Boehringer secures Patent Injunction for its Diabetes Drug – Empagliflozin

On May 30, 2024, the High Court of Himachal Pradesh granted an interim injunction in the patent infringement case filed by Boehringer Ingelheim International GmbH (“BI”) against Eris Lifesciences Limited. (“EL”). As a part of the case, the Court discussed different aspects of patent law, including the principles governing interim injunctions, the validity of patents, and the conduct expected of plaintiffs in patent proceedings.

BI filed a patent suit against EL, alleging infringement of its Indian Patent No. 268846, which covers the medicinal product Empagliflozin and its formulations used for the treatment of Type 2 Diabetes. During the pendency of the suit, BI sought an interim injunction to prevent Eris from manufacturing, selling, or marketing Empagliflozin tablets, claiming that EL’s product sold under the brand name “Linares-E” infringes its patent. BI had launched products covered by its patent under the brand names “JardianceR/Jardiance Duo” and “Glyxambi” in the years 2015 and 2018 respectively, which are commercially available.

BI primarily contended before the Court that it holds a valid patent, granted on September 18, 2015, and that BI has exclusive rights over the product. BI emphasized that Eris Lifesciences was marketing a product that directly infringed on its patent, causing substantial financial hardship and irreparable harm to its business. BI highlighted that the development of Empagliflozin involved significant research and investment, and that the patent-covered products had been commercially available in India for several years, which justified the grant of an injunction in its favor.

EL countered by questioning the validity of BI’s patent, arguing that it lacked inventive step based on prior art references, making the patent vulnerable. BI also argued that the patent of BI is not valid as it did not have enhanced therapeutic efficacy required under Section 3(d) of the Patents Act. It further argued that the patent had been invalidated in China and claimed that BI did not disclose this fact before the Court. EL also argued that its product provided a more affordable option for diabetes patients, aligning with public interest.

The court evaluated the arguments and evidence presented by both sides, and emphasized the importance of patent holders approaching the court with ‘clean hands.  The Court stated that plaintiffs have to disclose all relevant and material facts, including any adverse decisions regarding their patent. However, the court stated that BI’s failure to disclose the invalidation of its patent in China was not a serious lapse as the information was not related to the Indian patent and its validity. The Court therefore came to the conclusion that the lapse cannot be a ground for rejecting the interim injunction.

Based on facts before it, the court found that BI had established a prima facie case of patent infringement and that the balance of convenience was in its favor. The court stated that the BI had a duly registered patent with a successful commercial run, whereas EL did not have any registered patent pertaining to the infringing product. It also stated that El’s contentions relating to inventive step and Section 3(d) did not make BI’s patent vulnerable. The Court also concluded that public interest would not be relevant between commercial rivals as there are different mechanisms under the Indian patent law to handle public interest requirements.

In the light of its findings, the court decided in favor of Boehringer Ingelheim, and restrained Eris Lifesciences from manufacturing, selling, or marketing the infringing product during the pendency of the suit.

Relevant Paragraphs

While arriving at its decision, the Court delved into several important aspects of patent law such as principles for grant of interim injunctions, validity and vulnerability of patents, unclean hands and its import in patent cases, and the role of public interest in patent matters. We have extracted relevant paragraphs from the case for your review and reading.

17. The principles in general being followed for the purpose of grant of injunction in Patent matters as they stand summarized in Ten XC Wireless Inc. and Others vs. Mobi Antenna Technologies (Shenzhen) Co. Ltd., 2O11 SCC Online Delhi 4648 are as under:-

“(i) The registration of a patent per se does not entitle the plaintiffs to an injunction. The certificate does not establish a conclusive right.

1. There is no presumption of validity of a patent, which is evident from the reading of Section 13(4) as well as Sections 64 and 107 of the Patents Act.

iii.          The claimed invention has to be tested and tried in the laboratory of Courts.

1. The Courts lean against monopolies. The purpose of the legal regime in the area is to ensure that the inventions should benefit the public at large.
2. The plaintiff is not entitled to an injunction if the defendant raises a credible challenge to the patent. Credible challenge means a serious question to be tried. The defendant need not make out a case of actual invalidity.

Vulnerability is the issue at the preliminary injunction stage whereas the validity is the issue at trial. The showing of a substantial question as to invalidity thus requires less proof than the clear and convincing showing.

necessary to establish invalidity itself.

1. At this stage, the Court is not expected to examine the challenge in detail and arrive at a definite finding on the question of validity of the patent. That will have to await at the time of trial. However, the Court has to be satisfied that a substantial, tenable and credible challenge has been made.

vii.         The plaintiff is not entitled to an injunction, if the patent is recent, its validity has not been established and there is a serious controversy about the validity of the patent.”

