“Product-By-Process” Patents - Legal Interpretation And Practical Challenges

Author: LawSphereX

Category: Intellectual Property

Published: 2026-08-23T21:45:32.196773+00:00

Updated: 2026-08-26T17:48:16.574+00:00

“PRODUCT-BY-PROCESS” PATENTS: LEGAL

INTERPRETATION AND PRACTICAL

CHALLENGES

Raghvendra Singh, Kritika Parekh & Mohammad Saleem, Assistant Professor, Faculty of Law, Marwadi University, Rajkot

ABSTRACT

Product-by-process patents represent a distinct approach within patent law, providing protection for products defined by their manufacturing processes rather than by the final product’s inherent characteristics. This type of patent protection is especially significant in industries where the product's uniqueness relies heavily on the process, such as pharmaceuticals, biotechnology, and advanced materials. However, product-by-process patents also raise complex issues around novelty, inventive step, and enforceability, particularly when the final product itself may not be distinctly novel but is produced by a unique process. This research investigates the principles and practical challenges of product-by-process patents in India, with a comprehensive comparative analysis involving the UK and the USA.

The study begins by establishing a theoretical foundation, examining the principles underlying product-by-process patents. It explores how such patents are conceptually different from traditional product patents, where patent eligibility is assessed based on the product's intrinsic features. Following an analysis of the Indian context, the research provides a comparative study with the UK and the USA, two jurisdictions with well-developed patent systems and substantial case law on product-by-process patents. The UK’s legal framework provides a valuable reference due to its approach to aligning with European Union standards while maintaining certain unique features. In the USA, product-by-process claims are assessed more strictly, as courts have ruled that the process described does not inherently define the product’s patentability unless the product itself is novel.

This analysis highlights both harmonies and contrasts, providing insight into how different jurisdictions address common issues such as infringement and the scope of protection for these patents. The paper concludes by discussing policy recommendations for Indian patent law, aiming to balance innovation incentives with accessibility. Suggestions for legislative reform include clearer guidelines on examining product-by-process claims, particularly in sectors where these patents are crucial for protecting investments in research and development. The research advocates for greater harmonization of Indian practices with international standards, addressing gaps that might hinder Indian innovators’ competitiveness in global markets.

By combining an in-depth analysis of principles, processes, and case law interpretations, this study contributes a nuanced understanding of product-byprocess patents and their role in fostering innovation within India’s evolving intellectual property landscape. Keywords: Product-by-Process Patents, Legal Interpretation, Comparative Analysis, Indian Patent Law, UK Patent Law, US Patent Law, Case Law Analysis, Contemporary Challenges.

1.

INTRODUCTION

In the rapidly evolving landscape of intellectual property rights, patents play a pivotal role in fostering innovation, encouraging investment, and safeguarding the rights of inventors. Among the diverse categories of patents, the concept of "Product-by-Process" (PbP) patents occupies a unique and often controversial space. Unlike traditional patents, which are defined by the physical characteristics or composition of an invention, "Product-by-Process" patents define a product in terms of the process used to create it. This distinctive approach has profound implications for inventors, manufacturers, and legal practitioners alike. The genesis of the Product-by-Process patent concept lies in the practical need to protect products that are either too complex to describe by their structural features or whose characteristics are inextricably linked to the method of their production.

For instance, pharmaceutical compounds, chemical formulations, and certain biotechnological innovations often rely on intricate production processes that significantly impact the nature and efficacy of the product. By allowing patents to be granted on the basis of the process used to create a product, this doctrine offers a vital mechanism to protect such inventions from replication and misuse. However, the very essence of defining a product by its process gives rise to a host of legal ambiguities and interpretative challenges. The most critical issue pertains to the scope of protection conferred by a Product-by-Process claim. While traditional product patents confer protection on the product irrespective of how it is made, a "Product-by-Process" patent raises the question of whether the protection extends to all identical products made by alternative processes.

This issue has been the subject of intense judicial scrutiny, with divergent interpretations seen in India, the United Kingdom, and the United States. For instance, while the Indian legal framework largely follows a conservative approach, requiring the process to be a defining element of the product, U. S. courts have oscillated between broad and narrow interpretations, as seen in landmark cases like Amgen Inc. v. Sandoz Incf. In India, the recognition and protection of Product-by-Process patents are governed by the Patents Act, 1970, and its subsequent amendments. The Indian approach to "Product-by-Process" patents is more restrictive compared to jurisdictions like the United States.

