Biosimilars are highly similar versions of already approved biologic medications. They are not identical to the reference product but are designed to have no clinically meaningful differences in terms of safety, purity, and potency. Biologic medications are medicines that are obtained from living cells and organisms, while biosimilars are medicines that are highly similar to previously approved biologics. Unlike generic drugs, which are identical to the original small-molecule medications, biosimilars are not exact copies of the reference biologic due to their complex nature, and they are difficult to copy. In other words, it’s almost impossible to make a medication that’s the same, especially in bulk.

Some examples of biologics and their clinical equivalents are:

• Semglee (insulin glargine-yfgn), a biosimilar to Lantus
• Amjevita (adalimumab-atto), a biosimilar to Humira
• Inflectra (infliximab-dyyb), a biosimilar to Remicade
• Byooviz (ranibizumab-nuna), a biosimilar to Lucentis

Patenting of Biosimilar products in India

The Indian Patents Act, 1970, replaced the Indian Patent and Design Act of 1911 to encourage innovation while safeguarding public interests. While biosimilars offer immense promise in making biologics affordable, patenting them under Indian law presents unique hurdles, particularly under Sections 2(1)(j), 2(1) (ja), 3(d), 3(e), and 3(j) of the Patents Act. This article focuses on strategic drafting techniques to navigate these hurdles effectively.”

The sections mentioned below are:

1. [section 2(1)(j)]: Overcoming Novelty Rejections

“Invention” means a new product or process involving an inventive step and capable of industrial application. As we are aware that biosimilar products are similar to biological products and hence are not considered to be novel, and hence face challenges to establish the novelty of the biosimilar product. Hence, in order to be patentable, one should have to draft the patent in such a way not to fall under the ambit of section 2(1)(j), of the Indian Patent Act.

To overcome inventive step, one must establish the following features:    

I. Incorporation of Novel Features in Formulation

II. Utilization of a Distinct Manufacturing Process

III. Differentiated Pharmaceutical or Pharmacological Profile

2) [Section 2(1)(Ja)]: Establishing Inventive Step

“Inventive step” means a feature of an invention that involves a technical advance as compared to the existing knowledge or having economic significance or both, and that makes the invention not obvious to a person skilled in the art. As the biosimilar products are closely similar to their biosimilar biologic reference compound, and hence it often becomes difficult to establish their inventiveness over the existing biologic compound.  Even though the product is novel, it does not always involve an inventive step. Because minor changes, such as the use of alternatives, the changed quantity of components, process step variation, and process parameter variation, are all considered to be obvious to a person skilled in the art, and hence it becomes very difficult to overcome the criteria of inventive step.

To overcome inventive step, one must establish the following features:

I. Technical advancement

Demonstrate Unexpected Technical Advantage to show the biosimilar or its process provides surprising, non-obvious results, such as improved stability, aggregation resistance, or solubility not expected from minor changes, higher yield or enhanced purification efficiency beyond routine improvements, reduced immunogenicity or improved safety profile not predicted from the formulation change.

II. Novel Process with Unpredictable Outcome

III) Non-Obvious Formulation or Delivery

1. Need to prove that combining specific excipients or delivery systems was not obvious due to incompatibility or prior failure.
2. Need to demonstrate unexpected pharmacokinetic improvement (e.g., faster onset, longer duration).

3) [Section 3(d)]: Navigating Therapeutic Efficacy Objections

The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. This provision is particularly relevant in biosimilar patent applications, where the claimed product is often a variant, modified form, or different presentation of a known biologic. In order to overcome section 3(d) we can use the following strategies:

4) [Section 3(e)]: Avoiding Mere Admixture Objections

a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof, or a process for producing such substance. While claiming composition for a biosimilar product, where the biosimilar is combined with known excipients, such as stabilizers, antioxidants, the invention will fall under section 3(e) of the Indian Patent Act. In order to overcome section 3(e) we can use the following strategies:

1. Prove synergistic or unexpected behaviour of components (e.g., an excipient unexpectedly enhances stability or bioavailability).
2. Demonstrate that individual components alone would not yield the same outcome.
3. Provide comparative experimental data to support functional advantage.

5) [Section 3(j)]: Patent Eligibility of Biological Material

Plants and animals in whole or any part thereof other than micro­ organisms but including seeds, varieties and species and essentially biological processes for the production or propagation of plants and animals. In practice, this section has been interpreted by the Indian Patent Office to also exclude inventions involving naturally occurring cell lines, unmodified genes, and purely biological processes from patentability. Biologic inventions relying on natural cell lines, Unmodified human or animal genes, or Isolated proteins or peptides identical to those in nature may be objected under Section 3(j), unless the claimed subject matter demonstrates technical human intervention or modification beyond natural form.

To establish patentability, the applicant must show that the claimed invention is not a discovery of something that exists in nature, but is rather a result of human ingenuity and technical intervention. The following strategies are effective:

1. Claim Man-Made or Engineered Biological Materials
2. Use of recombinant DNA constructs, synthetic genes, or engineered antibodies (e.g., Fc-fusion proteins, chimeric antibodies).
3. Claim modified gene sequences with codon optimization, added tags (e.g., His-tag, FLAG), or fusion partners.
4. Emphasize Human Intervention and Technical Process
5. Distinguish from Naturally Occurring Substances in terms of highlighting differences in structure, glycosylation, or formulation from the natural counterpart.

Why Biosimilar Patent Protection and Drafting Matter

With rising healthcare costs and increasing reliance on biologic therapies, biosimilars offer a critical path to affordable, accessible treatment especially in emerging markets. They promote cost savings, market competition, and wider patient access. However, for developers, biosimilars are not just a technical or regulatory challenge they are a strategic intellectual property (IP) exercise. Careful patent drafting and protection are essential to:

How PATHtoIP Supports Biosimilar Innovators

At PATHtoIP, we work closely with biosimilar developers to navigate this complexity. Our services include:

• Freedom to Operate (FTO) and white space analysis
• IP landscaping and process claim reviews
• Strategic filing advice for biosimilar formulations
• Strategic patent drafting for biosimilar formulations
• Risk mitigation in multi-jurisdictional filings

With decades of collective experience, we support innovators in clearing IP pathways while accelerating product readiness.

If you have any queries related to the Biosimilar search, please feel free to connect. At PATHtoIP LLP we ensure that every client receives exceptional results & insights through high-quality Intellectual Property research. As an experienced firm, we are dedicated to providing IP protection & delivering results capable of reaching your goals.