18. Recently, the Hon’ble Division Bench of Delhi High Court in FAO(OS) (COMM 178/2021 and CM Nos.46299/2021, 46300/2021, 46301/2021, 46302/2021, 19118/2022, 19119/ 2O22 and 30850/2022, titled as Natco Pharma VS. NOVartiS AG and Anr., decided on 24.04.2024, on the point of Standard of Challenge to validity at interim stage has been pleased to hold as under:-

“39. At the outset, it is relevant to note that there is no presumption of validity of a patent by virtue of the same being granted by the Patent Office. Thus, the fact that the examiners have conducted necessary investigations prior to the grant of patent does not render a patent immune from challenge to its validity. The contention that there was no pre-grant or post-grant opposition to IN’i6i and.

therefore, Natco has to cross a very high threshold to assail the validity of the patent, is unmerited. The Act expressly enables a challenge to the validity of a patent at various stages. Section 25(1) of the Act enables any person to challenge the grant of a patent after the application for the patent has been published. This is, essentially, in aid of the examination process 6. In terms of Section 25(2) of the Act, an interested person can challenge the grant of a patent on the grounds as set out in the said sub-section, subject to the said challenge being raised within a period of one year from the date of publication of the patent. Section 64(1) of the Act also enables a person to file a petition for revocation of a patent on the grounds as set out in Section 64(1) of the Act. In terms of Section 64(1) of the Act, any person interested, or the Central Government is entitled to apply for revocation of the patent, either, by way of a petition or by way of a counter-claim in a suit for infringement on the grounds as set out in Section 64(1) of the Act. Additionally, in terms of Section 105 of the Act, any person is entitled to institute a suit for declaration, that the use by him of any process, or the making, use or sale of any article by him does not, or would not constitute infringement of a claim of a patent.

40. It is also material to note that there is.

no statutory provision similar to Section 31 of the Trade Marks Act, 1999, which posits a statutory presumption of validity on grant of a patent. It is also relevant UCB Parchim Sa v. Cipla Ltd. 8z Ors.: 2O1O SCC OnLine Del 523 to refer to Section 13(4) of the Act, which expressly provides that the investigation required under Section 12 of the Act – the pre- grant investigations and inquiries leading to the grant of patent – does in any way warrant the validity of any patent.

41. Absent any statutory presumption and given the scheme of the Act, which enables challenge to the validity of a patent at several stages, there is neither any presumption as to the validity of a patent nor renders the patent immune for challenge to its validity.
42. Thus, in an action for infringement of a patent, defence as to the invalidity of the patent on the grounds as provided in Section 64(1) of the Act, is available to the defendant. The court is required to examine the challenge with an open mindset and not from the standpoint of an assumption that the patent is validly granted.
43. Unless there is no real prospect of the defendant to succeed in its challenge and an appropriate application to allow the action is made prior to framing of issues, the questions as to the validity of the patent asserted, are.

required to be determined at the trial. However, at the stage of interim relief, the defendant has to establish its assertion that its defence is not insubstantial and sets out a credible challenge to the validity of the patent. The defendant is not required to establish that the patent is invalid, it has to merely show that the patent is vulnerable. If the challenge raised to the validity is substantial, the threshold standard for resisting an interim injunction in this regard –

subject to other relevant considerations -would be met. In this context, it is relevant to refer to the decision of the Division Bench of this Court in F. Hoffmann-LA Roche Ltd. 8z Anr. v. Cipla Ltd.7. In the said case, the Division Bench had rejected the contention that the defendant had a heavy burden to discharge and would have to establish a stronger prima facie case than the plaintiff. The Division Bench had also not accepted the contention that since there is a multi-level examination of opposition to the grant of patent, it ought to be accorded the highest weightage. The relevant extract of the said decision is set out below:

“53. The plea of the plaintiff that since there is a multi- layered, multi-level examination of the opposition to the grant of patent it should accorded the highest weightage, is not entirely correct. The contention that there is a heavy burden on the defendant to discharge since it has to establish that it has a stronger prima facie case of the plaintiff is contra indicated of the decisions in the context of Section 13(4).

Reference may be made to the decisions in Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries, (1979) 2 SCC 511 : MR 1982 SC 1444: Supp (1) PTC 731 (SC), Standipack Pvt. Ltd. v. Oswal Trading Co. Ltd., AIR 2OOO Del 23 : (1999) 19 PTC 479 (Del), Bilcare Ltd. v. Amartara Pvt. Ltd., (2007) 34 PTC 419 (Del), Surendra Lal Mahendra v. Jain Glazers, 1980 SCC OnLine Del 219. In Beecham Group Ltd.

1. Bristol Laboratories Pty Ltd., (1967-1968) 118 CLR 618 and Australian Broadcasting Corporation v. O’Neill, (2006) 229 ALR 457 it was held that the defendant alleging invalidity bears the onus of establishing that there is “a serious question” to be tried on that issue. In Hexal Australai Pty Ltd. v. Roche Therapeutics Inc., 66 IPR 325 it was held that where the validity of a patent is raised in interlocutory 2009 SCC OnLine Del 1074 proceedings, “the onus lies on the party asserting invalidity to show that want of validity is a triable question.”

In Abbot Laboratories v. Andrx Pharmaceuticals Inc. (decision dated 22nd June 2006 of the U.S. Court of Appeals for the Federal Circuit 05- 1433) the Court of Appeals followed its earlier ruling in Helifix Ltd. v. Blok-Lok Ltd. 208 F.3d 1339 where it was held (at 1359): “In resisting a preliminary injunction, however, one need not make out a case of actual invalidity.

Vulnerability is the issue at the preliminary injunction stage, while validity is the issue at trial. The showing of a substantial question as to invalidity thus requires less proof than the clear and convincing showing necessary to establish invalidity itself.” (emphasis supplied) In Erico Int’ll Corprn v. Vutec Corprn (U.S. Court of Appeals for the Federal Circuit, 2007- 1168) it was held that the “defendant must put forth a substantial question of invalidity to show that the claims at issue are vulnerable.”

