Calcutta High Court
Reata Pharmaceuticals Inc ... vs Deputy Controller Of Patents And Design on 12 June, 2025
Author: Ravi Krishan Kapur
Bench: Ravi Krishan Kapur
2023:CHC-OS:2305
OIPD-4
IN THE HIGH COURT AT CALCUTTA
ORIGINAL SIDE
(Intellectual Property Rights Division)
IPDPTA/22/2023
REATA PHARMACEUTICALS INC (OA/2/2018/PT/KOL)
VS
DEPUTY CONTROLLER OF PATENTS AND DESIGN
BEFORE:
The Hon'ble JUSTICE RAVI KRISHAN KAPUR
Date : 12th June, 2025.
Appearance:
Ms. Vindhya S.Mani, Adv.
Mr. Devesh Aswal, Adv.
Ms. Diya Mal, Adv.
...for the applicant.
Mr. Indrajeet Dasgupta, Adv.
...for controller.
The Court: This appeal has been filed under section 117A of the Act and
is directed against an order dated 2 June 2017, passed by the respondent No.
1, rejecting patent application no. 512/KOLNP/2010 dated 9th February 2010.
Briefly, the appellant had filed an application titled "NOVEL FORMS Of
CDDO METHYL ESTER", claiming priority to PCT Application No.-
PCT/US2008/009703 dated 14th August 2008.
On the receipt of the request for examination on 25 February 2011, the
application was examined. The application originally filed 18 claims. The First
Examination Report was issued on 14th October 2014. Subsequently, the
applicant filed a detailed response against the objection based in the FER on
7th April 2015.
2023:CHC-OS:2305
By, the impugned order, the subject application for patent was rejected
on the ground of not being patentable under sections 3(d) and 3(e) of the
Patents Act 1970.
It is contended on behalf of the appellant that in rejecting the above
application for patent, the respondent no.1 failed to appreciate and deal with
the evidence which had been filed by the appellant. In particular, the appellant
had in the Written Notes of Submissions filed before the respondent no. 1
relied on data from two test studies [BEAM (Form A) and BEACON (Form B)
(claimed)] which highlighted the therapeutic effect of CDDO-Me on human
patients who suffered from chronic kidney disease. In addition, therapeutic
efficacy was determined by the estimated glomerular filtration rate (eGFR),
which is the standard measure of kidney function in a patient. In this
connection, the appellant also relied on a Table filed along with the Written
Submissions dated 5.7.2016.
It is contended on behalf of the appellant that a comparison of the above
data would explain in detail studies undertaken in human patients suffering
with chronic kidney disease to test the efficacy of the claimed invention. The
results of the studies clearly show that the claimed invention is more effective
than the previously known compounds and that too when administered in
lower doses, patients showed greater receptiveness to the claimed invention. In
such circumstances, it is contended that the respondent no. 1 erred in passing
the impugned order without relying or dealing with the above technical and
scientific evidence.
2023:CHC-OS:2305
On behalf of the respondent authorities, it is fairly submitted that there
is nothing to suggest that the respondent no. 1 in passing the impugned order
has dealt with the above evidence which was admittedly relied on by the
appellant in the Notes of Submissions filed before the respondent no. 1.
In Novartis AG vs. UNI (2013) 6 SCC 1, it has been held as follows:
"Just increased bioavailability alone may not necessarily lead to an
enhancement of therapeutic efficacy. Whether or not an increase in
bioavailability leads to an enhancement of therapeutic efficacy in any
given case must be specifically claimed and established by research data."
Admittedly, the appellant had relied on and established the above data in
the Written Notes of Submissions which were filed before the respondent no.1.
The said data has been brought on record in terms of the decision in Ischemix
LLC vs. Controller of Patents, 2023 SCC Online Del 7519. All the clinical trial
data were brought on record in the form of comparative tables. Clear and
elaborate explanations were also provided with regard to the enhanced
therapeutic efficacy of the claimed data. Hence, it was obligatory on the
respondent no. 1 to deal with such evidence, regardless of the merits or the
demerits of the same. The respondent no.1 could not have determined the
efficacy of the claimed data unless the experimental and comparative data
provided were considered (Oyster Point Pharma Inc. vs. Controller of Patents and
Designs and Another, 2023 SCC Online Cal 2141).
In addition, the respondent has also failed to provide reasons for
considering the research data insufficient to establish the patentability of the
claimed invention nor did the authority provided reasons for rejecting the
application under section 3(d) or 3(e) of the Act.
2023:CHC-OS:2305
Reasons are an integral part of any order which reflect the views of the
decision maker. It is well settled that an order must be reasoned. In The State
Bank of India & Anr. vs. Ajay Kumar Sood MANU/SC/1040/2022, it has been
held as follows:
"A judgment culminates in a conclusion. But its content represents the
basis for the conclusion. A judgment is hence a manifestation of reason.
The reasons provide the basis of the view which the decision maker has
espoused, of the balances which have been drawn. That is why reasons
are crucial to the legitimacy of a judge's work. They provide an insight into
judicial analysis, explaining to the reader why what is written has been
written. The reasons, as much as the final conclusion, are open to scrutiny.
A judgment is written primarily for the parties in a forensic contest. The
scrutiny is first and foremost by the person for whom the decision is
meant-the conflicting parties before the court. At a secondary level,
reasons furnish the basis for challenging a judicial outcome in a higher
forum. The validity of the decision is tested by the underlying content and
reasons. But there is more. Equally significant is the fact that a judgment
speaks to the present and to the future. Judicial outcomes taken singularly
or in combination have an impact upon human lives. Hence, a judgment is
amenable to wider critique and scrutiny, going beyond the immediate
contest in a courtroom. Citizens, researchers and journalists continuously
evaluate the work of courts as public institutions committed to governance
under law. Judgment writing is hence a critical instrument in fostering the
rule of law and in curbing rule by the law."
Similar views have also been held in Agriboard International vs.
Controller of Patents and Designs, 2022 SCC OnLine Del 940 and Sr. Sapna
Nangia vs. The Assistant Controller of Patents and Designs 2023 SCC OnLine
Del 1098.
In view of the above, the impugned order is unsustainable and set aside.
The matter is remanded back to the Controller to hear the parties afresh after
2023:CHC-OS:2305
giving a right of hearing to the appellant. The above exercise is to be completed
within three months of the date of communication of this order. It is made
clear that there has been no expression or adjudication on the merits of the
case and all questions are left open to be decided by the respondent no. 1 in
accordance with law. With the above directions, IPDPTA/22/2023 stands
allowed.
(RAVI KRISHAN KAPUR, J.)
SK.
