Sanotize Research And Developement ... vs Lupin Limited And 2 Ors on 30 November, 2022

[Cites 8, Cited by 0]

Bombay High Court

Sanotize Research And Developement ... vs Lupin Limited And 2 Ors on 30 November, 2022

1. The present Appeal impugns an order dated 21 st October 2021, by which the Interim Application filed by Appellant (original Plaintiff) was dismissed and the ad interim order dated 6th October, 2021 stood vacated. By the said Interim Application, the Appellant had sought to restrain the Respondents (original Defendants) from manufacturing, selling and/or otherwise dealing with a nasal spray called "NOXGUARD", manufactured and marketed by Respondent No.1 as an advanced nasal spray which releases nitric oxide from natural sources and which kills 99.99% of virus within 2 minutes. The primary ground on which the injunction had been sought was that Respondent Nos.1 and 3 (hereinafter collectively referred to as "Lupin") had developed NOXGUARD by using Appellant's confidential 2/49 spm 3 Commercial Appeal (L) 29661-2021.doc information in breach of a Confidentiality Agreement dated 17 th May, 2021 entered into between Appellant and Lupin. Before adverting to the rival submissions, it is useful to briefly set out the following facts which are necessary to give a context to the submissions made and our findings thereon.

Brief Background

2. Appellant is a Canadian Corporation focused on developing and commercializing high-quality innovative pharmaceutical products. The founders/directors of the Appellant include one Dr. Gilley Regev, (a PhD in drug development and clinical trials), one Dr. Miller, (a pioneer in nitric oxide technology and therapeutic research) and one Ferid Murad, (co- recipient of the 1998 Noble Prize in medicine). With the outbreak of the SARS CoV-2 virus (COVID-19) the Appellant after substantial investment in research, development and clinical testing/efficacy studies, developed a Nitric Oxide Nasal Spray (NONS) which was a proprietorial, novel and unique technology/method in the form of a freshly prepared formulation i.e. a Nitric Oxide Releasing Solution (NORS) having a pH and dose which could safely be sprayed into the nasal cavity and was both safe and effective for the prevention and treatment of COVID-19. It was this product (i.e. NONS) and its development which the Appellant contends is its proprietary method which is both unique and had been developed solely 3/49 spm 4 Commercial Appeal (L) 29661-2021.doc by the Appellant. It is the Appellant's contention that NONS is both novel and unique because it is the first and only Nitric Oxide Nasal Spray, which uses a freshly prepared Nitric Oxide Releasing Solution (i.e. NORS) for the prevention and treatment of the COVID-19 virus.

3. In April 2020, the Appellant carried out phase 2 clinical efficacy studies/trials of NONS in Canada and the UK. The clinical trials carried out showed that the use of NONS significantly reduced the viral load of the COVID-19 virus and provided significant protective results for infections caused by the COVID-19 virus. In January 2021, the Appellant applied for regulatory approvals for the marketing and sale of NONS in various Countries. On 22nd February, 2021, NONS was approved for sale in Israel under the brand name ENOVID. On 23 rd March, 2021, an article appeared in a newspaper, which reported that " Israel, NZ approve sale of SaNOtize's anti-viral nasal spray"

4. On 15th April, 2021, Lupin, by three separate emails, reached out to the Appellant, inter alia, seeking to explore "the possibility of collaborating with SaNOtise Nitric Oxide Nasal Spray for marketing in India" and "to discuss possible partnerships for manufacturing and distribution in various countries of the world ". The very next day, i.e., on 16th April, 2021, Lupin applied to the Central Drugs Standard Control 4/49 spm 5 Commercial Appeal (L) 29661-2021.doc Organization (CDSCO) to obtain a test license to manufacture drugs for examination, test or analysis for five strengths of " Nitric Oxide Nasal Solution" which delivered a range of dosage of nitric oxide. The test license was stated to be required for research and development of the formulation for the US market. It is common ground that the Appellant became aware that Lupin had made such an Application only when Lupin filed its Reply to the Interim Application. It is also common ground that the said Application attached to it is only the press article dated 23 rd March, 2021 pertaining to the launch of NONS (labeled as Enovid) in Israel.

5. On 17th May, 2021 the Appellant and Lupin entered into a Confidentiality Agreement pursuant to which a Virtual Data Room was set up in order to facilitate the sharing of information. Thereafter, for a period of about 3 months, information pertaining to NONS was shared by the Appellant. However, by an email dated 18 th August, 2021, Lupin informed the Appellant that it had decided to officially disengage with the Appellant for both investment and distribution of NONS.

6. On 1st October, 2021 the Appellant learnt that Lupin was manufacturing, marketing and proposing for sale a Nitric Oxide Nasal Spray called NOXGUARD, the packaging of which stated as follows: 5/49

      spm                               6        Commercial Appeal (L) 29661-2021.doc



                               "Advanced Nasal Spray,
                             Releases Nitric Oxide from
                                  Natural Sources
                      kills 99.99% virus within two minutes"

The packaging material (box and insert) of NOXGUARD described it as an "Ayurvedic Proprietary Medicine" comprising only of Bijora Nimbu (Citrus Lemon i.e. citric acid) and Samudra Lavana (Sea Salt i.e. sodium cholride). The Appellant filed the present Suit on 4 th October, 2021 inter alia contending that NOXGUARD was infact nothing but NONS and had been developed by Lupin using the confidential information shared by the Appellant under the Confidentiality Agreement. On 6th October, 2021, this Court by an ad interim order was pleased to restrain Lupin inter alia from selling NOXGUARD.

7. Thereafter, pleadings were completed and the Interim Application was heard after which by the Impugned Order dated 21 st October, 2021 the Learned Single Judge was pleased to vacate the ad interim order dated 6th October, 2021 and dismiss the Interim Application. Thus, the present Appeal.

Submissions by Mr. Chinoy on behalf of Appellant A. Lupin had used Appellants confidential information as a springboard to develop, manufacture and sell NOXGUARD.

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8. The Appellant and its officers/directors were pioneers in nitric oxide technology and therapeutic research and had over the years developed various proprietary treatments for a range of diseases (bacterial, fungal and viral). Post the COVID-19 outbreak, the Appellant had, after substantial investment in research, development and clinical testing/efficacy studies, developed what was the first and only Nitric Oxide Nasal Spray in the world for the effective treatment and prevention of the COVID-19 virus. The fact that it was well known and in the public domain that the combination of a nitrate with an acid would result in the production of nitric oxide and also that nitric oxide had known viricidal properties was not disputed. However, what was not in the public domain and what was novel/proprietary was the Appellant's formulation of NONS/NORS. The Appellant, had, after research, development and clinical trials arrived at the formulation of NONS which had a specific pH and dose which was (a) safe to be sprayed directly into the nasal passage (without causing damage to the body tissues) and (b) was also effective to both prevent and treat the COVID-19 virus. It was this formulation of NONS of the specific pH and dose, which was both proprietorial and confidential. Lupin had been able to develop NOXGUARD with the specific pH level in such a short span of time and without any independent research and/or clinical trials only by virtue of having gained access to and having used the 7/49 spm 8 Commercial Appeal (L) 29661-2021.doc confidential information shared by the Appellant pursuant to the Confidentiality Agreement.

