'PRODUCT-BY-PROCESS' CLAIMS: VIFOR'S PATENT DISPUTE TAKES NEW TURN WITH DIVISION BENCH’S PERSPECTIVE
Introduction
Three suits were filed by Vifor (International) Limited (hereinafter referred to as Vifor), the Patentee, a Swiss company, and Emcure Pharmaceuticals Ltd., a License Holder, an Indian company against the Defendants, namely, (i) MSN Laboratories Private Limited and (ii) MSN Life Sciences Pvt. Ltd. collectively referred to as "MSN"; Dr. Reddy's Laboratories Limited referred to as "DRL"; and (i) Corona Remedies Private Limited and (ii) Virchow Biotech Private Limited referred to as "CRPL and VBPL". Additionally, another application seeking an interim injunction was filed by CRPL and VBPL against Vifor (International) Ltd. and Vifor Pharma Pvt. Ltd. in another suit. All suits involve issues related to alleged infringement and invalidity of IN 221536 (hereinafter referred to as IN’536), a patent titled 'Water Soluble Iron Carbohydrate Complex and A Process For Producing Water Soluble Iron Carbohydrate Complex,' concerning a product named FERRIC CARBOXYMALTOSE (FCM).
All suits and applications were adjudicated upon by a learned Single Judge of the Delhi High Court. Thereafter, the decision of the learned Single Judge was appealed by the Patentee before a Division Bench.
IMPORTANT ISSUES AND ARGUMENTS BEFORE THE LEARNED SINGLE JUDGE
I. SCOPE OF CLAIMS
Submissions of the Patentee:
Vifor presented the following arguments regarding the scope of their claims in the patent (IN’536):
1. Distinct Claims: The patent (IN’536) includes both product and process claims. The title, description, and claims of the patent covered both the product (FCM) and the process for preparing it. Vifor intended to protect both the product and the process of preparing it. Vifor further emphasized that the novelty and inventiveness of the product are separate from process limitations.
2. European Patent Office's Order: The European Patent Office's Opposition Division confirmed that the protection of Vifor's independent claim was for the new product itself, not just the process of making it.
3. Regulatory Approvals and Commercial Success: Vifor's US Patent 'US 7612109' for FCM was listed in the US FDA Orange Book as the "DS" (Drug Substance) for FCM, covering the product itself. Vifor also obtained regulatory approvals for FCM as a "new drug" in India, indicating commercial success.
4. Global Patent Grants: Vifor's patent corresponding to IN’536 was granted in 57 jurisdictions, including major ones like the US and EU. Vifor showed that they were proactive in protecting their rights in IN’536, filing multiple suits for infringement. The patent's strength was highlighted by the grant of interim injunctions and consistent Court support.
Submissions of the Defendants:
The Defendants (MSN, DRL, CRPL, and VBPL) presented the following common arguments regarding the scope of Vifor's claims and the alleged infringement:
1. Prior Art and Problem to be Solved: Vifor's patent identified prior iron deficiency treatments and addressed process-related problems, not product-related issues.
2. Scope of Claim 1: The scope of Vifor's Claim 1 was limited to a product obtained through a specific process, specifically the oxidation of maltodextrin using aqueous hypochlorite. The process was essential to the novelty and inventiveness claimed by Vifor as admitted during the prosecution of the patent application.
3. Different Component: Defendants' manufacturing process for FCM used a different chemical (Oxone instead of aqueous hypochlorite), resulting in distinct properties. Infringement analysis requires claim construction and comparison of their product/process with the patented claims.
4. Novelty of the Suit Patent: The Defendants’ use of starch hydrolysate as a starting material distinguished their product from Vifor's patent claims.
5. Different Product Names: Defendants argued that the product's various industry names invalidated any claim of monopoly on the name 'Ferric Carboxymaltose.'
The Defendants challenged the novelty and inventiveness of Vifor's patent, arguing that the patent was limited to a specific process and that their processes were different. They also raised concerns about the product's various names and highlighted the principle of balance of convenience in their favor.
Submissions of the Patentee:
Vifor contended that claim 1 of IN’536 could be considered both a product claim and a 'product-by-process' claim. While IN’536 claims an independent product claim 1 and dependent claims related to a process, claim 1 did not require the use of the specific process and could cover any product infringing claim 1, regardless of the manufacturing process.
Vifor emphasized several points to support its position:
1. Intent to Protect: They claimed that the intent of the patent was to safeguard both the product and the processes of producing it.
2. Product-by-Process Format: Vifor argued that the practice guidelines followed by the Indian Patent Office (IPO) supported the patentability of 'product-by-process' claims. They asserted that the novelty and inventiveness of the product were independent of the process used.
3. Statutory Recognition: They argued that the Indian Patent Act recognized "product" and "process" as patentable subject matters, but not a separate 'product-by-process' category.
Vifor argued that IN’536 distinctly claimed both the product and process for preparing FCM, and its commercial success supported their position. They asserted that the intent was to protect the product itself, irrespective of the manufacturing process used.
Submissions of the Defendants:
The Defendants (MSN, DRL, CRPL, and VBPL) challenged the patentability of IN’536, focusing on the distinction between product and process claims. They argued that the prior art and problems addressed in the patent were process-related, not product-related.
MSN AND DRL asserted that claim 1 was limited to a product obtained through a specific process, and that process was essential to the novelty and inventiveness claimed by Vifor. Moreover, a different chemical (Oxone) was introduced in their process, which resulted in distinct properties for the product, making their (Defendant’s) process non-infringing.
