The Delhi High Court clarifies the scope of product-by-process claims in patent cases: In Vifor International Ltd. and Anr. v. MSN Laboratories Pvt. Ltd. and Anr., CS(COMM) 261 of 2021, the Single Judge ruled that the patent protection for product-by-process claims is limited to the specific process claimed in the patent, rather than the product as a whole. The case is centered around Vifor's patent claim for a drug used in treating iron deficiency anemia.
Plaintiff: Vifor International Ltd., (“Vifor”)
Defendants: MSN Laboratories Pvt. Ltd. (“MSN”), Dr. Reddy’s Laboratories Ltd. (“DRL”), and Corona Remedies Pvt. Ltd. (“CRPL”)
Suit Patent No.: 221536 (“IN536”) titled “Water Soluble Iron Carbohydrate Complex and a process for producing water iron carbohydrate complex”
Vifor’s Claims:
Vifor contended rights over the IN536 for a drug used in treating iron deficiency anemia, by asserting that their patent covers the product per se, irrespective of the process used to manufacture the drug, Ferric Carboxymaltose (FCM). Vifor argued that the process mentioned in the patent claims was only an aid in describing the end product, and that the patent's scope extended to all processes leading to the creation of FCM.
The Plaintiff buttressed their claim by arguing that the definition of ‘invention’ under the Patents Act, 1970 (hereinafter the “Act”) only recognizes an invention as a ‘product’ or ‘process’ and does not have a separate category for patent-by-process claims. Vifor further contended that it had used the exemplary process of preparation of the product. This is because the molecular composition of the invented product in question is large and complex and could not be accurately described in a conventional sense using formulaeor chemical structure. Thus, Vifor insisted that the IN536 is a product claim, and they have acquired the exclusive right, under Section 48 of the Act, to prevent third parties from making or using the FCM product obtained directly from the process protected by IN536, or any other process.
Defendants’ Claims:
The Defendants submitted that since the claim of IN536 wasdrafted as a product claim with the limitation of a process, and if the claim leads to a monopoly of the product as a whole, itwill render the process limitations of the claim meaningless. Further, MSN and DRL contested Vifor’s claims by stating that since the scope of the product claim of IN536 is limited to a product obtained by a specific process, i.e., oxidation of maltodextrin using aqueous hypochlorite, which is an essential and critical determinant of Vifor’s FCM, and does not cover any other process to obtain FCM, use of a different process by MSN and DRL to produce FCM will not amount to infringement.
Court’s Observations:
At the outset, the Court referred to the ‘Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals’ issued by the Patent Office in October 2014 to indicate that concept of product-by-process claims was not alien to the patent jurisprudence of India.
The Court observed that the scope of rights granted by means of a patent is in exchange for the disclosure of the invention in the patent claim, and the scope cannot travel beyond the disclosure made by the patentee. The Court concurred with the contentions of the Defendants and observed that in a product-by-process claim, the process terms in the claims are the limitations, rather than the additional features of the product. A case for infringement in such cases can only lie where the product is prepared by the specific process of the claim in the suit patent. The Court categorically rejected the contention of the Plaintiff that the use of the words ‘obtainable from’ in the patent claims is a description of one of the various ways in which FCM can be produced.
The Court noted that Vifor in its response to the FER issued by the Indian Patent Office, while distinguishing IN536 from the cited prior art, had submitted that the essence of the invention resided in a specific limitation of the claim, thereby limiting the scope of its patent claim. Moreover, Vifor had also submitted that IN536 is a process claim in an opposition matter, and that it is a product-by-process patent during patent infringement proceedings. Hence, Vifor cannot be allowed to approbate and reprobate, especially when it has obtained the patent by representing that the novel properties in its product are attributable to the characteristic features in the process involved.
The Court concluded that since MSN and DRL claimed to have used a different oxidizing agent than Vifor (aqueous hypochlorite v. oxone), and CRPL claimed to have used a starting material than Vifor (maltodextrin v. starch hydrolysate), such changes in the oxidizing agent and starting material are not insignificant, and therefore, Vifor had failed to make a prima facie case of infringement by the Defendants.Accordingly, the Court permitted the Defendants to launch their product FCM with the caveat that the Defendants shall not use a process/set of processes covered under IN536.
Conclusion:
The Court has recognized that product-by-process claims are not unknown to Indian jurisprudence. The Court has alsoreinstated the principle that since grant of patent rights is restricted to the disclosure in complete specification, patent protection in product-by-process claims will be restricted to the process by which the product is obtained, and monopoly right cannot be claimed on a product as a whole.