8.1. The sequence of events since the launch of ENOVID (i.e. NONS as labelled in Israel) left no manner of doubt that Lupin had used the Appellant's confidential information as a springboard to manufacture and sell NOXGUARD, a similar if not identical rival product in India. Reliance was placed upon the following dates and events to buttress the submissions, viz.

i. April, 2020 NONS had successfully undergone clinical efficacy testing and trials in Canada which had shown NONS to be both safe and effective in the treatment and prevention of the COVID-19 virus. ii. January, 2021 the Appellant applied for regulatory approvals for the marketing and sale of NONS under the brand name ENOVID in several countries.

iii. 15th April, 2021 Lupin addressed three E-mails to Appellant inter alia seeking to explore the possibility of collaborating with the Appellant for marketing and distribution of NONS in various countries as also in India.

iv. 16th April, 2021 Lupin applied to Central Drugs Standard Control Organization (CDSCO) for the grant of a test license for the purpose of examination, testing or analysis in respect of a Nitric Oxide Nasal 8/49 spm 9 Commercial Appeal (L) 29661-2021.doc Solution which delivered a range of dosage of nitric oxide. The application attached to it only the press article dated 23 rd March, 2021 which pertained to ENOVID.

v. 17th May, 2021 a Confidentiality Agreement was entered into between the Appellant and Lupin pursuant to which the Appellant set up a Virtual Data Room which permitted certain officers of Lupin to access and obtain the confidential information shared by Appellant.

vi. On 18th August, 2021 Lupin addressed an email to the Appellant discontinuing negotiations qua investment and distribution of NONS. vii. On 1st October, 2021 Appellant launched NOXGUARD with the following description on the box, viz.

"Advanced Nasal Spray, Releases Nitric Oxide from Natural Sources kills 99.99% virus within two minutes"

8.2. Lupin had, within a short span of approximately 45 days from terminating discussions launched NOXGUARD as a Nitric Oxide Nasal Spray without any independent research, development or clinical efficacy and safety trials. All the material which had been relied upon by Lupin in respect of the development and safety/clinical trials of NOXGUARD were only those pertaining to NONS/ENOVID. Lupin had not relied upon or produced any independent material and/or research and/or safety and/or 9/49 spm 10 Commercial Appeal (L) 29661-2021.doc clinical efficacy trials/reports in respect of NOXGUARD. Thus it was inconceivable for Lupin to have, in such a short span of time, developed a Nitric Oxide Nasal Spray of the specific pH and dose which was both safe for the human body and could also effectively kill 99.99% of viruses without making use of the confidential information shared by the Appellant. It was inconceivable for a Nitric Oxide Nasal Spray to be launched without there being any independent clinical safety trials. Therefore, the fact that no independent safety and/or clinical trials in respect of NOXGUARD were produced by Lupin made plain that Lupin had used the Appellant's confidential information as a springboard to launch NOXGUARD.

8.3. Achieving the specific pH was on account of the ingenuity, research and development of the Appellant. Achieving the specific pH entailed several clinical trials, which had been carried out by the Appellant. While it was certainly in the public domain that nitric oxide could be produced from a combination of sodium nitrite and citric acid what was not in the public domain and was accountable solely to the Appellant's ingenuity, research and development was determining the specific pH level which was both effective and safe for the prevention and treatment of the COVID-19 virus. It was this proprietorial and confidential information shared with Lupin pursuant to the Confidentiality Agreement 10/49 spm 11 Commercial Appeal (L) 29661-2021.doc of which the Appellant sought protection. In support of the contention that the Appellant was both entitled to the reliefs sought for and that such reliefs could in fact be granted, reliance was placed upon the following paragraphs from the judgment of this Court in the case of Zee Telefilms Ltd. Vs. Sundial Communications Pvt. Ltd.1, which held as follows:

"11. .. .. .. In Saltman Engineering Co. Ltd. v. Campbell Engineering Co. Ltd., (1948) 65 RPC 203 and in particular in the statement of principles in the judgment of Lord Greene (at page 213);

.. .. On the other hand, it is perfectly possible to have a confidential document, be it a formula, a plan, a sketch, or something of that kind, which is the result of work done by the maker upon materials which may be available for the use of anybody; but what makes it confidential is the fact that the maker of the document has used his brain and thus produced a result which can only be produced by somebody who goes through the same process."

AND at para 19 page 708 "19. .. .. .. In Coco case, Megarry J. observed that something that has been constructed solely from materials in the public domain may possess necessary quality of confidentiality; for something new confidential may have been brought into being by an application of skill and ingenuity of the human brain. Novelty depends upon the thing itself, and not upon the quality of its constituent parts. Indeed, often the more striking the novelty, the more commonplace its components.. .. .." Every aspect of the Lupin's conduct reeked of dishonesty and that the germ of the idea of a Nitric Oxide Nasal Spray was sowed in Lupin's "mind" only when ENOVID was launched in Israel. The mislabeling of NOXGUARD as a Proprietary Ayurvedic Medicine, failure of Lupin to show that any independent research and development, or any independent clinical or 1 (2003) 3 Mah LJ 695 11/49 spm 12 Commercial Appeal (L) 29661-2021.doc safety trials, any explanation how the specific pH level had been arrived at in respect of NOXGUARD all overwhelmingly made evident that Lupin had used the information pertaining to NONS as a springboard to launch its own rival product NOXGUARD.

B. Lupin had made false and misleading claims in respect of NOXGUARD in an attempt to conceal the fact that they had used the Appellant's confidential information.

8.4. Lupin's claim that NOXGUARD was an "Ayurvedic Proprietary Medicine" was patently false and dishonest. The only two ingredients of NOXGUARD, as stated on the packaging, i.e., "Bijora Nimbu (Citrus Lemon i.e. citric acid) and "Samudra Lavana" (Sea Salt, i.e., sodium chloride), could not by themselves, in the absence of a nitrate, produce nitric oxide. Lupin had, deliberately and dishonestly, described NOXGUARD to be an "Ayurvedic Proprietary Medicine" and falsely claimed that its composition only had two ingredients "Bijora Nimbu" (Citrus Lemon) and "Samudra Lavana" (Sea Salt). The dishonesty of Lupin was manifest from the following, viz., i. That Lupin had in its Application dated 12th August 2021 to Ministry of Health and Family Welfare (Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy) (Ayush Vibhag) for approval/issuance of manufacturing license for NOXGUARD stated 12/49 spm 13 Commercial Appeal (L) 29661-2021.doc that "Sodium Nitrate" was an "excipient" in the product NOXGUARD; ii. That Lupin had in its "Development Methodology for the NOXGUARD Formulation" which was annexed to the Affidavit-in- Reply specifically referred to sodium nitrate as an " Ingredient" and it was not included in the list of excipients.

iii. Lupin had in its product presentation for NOXGUARD issued on 3 rd October, 2021 stated "Nitric Oxide Nasal Spray is a safe and effective anti-viral and is designed to kill SARS - CoV2 in the Nose and prevent the virus from incubating and spreading to the lungs ". In the Affidavit-in-Reply, however, Lupin had stated as follows:-

"Since the efficacy of NOXGUARD had not been proved against the SARS-Cov 2 virus in particular, the application for the license [made to the ministry of Ayush] as well as the Draft Label submitted alongwith it, never specified that NOXGUARD is effective against the SARS Cov2 Virus"

iv. Lupin had in its product presentation for NOXGUARD stated that Lupin had with the relentless efforts of 1400 scientists indigenously developed a unique and advanced nasal spray device which releases nitric oxide. However, Lupin had not in any of its Affidavits referred to and/or disclosed any independent research and/or development carried out by them for the production of NOXGUARD. Additionally, Lupin had also not produced any safety and/or efficacy trials carried out independently by them for NOXGUARD.

