made when the end product is “novel” or “unobvious”. The process even if novel with no novelty in the end product cannot be sanctioned as a patent through process.

Secondly, the court delved into the argument made by the respondent in the appeal that in patent infringement proceedings, the contention is limited by process, and the question of the product being novel is not taken into account. The court in this argument contended that the basis of product-by-process patent is fundamentally claimed on the novel product, so limiting the infringement proceedings only to the process is inherently untenable. The court reiterated that “product-by-process claims, although employing process terms, are fundamentally concerned with an inventive product and the reference to a process being only to aid in explaining the novel attributes of a new product unknown in the prior art”. Therefore, to limit the validity of the infringement claims to merely the “process” is ‘unjust’ and ‘incorrect’.

CLEARING THE AIR

The court in the present case has tried to counter layers of fallacies in the understanding of the patent under section 48(b) which mentions the product-by-process claim. Primarily, the court reiterated the major contention by emphasizing that process patents cannot be read in seclusion and must look concerning “product” under section 48(a). Even for claiming a product-by-process patent, the product must primarily be novel.

The court’s rationale concerning the second part of its judgment is exemplary for its unambiguous character which is highly required in the current jurisprudence. The court has rightly in its judgment indicated that the current ruling deviates, for rightful reasons, from the judgment of the landmark Abbott Laboratories v. Sandoz case.  In Abbott’s case, it was concluded by the majority viewpoint of the learned judges that the aspect of novelty would be relevant only for patent grants and patent invalidity and not in cases of patent infringement claims. The court in the recent case referred to many judgments that followed after the Abbott case which must be rendered sufficient to not rely again on the ill-founded and ambiguous ruling of the Abbott Laboratories case. The court in its judgment read out the minority viewpoint in the Abbott case which stated,

“The majority opinion essentially accepts the proposition that the aspect of a product being new and unknown is wholly irrelevant and thus significantly impacting the class of inventions where the applicant may be constrained to describe the invention concerning the process by which it is made”.

 If the current judgment had not delved rightly concerning the infringement claim in the case of product-by-process, the future jurisprudence regarding the same would have been difficult and cumbersome to carve through. The judgment comes at an opportune time when the infringement claims in process patents have not been much looked into in India.

Author: Anam Sadaf, in case of any queries please contact/write back to us via email to chhavi@khuranaandkhurana.com or at  Khurana & Khurana, Advocates and IP Attorney.

REFERENCES:

• VIFOR (INTERNATIONAL) LIMITED & ANR. v. MSN LABORATORIES PVT LTD & ANR.
• Abbott Laboratories v. Sandoz 566 F.3d 1282