54. In the present case, the grant of a patent to the plaintiffs for Erlotinib Hydrochloride as a mixture of Polymorphs A and B will not ipso facto entitle them to an interim injunction if the defendant is able to satisfy the court that there is a serious question to be tried as to the validity of the patent. The use by the learned Single Judge of the expressions “strong credible challenge”, “arguable case” or that the defendants claim being not unfounded, cannot be termed as vague and inconsistent since they convey the same meaning in the context of the strength of the defendant’s challenge.
55. The question before this Court is when can it be said that the defendant has raised a credible challenge to the validity of a patent held by the plaintiff in an infringement action? During the course of the argument it was suggested by counsel that the challenge had to be both strong and credible. Also, the defendant resisting the grant of injunction by challenging the validity of the patent is at this stage required to show that the patent is “vulnerable” and that the challenge raises a “serious substantial question” and a triable issue. Without indulging in an exercise in semantics, the Court when faced with a prayer for grant of injunction and a corresponding plea of the defendant challenging the validity of the patent itself must enquire whether the defendant has raised a credible challenge. In other words, that would in the context of pharmaceutical products, invite scrutiny of the order granting patent in the light of Section 3(d) and the grounds set out in Section 64 of the Patents Act, 1970. At this stage of course the Court is not expected to examine the challenge in any great detail and arrive at a definite finding on the question of validity. That will have to await the trial. At the present stage of considering the grant of an interim injunction, the defendant has to show that the patent that has been granted is vulnerable to challenge.

Consequently, this Court rejects the contentions of the plaintiffs on this issue and affirms the impugned judgment of the learned Single Judge”

44. It is also relevant to refer to the decision of the learned Single Judge of this Court in Astrazeneca AB & Anr. v. Intas Pharmaceuticals Ltd.8. In the said case, the learned Single Judge rejected the contention that since the suit patents were old, they should be presumed to be valid. The learned Single Judge did so for two reasons. First, the learned Single Judge found – much like in the present appeal where it is the stated case that ELT-O is covered under both IN’ 176 and the suit patent IN’ 161 – that there was an overlap in the genus patent and the species patent. And second, that the presumption of validity exists only till such time the patent is challenged and the challenge is credible. The relevant extract of the said decision is set out below:

“51. Furthermore, the argument advanced on behalf of the plaintiffs that since the suit patents are old and thus, should be presumed to be valid cannot be accepted for two reasons.

625. First, there is a period of overlap between the genus patent i.e. IN 147 and the species patent i.e. IN 625. The defendants, in this case, chose to wait [in line with arguments advanced in their defence of the suit actions] till such time the validity period of the genus patent i.e. IN 147 expired.
626. Second, as indicated above, the scheme of the Act does not foreclose the right of the defendants in defence to an infringement action to question the validity of the patent. Section 107 of the Act, expressly confers a right on the defendants to raise, in defence, in an infringement suit, all those grounds on which the patent can be revoked under Section 64 of the very same Act. Therefore, the judgment in Bristol-Myers Squibb Company v. J.D. Joshi, 2015 SCC OnLine Del 10109, if read in context, would demonstrate that it has not emasculated the right of the defendant, as conferred under the Act, to challenge the validity of the patent.

The presumption of validity exists only till such time the patent is challenged – a challenge which is credible and no further. In my opinion, if the plaintiffs’ argument was to be accepted, then, it would have to be held that the older the patent, the stronger the firewall. Such an interpretation, in my view, would be contrary to the plain words of the Statute.”

19. As I have already mentioned hereinabove, the test which the defendant has to cross to deny the plaintiffs the interim relief during the pendency of the Civil Suit is that the subject patent is “vulnerable”. This Court reiterates that it understands the difference between “vulnerability” and “validity”, i.e., to say that at this stage this Court is not venturing into the issue as to whether subject patent is valid or not and only thing which this Court would decide is as to whether the defendant has been able to lay a “credible challenge” to the subject patent by demonstrating that the subject patent is “vulnerable” on three grounds urged in this regard by learned Senior Counsel appearing for the defendant or not.

2O. The contention of the defendant as submitted by learned Senior Counsel is that the subject patent lacks inventive steps as compared to the prior art documents. The main argument of the defendant revolves around the aspect of vulnerability of the plaintiffs patent on account of obviousness [Section 64(1)(f)] and on account of lack of therapeutic efficacy [Section 64(1)(k) r/w 3(d)]. As per the defendant, the suit patent is not an invention within the meaning of Section 2(j) and there is no inventive step within the meaning of Section 2(1)(j a). In addition, there is no enhancement of therapeutic efficacy and the patent is hit by Section 3(d) of the Patents Act, 1970. The defendant has cited the following prior arts:-

“A. W02001027128-Dapa 1; and

B   W02003099836 -Dapa 2″

As per the defendant, Dapa 1- a Markush patent- provides 8o exemplified examples. Of these, the starting point is example 12 (provided in the specification of Dapa 1). The only difference between example 12 of Dapa 1 and Dapa 2 is the substitution at one position from Ethoxy to Methoxy. A Person skilled in the art, after a combined reading of Dapa 1 and Dapa 2, would be motivated to make substitutions at the same position. The specification of the impugned patent shows no technical advance over Dapa patents.