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spm 14 Commercial Appeal (L) 29661-2021.doc v. Lupin's statement on the packaging of NOXGUARD namely " proven efficacy to kill 99.9% of virus 2 Mins " was a direct copy of that which appeared on ENOVID and was unsupported by any independent clinical trials carried out by Lupin for NOXGUARD. 8.5. Thus there could be no manner of doubt that Lupin had willfully and deliberately mislabeled NOXGUARD as an Ayurvedic Proprietary Formulation when in fact the same could never be so and this was done only in an attempt to create a smoke screen to distinguish NOXGUARD from NONS when in fact the two products were similar, if not identical. Such conduct amounted not only to patent dishonesty but also to fraud on the regulator and public in general. The Learned Single Judge had therefore gravely erred by holding that " The case is not about the manner in which the defendants conducted themselves " when in fact the conduct of the Respondents was absolutely central since the same pertained to the willful and deliberate misuse of the Appellant's proprietary and confidential information by Lupin to develop and launch a similar if not identical rival product.

C. The Learned Single Judge had completely misconstrued the Affidavit of Thomas Abraham, Appellant's expert and thus committed a patent error.

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spm 15 Commercial Appeal (L) 29661-2021.doc 8.6. The Learned Single Judge had gravely erred and completely misconstrued the Affidavit of Mr. Thomas Abraham (Appellant's expert witness) and the conclusions and findings of the Learned Single Judge in respect of the said Affidavit that (i) the Plaintiff "has more or less abandoned the case with which it came to Court. Instead it now seeks to project the argument that the Defendant's product is ineffective and cannot deliver what it claims. That is not the frame of the suit ." (ii) that "the Plaintiff has itself produced the Evidence Affidavit of an expert who says that the Defendants product cannot deliver Nitric Oxide " and that as "the ingredients are different. The resultant product, according to the Plaintiff, cannot be Nitric Oxide" (iii) that the Plaintiffs could not succeed as "its own expert accepts that the two products are entirely different. Indeed he asserts that the Defendant's product cannot possibly generate the same end result as the Plaintiff" (iv) that "the Plaintiff itself says that the defendants do not use these ingredients [Sodium Nitrite and Citric acid] and what the defendants do use cannot generate Nitric Oxide. " and (v) that there was an "inherent conflict between the claim in the Plaint and the evidence of the Plaintiff's own expert" were patently erroneous. This is because the affidavit of Thomas Abraham, had to be read and construed in the context of the case pleaded in paragraph 49 of the Plaint, where, the Appellant had, inter alia, pleaded (i) that the representation of NOXGUARD as an Ayurvedic product was incorrect and a deliberate misrepresentation made 15/49 spm 16 Commercial Appeal (L) 29661-2021.doc to subvert the approval process for what is a drug or device subject to regulation under the Drug Administration and Control Authority (DACA)

(ii) that the statement made on the packaging of NOXGUARD that the only ingredients were Bijora Nimbu (Citrus Lemon) and Samudra Lavana (Sea Salt) were an eye wash and a fraud on the drug regulator and members of the public as those substances by themselves could not result in the production of nitric oxide (iii) that one of the main ingredients of NOXGUARD was sodium nitrate which had been deliberately suppressed/concealed by Lupin and (iv) that NONS and NOXGUARD were essentially the same and/or similar product. It was in this context that Thomas Abraham had been asked to opine (i) whether NOXGUARD could be described as an Ayurvedic Proprietary Medicine and (ii) whether NOXGUARD was materially similar to Appellant's ENOVID. It was thus and in the context of what had been pleaded in paragraph 49 of the Plaint that the Appellant's expert, Thomas Abraham concluded viz., i. That the claim made by Lupin (in its packaging) that NOXGUARD was an "Ayurvedic Proprietary Medicine", whose only ingredients allegedly were Bijora Nimbu and Samudra Lavana was false and incompatible with its claim to be a delivery system of nitric oxide to prevent viral infections in human beings; and ii. That two products were materially similar.

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spm 17 Commercial Appeal (L) 29661-2021.doc Therefore, the Affidavit of Thomas Abraham when construed in the context of what was been pleaded in paragraph 49 of the Plaint could in no manner mean that the Appellant had (a) either abandoned its case that NOXGUARD was similar to NONS or that (b) the Appellant had accepted that the ingredients of NOXGUARD were different from NONS or that NOXGUARD was ineffective or could not produce nitric oxide. 8.7. The conduct of Lupin had been patently dishonest. The facts left no manner of doubt that Lupin had decided to manufacture and sell a Nitric Oxide Nasal Spray only upon seeing the novelty and uniqueness of the Appellant's product, i.e., NONS. Lupin thus used the confidential information obtained by them from the Appellant as a springboard to launch its own rival Nitric Oxide Nasal Spray. In the circumstances failure to grant injunctive relief would allow Lupin to succeed in such fraudulent and dishonest conduct. The impugned order was patently erroneous as the same contained findings which were plainly contrary to the evidence, facts and pleadings. The ad interim injunction which had been granted on 6 th October, 2021 ought to have been continued by the Learned Single Judge. Thus the present case was a fit case to warrant interference. Submissions by Dr. Tulzapurkar on behalf of Respondent No. 1

9. At the outset it was submitted that the Appellant's entire case 17/49 spm 18 Commercial Appeal (L) 29661-2021.doc was based only on breach of confidentiality and nothing else as the Appellant had given up its claim of breach of copyright. In any claim pertaining to confidentiality and/or breach of confidential information three things were necessary, (i) identification of the confidential information, (ii) whether in fact such confidential information was passed on and (iii) whether that confidential information was in fact used by the party/person of whom breach was alleged. Our attention was invited to paragraph 15 of the Plaint and from that it was pointed out that the Appellant's specific case pleaded qua confidentiality was, viz.,

15. With the onset of covid-19, Drs. Regev and Miller (who had by then incorporated the Plaintiff) turned their attention, and formidable expertise, to adapting and further developing the Plaintiff's Proprietary Method, ultimately resulting in a Nitric Oxide nasal spray (viz. NONS) which delivered gNO to the upper airway through a proprietary spray mechanism and provided a defence against infection by SARS-CoV-2. The unique features of NONS include the following;

a. The presence of precise quantities of "citric acid"

and "sodium nitrite", which when delivered at specific point, at specific pressure and in specific doses, effectively prevents the penetration of the target virus into human cells (this is hereinafter referred to as the "Plaintiff's Formulation"). The Plaintiff's Formulation is unique and sophisticated. Any arbitrary variation to the composition thereof would not serve the intended purpose of viral elimination or cause damage or adverse reactions to the human body. A concise explication of the Plaintiff's Formulation is given in Exhibit "C-1" in a sealed envelope;

b. The use the aforesaid Dual-Chamber Container, conceptualised, designed and executed by the Plaintiff to administer the Plaintiff's Formulation (this is hereinafter referred to as the "Plaintiff's Delivery System". A 18/49 spm 19 Commercial Appeal (L) 29661-2021.doc diagrammatic explanation of the Plaintiff's Delivery System is given in Exhibit "C-2" in a sealed envelope.

(Emphasis supplied) From the above, it was pointed out that it was the Appellant's specific case in the Plaint that the Appellant's formulation was unique and sophisticated because viz., i. It contained the presence of precise quantities of "citric acid" and "sodium nitrite"

ii. That any arbitrary variation to the composition of NONS would not serve the intended purpose of viral elimination.

iii. That the formulation had to be delivered at a specific point, specific pressure and specific dose in order to be effective; iv. That Appellant was using Dual-Chamber Container, conceptualized, designed and executed by the Appellant.

v. The formulation to be effective had to be administered by the said Dual Chamber Container.

