Novelty assessment of combination inventions under Vietnam’s patent examination guidelines

Combination inventions are particularly important in the pharmaceutical field, where a claimed invention may involve two or more active ingredients that are administered or formulated together. The Vietnam’s patent examination guidelines provide specific guidance on how the novelty of combination inventions should be assessed, including the treatment of general disclosures, implicit disclosures, and inherent properties of the claimed combination.

General Principles

A claim directed to a combination is regarded as a product-type claim in which the product contains at least two active components. These components may be individual substances or groups of substances, for example, an EGFR inhibitor or an HIV integrase inhibitor.

When assessing novelty, the technical features of the claimed combination must be considered as a whole, rather than examining each component separately. Accordingly, the mere fact that individual active ingredients are separately known does not necessarily destroy the novelty of the combination.

Features relating to disease to be treated, dosing regimen, manner of use of individual active components, or similar features are regarded as features of a method of treatment and are therefore not considered when assessing the novelty of the combination itself.

An important principle is that a general disclosure of a combination does not destroy the novelty of a specific combination, whereas disclosure of a specific combination can destroy the novelty of a general combination.

In addition, novelty may be destroyed by features that are implicitly disclosed in prior art. If a skilled person can derive a specific combination from the prior art disclosure and carry out the corresponding embodiment, the combination may be considered disclosed even though it is not expressly stated.

The inherent properties of the combination or its components must also be considered. Where the prior art discloses all technical features defining the claimed combination, an additional feature may not preserve novelty if that feature is inherently present in the prior art disclosure. It is not necessary that the inherent property was recognized at the time the prior art document was published.

The following examples illustrate these principles.

Example 1: Individual components disclosed separately

Claim: A pharmaceutical composition comprising trastuzumab-MCC-DM1 and a chemotherapeutic agent selected from GDC-0941 or GNE-0390, together with pharmaceutical excipients.

Prior art: D1 discloses trastuzumab-MCC-DM1, while D2 separately discloses GDC-0941 and GNE-0390.

Assessment: The claim satisfies the novelty requirement because neither D1 nor D2 discloses the claimed combination as a whole. The fact that each active component is individually known does not destroy the novelty of their specific combination.

Example 2: Specific combination directly disclosed

Claim: A combination comprising preconditioned agents capable of increasing IL-15, IL-17, and at least one other specified cytokine for identifying patients suitable for cell therapy.

Prior art: D1 discloses an agent capable of increasing IL-15, IL-7, and one or more of the specified cytokines in connection with cell therapy.

Assessment: The claim does not satisfy the novelty requirement because the claimed combination has already been disclosed in D1. The feature “for identifying patients suitable for cell therapy” is considered a method-of-treatment feature and is not considered in assessing novelty.

Example 3: Implicit disclosure of a combination

Claim: A pharmaceutical combination of sepetaprost and timolol or a pharmaceutically acceptable salt thereof.

Prior art: D1 discloses sepetaprost and states that it may be used in combination with another glaucoma treatment, such as a β-blocker, which may be timolol.

Assessment: Although D1 does not expressly disclose the specific combination of sepetaprost and timolol, its disclosure is considered sufficient to implicitly disclose the claimed combination. Accordingly, the claim lacks novelty.

Example 4: Inherent Suitability of the prior art product

Claim: An intramuscularly injectable preparation comprising diclazuril and an iron complex, with additional active ingredients and in suspension form.

Prior art: D1 discloses a preparation containing diclazuril and an iron complex, together with vitamins and/or minerals, in suspension form. D1 further states that the preparation may be administered by injection.

Assessment: Although D1 does not expressly specify intramuscular injection, the disclosed preparation is entirely suitable for such administration. The claimed feature is therefore inherently present in prior art. The combination consequently lacks novelty.

Example 5: Inherent disclosure based on another prior art ocument

Claim: A combined pharmaceutical product comprising an EGFR inhibitor and a MEK inhibitor selected from specified compounds.

Prior art: D1 discloses AZD9291 and its use in combination with specified MEK inhibitors. D2 identifies AZD9291 as an EGFR inhibitor.

Assessment: The claim lacks novelty. Although D1 does not expressly characterize AZD9291 as an EGFR inhibitor, D2 establishes this property. Therefore, the combination disclosed in D1 inherently corresponds to the EGFR inhibitor/MEK inhibitor combination recited in the claim.

Key Takeaway

The novelty of a combination invention is assessed based on the combination as a whole, rather than by separately considering whether each individual component is known. Features relating to disease to be treated, dosing regimen, manner of use of individual active components, or similar features are regarded as features of a method of treatment and are therefore not considered when assessing the novelty of the combination itself.