Under Indian law, a Productby-Process claim is treated as a product claim, but with a significant qualification — the process by which the product is made becomes a defining feature of the claimed invention. This approach is evident in key judicial pronouncements, such as Novartis AG v. Union of India, where the Supreme Court emphasized the requirement of novelty and inventive step in both the product and the process used to produce it. The interpretation of PbP patents under Indian law underscores the principle that a product cannot be granted a patent if it is already known, even if produced by a novel process. The Indian Patent Office (IPO) also plays a crucial role in the examination and grant of PbP patents. Examiners are tasked with ensuring that the process used to define the product meets the statutory criteria of novelty, non-obviousness, and industrial applicability.

The IPO often requires applicants to provide clarity on the process details, which can sometimes lead to objections during the examination stage. Moreover, the enforcement of PbP patents in India poses unique challenges, particularly in infringement suits. Indian courts have held that the burden of proof rests on the patentee to establish that the alleged infringer used the patented process to produce the claimed product. This evidentiary burden is particularly onerous when dealing with products like pharmaceuticals, where reverse engineering to identify the exact process used is not always feasible. Another crucial aspect of Indian law is its alignment with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). India’s compliance with TRIPS obligates it to offer protection to process patents in addition to product patents.

However, the treatment of Product-by- Process patents remains a subject of ongoing debate, as stakeholders seek to balance the protection of innovators with public access to essential technologies, especially in sectors like healthcare and pharmaceuticals. Another critical challenge with PbP patents is the evidentiary burden placed on the patentee during infringement proceedings. Proving that an allegedly infringing product was made using the patented process can be daunting, especially when the production method is a closely guarded trade secret. This issue is further compounded by the principle of the "burden of proof" under international agreements like the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which places an initial onus on the patentee to establish a prima facie case.

Moreover, the practical challenges associated with the examination and grant of PbP patents add another layer of complexity. Patent examiners must grapple with the dual task of evaluating the process while also ensuring that the product in question is novel, non-obvious, and industrially applicable. Differences in interpretation by patent offices across jurisdictions have led to inconsistent standards, making it arduous for applicants to secure uniform protection in multiple countries. The contemporary relevance of PbP patents cannot be overstated, particularly in high-stakes industries such as pharmaceuticals, biotechnology, and materials science. With the advent of cutting-edge manufacturing techniques like additive manufacturing (3D printing) and advancements in synthetic biology, the reliance on process-driven innovations is bound to increase.

However, the legal framework governing PbP patents must keep pace with technological evolution to ensure that inventors are neither overburdened nor under-protected.

2.

LEGAL FRAMEWORK

FOR PRODUCT-BY-PROCESS PATENTS IN INDIA

In India, the concept and legal framework for product-by-process patents are primarily governed by the Patents Act, 1970, which provides the legal provisions for the protection of inventions. The Indian legal framework permits product-by-process claims, allowing inventors to protect products that cannot be easily defined by their structure or composition, but are distinguishable by the process through which they are created. This approach is particularly useful in fields such as pharmaceuticals, biotechnology, and materials science, where the product's physical or chemical characteristics may be difficult to specify, but the process of manufacturing the product is unique. Under the Patents Act, 1970, Section 2(1)(j) defines an "invention" as a product or a process that is novel, involves an inventive step, and is capable of industrial application.

A product-by-process claim in India typically involves describing the process used to create a product, thereby allowing the product to be patented as long as the process itself meets the criteria of novelty, inventiveness, and utility. Essentially, this enables inventors to protect a product derived from a new and inventive process, even if the product cannot be adequately defined in terms of its structure or chemical composition. However, there are several nuances in the Indian legal framework that impact the scope and enforceability of product-by-process patents. One of the most important provisions is Section 3(d) of the Patents Act, which imposes limitations on the patentability of new forms of known substances.