9.1. After Lupin had filed its Affidavit-in-Reply, the Appellant had completely abandoned the case as pleaded in paragraph 15 of the Plaint. The Appellant had in its Affidavit in Rejoinder changed its stand to state that the essential parameters and characteristics of NOXGUARD fell squarely within the range which had been disclosed to Lupin under the 19/49 spm 20 Commercial Appeal (L) 29661-2021.doc Confidentiality Agreement. This stand of Lupin was diametrically opposite to that which was pleaded in paragraph 15 of the Plaint which inter alia spoke of precise quantities of citric acid and sodium nitrite. The Appellant had also conceded that NOXGUARD did not use the same dual chamber delivery mechanism that had been devised by and was being used by the Appellant. The case as pleaded in the Plaint was that the dual chamber delivery mechanism used by the Appellant was infact integral to the administration and efficacy of NONS. Thus the Appellant having conceded that Lupin was not using the dual chamber delivery mechanism, the specific case as pleaded in paragraph 15 of the Plaint was therefore ex facie untenable on the Appellant's own showing.

9.2. The Appellant had in specific response to the table depicting the differences between NONS/ENOVID and NOXGUARD as had been set out by Lupin in Annexure IV to Exhibit-A to the Affidavit-in-Reply, filed a document in a sealed envelope titled " Envelope C" along with its Affidavit in Rejoinder by which the Appellant responded to Annexure IV. The Appellant had in Envelope C contrary to the case pleaded in the Plaint now inter alia contended as follows viz., i. Citric Acid "a deviation, if any, in the quantity/volume of Citric Acid would not be significant or material to the production of 20/49 spm 21 Commercial Appeal (L) 29661-2021.doc gNO" and ii. Sodium Nitrite content "a deviation, if any, in the quantity/volume of Sodium Nitrite would not be significant or material to the production of gNO and its specific dose remains unchanged despite deviation in the quantities of the base components. Therefore the specific dose of gNO achieved by NOXGUARD would continue to be identical as the specific dose of gNO regardless of deviation in the quantity of Sodium Nitrite". What the Appellant had stated in Envelope C was plainly contrary to the specific case pleaded in paragraph 15 of the Plaint. In the Plaint, Appellant had specifically pleaded that the formulation was unique and sophisticated and any arbitrary variation to the composition thereto would not serve the intended purpose of viral elimination or cause damage or adverse reactions to the human body.

9.3. In any action for breach of confidentiality the primary burden lies upon the party alleging the breach to precisely identify the confidential information. A party who fails to identify such confidential information is not entitled to any interim reliefs. In support of this contention, reliance was placed upon the judgment of this Court in the case of Narendra Mohan Singh vs Ketan Mehta & Ors2 which held as follows, viz., 2 2015 SCC OnLine Bom 8761 21/49 spm 22 Commercial Appeal (L) 29661-2021.doc "16. Plaintiff in a breach of confidence action must address, viz.: (i) to identify clearly the information relied on; (ii) to show that it was handed over in circumstances of confidence; (iii) to show that it was information that could be treated as confidential; and (iv) to show that it was used, or threatened to be used, without his licence. At the stage at which we find ourselves today, i.e., an interlocutory stage, a plaintiff in this kind of action does not need to prove the second and fourth of these as he would at the trial of the suit. But they must still be satisfactorily addressed. The plaintiff must demonstrate, at a minimum, a seriously arguable case in relation to each of these four aspects. I read the words 'seriously arguable' as meaning 'eminently plausible', and it is this measure that mus be applied...

18. But there are two key sets of observations in Beyond Dreams that we might profitably use in this case. The first is what the learned singe Judge (S.C. Gupte J.) succinctly summarized as the sub- elements or sub-branches of confidentiality itself. Gupte J. held that the confidential information, properly so-called, must be identified. I understand this to demand a degree of precision in isolating what is or is not covered by the confidentiality sought. In the context of material that straddles the public domain and original works, I should imagine this to be of primary importance. Next, the confidential information so identified must be original and not in the public domain. As I have noted, in the plaintiffs' tabulation this is not done accurately. All manner of things are claimed to be original and fictionalized. Many are demonstrably not. Finally, in Gupte J.'s formulation, the material must be sufficiently developed to the extent that it lends itself to realisation. All these elements must exist and must be shown for the plaintiff to succeed. It is not enough to claim one or the other, nor is it possible for a plaintiff to lay claim to very many things as being original and than hope that some of them may, in the estimation of the Court, be found to be original (or, in this case, fictionalized). In three words: precision, originality, and fullness. All three must be seated at the heart of the plaintiffs cause in a breach of confidence action."

Dr. Tulzapurkar submitted that the Appellant in the present case had not only failed to specifically identify what the confidential information was but also that the Appellant had changed its stand in respect thereof. 22/49

spm 23 Commercial Appeal (L) 29661-2021.doc 9.4. Without prejudice to the above submission, he submitted that all the information required for the development of NOXGUARD was in fact available in the public domain. In support of this contention our attention was invited to the Respondent's Affidavit-in-Reply dated 13 th October, 2021 and the further Affidavit-in-Reply dated 18th October, 2021 and therefrom to the previously published literature regarding the preparation of nitric oxide products which discussed various ways to formulate nitric oxide including by mixing specific ratios of sodium nitrite and citric acid, the details of commercially available nitric oxide products that used dual chamber delivery system similar to the one used by the Appellant for production of nitric oxide, a US patent No.7875001B2 granted for the use of dual chamber bottles for nasal sprays, compilation of reported studies/articles regarding nitric oxide based anti-viral and use of nitric oxide for preventing infections, PCT patent No. WO 2011/085484 A1 regarding which pertinent to the use of nitric oxide based Nasal Sprays for treatment of respiratory infections such as cold and flu etc. Additionally it was pointed out that even the required levels of pH of the formulation and the acceptable concentrations of sodium nitrite for the treatment of viral infections in human beings was made available in the public domain by the Appellant's Patent Application No. WO 2015/138406 A1. It was well settled that information which was in the public domain was not capable of 23/49 spm 24 Commercial Appeal (L) 29661-2021.doc being treated as confidential. The Confidentiality Agreement itself provided that information which is in or becomes part of the public domain is not to be treated as confidential. Even assuming for the sake of argument that there was in fact some confidential information which was not in the public domain that had been shared by the Appellant, it was incumbent upon the Appellant to clearly and specifically identify that information and distinguish the same from what was available in the public domain. The Appellant had completely failed and neglected to specifically identify such confidential information from that which was available in the public domain.

9.5. He submitted that even the information shared by the Appellant pursuant to the Confidentiality Agreement was not shared in its entirety. He pointed out that in respect of the crucial aspects pertaining to NONS the Appellant had either not disclosed the specific details of the same or had then redacted the relevant portions of the same. The following important information relating to NONS/ENOVID was either redacted in or then did not form part of the said documents shared pursuant to the Confidentiality Agreement, viz.

i. the acid type chosen by the Appellant to produce nitric oxide and its precise concentration;

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spm 25 Commercial Appeal (L) 29661-2021.doc ii. the buffer capacity of the formulation;

iii. the pH of the Solution;

iv. the amount of gNO released per spray;

v. the pressure required for actuation per kg.