The specification of Dapa 1 clearly states that SGLT 2 inhibitors are helpful in normalizing blood sugar. Dapa 1 was the first invention to state that SGLT 2 inhibition is helpful for controlling diabetes and thus SGLT 2 inhibitors got the name Gliflozins. Suit patent teaches exactly what Dapa 1 taught and that there is no technical advance.

Technical advancement needs to be shown from the patent specification. Thus, the arguments of the defendant on the aspect of vulnerability of plaintiffs’ patent are on account of obviousness and also on account of therapeutic efficacy.

21. The specifications of Dapa 1 clearly stated that SGLT 2 inhibitors are helpful in normalizing blood sugar. Dapa 1 was the first invention to state that SGLT 2 inhibition is helpful for controlling diabetes and thus SGLT 2 inhibitors got the name Gliflozins.

According to the defendant, the suit patent teaches what Dapa 1 taught and that there is no technical advance and the technical advancement needs to be shown from the patent specification and since a POSA would be motivated to make structural changes at the same position to come to compounds showing similar activity vis-a- vis Dapa 1 and the suit patent, therefore, the subject patent is nothing but an ever greening of the earlier existing art and such patent is vulnerable. Its contention is that as far as the subject patent is concerned, Methoxy in example 12 of Dapa 1 has been replaced by tetrahydrofuranyloxy (THF) in the subject patent. According to the defendant, in Dapa 2 Astra Zeneca attempted to do exactly the same and this was held to be obvious by the High Court of Delhi in Astrazeneca AB and another Vs. Torrent Pharmaceuticals Ltd., 2020 SCC Online Del. 1446. As per the defendant, the inventive step and technical advance has to have its genesis in the patent specification and the plaintiffs were required to state in the specification how suit patent has a technical advance over Dapa and as the subject patent failed to do so, therefore, the same is vulnerable.

22. It has also been argued on behalf of the defendant that the application for grant of interim is liable to be rejected on the ground that the plaintiffs have not approached the Court with clean hands. It is contended by the defendant that the same patent of plaintiff No. 1 having been invalidated by the Supreme People’s Court of the People’s Republic of China, having been concealed in the plaint itself deserves dismissal of the application. According to the defendant, as the plaintiff did not approach the Court with clean hands, therefore, no indulgence can be shown to the plaintiffs. To substantiate this argument, reliance has been placed on the following judgments:-

“1. Freebit As Vs. Exotic Mile Private Limited, FAO (OS) (COMM) 15/2024 and CAV43/2024 and CM Nos. 5698/2024, 5699/2024 & 5700/2024.

2. Natco Pharma Vs. Navartis AG and anr. FAO (OS) (COMM) 178/2021 and CM Nos. 46299/2021, 46300/2021, 46301/2021, 46302/2021, 19118/2022, 19119/2022 and 30850/2022.”

The defendant has also referred to the affidavit filed by an expert Dr. Prabuddha Ganguli and argued that the expert has clearly held that there is no inventive step involved in the subject patent and the same is an ever greening of an already exiting patent and thus, as the defendant has demonstrated the vulnerability as far as the subject patent is concerned, therefore, the application for grant of interim injunction is liable to be dismissed.

