Taiho Pharmaceutical Co. Ltd. Vs. The Controller of Patents

The Delhi High Court recently set aside the refusal of patent application by the Indian Patent Office, reiterating the procedural rigor required for objections under Section 3(d) of the Patents Act, particularly in pharmaceutical inventions.

The appeal was filed by Taiho Pharmaceutical Co. Ltd. against the refusal of Indian Patent Application No. 7283/DELNP/2014 titled "Novel Piperidine Compound or Salt thereof." The Patent Office had rejected the application on grounds of lack of inventive step (Section 2(1)(ja)) and non-patentability under Section 3(d).

The Court, however, found that:

• The Controller failed to identify a specific 'known substance' from the prior art D1 in the hearing notice or the impugned order, a mandatory requirement for sustaining a Section 3(d) objection.

• As held in DS Biopharma v. Controller of Patents, the applicant must be given an opportunity to respond to a properly framed 3(d) objection, which includes:

  i. clear identification of the known compound,

  ii. reasoning for its structural similarity, and

  iii. a fair opportunity to show enhanced efficacy.

• The Patent Office instead relied on broad Markush structures without pinpointing any particular compound from D1, leaving the applicant unable to provide targeted efficacy data.

  
  

The Court held that:

• The rejection under Section 3(d) was procedurally flawed and thus unsustainable.

• Since the objection under Section 2(1)(ja) (inventive step) was intertwined with the Section 3(d) analysis, it too warrants reconsideration.

• The matter was remanded to the Patent Office for fresh consideration.

  
  

This judgment reinforces the procedural safeguards surrounding Section 3(d) objections, especially in pharmaceutical patents, and affirms that ambiguous citations of prior art cannot form the basis of a valid rejection.

Taiho Pharmaceutical Co Ltd vs The Controller Of Patents, (H.C. Delhi May 15, 2025), C.A. (COMM.IPD-PAT) 6/2022. Read the judgement copy here.