Lupin had set out the fact of such redaction/non-disclosure by the Appellant in Annexure IV of Exhibit A of its further Affidavit-in-Reply dated 18th October, 2021. The Appellant had in its response to Annexure IV of Exhibit A to the further Affidavit-in-Reply not disputed the fact that the acid type (i.e., citric acid) and quantity had been redacted. It was therefore inconceivable how the Appellant could then allege breach of confidentiality over precise quantities of citric acid when neither the name of the acid nor its quantity had been disclosed by the Appellant. Therefore, the conclusions reached by the Learned Single Judge in paragraph 17 of the impugned order were correct and the judgment of the Learned Single Judge did not warrant any interference with. It was plain that the case as pleaded by the Appellant, as more particularly set out in paragraph 15 of the Plaint, was completely negated by the Appellant's own showing and that the Appellant had (i) not only failed and neglected to identify the specific formulation of NONS, but also (ii) the Appellant had not, in the first place, made full and complete disclosure of all the relevant information.

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9.6              Dr. Tulzapurkar then submitted that since the present Appeal

was from an interlocutory order, to scope of challenge and/or interference therewith would be governed by the judgment of the Hon'ble Supreme Court in the case of Wander Ltd. & Anr vs Antox India P. Ltd. 3 Dr. Tulzapurkar placed reliance upon the following paragraphs from the judgment in the case of Wander Ltd. in support of his contention that the scope of interference by the Appeal Court with a interlocutory order was very limited, viz.

"9. Usually, the prayer for grant of an interlocutory injunction is at a stage when the existence of the legal right asserted by the Plaintiff and its alleged violation are both contested and uncertain and remain uncertain till they are established at the trial on evidence. The court, at this stage, acts on certain well settled principles of administration of this form of interlocutory remedy which is both temporary and discretionary. The object of the interlocutory injunction, it is stated "..... to protect the plaintiff against injury by violation of his rights for which he could not adequately be compensated in damages recoverable in the action if the uncertainty were resolved in his favour at the trial. The need for such protection must be weighed against the corresponding need of the defendant to be protected against injury resulting from his having been prevented from exercising his own legal rights for which he could not be adequately compensated. The Court must weigh one need against another and determine where the 'balance of convenience' lies"

The interlocutory remedy is intended to preserve in status quo, the rights of parties which may appear on a prima facie case. The court also, in restraining a defendant from exercising what he considers his legal right but what the plaintiff would like to be prevented, puts into the scales, as a relevant consideration whether the defendant has yet to commence his enterprise or whether he has already been doing so in which letter case considerations somewhat different from those that apply to a case where the defendant is yet to commence his enterprise, are attracted"

3 1990 (Supp) SCC 727 26/49 spm 27 Commercial Appeal (L) 29661-2021.doc

10. .....

11. ....

12. ....

13. ....

14. The appeals before the Division Bench were against the exercise of discretion by the Single Judge. In such appeals, the appellate court will not interfere with the exercise of discretion of the court of first instance and substitute its own discretion except where the discretion has been shown to have been exercised arbitrarily, or capriciously or perversely or where the court had ignored the settled principles of law regulating grant or refusal of interlocutory injunctions. An appeal against exercise of discretion is said to be an appeal on principle. Appellate court will not reassess the material and seek to reach a conclusion different from the one reached by the court below if the one reached by that court was reasonably possible on the material. The appellate court would normally not be justified in interfering with the exercise of discretion under appeal solely on the ground that if it had considered the matter at the trial stage it would have come to a contrary conclusion. If the discretion has been exercised by the trial court reasonably and in a judicial manner the fact that the appellate court would have taken a different view may not justify interference with the trial court's exercise of discretion. After referring to these principles Gajendragadkar, J. in Printers (Mysore) Private Ltd. v. Pothan Joseph [(1990) 3 SCR 713: AIR 1960 SC 1156]:

"..... These principles are well established, but as has been observed by Viscount Simon in Charles Osenton & Co. v. Jhanaton [1942 AC 130] '... the law as to the reversal by a court of appeal of an order made by a judge below in the exercise of his discretion is well established, and any difficulty that arises is due only to the application of well settled principles in an individual' The appellate judgment does not seem to defer to this principle. Submissions by Mr. Madon on behalf of Respondent No. 3.

10. The Appellant had through the different stages of the proceedings adopted changing stands in respect of its case on what it 27/49 spm 28 Commercial Appeal (L) 29661-2021.doc claimed was the confidential information. The Appellant has (i) in the Plaint, inter alia, pleaded a case of precise quantities of citric acid and sodium nitrite which were claimed to be proprietary and confidential (ii) in the Rejoinder, claimed that the essential characteristics of NOXGUARD fell within the range of parameters which had been disclosed and (iii) for the first time, in the arguments in the Appeal, had argued that what was confidential and proprietorial was the specific pH of NONS. The Appellant's contention that the information on how to arrive at the specific pH of NONS had been divulged to Lupin was itself entirely misplaced. In support of this contention our attention was invited to Lupin's Application dated 16th April, 2021 addressed to the CDSCO and it was pointed out therefrom that the same mentioned that the formulation proposed therein had a pH of 3.7 as also named the acid type for the proposed formulation was citric acid. This Application had been made well before execution of the Confidentiality Agreement dated 17 th May, 2021 and therefore before any information was shared by the Appellant. It was thus clear and beyond the pale of doubt that Lupin was aware of the required pH of the proposed formulation as also the acid to be used for the production of nitric oxide well before the Confidentiality Agreement had been entered into. 10.1. The specific pH of NONS/NORS could never be construed to be proprietary information as the Appellant had itself in Patent Application 28/49 spm 29 Commercial Appeal (L) 29661-2021.doc No.WO2015/138406A1 published on 17th September, 2015 had at numerous places spoken of and described the pH. It was pointed out from the said Application that the same mentioned a pH of 3.7. Our attention was then invited to paragraph 14 of the Plaint wherein the Appellant had specifically pleaded that no part of the said Application or of any patent issued in pursuance thereof contained any material in which confidentiality was claimed by the Appellant. The Appellant could not therefore now claim confidentiality in respect of the contents of the said Application as the same was in the public domain much prior to the Confidentiality Agreement having been entered into. The submission made by Dr. Tulzapurkar that the present Suit was not for enforcement of patent and/or copyright, but was purely for breach of confidentiality was reiterated. That the specific and precise pH of the Appellant's formulation was never disclosed to Lupin at the relevant time. All that was disclosed was that the pH in the Appellant's formulation was below 4 and no specific/precise pH was ever disclosed as contended by the Appellant. Thus there was no merit in the Appellant's contention pertaining to pH and the same was merely an afterthought since the Appellant's case in paragraph 15 of the Plaint had fallen through. Even assuming the pH of NONS had been disclosed, the same was immaterial as the pH of NOXGUARD and NONS were different. 29/49

spm 30 Commercial Appeal (L) 29661-2021.doc 10.2. The next contention of the Appellant, namely that, the concentration of sodium nitrite in NONS was also proprietary and confidential information was also entirely misplaced. In any event, without prejudice, the precise concentration of sodium nitrite in NONS was also never disclosed to Lupin and therefore the question of Lupin utilizing such information did not arise. What had been disclosed by the Appellant was merely that sodium nitrite "less than 0.2%" was used in the Appellant's formulation. He pointed out that the concentration of sodium nitrite in NOXGUARD was not less than 0.2% but was 0.2% which was greater than the range admittedly disclosed by the Appellant. From the Appellant's Patent Application it was pointed out that sodium nitrite levels of less than 0.2 were acceptable in formulations used on human beings and by virtue of the fact that this information was available in the public domain the same could not be claimed as confidential information. Moreover, without prejudice, Lupin was a leading pharma company and thus was well placed to independently develop and ascertain the most suitable concentration of sodium nitrite required to produce nitric oxide. Lupin had thus independently developed NOXGUARD by using publicly available information. Accordingly the impugned order did not warrant any interference with.