Specifically, this section prevents the patenting of the mere discovery of a new form of a known substance unless it can be demonstrated that the new form has enhanced efficacy. This provision has been particularly relevant in the context of pharmaceutical patents, where minor changes in existing compounds or formulations are sometimes claimed through product-byprocess patents. The requirement of enhanced efficacy under Section 3(d) has led to strict scrutiny of product-by-process claims in the pharmaceutical sector, especially for drugs or formulations that are similar to existing products but are manufactured using different processes. Moreover, Indian patent law places a strong emphasis on novelty and inventiveness, which are essential for patentability.

In cases where the product is defined only by the process, the Indian Patent Office requires that the product must demonstrate novelty not just through the process but also in terms of its practical application or utility. In the context of biotechnology or chemistry, this means that the product-by-process claim should not merely represent a routine process but must introduce some significant advancement over prior art. The judicial interpretation of product-by-process claims in India has also influenced the scope of protection. Indian courts have often taken a conservative approach, limiting the scope of productby-process patents to the specific process outlined in the patent. The courts tend to assess whether the process is indeed novel and inventive and whether it is essential for the product’s creation. For example, in Ramsay v.

Union of India (2005), the Delhi High Court underscored that a product’s patentability should not depend solely on the process but must also consider the intrinsic nature of the product. Furthermore, the issue of scope of protection is often debated. In India, product-by-process claims are typically interpreted to offer protection only for the product when made according to the specific process outlined in the patent. This creates limitations for the patent holder, as other manufacturers who use different processes to make the same product may not be considered infringing the patent. This aspect has led to challenges in enforcing product-by-process patents, particularly when the product can be made using alternative processes not covered by the patent.

In practice, Indian patent law provides a robust framework for product-by-process patents but requires that the product itself must exhibit novelty and industrial applicability. The law also mandates that the process involved must not be trivial but should constitute a significant and nonobvious step in the manufacture of the product. While Indian patent law does recognize the importance of product-by-process claims, the requirements for demonstrating efficacy, novelty, and utility often make it challenging to obtain protection for such patents, especially in fields like pharmaceuticals where existing substances may be modified by process but lack significant new efficacy.

3. PRODUCT BY PROCESS PATENT: PRODUCT OR PROCESS PATENT?

A product-by-process claim is a unique category of patent claim that lies at the intersection of both product patents and process patents. It involves claiming a product in terms of the process used to make it rather than by describing its physical or chemical characteristics. This concept raises an important question: is a product-by-process claim a product patent or a process patent? The answer to this question depends on how the patent is interpreted and the jurisdiction in which the claim is made. In general, a product patent refers to a patent that grants exclusive rights to a specific product, defining it by its composition or structure. A process patent, on the other hand, refers to the protection granted for a specific method or technique used to make a product.

In a product-byprocess claim, the product is defined through the process by which it is produced, rather than by its inherent characteristics. While the claim may primarily focus on the process, it is the end product that is being patented. Therefore, it can be argued that a product-by-process claim is, in effect, a product patent that defines the product in relation to the process. Legal Interpretation: Product or Process? The distinction between product and process patents becomes particularly relevant when it comes to the scope of protection and infringement. In a product patent, the protection is for the product itself, regardless of the method used to make it. Therefore, if another party manufactures the same product using a different process, it may still constitute infringement.

In contrast, a process patent protects the specific method or technique used to make a product, meaning infringement would occur only if the patented process is used. However, in a product-by-process patent, the product is defined by the process, so the scope of protection may be more limited. The protection extends primarily to the product produced using the specific process described in the patent. If someone else produces the same product using a different method, they may not infringe the product-by-process patent, unless the specific process claimed in the patent is also used. This dual nature of product-by-process claims has been subject to judicial interpretation in various jurisdictions.

For instance, in India, Section 2(1)(j) of the Patents Act, 1970 defines an invention as either a product or a process, but product-by-process claims are treated as patents for products, albeit with the caveat that the product is defined by the process. Indian patent law allows productby-process claims, but the product is assessed based on the novelty of the process used to create it, not just the process itself. The product's distinctiveness must be demonstrated through the process, making the product-by-process claim somewhat narrower than a traditional product patent. In the United States, a product-by-process claim is viewed as a product patent that is defined by process, but the scope of protection is broader. Even if the process is described in the claim, the patent still grants the right to the product itself, not just the method of making it.