23. On the other hand, the contention of the plaintiffs is that the so called ever greening of an existing patent by plaintiff No. 1- Company is incorrect. According to the plaintiffs, there is an inventive step involved over and above the existing arts and, therefore, it cannot be said that the subject patent is an ever greening of an already existing patent. Empagliflozin is a highly potent SGLT2 inhibitor (EC50 1-3 nM) and has a high selectivity for SGLT2 over SGLT1. The selectivity of Empagliflozin (>2500 is higher than the selectivity of Dapagliflozin (around 1200) which in turn has a higher selectivity than the compound of Example 12 (around 900 of IN ‘147. Therefore, in view of the improved selectivity, Empagliflozin has a technical advancement over Dapagliflozin (WO ‘836/IN ‘625) and over the Example 12 of WO ‘128/ IN ‘147. In addition, further compounds covered by the claims of IN ‘846 including, but not limited to compounds of claims 1 and claim 4 corresponding to Example 2; claim 1 according to the compound of Example 10; claim 1 and claim 2 corresponding to Example 21; claim 1 and claim 3 corresponding to Example 22 are potent SGLT2 inhibitors and selective for SGLT2 as opposed to SGLTI (over 900 times more selective). In particular like Empagliflozin, the compound of claim 4 (Example 2), which is the R- diastereomer of Empagliflozin, has a higher selectivity for SGLT2 over SGLTI. than Dapagliflozin and even more than the compound of Example 12 of IN ‘147. Also, the compounds of the claims 2 and 3 (Examples 21 and 22), which bear a methyl substituent at the central phenyl ring, have a better selectivity for SGLT2 over SGLT 1 than the respective compound of Example 8 of IN ‘147. It also stands urged on behalf of the plaintiffs that there was a specific mention of the existing prior arts in the application that was submitted by the plaintiffs for registration of its patent and, thus, there was no concealment of any fact from the statutory authorities. The fact that the patent was granted in favour of the plaintiff-Company thereafter, itself is demonstrative of the fact that the subject patent is not an ever greening of an already existing patent. It is also the contention of the plaintiffs that the factum that the subject patent is registered under the jurisdiction of more than 70 countries worldwide is also an indicator of the fact that the subject patent is not vulnerable patent and simply because the jurisdiction of one country has invalidated the patent of the plaintiff-Company, this does not render the patent to be vulnerable as compared to the number of countries, which have registered the subject patent of the plaintiff-Company, vis-à-vis one country which has invalidated it. It cannot said that invalidation by one country will tilt the balance of convenience in favour of the defendant by any stretch of imagination.
24. Similarly, with regard to the affidavit of the expert, the contention of the plaintiffs is that there is an affidavit of the expert of the plaintiffs also, which stands filed by it in other proceedings and otherwise also, the so called affidavit of the expert is based on the material which was provided by the defendant to the expert, who obviously submitted the affidavit on the terms as were dictated by the defendant.
25. Be that as it may, on the issue of obviousness, the primary contention of the defendant is that the subject patent does not contain any technical advancement and it is just an ever greening of papa 1, primarily the substitution of Methoxy by tetrahydrofuranyloxy (THF), which cannot be said to be an inventive step. The contention of the defendant is that the substitution of Methoxy by tetrahydrofuranyloxy (THF) does not amount to an inventive step, which enhances therapeutic efficacy. To substantiate this fact, reliance has been placed on the affidavit of its expert.
26. On the other hand, the stand of the plaintiffs is that Empagliflozin is a highly potent SGLT2 inhibitor (EC50 1-3 nM) and has a high selectivity for SGLT2 over SGLTi. The selectivity of Empagliflozin (>2500) is higher than the selectivity of Dapagliflozin (around 12OO) which in turn has a higher selectivity than the compound of Example 12 (around 900) of IN ‘147. Therefore, in view of the improved selectivity, Empagliflozin has a technical advancement over Dapagliflozin (WO ‘836/IN ‘625) and over the Example 12 of WO ‘128/ IN ‘147. In addition, further compounds covered by the claims of IN ‘846 including, but not limited to compounds of claims 1 and claim 4 corresponding to Example 2; claim 1 according to the compound of Example 1O; claim 1 and claim 2 corresponding to Example 21; claim 1 and claim 3 corresponding to Example 22 are potent SGLT2 inhibitors and selective for SGLT2 as opposed to SGLTI (over 900 times more selective). In particular like Empagliflozin, the compound of claim 4 (Example 2), which is the R-diastereomer of Empagliflozin, has a higher selectivity for SGLT2 over SGLTi than Dapagliflozin and even more than the compound of Example 12 of IN ‘147. Also, the compounds of the claims 2 and 3 (Examples 21 and 22), which bear a methyl substituent at the central phenyl ring, have a better selectivity for SGLT2 over SGLT 1 than the respective compound of Example 8 of IN ‘147.
27. It is a matter of record that the prior art being relied upon by the defendant was referred to in the application that was filed by the plaintiffs for the registration of the trademark. The reference thereof is in the application that was filed by the plaintiffs in Form 2 as per Section 1O of the Patents Act and Rule-13 framed thereunder. The relevant portion thereof is reproduced herein below:-

“In the literature, compounds which have an inhibitory effect on the sodium-dependent glucose cotransporter SGLT2 are proposed for the treatment of diseases, particularly diabetes.

Glucopyranosyloxy-substituted aromatic groups and the preparation thereof and their possible activity as SGLT2 inhibitors are known from published International applications WO 98/31697, WO 01/27128, WO 02/083066, WO 03/099836, WO 2004/063209, WO 2004/080990, WO 2004/013118, WO 2004/052902, WO 2004/052903 and US application US 2003/0114390.”

2. There is no dispute on the issue that published International Application WO 01/27128, refers to DAPA 1 and published International Application WO 03/099836, refers to DAPA
3. The application was scrutinized by the Statutory Authorities, whereafter, the patent was granted. Though the grant of patent per se does not amount to issuance of a certificate qua its validity, but fact of the matter still remains that it not as if the patent was obtained by the plaintiffs by concealing prior publications relating to DAPA 1 and DAPA 2, which is the main and only argument of defendant on Obviousness. Now, as per the plaintiffs, the subject patent is an improvement over the existing prior act as it contains an inventive step, whereas, this is denied by the defendant. In other words, as per the defendant, there is no inventive step in the subject patent and it is an ever greening of the existing art.
4. This Court is of the considered view that whether or not substitution of Methoxy by tetrahydrofuranyloxy (THF) etc. has enhanced the therapeutic efficacy or not, is an issue which has to be decided at the stage of adjudicating the validity of the patent. I have already observed hereinabove that in the application that was filed by plaintiff No. 1 for registration of the patent, there was a reference of Dapa 1 and Dapa 2 as SGLT2 inhibitors. Therefore, as from the date of fling of the application, this fact is in public domain since then. For the purpose of holding that the patent is vulnerable, this Court cannot, at this stage, return a finding that the substitution of Methoxy by tetrahydrofuranyloxy (THF) etc. was nothing but an ever greening of the existing art. This is the stand of the defendant, which it has to prove. The defendant cannot be permitted to say that its allegation is enough to render the subject patent vulnerable. Even, the affidavit filed by the expert which has been placed on record by the defendant cannot be read so as to hold at this stage that the subject patent stands rendered vulnerable on the basis of the contents of the affidavit, because the veracity of the affidavit is yet to be established, which is subject to cross-examination of the expert witness by the plaintiffs. This Court cannot lose sight of the fact that the affidavit filed by the expert is at the behest of the defendant. The affidavit is neither a publication nor it was in existence prior to the filing of this Civil Suit. In a suit of infringement, ordinarily, no defendant would admit the allegations. But obvious, it will deny the contentions of the plaintiff that the defendant is infringing its patent.

