Patents On Life-Saving Drugs: Kerala High Court Directs Union Health Ministry And Department Of Pharmaceuticals To File Response

Taking serious note of the unaffordability of a life-saving patented medicine for breast cancer, the Kerala High Court on Thursday directed a competent officer of the union health ministry and the department of pharmaceuticals to file their response on the issue within a month.

The Court issued the direction after noting that the matter had to be taken up at the higher level.

Justice V.G. Arun warned that if the counter is not filed within the stipulated time, the court would be constrained to proceed with the case based on the "uncontroverted averments in the writ". 

During the hearing today, the counsel appearing on behalf of the Department for Promotion of Industry and Internal Trade (DPIIT) and the Controller General of Patents, Patent Department, Standing Counsel T.C. Krishna submitted that the situation to invoke Sections 92 and 100 for compulsory license of the patented drug as sought for in the plea, was not prevalent as of present.

The counsel further asked how far the court could interfere in this case, since the plea had sought that the drug be made available at a reasonable price. He questioned whether the Court could suggest what a 'reasonable price' would be to the government. 

In response to a question, advocate Rahul Bajaj clarified to the Court that cancer was not part of the list of the notifiable diseases list issued by the Central Government.

Advocate Maitreyi Sachidananda Hegde, the amicus curiae, submitted that the the authority to take decision under Section 92 or Section 100 of the Patent Act ought to be of the Joint Secretary level as the Assistant Patent Officer could not decide whether the issue falls within the government realm or not.

The Amicus also argued that the legal question which has been raised could be decided by the Court.

It was further submitted by the Amicus that the counter Affidavit that had been submitted by DPIIT and Patent Department suffered from certain drawbacks for not addressing whether reasonable discretion had indeed been exercised in the instant case or not.

This was refuted by the Counsel for the respondents stating that the government has to take the decision in this regard, before the Patent Department could go ahead with compulsory licensing or any other such measure. 

Advocate Bajaj, who represents an intervenor, pointed out that the right to health in Indian and International spectrum includes within its ambit the right to life-saving medicines, as well. Hence, the counsel submitted that the issue could not merely be looked into from a policy lens alone, but that it is a rights-based issue in itself. 

On September 16, 2022, the Court had taken suo motu cognizance of the issue of unaffordability of patented life-saving medicines, in light of the death of the petitioner who had espoused this cause having not been able to afford the Ribociclib drug for treatment of her breast cancer.  

The Court has posted the case for the next hearing on 2nd November 2022. 

Case Title: XXX v. Union of India