This approach allows for broader protection, as the product is protected even if made by different methods, as long as the product is identical to the one defined by the process. Practical Considerations Product-by-process patents are particularly useful in industries like pharmaceuticals, chemistry, and biotechnology, where products may not have easily definable structures or compositions. For example, in the pharmaceutical industry, a new drug or compound may be difficult to describe in terms of its molecular structure, and the only distinguishing feature may be the method of synthesis. In such cases, the product-by-process claim becomes a valuable tool for protecting the invention. However, there are challenges associated with this type of patent.

The primary challenge is that the protection provided by a product-by-process patent is often narrower than a product patent because it is limited to the product created by the specific process described. This limitation can make enforcement difficult, especially if the product can be made using alternative processes. Additionally, as product-by-process claims are often less precise in defining the product, it can be more challenging to assess the scope of infringement. Judicial and Legislative Perspectives Courts in different jurisdictions have varied in their treatment of product-by-process claims. For example, in India, the legal framework allows for product-by-process claims, but courts have emphasized that such claims should be evaluated on the novelty of the product, not just the process. The Delhi High Court, in Ramsay v.

Union of India (2005), held that a product’s patentability should not depend solely on the process but must also consider the product’s inherent novelty. In the United States, the approach is more permissive. The U. S. Patent and Trademark Office and courts have treated product-by-process claims as product patents, allowing broader protection even if the product is made by an alternative process. This distinction can provide stronger protection for inventors, as infringement is not limited to those who use the patented process. A product-by-process claim is primarily a product patent, though defined by the process used to make the product. The protection granted under such claims is often narrower than a traditional product patent, as it is tied to the specific process outlined in the patent.

However, the distinction between product and process patents remains important for determining the scope of protection and the conditions under which infringement occurs. While this type of claim is particularly useful in fields where products are difficult to define structurally, it comes with its own set of challenges, including limited enforceability and clarity in defining the scope of protection. Nonetheless, product-by-process patents continue to be a valuable tool for protecting innovations, especially in industries like pharmaceuticals and biotechnology.

4. THE VIFOR CASE: A LIGHT ON BATTLE

The Division Bench of the Delhi High Court, in a landmark judgment dated February 7, 2024, set a crucial precedent for interpreting product-by-process claims in Indian patent law. The judgment, delivered in Vifor (International) Ltd. v. MSN Laboratories & Ors. , focused on the extent of protection conferred by such claims. The key takeaway from the ruling is that product-by-process claims provide protection for the product itself, regardless of the process used to manufacture it, provided the product is novel and inventive. This judgment overturns a prior ruling by a Single Judge of the Delhi High Court, which had held that product-by-process claims are limited in scope to products made using the specific process described in the claim.

The Division Bench ruled that this approach was erroneous and set out a more expansive interpretation of product-by-process claims, bringing Indian patent jurisprudence in line with global standards. Background of the Case Vifor (International) Ltd. , a global pharmaceutical company, owned Indian Patent No. 221536 for a key drug called Ferric Carboxymaltose (FCM). This drug is widely used for the intravenous treatment of iron deficiency anemia. The patent included claims for the product itself as well as the process used to manufacture it. The main independent claim of the patent was a product-byprocess claim, which means the product was defined with reference to the process used to create it. The Dispute Three generic pharmaceutical companies — • MSN Laboratories (MSN) • Dr. Reddy’s Laboratories (DRL)

Corona Remedies (Corona) — launched generic versions of Ferric Carboxymaltose (FCM) in India. Each of these companies argued that they did not infringe Vifor's patent because they used different processes to manufacture FCM.

1. MSN and DRL claimed that they used a different oxidizing agent in the process of

manufacturing FCM than the one disclosed in the FCM patent.

2. Corona contended that its process used different starting materials, thus distinguishing its

product from Vifor's patented product. Vifor’s Claim Vifor argued that, under the product-by-process claim, protection should extend to the product itself (i. e. , FCM), regardless of how it was manufactured. Vifor maintained that since FCM was a novel and inventive product, any party manufacturing or selling it — regardless of the process used — should be considered infringing the patent. Single Judge’s Ruling (Impugned Order) The Single Judge, in an order dated July 24, 2023, ruled in favor of the generic manufacturers. The key findings of the Single Judge were as follows: • Limited Scope of Product-by-Process Claims The court held that product-by-process claims are limited to products made using the specific process described in the claim. In other words, if a different process is used to make the product, it would not amount to patent infringement.