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spm 31 Commercial Appeal (L) 29661-2021.doc Mr. Chinoy's submissions in Rejoinder for the Appellant

11. The Appellant's contention that citric acid had been not disclosed was patently false. The " AMAR technical file" document which was a part of the documents which formed part of Exhibit-F to the Plaint (i.e. the confidential documents disclosed to Lupin) specifically disclosed at paragraph 1.2.2 read with the diagram/figure 1 of the ENOVID bottle that citric acid is used in NONS/ENOVID. Thus the contention that the acid type was not disclosed by the Appellant was thus patently false. The AMAR technical file document in table 1 thereof specifically mentioned that the content of sodium nitrite in NONS/ENOVID was "<0.2%". Lupin had accepted and confirmed in its second Affidavit-in-Reply that sodium nitrite content of "<0.2%" had been disclosed by the Appellant. Despite this submission/confirmation by Lupin, the Learned Single Judge concluded "for Sodium Nitrite component the precise percentage amount was redacted; only the ingredient was mentioned ". Such finding constituted an error apparent on the record.

11.1. Mr. Chinoy submitted that the Lupin had merely used a different gelling agent from that used by the Appellant which would not, in any manner, affect the essential identity of two products. He submitted that in an attempt to create a smoke screen that the two products were different, Lupin had also added sodium citrate as a buffer to the 31/49 spm 32 Commercial Appeal (L) 29661-2021.doc formulation of NOXGUARD. He submitted that although a buffer was not necessary the reason for adding sodium citrate as a buffer was that the same allowed Lupin to alter and/or reduce the content of sodium chloride and substantially alter/increase the quantity of citric acid and slightly increase the quantity of sodium nitrite without altering the specific pH and either the specific pH or dose/quantity of nitric oxide produced in NOXGUARD.

11.2. He submitted that Appellant after conducting extensive research, had concluded that a buffer capacity was not required for NONS and the introduction of a buffer would not yield better results. The buffer/sodium citrate had been added by Lupin only to enable them to alter the quantity of the ingredient of citric acid and sodium nitrite in a malafide attempt to show that two products were different when in fact they were not. He submitted that what was crucial to note was the fact that notwithstanding the addition of the buffer (sodium citrate) in NOXGUARD and the consequent increase in the quantity of citric acid and slight increase in Sodium Nitrite the crucial pH of the formulation and the crucial quantity/dose of NONS were substantially similar. 11.3. Lupin's contention that the information used by Lupin for developing NOXGUARD was already available in the public domain was 32/49 spm 33 Commercial Appeal (L) 29661-2021.doc patently false. The sequence of events were reiterated to point out that Lupin could not have independently produced NOXGUARD absent the confidential information shared pursuant to the Agreement dated 17 th May, 2021. The record reflected that Lupin had not carried out any independent research and/or experiments for the development of NOXGUARD nor had they conducted any clinical trial for proving the safety and efficacy of NOXGUARD. In these circumstances, it was not open for Lupin to contend that they had the requisite material/information for developing NOXGUARD or that the same was available in public domain prior to entering into their Confidentiality Agreement. Reliance was placed upon the judgment in Coco Vs. A N Clark (Engineers)4 which held;

"In particular where information of commercial or industrial value is given on a business like basis and with some avowed common object in mind, such as a joint venture or the manufacture of articles by one party for the other, I would regard the recipient as carrying a heavy burden if he seeks to repel a contention that he was bound by an obligation of confidence" [relied on in "Fraser Vs. Thames Television" (1984)1 QB 44 at Pg 64 [H].

11.4. Therefore, it was evident and beyond the pale of doubt that Lupin had arrived at the precise quantity of sodium nitrite for NOXGUARD from the confidential information shared with them by the Appellant as was evident from the following viz., 4 (1969) RPC 41 33/49 spm 34 Commercial Appeal (L) 29661-2021.doc i. The Patent Application dated 17th September, 2015 referred only to laboratory experiments (in vitro) conducted to show the efficacy of NONS against bacteria and against influenza H1N1 by using NONS of varying nitrite concentrations.

ii. The Patent Application did not specify a definite/specific quantity of sodium nitrite but only referred to varying nitrate concentrations. iii. On 16th April, 2021 Lupin had in its Application to CDSCO for the grant of a test license referred to five different strengths of Nitric Oxide Nasal Solutions which delivered a range of dosage of nitric oxide equivalent to a wide range of sodium nitrite from 0.1 mg to 0.5 mg. Had the information been in the public domain Lupin would not have listed a range of sodium nitrite.

iv. Lupin provided no explanation as to how from five varying quantities/strengths of sodium nitrite which had been referred to in their Application dated 16th April, 2021 made to CDSCO they suddenly have arrived at the figure/quantity of sodium nitrite content of 2 mg/ml (i.e. 0.2%) without having used the Appellant's confidential information regarding the quantity/content of sodium nitrite in NONS.

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spm 35 Commercial Appeal (L) 29661-2021.doc Thus clearly, Lupin had used the confidential information shared by the Appellant to arrive at the specific amount of sodium nitrite which was required for achieving the specific pH for NOXGUARD. The record when analyzed properly made glaring the fact that Lupin had misused the Appellant's confidential information qua the precise quantity of sodium nitrite in NONS to arrive at the specific/optimal pH for NOXGUARD. 11.5. That the figures regarding the formulation of NORS as stated in the Patent Application referred to by Lupin related only to laboratory (in vitro experiments) that had been conducted. These laboratory experiments and the facts and figures relating thereto could not, without considerable further experimentation and development as also without conducting extensive clinical trials for safety and efficacy, have resulted in the production of NONS/ENOVID. Since NORS was required to be sprayed directly into the nasal cavity of the human body in order to both treat and prevent COVID-19, the same specific pH of the nitric oxide could be achieved by the Appellant only after considerable development and research extensive clinical trials. Without such extensive research, development and clinical trials about the safety and efficacy, NONS/NORS could not have been developed or produced for use as a safe and effective treatment and preventive for the COVID-19 virus. This research and 35/49 spm 36 Commercial Appeal (L) 29661-2021.doc development along with clinical safety trials ensured the safe and effective usage of NONS/NORS and constituted both proprietorial and confidential information of the Appellant. Despite the Patent Application being in the public domain from 2011 and 2015 no one in the world had till the launch of ENOVID successfully produced and clinically tested a Nitric Oxide Nasal Spray for the treatment and prevention of COVID-19. It was reiterated that the Patent Application referred to and relied upon provided figures based only upon in vitro experiments and could not have by itself have enabled Lupin to produce NOXGUARD.

11.6. Though Lupin had claimed NOXGUARD had been developed with the relentless effort of 1400 Scientists indigenously nothing had been brought on record to support such contention. It was only to bypass the stringent testing requirements under the Drugs and Cosmetics Act, 1940 (DACA) necessary for a Nitric Oxide Nasal Spray that Lupin labeled NOXGUARD as an Ayurvedic Proprietary Medicine. If all the necessary information for making NOXGUARD was indeed in the public domain, then it was indeed inexplicable why Lupin had contacted the Appellant in April, 2021.

