Product-By-Process Claims Must Be Examined on Standards of Novelty and Non-Obviousness

Product-By-Process Claims Must Be Examined on Standards of Novelty and Non-ObviousnessThe Division Bench of the Delhi High Court, consisting of Justices Yashwant Varma and Dharmesh Sharma, stated in the case of Vifor (International) Limited & Anr. vs. MSN Laboratories Pvt Ltd, Corona Remedies Pvt Ltd, and Dr Reddy’s Laboratories Ltd that the evaluation of a product-by-process claim under the Patents Act should be grounded on the notion that the product in question must be unique and not readily apparent to others. It holds true irrespective of whether the applicant has defined the invention via a manufacturing process.

The plaintiff/appellant contended that their patent 221536, commonly known as IN’536, was predominantly a product-by-process claim for Ferric Carboxymaltose (FCM), a substance engineered to meet the requirements of a non-toxic, quickly sterilising intravenous iron therapy in a variety of clinical contexts. In an effort to obtain relief, the plaintiff petitioned for a provisional restraining order that would forbid MSN Laboratories Limited from employing an alternative process to manufacture a product that is comparable to FCM. The Honourable Single Judge denied the petition for an interim injunction on the grounds that the plaintiff’s patent protection was limited to the process of acquiring the product, not the product itself.

Subsequently, the plaintiff/appellant filed an appeal with the Division Bench, contending that the patent defined a process rather than a product and, thus, should not be limited to the particular manufacturing method specified in the patent. With respect to their patented product, the plaintiff, acting as the appellant, filed a lawsuit against MSN Laboratories Pvt Ltd, Corona Remedies Pvt Ltd, and Dr Reddy’s Laboratories Ltd.

The Court’s decision established that the mere use of process-related terms does not inherently limit or offer a valid justification for distinguishing between validity and infringement. Even if the applicant is obligated to provide a product-by-process claim due to unforeseen circumstances, there is no justification for restricting the extent of protection. In the case, the Court saw that for a product-by-process claim to be deemed genuine, it must exhibit novelty and inventiveness, in contrast to a simple process.

The Court emphasised that using the product-by-process format alone does not automatically reclassify a new product as falling under Section 48(b) of the Act; instead, the product must adhere to the standards outlined in Section 48(a). The patentees’ rights are outlined in Section 48 of the Patents Act. Specifically, Section 48(a) states that patentees possess exclusive jurisdiction over any third party attempting to manufacture, distribute, import, or utilise the patented product in India. In a similar fashion, patentees are granted the same rights under Section 48(b) when the patent relates to a particular process.

Additionally, the Court underscored the improperness of restricting or abbreviating a product-by-process claim for the purpose of complying with Section 48(b) of the Patents Act. The Court ruled that a product-by-process claim remains eligible for protection under Section 48(a) of the Act so long as it pertains to a novel and inventive product that is not previously recognised in the art. The Court also said that the process language used to describe an invention shouldn’t change the standards for figuring out whether it is new or patentable if the claim is for a unique, original, and different product from previous designs.

In its decision, the Court said that previous decisions and guidelines on product-by-process claims all agree that process terms should not be considered when figuring out novelty. Instead, the Court noted that people should focus on the product’s unique qualities. The Court emphasised that the use of a novel manufacturing process does not inherently confer novelty on a product. Furthermore, the Court emphasised that a product-by-process claim amalgamates the conventionally distinct classifications of process patents and product patents.

The Court said that the Single Judge’s decision was clearly wrong because it didn’t understand the scope of product-by-process claims and made it sound like different rules apply to infringement cases. After reviewing the case’s facts and circumstances, the Court determined that Vifor has the right to prosecute its claim for the deposit of a percentage of sales at the opportune time, pending the outcome of any ongoing litigation. Therefore, the panel granted the appeal and reversed the judge’s decision.

Authors: Manisha Singh and Pnakaj Musyuni

First Published By: IP STARS here