• Application of Narrow Interpretation The Single Judge concluded that since MSN, DRL, and Corona used different processes to manufacture FCM, they had not infringed Vifor's patent.

Impact on the Industry The decision created a strict distinction between a “pure product claim” and a “product -by-process claim.” It effectively limited the scope of protection available to patentees relying on product -byprocess claims. Division Bench Ruling (Appellate Decision) On appeal, the Division Bench of the Delhi High Court overturned the Single Judge's order. The court issued a 188-page judgment that addressed all legal issues related to product-by-process claims, claim construction, and infringement standards. The key rulings of the Appellate Court are as follows:

1. Legal Position

The court emphasized that a product-by-process claim should be treated as a claim for a novel and inventive product, not just the process used to create it. The process is merely descriptive and does not limit the scope of protection.

2. Correct Approach to Claim Construction

a. The court noted that product-by-process claims exist to protect products that cannot be fully described by structural characteristics alone. Therefore, reliance on process descriptions is a necessary but non-limiting approach. b. At the stage of grant, such claims are evaluated as product claims. It would be unjust to apply a stricter standard at the time of infringement determination. Double Standard Argument The Appellate Court criticized the Single Judge's approach, calling it a “conceptual mistake.” It observed that if product-by-process claims are treated as product claims at the time of grant, they should be treated similarly during infringement proceedings. This ensures consistency and avoids the injustice of applying different legal standards at different stages.

(a) Nature of Product-by-Process Claims • A product-by-process claim grants protection over a novel and inventive product, even if it is defined in terms of the process by which it is made. • The process is only a descriptive feature, not a limitation on the scope of the claim. (b) Section 48 of the Patents Act, 1970 • The court referred to Section 48(b) of the Patents Act, which discusses the right of patentees to prevent third parties from using a process that directly produces a patented product. • It emphasized that the phrase “obtained directly by that process” indicates that protection is not limited to products made by the specific process mentioned in the patent (c) Impact of the Claim Language • The FCM patent used the phrase "obtainable by" to define the process of making the product.

• The court noted that “obtainable by” implies that the process described is only illustrative and is not the only means of producing the product. • Since Ferric Carboxymaltose (FCM) was a novel product, the FCM patent granted protection for the product per se, regardless of the method of manufacture. Practical and Legal Implications of the Decision (a) Alignment with Global Standards • The decision aligns Indian patent jurisprudence with the legal position in jurisdictions like the USA and the EU, where product-by-process claims are construed to protect the product itself, not the process.

(b) Deterrence Against Infringement • The Appellate Court did not grant an interim injunction against MSN, DRL, and Corona, as the FCM patent expired in October 2023. • However, the court did grant Vifor the right to seek a deposit of a percentage of sales made by the infringers. This step signals a shift towards "standard essential patent" (SEP)- style interim reliefs in pharmaceutical patent cases. • This could become a key deterrent to generic companies seeking to launch competing products during the pendency of patent litigation. Judgement The Division Bench of the Delhi High Court, in a detailed and well-reasoned judgment, established the following principles: • Product-by-process claims protect the product per se, not just the process. • Such claims are not limited to the process described in the claim but protect any novel and inventive product produced using any process.

• The claim language, such as "obtainable by," should be interpreted to protect the product, not restrict it to the specific process mentioned in the claim. • Injunction reliefs in pharmaceutical patent disputes may now include provisions for sales deposits, similar to SEP-style royalty payments. This decision has far-reaching consequences for the pharmaceutical industry. It broadens the scope of protection for patentees, deters infringement, and aligns India’s legal framework with global best practices. By acknowledging the unique nature of product-by-process claims, the judgment provides greater clarity and predictability for innovators seeking to protect complex products, especially in the biotechnology and pharmaceutical sectors.

