The 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.
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About the Authors:
Manisha Singh (Partner)
Ms. Singh is a seasoned IP professional holding a decorated career spanning over 2 decades and repute as one of the most distinguished lawyers in the domain. She started her career at a time when Indian IP laws and practices were undergoing substantial changes pursuant to India’s obligations to comply with the TRIPS agreement. Through the years, she has been consistently involved in the betterment of the country’s IP regime and has been engaged in advising Indian policymakers, implementers, and IP owners on global IP standards and enforcement systems.
She is a true strategist and has led some of the most prominent and complex cases for large multinational and domestic corporations. She is identified by her clients as a seasoned and reliable counsel for the prosecution and enforcement of all forms of IP rights and planning and management of global patents, trademarks, and designs portfolios. She has also led numerous negotiation deals on behalf of her clients for both IP and non-IP litigation and dispute resolution.
Ms. Singh has served as the leading counsel for a client base in over 138 countries in their IP management and litigation matters. She has assisted numerous technology giants, Fortune 500 companies, globally renowned universities, and public sector research institutions in the APAC region, the USA, EUROPE, the UK, Oceania, Latin America, and MENA.
Ms. Singh is also the Standing Counsel for the Reserve Bank of India at the Delhi High Court and is known for her deep understanding of corporate, banking, and financial services laws. Manisha is a prolific writer and has contributed chapters in Indian IP laws to many leading publications including Mondaq, IP Media Group, Vantage Asia, Managing IP, Asia IP, CTC Media to name a few.
Pankaj Musyuni (Associate Partner)
Pankaj Musyuni is an Advocate registered with the Bar Council of India, as well as a patent agent. He has a Master’s degree in pharmaceutical science and management. He regularly advises clients on IP strategy and portfolio management. Pankaj has in-depth knowledge of patent law and the healthcare regulatory framework in India, as well as extensive experience in patent filing, drafting, prosecution, and advisory matters, especially in the chemical, pharmaceutical, and start-up fields. He has written several articles and delivered talks at various forums on patent law practice, the regulatory landscape, and clinical research.
