NCLAT rules CCI has no jurisdiction over patent disputes
Tribunal underscores that patent protections override competition law oversight, ruling that CCI cannot probe alleged anti-competitive conduct tied to patented drugs.
The NCLAT has ruled that the Competition Commission of India cannot probe disputes involving patented drugs, holding that the Patent Act prevails over the Competition Act.
Dismissing an appeal against a CCI order, in which the regulator had closed a complaint against Swiss pharma major Vifor International (AG), a two-member NCLAT bench said the 'Patent Act will prevail over the Competition Act'.
Citing the earlier judgments, NCLAT said: "Considering the judgment of the Delhi High Court in the case of Telefonaktiebolaget LM Ericsson (PUBL) and the Supreme Court in the SLP No. 25026/2023, it is apparent that the CCI lacks the power to examine the allegations made against Vifor International (AG)."
NCLAT, which is an appellate authority over the orders passed by the CCI, said Vifor International had the patent for Ferric Carboxymaltose (FCM) injection, which is required for the treatment of Iron Deficiency Anaemia (IDA).
"The Patent Act will prevail over the Competition Act in the facts of this case, as the subject matter of contention is FCM, which was developed and patented by Respondent No 2 (Vifor International). There is no dispute that Respondent No. 2 held the said patent at the relevant time," said the National Company Law Appellate Tribunal (NCLAT).
NCLAT, in a 14-page-long order, noted that Section 3(5) of the Competition Act protects a person holding a patent to restrain any infringement of or to impose reasonable conditions, as may be necessary for protecting their rights.
"The Competition Act, in Section 3(5), has laid down that the Competition Act will not restrict the right of any person in protecting his rights under the Patent Act," said NCLAT.
NCLAT order came over an appeal filed by one Swapan Dey, who is the CEO of a hospital providing free dialysis services to patients on behalf of the Government through a Private Pubic Partnership under Pradhan Mantri National Dialysis Programme (PMNDP).
He submitted that it is common for the patients under dialysis to develop Iron Deficiency Anaemia (IDA), for which the injection referred to as Ferric Carboxymaltose (FCM) injection is required for treatment.
Dey alleged that due to the anti-competitive and abusive conduct of Vifor International (AG), Switzerland, the FCM injections are neither accessible nor affordable to patients in large.
He had filed information with CCI, which, passing an order on October 25, 2022, closed the probe as prima facie it did not find any contravention on the part of Vifor either under Section 4 or Section 3(4) of the Act.
This CCI order was challenged before NCLAT by the petitioner, who submitted that CCI had failed to deal with the issue of ‘relevant market’ and had failed to assess the ‘dominant position’ of Vifor International.
Moreover, CCI committed an error in conducting ex-ante analysis instead of ex-post analysis for examining the violation of Section 3(4) of the Competition Act, he submitted.
He submitted that Vifor has given a license to Emcure Pharmaceutical for manufacturing FCM injections. It also entered into a second agreement with the drug major Lupin for the import and distribution of FCM manufactured by Vifor.
However, responding to it, Vifor International has challenged the jurisdiction of CCI and stated that since the molecule is governed by the Patent Act, CCI has no jurisdiction to consider the issue raised here. It also alleged that the appellant had approached the CCI with unclean hands, and similar issues were raised before the Delhi High Court.
Moreover, in its notes of submission, Vifor International informed a two-member NCLAT bench comprising Justice Yogesh Khanna and Ajai Das Mehrotra that the patent for FCM, which was granted on June 25, 2008, has expired on October 21, 2023. It is now passed into the public domain and is available for free exploitation by interested parties and consumers pan-India.
On this, NCLAT said that though now the patent on drug FCM has expired and it is now available in the public domain for manufacturing, it will examine whether the CCI has the power to examine the case, where the subject matter, being drug FCM, was protected by the Patent Act.
NCLAT said the Division Bench of the Delhi High Court in the case of Telefonaktiebolaget LM Ericsson (PUBL) held that the Patent Act will prevail over the Competition Act. This was challenged by CCI before the Supreme Court; however, the apex court recently on September 2, 2025 dismissed the plea.
"Following the judicial guidance as noted above, we hold that there is no merit in this appeal. Accordingly, the appeal is dismissed," said NCLAT.
(With inputs from PTI.)