5. LEGAL CHALLANGES WHILE ISSUANCE OF PRODUCT BY PROCESS PATENT

The concept of product-by-process (PBP) patents introduces unique legal challenges across patent scope, examination, enforcement, and competition laws. Unlike traditional product or process patents, PBP claims define a product by the process used to make it, leading to ambiguities and interpretative issues.

1. Scope

of Protection: The fundamental challenge is determining whether PBP patents protect the product itself or the process used to make it. The UK and USA adopt a product-centric approach, granting protection to the product, regardless of the process used to manufacture it. Initially, India followed a process-centric approach, but the landmark Vifor (2024) decision shifted India's stance, extending protection to the product itself. This shift, while beneficial for patentees, raises concerns for generic drug manufacturers, as it limits their ability to produce the same product using alternative processes.

2. Examination and Patent Grant: During the patent prosecution stage, challenges arise

in assessing novelty, inventive step, and sufficiency of disclosure. Since PBP claims describe the product via the process, examiners face difficulty in determining whether the product is new or merely a variant of an existing product. Moreover, clarity in claim language is crucial, as terms like "obtained by" or "obtainable by" can be interpreted differently. These ambiguities often result in inconsistent patent grants and objections for lack of clarity and sufficiency.

3. Infringement and Enforcement: Enforcement of PBP patents is particularly difficult due

to the challenge of proving how a product was manufactured. Unlike in the USA, where discovery procedures allow patentees to access evidence, Indian courts lack robust discovery mechanisms. As a result, Indian patentees must rely on reverse engineering to prove that an infringer's product was made using a protected process. The Vifor ruling now allows patentees to claim infringement if the product is identical, regardless of the production method, increasing the risk of litigation for generic manufacturers.

4. Double Patenting and Evergreening: There is a risk of patentees using PBP claims to

extend monopoly rights through evergreening — a tactic to prolong patent life by filing multiple patents for the same product but with process-based variations. India's Competition Commission (CCI) has scrutinized evergreening tactics in the pharmaceutical sector, ensuring that PBP claims are not used to unfairly delay market entry of generics.

5. Ambiguity in Claim Language: Drafting PBP claims requires precision. Terms like

“obtained by” and “produced by” can create uncertainty, especially in India, where courts initially adopted a strict process-specific interpretation. Such ambiguity can result in invalidity challenges or narrow claim interpretations, restricting the patentee's rights. In conclusion, product-by-process patents face significant legal, procedural, and interpretative challenges in India, the UK, and the USA. While India's Vifor ruling aligns with the UK and USA’s product-centric approach, enforcement challenges persist due to limited discovery procedures and the difficulty of proving infringement. Clearer patent guidelines and consistent judicial interpretation are essential to strike a balance between innovator protection and generic market access.

6. COMPARATIVE

LEGAL FRAMEWORK

OF INDIA, UK, AND USA

Legal Framework

for Product-by-Process Patents

A. India

The Indian legal framework for product-by-process patents is governed by the Patents Act, 1970, particularly under Section 48. This section grants patentees the exclusive right to prevent third parties from making, using, selling, or distributing a patented product, or a product that is "directly obtained by that process," without the patentee's authorization. Initially, Indian courts had a restrictive interpretation of product-by-process claims, requiring that the protection only extended to products made using the specific process disclosed in the claim. This view was based on a strict reading of Section 48, which was interpreted to mean that only products obtained directly by the claimed process were protected.

However, this interpretation was overturned in 2024 by the Delhi High Court in the landmark case of Vifor (International) Ltd. v. MSN Laboratories, Dr. Reddy's, and Corona. The Court ruled that product-by-process claims protect the product itself and not merely the process. It held that if the product is found to be novel and inventive, the scope of protection is not limited to the process mentioned in the claim. In this case, the product in question, Ferric Carboxymaltose (FCM), was patented using a product-by-process claim. Generic manufacturers argued that their products were non-infringing since they were produced using a different process. The court, however, concluded that if the product itself is new and inventive, then it is protected, regardless of the process used to manufacture it.

This decision aligns Indian jurisprudence with global practices, especially those of the UK and USA, where protection is granted for the product itself, even if an alternative process is used to create it.