In view of the statutory provisions, as they exist in the Patent Act, such a defendant would take all the defences as are available to it in law. Availability of these defences and defendant harping upon them, has to be kept in mind by the Court while deciding an application under Order 39, Rules 1 and 2 of the Code of Civil Procedure. This is more so for the reason that in a case of infringement under the Patents Act, at the stage of interim, the Court has to consider the factum of “credible challenge”, if any, laid by the defendant to the patent of the plaintiff or the aspect of vulnerability qua the subject patent. The Court therefore has to be careful that until and unless there is material on record, more than mere allegations, a powerfully put defence per se, in the absence of a prima facie satisfaction of the Court, cannot bound the Court to not grant the interim injunction.

2. Now, I will deal with the ground that the plaintiffs have not approached this Court with clean hands and they have suppressed the material facts from the Court. The contention of the defendant is that same patent of plaintiff No. 1, which was registered in China, was invalidated by the Competent Court of law in China and this fact was concealed by the plaintiff from this Court. Learned Senior Counsel for the defendant submitted that this act and conduct of the plaintiffs alone, disentitles them from grant of any interim relief.

Learned Senior Counsel referred to judgment dated 14.12.2023, passed by the learned Single Judge of High Court of Delhi in Freebit AS Vs. Exotic Mile Private Limited, CS (COMM) 884/2023, I.As.

25074/2023, 25075/2023, 25076/2023 and 25077/2023 as also judgment 31.01.2024, passed by the Hon’ble Division Bench of Delhi High Court in Freebit As Vs. Exotic Mile Private Limited, FAO (OS) (COMM) 15/2024 and CAV43/2024 and CM Nos. 5698/2024, 5699/2024 & 5700/2024 to substantiate his contention.

31. Learned Single Judge of Delhi High Court in Freebit AS Vs. Exotic Mile Private Limited (supra) has held as under:-

“29. As per the High Court of Delhi Rules Governing Patent Suits, 2O22, (hereinafter, ‘Patent Suit Rules’) it is necessary, to the extent possible, for a plaint to include details of corresponding foreign patent applications, as well as information relating to any orders passed by a Court or Tribunal concerning the same or substantially similar invention as asserted in the suit. The relevant extracts from the Patent Suits Rules are set out below:

“3. Content of Pleadings A. Plaint The Plaint in an infringement action shall, to the extent possible, include the following aspects:

1. Brief summary of international corresponding applications/patent(s) and grant thereof including details of worldwide protection for the invention;
2. Brief prosecution history of the suit patent(s);
3. Details of any challenge to the suit patent(s) and outcome thereof;

vii.         Details of orders, if any, passed by any Indian or international court or tribunal, upholding or rejecting the validity of the suit patent or a patent which is for the same or substantially the same invention:”

30. Further, Order XI Rule 1 CPC, as amended by the Commercial Courts Act, 2o15,obligates the Plaintiff filing suit, to file all documents which would have a bearing on the suit. The said Rule specifies that the Plaintiff even has a duty to file those documents, which are adverse to the case of the Plaintiffs. Therefore, overall, the said Rule mandates comprehensive disclosure by a Plaintiff, to ensure that all relevant information is available to the Court, for a fair adjudication. The relevant extract of the said rule is set out below:

“ORDER XI DISCLOSURE, DISCOVERY AND INSPECTION OF DOCUMENTS INSUITS BEFORE THE COMMERCIAL DIVISION OF A HIGH COURT OR ACOMMERCIAL COURT

1. Disclosure and discovery of documents. – (1) Plaintiff shall file a list of all documents and photocopies of all documents, in its power, possession, control or custody, pertaining to the suit, along with the plaint, including: –
2. documents referred to and relied on by the plaintiff in the plaint;
3. documents relating to any matter in question in the proceedings, in the power, possession, control or custody of the plaintiff, as on the date of filing the plaint, irrespective of whether the same is in support of or adverse to the plaintiffs case….”
4. The above set of rules show that at the time of filing of the suit, a basic enquiry ought to be made, if there are corresponding patents internationally, and if any of them have been rendered invalid by any Court or Tribunal.
5. In the present suit, however, a bare perusal of paragraph 19 of the plaint shows that in respect of some of the countries, where the suit patent has either been revoked, refused, abandoned, lapsed, have been shown as either pending or granted
6. In Satish Khosla v. M/s. Eli Lilly Ranbaxy Ltd. (MANU/DE/o763/1998: 71 (1998)DLT 1 (DB)], the Id. Division Bench of this Court has underscored the importance of candour and forthrightness in instituting legal proceedings. It Is Incumbent upon a Plaintiff that approaches the Court to approach the Court with ‘clean hands’, a principle that mandates the full disclosure of all relevant and material facts. This disclosure is not limited to facts that bolster a party’s case but extends to all information that could potentially aid in a comprehensive and fair adjudication of the dispute. The duty of disclosure encompasses not only the submission of all documents pertinent to the current litigation but also an obligation to inform the Court of any previous litigations between the parties, any previous litigations concerning the suit patent, along with their respective outcomes.

