Intra-cellular therapies Vs. Controller of patents- A case study

On July 6, dismissing the appeal filed by Intra-cellular Therapies , the Delhi High Court upheld the Controller's decision on the grounds of lack of novelty and non-patentability under Section 3(d) while choosing not to delve into the more rigorously contested inventive-step objection.  Besides dealing with the controversial coverage/  disclosure dichotomy, the discussion focused on the “person in the know” versus the "person ordinarily skilled in the art" and the missing link between bioavailability leading to enhanced therapeutic efficacy.

 Intracellular Therapies filed an application before the Indian patent office titled "Organic Compounds, in particular deuterated heterocycle fused gamma carbolines, used in the treatment of diseases involving 5-HT2A receptor, serotonin transporter (SERT) and related conditions" under Patent Application No. 201817033732.

After two rounds of hearings, extensive examination, disclosure of in vivo experimental data in the specification and submission of  affidavits

by the co-inventor, the Controller rejected the application on the grounds of lack of novelty, inventive step and non-patentability under

Section 3(d).

The Controller identified D1 and D7 as the closest prior art to conclude that the present invention lacks  novelty. For inventive step, the Controller observed that documents D4 to D6 disclosed the principle of using deuterated alternatives and thus it would be obvious for  a person skilled in the art to bring deuterated alternatives of known drugs disclosed in D1 and/or D7. On Section 3(d), the Controller observed that compound I -IV are same as those disclosed in D1 and D7 and thus fall under Section 3(d). The order was silent about the experimental data disclosed in the specification as well as the affidavit submitted by one of the inventors during the prosecution proceedings. 

Aggrieved by the order, the Appellant filed an appeal and made extensive submissions defending novelty , inventive step as well as Section 3(d) objection.

The Appellant contended that despite the Controller’s own admission in the first hearing notice  that multiple selections would be necessary to arrive at the presently claimed compounds , the objection on the ground of lacking  in novelty was introduced at a later stage of prosecution while issuing the second hearing notice. The Appellant also contended that  for assessing novelty, a single document must be considered as the closest prior art, whereas the Controller relied on multiple prior arts.

While extending their defense on inventive step , giving reference to judicial precedents , Appellant contended that impugned order is contrary to the principle laid down in cases of Hoffmann La Roche Vs. Cipla and Agriboard International Vs. Controller of patents . Appellant emphasized that the impugned order was silent about the inventor’s affidavit submitted by the Appellant on three occasions during the prosecution of the application and the experimental data disclosed in examples 5 to 7 of the specification. They contended that the order is contrary to the judgements passed in Milliken and the Reagents of the university of California .

On Section 3(d), the Appellant contended that the order is flawed as the  respondent failed to identify any ‘known’ substance, besides reaching an unsustainable conclusion by conflating the criteria required for evaluating novelty and inventive step and Section 3(d).

The Appellant also vehemently stressed on the fact that the corresponding European application examined against the very same D1 - D7 prior art, had received a European Search Opinion stating that claims 1–16 “appear novel” because no cited document disclosed the specific deuterated compounds claimed. The Indian Patent Office reached the opposite conclusion on the same prior art without substantiating the reason for arriving at such contradictory conclusion.

The Respondent countered each ground. On the aspect of selection invention, Respondent emphasized that the selection was routine and no inventive ingenuity was required for the same. It was contented by the Respondent that selecting the stated substituents from D1 (Example 1.21) yields Formula IV (Claims 4, 5-7) and  selecting the stated substituents from D7 yields Formula I–III exactly (Claims 1-3, 5-10).

 Relying on AstraZeneca AB v. Intas Pharmaceuticals Ltd. (2021 SCC OnLine Del 3746), the Respondent contended that since the  inventor(s) of the prior art and of the present application were the same (i.e., the appellant), the anticipation test should be applied from the perspective of the “person in the know” and not  the  "person ordinarily skilled in the art.

On Section 3(d), respondent contended that  Compound of formula I-IV are the same as disclosed in D1 and D7 , thus the same is considered to be a  “new form” of a  known substance. Relying on Novartis AG, the Respondent also contended that there was no technical advancement in terms of enhancement of therapeutic effect as the in vivo mouse/rat/dog data showed only improved pharmacokinetics/bioavailability and not an increase in therapeutic efficacy, which Section 3(d) specifically requires.

On the grant of patent in foreign jurisdictions, it was contended that the Patent rights are territorial and thus grants abroad do not bind the Indian Patent Office .

After considering the submissions made by Appellant as well as the Respondent, the Court upheld the Controller’s order.  

The Court accepted the Respondent's claim mapping to conclude that the claimed compounds were expressly recited in the prior art.  Referring to Astrazeneca AB and Boehringer Ingelheim vs. Vee Excel, the Court held that the Appellant’s “multiple selections” argument could not be accepted because once a compound is disclosed under the genus patent, specific disclosure is immaterial.

While dealing with the objection under Section 3(d), the Court reviewed the data placed on record in the specification (Example 7 (dog PK study) as well as the technical affidavit of one of the inventors. Applying Novartis AG's teaching of “efficacy” as therapeutic efficacy, the Court concluded that the data referred only to pharmacokinetics/bioavailability and did not exhibit any enhancement in therapeutic outcome. 

Citing Novartis AG (paras 180, 187, 189) and the Division Bench decision in Natco Pharma v. Novartis AG & Anr. (FAO(OS)(COMM) 178/2021, 24.04.2024), the Court reiterated that enhanced bioavailability is not, by itself lead to enhanced therapeutic efficacy and the link must be specifically established by research data that improved bioavailability actualy translates into a theraupeutic benefit.

Addressing the Appellant's concern on the affidavit being ignored by the  Controller, the Court expressly recorded that it had considered the co-inventor's affidavit on merits  but still found the data insufficient.

 The Court did not adjudicate upon the extensive arguments extended by the Appellant on Inventive Step, citing that since the rejection on both novelty and Section 3(d) was upheld, there was no requirement to address the inventive step objection.

To conclude, the coverage vs. disclosure / species over genus debate still requires more deliberation. A more pragmatic approach needs to be followed  when dealing with selection inventions and addressing the coverage/disclosure issue, besides the data requirement to satisfy 'efficacy'!

Ranjna Mehta-Dutt  

Partner | Attorney at Law | Patent Attorney

ranjnamehtadutt@iprattorneys.com