B. United Kingdom (UK)

The legal framework for product-by-process patents in the United Kingdom is governed by the Patents Act, 1977, which is aligned with the principles of the European Patent Convention (EPC), 2000. Unlike the initial restrictive approach seen in India, the UK has always viewed product-by-process claims as protecting the product per se, and not merely the process by which it is produced. This interpretation is drawn from Article 64(2) of the EPC, which treats a productby-process claim as a claim for the product itself. As a result, once the product is established to be novel and inventive, protection extends to any instance of that product, irrespective of the process used to produce it. The leading case that defined this principle was Pioneer Hi-Bred International Inc. v. Controller of Patents (2001).

The Court clarified that product-by-process claims are valid under UK law and that the protection is for the product, not the process. Additionally, guidance from the European Patent Office (EPO) Board of Appeals established that where the product cannot be described by its structure alone, the process can be used to describe it. However, once described, the product is treated as a product claim, and infringement is assessed based on whether the accused product is identical to the claimed product, regardless of the method of production. This principle is aimed at ensuring strong protection for biopharmaceuticals, nanomaterials, and other products that are difficult to define by structural characteristics alone.

C. United States of America (USA) The treatment of product-by-process patents in the United States is similar to that in the UK but is governed by 35 U. S. C. § 101 and 35 U. S. C. § 271. Product-by-process claims are recognized as legitimate forms of product claims, and courts have consistently ruled that such claims cover the product itself, not the process. A critical feature of US law is that product identity determines infringement — if a third party produces a product that is identical or substantially equivalent to the patented product, infringement is found, regardless of how the product was made. The leading case in US jurisprudence is Abbott Laboratories v. Sandoz, Inc. (2009). The Court of Appeals for the Federal Circuit (CAFC) held that for product-by-process claims, the focus should be on the final product, not the process used to produce it.

The court emphasized that protection is granted to the product itself, and if the accused product has identical characteristics, infringement is established. The same principle was upheld in Amgen Inc. v. F. Hoffmann-La Roche Ltd. (2009), where the Federal Circuit reiterated that product equivalency is the key criterion for infringement. Unlike earlier interpretations seen in India, US law does not require the patentee to prove that the accused infringer used the same process disclosed in the patent. Instead, if the final product is substantially identical, infringement is established. This principle provides strong protection for pharmaceutical companies and biotechnology firms, as it ensures that competitors cannot bypass patent protection by making trivial changes to the production process.

3. Comparative Analysis

of India, UK, and USA

Parameter India United Kingdom (UK) United States (USA) Governing Statute Nature of Protection

Scope

of Protection

Key Infringement Test Patents Act, 1970 (Sec 48) Product itself (after Vifor case) Product per se, process descriptive If the product is identical Patents Act,

(EPC)

Product itself (via EPO guidance) Product per se, process descriptive If the product is identical

35 U.S.C. § 101, 271

Product itself (via CAFC case law) Product per se, process descriptive If the product is identical Leading Case Vifor v. MSN (2024) Pioneer Hi-Bred (2001). Abbott v. Sandoz (2009) Limitation Limited clarity pre- Vifor Clarity established by

CAFC

Clarity established by

EPC/EPO

The legal treatment of product-by-process patents in India, the UK, and the USA has now converged to a large extent. Earlier, Indian courts required proof that the product was made using the exact process specified in the claim, thereby limiting the scope of protection. However, the Vifor judgment (2024) brought India in line with the positions in the UK and USA, where protection extends to the product itself, irrespective of the method of production. The UK follows the EPC model, and the USA follows the "identical product" test established by cases like Abbott v. Sandoz. This alignment benefits pharmaceutical companies and biotech firms, offering broader protection for novel products, even if they are produced using alternative processes.

The shift in India's position is significant for global patent holders, as it strengthens patent protection in India, deters infringers, and ensures parity with other key jurisdictions like the UK and USA.

7.

CONCLUSION

The concept of Product-by-Process (PBP) patents occupies a crucial space in the realm of Intellectual Property Rights (IPR), particularly in industries like pharmaceuticals, biotechnology, and chemicals, where product characterization is often challenging. This form of patent protection ensures that novel and inventive products, which cannot be distinctly described in structural terms, are still eligible for protection when defined through the process by which they are produced. The central idea is that while the process serves as a descriptor, protection is ultimately granted to the product itself, thereby strengthening the scope of patent rights. A comparative analysis of the legal frameworks governing Product-by-Process patents in India, the United Kingdom (UK), and the United States of America (USA) reveals both convergences and divergences.