11.7. That as a matter of law in cases based on misuse of confidential information, the precise identity of the product and the 36/49 spm 37 Commercial Appeal (L) 29661-2021.doc confidential information is not necessary as long as two products are similar. A wrong doer who is misusing confidential information will always make embellishment in its product to cover up his wrong doing. Thus the Appellant was not required to establish that Lupin's impugned product (NOXGUARD) was identical in all respects with the Appellant's product (NONS/ENOVID). The Appellant only had to show that Lupin had wrongfully used the Appellant's confidential information as a springboard to develop and make its competing rival product, i.e., to say it has used the confidential information to produce a similar/competing product. Findings and conclusion

12. We have heard learned counsel at length, perused the pleadings and considered the case law cited. Before dealing with the submissions made by the Learned Senior Counsel for the Appellant we have to bear in mind the law laid down by the Hon'ble Supreme Court in the case of Wander Ltd. Vs. Antox India (P) Ltd.5 which does not permit the Appellate Court to interfere with the discretion exercised by the Court of first instance and substitute its own discretion except where such discretion has been shown to have been exercised arbitrarily or capriciously or perversely or where the Court of the first instance had ignored the well settled principles of law regulating the grant or refusal of interlocutory 5 1990 Supp SCC 727 37/49 spm 38 Commercial Appeal (L) 29661-2021.doc injunctions. Thus it is not upon us to reassess the material and seek to reach a conclusion different from the one reached by the Learned Single Judge solely on the ground that had we done so we might have come to a contrary conclusion. We have to only see if the discretion had been exercised by the Learned Single Judge reasonably and in a judicial manner and merely the fact that we would have taken a different view would not justify us in interfering with the order of the Learned Single Judge. This is the law laid down by the Hon'ble Supreme Court and we are respectfully bound by the same.

13. Even though it would seem there is some merits in the Appellant's submission that the germ of the idea for the manufacture of NOXGUARD was the launch of ENOVID in Israel that by itself is not enough to grant the Appellant the relief sought for. The Appellant's entire case is premised only upon a breach of confidentiality. It is thus necessary for the Appellant to succeed to unequivocally establish (a) what exactly the confidential information was (b) that the confidential information was shared with Lupin in confidence; (c) that the confidential information shared was not in the public domain; and (d) that Lupin made use of that confidential information in the manufacture of NOXGUARD. 38/49

spm 39 Commercial Appeal (L) 29661-2021.doc

14. In the present case it is crucial to note that it is not the Appellant's case that only the specific formulation of NONS had been shared with Lupin and that Lupin had merely replicated and/or used such specific formulation and manufactured NOXGUARD in breach of confidence. It is the Appellant's case that for over three months, a vast amount of confidential material pertaining to NONS had been shared with Lupin and that Lupin had by way of reverse engineering manufactured NOXGUARD from the information shared. From the information shared with Lupin it is the Appellant's case that the following information was both confidential and proprietorial and had been used by Lupin to formulate NOXGUARD, viz.

A) The specific quantities of sodium nitrite and citric ccid used in NONS.

B) The specific pH and dose of NONS.

C) The clinical trials successfully undertaken by the Plaintiffs for establishing the safety and efficacy of NONS in killing and treating the SARS CoV-2 virus.

It is therefore necessary to see if the Appellant has succeeded establishing the above.

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  spm                                 40        Commercial Appeal (L) 29661-2021.doc


A.     The specific quantities of sodium nitrite and citric acid in NONS:

15. It is not in dispute that the fact that nitric oxide is produced by a combination of sodium nitrite and citric acid is in the public domain. What the Appellant has claimed as confidential and proprietary was the specific quantities of sodium nitrite and citric acid contained in its formulation of NONS/ENOVID. After hearing parties, and considering the pleadings, the following position has emerged, viz.

(a) Citric Acid i. We find that the Appellant has failed to clearly establish where in the material relied upon as confidential, the precise quantity of citric acid used in NONS had been disclosed to Lupin. It in fact, appears that insofar as citric acid is concerned, both the acid type and quantity which was used in NONS had been redacted in the information shared. Lupin pointed out this fact in Annexure IV to its Affidavit-in-Reply, to which there was no denial by the Appellant. The Appellant thereafter merely stated that the acid name was to be found in the AMAR files which formed a part of Exhibit F-2. The Appellant, however, was unable as to point out where in the AMAR files the precise quantity of citric acid used in NONS had been mentioned.

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spm 41 Commercial Appeal (L) 29661-2021.doc ii. The Appellant had in its Rejoinder taken a stand which was different from the case pleaded in paragraph 15 of the Plaint. While the Appellant had, in paragraph 15 of the Plaint, pleaded that one of the unique features of NONS was the precise quantities of citric ccid and sodium nitrite, in Rejoinder, the Appellant had, contended viz., "Citric Acid "a deviation, if any, in the quantity/volume of Citric Acid would not be significant or material to the production of gNO".

iii. That the Application made by the Appellant to CDSCO which was admittedly well prior to the Confidentiality Agreement being entered into also mentioned that citric acid was proposed to be used by the Appellant in the formulation proposed.

(b) Sodium Nitrite :

i. Lupin had set out in Annexure IV that the Appellant had only disclosed that sodium nitrate was used in NONS and had not disclosed the precise/specific quantity thereof. The Appellant, had not disputed and/or denied this.

ii. Additionally, the Appellant had failed to point out where the specific quantity of sodium nitrite contained in NONS had been disclosed. The record, as shown to us, reflects that from 41/49 spm 42 Commercial Appeal (L) 29661-2021.doc the material shared the Appellant had qua the quantity of sodium nitrate used in NONS only disclosed that "quantity less than 0.2%". Thus only a range had been disclosed and not the precise quantity of sodium nitrate.

iii. The Appellant had in its Rejoinder pleaded a case different from the one taken in paragraph 15 of the Plaint. While the Appellant had, in paragraph 15 of the Plaint pleaded that one of the unique features of NONS was the precise quantities of citric acid and sodium nitrite, in rejoinder, the Appellant had contended viz., "Sodium Nitrite content "a deviation, if any, in the quantity/volume of Sodium Nitrite would not be significant or material to the production of gNO and its specific dose remains unchanged despite deviation in the quantities of the base components. Therefore the specific dose of gNO achieved by NOXGUARD would continue to be identical as the specific dose of gNO regardless of deviation in the quantity of Sodium Nitrite"

Thus, from the above, we find that the Appellant has not at this stage been able to unequivocally demonstrate that it had shared with Lupin the precise quantities of citric acid and sodium nitrite as contained in NONS. It is not 42/49 spm 43 Commercial Appeal (L) 29661-2021.doc only well settled that confidential information in respect of which an injunction is sought must be clearly and specifically identified but it is also the Appellant's specific case as pleaded in paragraph 15 of the Plaint that one of the unique features of NONS infact the precise quantities of sodium nitrite and citric acid contained therein. At this stage and without a trial it is not possible to conclude that the Appellant had infact shared the precise quantities of sodium nitrite and citric acid and that Lupin had infact made use of the same in formulating NOXGUARD. Subject to proper evidence being led by the Appellant the Appellant might be in a position to establish that it had shared with Lupin the specific quantities of both citric acid and sodium nitrite and that Lupin had made use of the same to formulate and manufacture NOXGUARD but the same is not possible at this stage and in the circumstances.