Additionally, CRPL, and VBPL emphasized that their process used a different starting material (starch hydrolysate), making the claims of IN’536 irrelevant. They referred to Vifor's prosecution admission of novelty due to 'oxidized maltodextrin,' which, according to them, contradicted Vifor's current position. Further, They argued that the claims of IN’536 were ‘product-by-process’ claims, inherently tied to the specific process used for obtaining the product.
III. IMPORTANCE OF THE PHRASE “OBTAINABLE FROM”
The phrase "obtainable from" was a key element in the analysis of the patent dispute between Vifor and the Defendants. It played a crucial role in determining the scope of the patent claims and whether the Defendants' products/processes infringed upon Vifor's patent.
Independent claim 1 of IN’536
1. “Water soluble iron carbohydrate complexes obtainable from an aqueous solution of iron (111) salt and an aqueous solution of the oxidation product of one or more maltrodextrins using an aqueous hypochlorite solution at a pH-value within the alkaline range, …”
Submissions of the Patentee:
Vifor's claim is that their patent covers FCM "obtainable from" a certain process, but it does not limit the product claim exclusively to that specific process. This interpretation would give them a wider scope of protection, allowing them to assert infringement even if the Defendants used different processes to create FCM. Vifor further argued that the term ‘product-by-process’ has evolved over time and no longer necessarily ties the product claim to a specific process. They emphasize that the focus should be on the product itself, rather than the process used.
Submissions of the Defendants:
The Defendants contended that the phrase "obtainable from" was indicative of a process limitation. They argued that Vifor's claim was inherently tied to the specific process described in the patent, and any product obtained through a different process should not be considered infringing. They further interpreted Vifor’s patent as a whole and further highlighted that Vifor's prosecution history and emphasis on the specific process during the application process, suggested that the claim was limited to that process.
LEARNED SINGLE JUDGE’S FINDINGS
The learned Single Judge’s analysis of the scope of claims considered whether claim 1 of IN’536, should be construed as a pure product claim or a ‘product-by-process’ claim. The learned Single Judge emphasized that a product claim should describe the product's composition and structure without being limited by the process whereas product-by-process claim is restricted to a specific process used to create the product. It concluded that claim 1 of Vifor's patent fell into the category of a product-by-process claim. The learned Single Judge's approach was rooted in the understanding that the invention's novelty and inventiveness lay in the specific process used to prepare the product, rather than the product itself. The interpretation of the term "obtainable from" played a crucial role in its analysis. The learned Single Judge acknowledged that Vifor had used the language "obtainable from" in the claims of its patent. The prosecution history of the patent was considered, and it was noted that Vifor had limited the invention to certain features of the process during the prosecution. Therefore, the learned Single Judge concluded that the term "obtainable from" did not change the restricted scope of the claim as a ‘product-by-process’ claim.
APPEAL BEFORE THE LEARNED DIVISION BENCH:
In the wake of the above findings, wherein the learned Single Judge’s determination was that patent IN'536 constituted a ‘product-by-process’ claim, thereby confining its scope exclusively to the product derived from the specified manufacturing process outlined in the claim, a new phase of analysis emerged after the Patentee filed an appeal before the learned Division bench.
The learned Division Bench found itself unable to concur with the findings of the learned Single Judge that considered FCM to be exclusively protected under a patent for its method of production and that the patent was exclusively a ‘product-by-process’ claim.
The central focus of the Division Bench was the product in question, which had been designated the International Non-proprietary Name of Ferricum Carboxymaltose by the World Health Organisation. The Court noted that the Defendants were unable to challenge the assertion of novelty regarding Ferricum Carboxymaltose as a product. Notably, the Defendants did not contend that Ferricum Carboxymaltose was either known or discernible from prior art. The learned Division Bench also drew attention to clause 7.9 of the "Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals" published by the Office of the Controller General of Patents, Design, and Trademarks, October 2014. The clause highlighted that any preexisting disclosure of the product, regardless of the method of its creation, would affect the novelty of a claim exclusively rooted in the process. The bench invoked that the patentability of a ‘product-by-process’ claim rested on the novelty and inventiveness of the product itself, rather than the method of production.
In light of the above considerations, the learned Division Bench acknowledged the request for a swift resolution of the appeals. Consequently, the operation and effect of the directions by the learned Single Judge wherein the Defendants were permitted to launch their product, FCM, as long as they did not use any process claimed under IN’536 that would infringe the patent, were temporarily stayed.
CONCLUSION:
The learned Single Judge concluded that the patent in question, IN’536, was a ‘product-by-process’ claim, meaning its scope was limited to the product obtained through the specific process described in the claim. As a result, the Defendants could not be accused of patent infringement if they used a different process to manufacture the same product. The learned Single Judge emphasized the importance of proper claim construction and clarified that a product claim must describe the product's composition and structure without being limited by a specific process. The learned Single Judge also highlighted the need to strike a balance between patent rights and public interest, and in this case, it found that granting injunctions in favor of the patent holder would cause irreparable harm to the Defendants and be prejudicial to the public interest. Therefore, the Defendants were permitted to launch their product, FCM, as long as they did not use any process claimed under IN’536 that would infringe the patent.
In a conflicting opinion, the learned Division bench delved into crucial aspects pertaining to the product of the Patentee and opined that the scope of the patent did, in fact, involve a product and not merely a ‘product-by-process’. Consequently, the learned Single Judge’s order in favor of the Defendants been temporarily stayed.Top of Form