Historically, India followed a restrictive approach, offering protection only for products that were explicitly derived from the specific process outlined in the claims. However, the landmark Vifor (International) Ltd. v. MSN Laboratories, Dr. Reddy's, and Corona (2024) case marked a paradigm shift in India's approach, bringing it in alignment with the principles followed in the UK and USA. The decision clarified that product-by-process claims protect the product per se, regardless of the process used to create it, provided that the product is novel and inventive. In the UK, product-by-process claims have been consistently treated as claims to the product itself under the guidance of the European Patent Convention (EPC) and jurisprudence from the European Patent Office (EPO) Board of Appeals.

The UK courts recognize that if a product is new and inventive, it should be protected as such, irrespective of the method of production. Similarly, the United States legal framework, guided by decisions like Abbott Laboratories v. Sandoz, Inc. (2009), emphasizes that infringement occurs if the accused product is identical or substantially equivalent to the patented product, regardless of the process by which it was made. From the comparative analysis, it is evident that the UK and USA frameworks offer smoother, clearer, and more consistent interpretations of product-by-process claims. The principle that the process is merely a descriptor, and that protection extends to the product itself, is well entrenched in both jurisdictions. In contrast, India’s earlier restrictive approach created legal uncertainty, which discouraged innovation and increased the risk of infringement loopholes.

However, the recent Vifor judgment has brought India’s stance closer to the global standard, offering greater protection to patent holders. Which Legal Framework is Better? Based on the analysis, the UK and USA frameworks are more effective in ensuring smooth and consistent protection for product-by-process patents. Their approach not only protects innovative products but also provides clarity for industry stakeholders, particularly in sectors like biotechnology and pharmaceuticals. The principle of focusing on the product rather than the process offers stronger protection for patentees and reduces litigation related to process comparisons. The broad protection granted in the UK and USA ensures that alternative methods of producing an identical product are also covered under the patent. This serves as a strong deterrent against patent infringement and promotes innovation.

In India, the shift from a process-restrictive approach to a product-centric interpretation following the Vifor judgment is a welcome change. However, some degree of legal and procedural clarity is still required. Indian courts must continue to follow and solidify this new approach in subsequent case law to eliminate any remaining ambiguity. Further, India's patent examination guidelines must explicitly incorporate the product-per-se principle for product-by-process claims, aligning it with the UK and USA standards. Proposed Changes for the Betterment of India’s Legal Framework While the Vifor judgment signifies substantial progress, further steps are necessary to achieve a smoother and more transparent legal framework for product-by-process patents in India. The following recommendations are proposed:

1. Legislative Clarity: Amend Section 48 of the Indian Patents Act, 1970 to explicitly incorporate

the principle that protection extends to the product itself, not merely the process. This amendment would eliminate the possibility of conflicting interpretations by courts.

2. Comprehensive Guidelines: The Controller General of Patents, Designs, and Trademarks

(CGPDTM) should issue revised examination guidelines for product-by-process claims, ensuring that patent examiners uniformly apply the principle of product-per-se protection. This will improve consistency and predictability in the examination process.

3. Judicial Precedent: Indian courts should continue to build on the Vifor ruling, developing a

consistent body of case law that reinforces the product-per-se approach. This will offer clearer guidance to industry stakeholders and reduce the likelihood of conflicting judicial decisions.

4. Awareness and Training: Conducting training sessions for patent examiners, legal

professionals, and industry stakeholders on the implications of the new product-by-process principles will enhance awareness and promote compliance. In conclusion, the evolution of India’s approach to product-by-process patents is a step in the right direction, especially with the shift from a process-centric view to a product-centric one. The Indian framework now mirrors the more robust and predictable systems of the UK and USA, which offer superior protection to patentees and foster innovation. However, further legislative, administrative, and judicial measures are required to strengthen the Indian framework. These changes will ensure that India’s patent regime remains aligned with global best practices, thereby attracting greater foreign investment, encouraging innovation, and enhancing India’s standing in the global intellectual property landscape.