16. Another aspect which we must note and one which is not really pleaded in the Plaint is the argument advanced by the Appellant qua the introduction of a buffer i.e. sodium citrate in the formulation of NOXGUARD. It was the Appellant's submission that sodium citrate was introduced as a buffer to create a smoke screen in an attempt to establish that the two products i.e. NONS and NOXGUARD were different since the use of a buffer would permit the variation of the quantities or citric acid and sodium nitrite to be varied yet ensure that the resultant product was 43/49 spm 44 Commercial Appeal (L) 29661-2021.doc the same and/or similar. It is crucial to note that this is not the case in the Plaint but this submission infact militates against the Appellant's case pleaded in paragraph 15 of the Plaint in which the Appellant has pleaded that the specific quantities of citric acid and sodium nitrite were one of the unique features of NONS.

B. The specific pH and dose of NONS

17. The next contention of the Appellant was that it was the specific pH of NONS which was both confidential and proprietorial. This was so because a Nitric Oxide Nasal Spray which contained a high-level of pH could have harmful effects upon the human body and conversely a low pH could be of no efficacy. The Appellant had submitted that it had undertaken a lot of research and clinical trials in order to determine and arrive at the specific pH for NONS. The argument pertaining to pH was vehemently opposed by the Respondents who contended that did not find mention in the Plaint nor was it argued before the Learned Single Judge. However, we find that the specific pH level having being disclosed to Lupin is also one which is untenable at this stage for the following reasons, viz. i. Achieving the specific pH would necessarily be dependent upon the precise quantities of citric acid and sodium nitrite in NONS. As we have held above, the Appellant has at this stage not been able to 44/49 spm 45 Commercial Appeal (L) 29661-2021.doc conclusively establish that the precise quantities of either sodium nitrite or citric acid as contained in the formulation of NONS had been disclosed to Lupin. Additionally as we have held, the argument re sodium citrate as a buffer militates against the specific case with which the Appellant came to Court with. Even assuming that the use of buffer would result in the production of the same pH this is something which would have to be tested by both (a) evidence and

(b) if established in evidence, whether the same would be in consonance with the case pleaded in the Plaint. This would therefore necessitate a trial.

ii. Lupin, in the Application made to CDSCO in April, 2021, had mentioned that the formulation proposed by them would have a pH of 3.7. This was before the Confidentiality Agreement had even been entered into. Hence it was in the public domain.

iii. In any event the pH of NONS/ENOVID and NOXGUARD were infact not the same. The pH of NONS/ENOVID was 3.522 and that NOXGUARD was 3.72.

iv. The Appellant had not pointed out from the confidential documents where the specific pH of NONS had been mentioned/stated. That the confidential documents only revealed that NONS had a pH of below

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spm 46 Commercial Appeal (L) 29661-2021.doc C. The clinical trials successfully undertaken by the Appellant for establishing the safety and efficacy of NONS in killing and treating the SARS CoV-2 virus.

18. The Appellant had submitted that the clinical trials pertaining to the safety and efficacy of NONS were both confidential and crucial for the protection of NONS since the same determined the specific pH of NONS. The specific pH of NONS intern was crucial as a Nitric Oxide Nasal Spray having a high pH and could be harmful for the human body whereas a low pH would be ineffective. Therefore, before the launch of any Nitric Oxide Nasal Spray ascertaining the safe, effective pH was a crucial factor. In order to ascertain the safe and effective pH, clinical trials and not merely laboratory experiments, were essential. We find that while there can be no argument with this contention of the Appellant. However in the present case, NOXGUARD is being marketed and sold by Lupin as an Ayurvedic proprietary medicine and has been certified as such by the Ministry of Health and Family Welfare (Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy) (Ayush Vibhag). It was also pointed out from the relevant provisions of Drugs and Cosmetics (6 th Amendment) Rules, 2010 that such proprietary Ayurvedic medicine does not in fact need any clinical trials. Given this position at this stage the 46/49 spm 47 Commercial Appeal (L) 29661-2021.doc question of ascertaining whether Lupin has used/misused or relied upon the Appellant's clinical trials does not really arise. Dual Chamber Mechanism

19. Another aspect we find which would dis-entitle the Appellant from interlocutory relief is the fact that the Appellant has since filing of the Plaint abandoned its case on the use of the dual chamber mechanism by Lupin. The Appellant had, in paragraph 15 of the Plaint, pleaded that one of the unique features of NONS was the use of a proprietary spray mechanism referred to as the Appellant's delivery system. This delivery system was integral to the proper administration and efficacy of NONS since, NONS was delivered at a specific point, at specific pressure and in specific dose. The Appellant abandoned this case after filing of the Plaint. Having done so, clearly on the Appellant's own showing the Appellant's delivery system is an integral unique feature of NONS was missing in NOXGUARD. Therefore, admittedly, at this stage the Appellant could not sustain the case pleaded in paragraph 15 of the Plaint. Similarity between NOXGUARD and NONS

20. Another crucial factor which is imperative for the Appellant to establish to succeed on the springboard test is whether NOXGUARD and NONS can be said to be identical and/or similar products. While both claim to be Nitric Oxide Nasal Sprays it is crucial to note two following 47/49 spm 48 Commercial Appeal (L) 29661-2021.doc glaring differences:-

i. NONS/ENOVID claims to be a treatment and preventive for COVID- 19, NOXGUARD does not.

ii. NOXGUARD has been certified by the competent authority to be an Ayurvedic proprietary formulation, which NONS is not. We must admit that it is indeed befuddling that Lupin has claimed that the only two ingredients of NOXGUARD were Bijora Nimbu and Samudra Lavana when Lupin had viz.

i. In its Application dated 12 th August 2021 to Ministry of Health and Family Welfare (Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy) (Ayush Vibhag) for approval/issuance of manufacturing license for NOXGUARD stated that "Sodium Nitrate" was an "excipient" in the product NOXGUARD; ii. That Lupin had in its "Development Methodology for the NOXGUARD Formulation" which was annexed to the Affidavit-in- Reply specifically referred to sodium nitrate as an " Ingredient" and it was not included in the list of excipients.

Also Annexure IV to Exhibit-A of the further Affidavit-in-Reply accepts that the constituents of NOXGUARD and NONS were largely overlapping. However, once a product has been certified by the competent authority it is not for us at this stage to go into or behind such certification. The 48/49 spm 49 Commercial Appeal (L) 29661-2021.doc Appellant no doubt will have adequate opportunity to lead evidence to establish its contention that Lupin and NOXGUARD are similar if not identical products. The same cannot, however, be conclusively determined by us at this stage without the necessary evidence coming on record through the process of trial.

21. While concluding, we do note that we agree with the Appellant's submission pertaining to the findings of the Learned Single Judge in respect of the Affidavit of Thomas Abraham (Appellant's expert). We find that the Learned Single Judge has misread the Affidavit of Thomas Abraham. We find the Affidavit of Thomas Abraham is not a chemical analysis of NOXGUARD but an opinion which has been furnished on the basis of the stated ingredients of NOXGUARD. At the same time we find that this Affidavit of Thomas Abraham would not aid the Appellant in being granted the relief sought for. Respondents should be given an opportunity to cross examine Thomas Abraham, should the Appellant lead its evidence at the trial, and also the Appellant should be given an opportunity to lead its own expert evidence.

22. For the reasons set out above the Appeal is dismissed. Costs to be costs in the suit.

 (ARIF S. DOCTOR, J.)                              (K. R. SHRIRAM, J.)

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