Madras High Court Clarifies "Person Interested" Definition,
Rules in Favor of Patent Holder in Embio Limited vs. Malladi Drugs Case

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Madras High Court Clarifies "Person Interested" Definition, Rules in Favor of Patent Holder in Embio Limited vs. Malladi Drugs Case

The Madras High Court has delivered its ruling in the case of Embio Limited v. Malladi Drugs & Pharmaceuticals Ltd. (T)OP(PT) No.45 of 2023(ORA/35/2014/PT/CHN), wherein Embio Limited (Petitioner) sought the revocation of a patent granted to Malladi Drugs and Pharmaceuticals Ltd. (Respondent) for a method of preparing new chiral beta-amino alcohols from r(-) - phenyl acetyl carbinol. The judgment, delivered by Justice P.B. Balaji, addresses key aspects of patent law, particularly issues surrounding the validity of patents and the concept of a "person interested."

Embio Limited (Petitioner) sought to invalidate the patent granted to Malladi Drugs on the grounds of lack of novelty and inventive step.

The petitioner also claimed that they are person interested since both the Petitioner and the Respondent are in the same industry, dealing with similar kind of medicines.

Malladi Drugs (Respondent) defended the patent, claiming that the invention involved a novel process for synthesizing optically pure beta-amino alcohols, achieving higher yields and optical purity than prior arts.

Furthermore, the respondent argued that the petitioner was not a “person interested” in challenging the patent, pointing out that while petitioner claims to be manufacturing Ephidrine, the claim remained on paper and, they had not produced any material to establish the claim and merely claiming to be a leading manufacturer of ephedrine would not make the Petitioner, 'a person interested'.

The court first examined whether the petitioner qualifies as a "person interested" who is competent to challenge the patent granted to Malladi Drugs under Section 64 of the Patents Act, 1970.

Section 2(t) of the Act defines a “person interested” as someone who is engaged in or promoting research in the same field as the invention.

In this case, the petitioner argued that it manufactures Ephedrine and Pseudoephedrine salts and has a bulk manufacturing facility, while the Respondent also manufactures Active Pharmaceutical Ingredients (APIs), including DL-Ephedrine HCl, DL-Methylephedrine HCl, and Pseudoephedrine. The court noted that both parties operate in the same industry, dealing with similar chemicals, and thus the Petitioner has a direct interest in the matter.

The court relied on the Supreme Court's ruling in the Aloys Wobben and another, reported in (2014) 15 SCC 360 case, which clarified that the term ‘person interested’ is not static and even if he may not be a ‘person interested’ when the grant of the patent concerned was published and yet on account of his activities at a later point of time, he may assume the character or disposition of a ‘person interested’.

The court further relied on the M/s. La Renon case, held that ‘person interested’ is an inclusive definition and merely because the petitioner is not a manufacturer, he cannot be shut out from filing an application for revocation under Section 64(1).

Based on these legal precedents, the court concluded that being a competitor is enough to qualify as a “person interested,” and that the law does not require that the person interested should be only in manufacturing in the same field.

Thus, the court held that the petition filed by Embio Limited is maintainable under Section 64 of the Patents Act, 1970, and the case could proceed.

In this case, the Madras High Court broadened the definition of "person interested" under Section 2(t) of the Patents Act, 1970, and emphasized that it is inclusive and does not require that the person challenging a patent must be involved in the exact same manufacturing field as the patented invention. The competitor in the same industry can qualify as a "person interested" if they have a direct, present, and tangible interest in the matter.