Such transparency is indispensable for ensuring that the Court has a complete and unobscured view of the relevant factual landscape, which is crucial for the fair dispensation of justice. The relevant extract of the said decision is set out below:

“15. In S.P. Chengalvaraya Naidu V. Jagannath and Others, MANU/SC/m92/1994: AIR 1994 Sc 853 it was held that the Courts of Law are meant for imparting justice between the parties. One who comes to the Court, must come with clean hands. “It can be said without hesitation that a person whose case is based on false-hood has no right to approach the court. He can be summarily thrown out at any stage of the litigation. A litigant, who approaches the Court, is bound to produce all the documents executed by him

vital document in order to gain advantage on the other side then he would be guilty of playing fraud on the Court as well as on the opposite party.”

16. …It is contended by Mr. Oberoi, appearing on behalf of the respondent that the respondent had no intention or motive to suppress the pendency of the earlier application in which the stay was not granted and having disclosed in the plaint that a suit between the parties was pending, it was not relevant or necessary to mention that in the said suit the Court had not granted any stay in its favour. In our view, the arguments are wholly fallacious. A party must come to the Court with clean hands and must disclose all the relevant facts which may result in appreciating the rival contentions of the parties. In our view, a litigant, who approaches the Court, must produce all the documents which are relevant to the litigation and he must also disclose to the court about the pendency of any earlier litigation between the part is and the result thereof.

….In our opinion, it was obligatory upon the respondent to disclose to the Court that in the application filed in the earlier suit a similar relief had been claimed, however, the Court had not granted the said relief. In our view, if these facts were before the Court on February 6, 1997 when the second suit came up for hearing before it, may be Hon'ble the Single Judge was persuaded not to grant any ex parte stay in favor of the respondent. Moreover, in a suit for specific performance of an agreement to register the agreement of lease, it appears to us that the plaintiff could not claim an injunction which had already been claimed in Suit No. 3064/96. We are, Therefore, of the opinion that the respondent has not come to the Court with clean hands and has also suppressed material facts from the Court with a view to gain advantage in the second suit. This in our view is clearly over reaching the Court.”

37. The Supreme Court in Arunima Baruah V. Union of India (UOI)[MANU/SC/7366/2007] emphasised the importance of the maxim “He who comes into equity must come with clean hands.” The Supreme Court ruled that suppression of material facts by a party can impact their right to equitable relief. This principle would also be relevant in a suit for patent infringement, where the Plaintiffs failure to disclose revocations or invalidations of corresponding foreign patents of the asserted patent has a material bearing on the case. Such suppression and misrepresentation would undoubtedly affect the Court’s willingness to grant equitable relief, as it contradicts the principle of approaching the court with clean hands.
38. Vide judgement dated 29th July, 2O1O, a Id. Single Judge of this Court, in Charanjit Thukral and Ors. v. Deepak Thukral and Ors.

(MANUME/1814/2010 2O1O: DHC:3737) again emphasised that Plaintiffs seeking relief from the Court, whether equitable or otherwise, are obligated to honestly disclose all material facts relevant to a case. Plaintiffs seeking an injunction must inform the Court of all material facts pertinent to their claim for an injunction. Failure to do so, even under the guise of being unaware of the significance of any omitted facts, is not permissible. Court possesses the inherent authority to deny an injunction if the plaintiff acts in bad faith or withholds any material facts. The relevant extracts of the said decision are set out below:

“17. Interim order is passed as a temporary arrangement to preserve the status quo till the matter is decided finally, to ensure that the matter does not become either infructuous or a fate accompli before the final hearing. The purpose of an interlocutory injunction is, to protect the plaintiff against injury by violation of his right for which he could not be adequately compensated in r damages recoverable in the action if the uncertainty was resolved in his favour at the trial.

18. It is settled principle of law that a person who approaches the Court for grant of relief, equitable or otherwise, is under a solemn obligation to candidly disclose all the material/important facts which has bearing on the adjudication of the issues raised in the case. It is the duty of the party asking for an injunction to bring to the notice of the Court all facts material to the determination of his right to have injunction and it is not an excuse for him to say that he was not aware of the importance of any facts which he has omitted to bring forward. Where plaintiff does not act bonafidely and does not put every material facts before the Court, the Court is within its inherent power to refuse to grant him injunction, even though there might be facts upon which injunction might be granted. Conduct of the plaintiff is very material in bringing the case and disclosing the facts before the Court. plaintiff is required to make fullest possible disclosure of all material facts within his knowledge to the Court and if he does not make that fullest possible disclosure, he cannot obtain any advantage from the proceedings and is liable to be deprived of any advantage he might have already obtained by means of the order which has thus wrongly been obtained by him by concealment of material facts.”
19. The specific view that suppression and misrepresentation can have a bearing interim injunction application, especially in the context of IP disputes, was upheld by a ld. Single Judge of this Court in Aura Synergy India Ltd. v. New Age False Ceiling Co. Pvt. Ltd., [2016 : DHC: 1109]. The said decision has also been approved by the ld. Division Bench vide judgment dated 18th November, 2016 in Aura Synergy India Ltd. v. New Age False Ceiling Co. Pvt. Ltd., [2016: DHC : 753o-DB].
20. Further, in FMC Corporation v. GSP Crop Science Private Limited, [2O22 SCC OnLine Del 3784], this Court held that ‘suppression and misrepresentation’ is one of the grounds available to a Defendant to challenge the grant of an interim injunction. Vide judgment dated 5th July, 2023, similar grounds of concealment of documents was cited as one of the factors for denial of interim injunction by the Coordinate Bench of this Court in Bayer Healthcare LLC v. Natco Pharma Limited, [2023 : DHC: 4458].
21. The ld. Division Bench of this Court in F. Hoffmann-LA Roche Limited v. Cipla Limited, [ILR 2009 Supp (2) Del 551], held that the grant of an interim injunction is not based solely on the patent’s existence or grant, but needs to take into account the potential challenges to its validity. The relevant extract from the said decision in set out below:

“55. The question before this Court is when can it be said that the defendant has raised a credible challenge to the validity of a patent held by the plaintiff in an infringement action? During the course of the argument it was suggested by counsel that the challenge had to be both strong and credible. Also, the defendant resisting the grant of injunction by challenging the validity of the patent is at this stage required to show that the patent is “vulnerable” and that the challenge raises a “serious substantial question” and a triable issue. Without indulging in an exercise in semantics, the Court when faced with a prayer for grant of injunction and a corresponding plea of the defendant challenging the validity of the patent itself, must enquire whether the defendant has raised a credible challenge. In other words, that would in the context of pharmaceutical products, invite scrutiny of the order granting patent in the light of Section 3(d) and the grounds set out in Section 64 of the Patents Act, 1970. At this stage of course the Court is not expected to examine the challenge in any great detail and arrive at a definite finding on the question of validity. That will have to await the trial. At the present stage of considering the grant of an interim injunction, the defendant has to show that the patent that has been granted is vulnerable to challenge. Consequently, this Court rejects the contentions of the plaintiffs on this issue and affirms the impugned judgment of the learned Single Judge.

42. In the instant case, apart from the non-disclosure or mis-description of the above facts relating to revocation, invalidation of the corresponding patents, there are at least two judgments which seriously impinge upon the validity of the suit patent. The said judgments which discuss in detail the reasons for invalidating the corresponding patents, could not have been held back from the Court and not filed on record.

They have been rendered by the US Federal Court of Appeals and the UK Patent court in the following decisions:

• Freebit AS v. Bose Corporation, decision dated 8 October, 2019 bearing no. 18-2365.

th • Bose Corporation v. Freebit AS, [2018] EWHC 889 (Pat).

43. In view of the above facts, clearly, no prima facie case has been established by the Plaintiff, considering that the Defendant has been able to demonstrate that the suit patent, on the strength of which the suit has been initiated is vulnerable to revocation, on account of invalidation as demonstrated by decisions from several jurisdictions across the world. The absence of a prima facie case would be a fundamental barrier to the grant of an interim injunction.
44. Secondly, the balance of convenience is also tilted heavily in favour of the Defendant, especially considering a situation where there are serious assertions regarding the potential revocation of the suit patent, granting an injunction could unduly prejudice the Defendant. This is particularly relevant if the suit patent is later found to be invalid or revoked, as it would mean that the Defendant was unnecessarily restrained from conducting its business activities.
45. Finally, there is a real possibility of irreparable injury to the Defendant if an injunction is granted in these circumstances. The grant of an injunction based on a potentially revocable or invalid patent could lead to significant losses for the Defendant, which is incapable of being adequately compensated. On the other hand, if the patent is held to be valid after trial monetary amounts can be awarded in the form of damages to the Plaintiff.
46. In Gujarat Bottling Co. Ltd. v. Coca Cola Co. [(1995) 5 SCC 545], the Supreme Court categorically held that since the grant of an injunction is wholly equitable in nature, the conduct of parties have a significant bearing on the grant or non-grant of an interim injunction. The relevant extract of decision is as follows:

“In this context, it would be relevant to mention that in the instant case GBC had approached the High Court for the injunction order, granted earlier, to be vacated. Under Order 39 of the Code of Civil procedure, jurisdiction of the Court to interfere with an order of interlocutory or temporary injunction is purely equitable and, therefore, the Court, on being approached, will, apart from other considerations, also look to the conduct of the party invoking the jurisdiction of the court, and may refuse to interfere unless his conduct was free from blame. Since the relief is wholly equitable in nature, the party invoking the jurisdiction of the Court has to show that he himself was not at fault and that he himself was not responsible for bringing about the state of things complained of and that he was not unfair or inequitable in his dealings with the party against whom he was seeking relief. His conduct should be fair and honest. These considerations will arise not only in respect of the person who seeks an order of injunction under Order 39 Rule 1 or Rule 2 of the Code of Civil Procedure, but also in respect of the party approaching the Court for vacating the ad-interim or temporary injunction order already granted in the pending suit or proceedings.”

47. Under such circumstances, in terms of the settled legal position, as also the factual matrix of this case, this Court is of the opinion that the Plaintiff is not entitled to any interim injunction, let alone ex-parte or ad interim injunction. In addition, the Court is also of the opinion that such conduct cannot be ignored by the Court especially in a case where the Plaintiff ought to come clean and there is specific provisions set out in the various Rules.”
48. The judgment of the learned Single Judge was appealed against. The Hon’ble Division Bench while adjudicating the appeal, vide judgment dated 31.01.2024, passed in Freebit AS Vs. Exotic Mile Private Limited (supra), FAO (OS) (COMM) 15/2024 and CAV43/2024 and CM Nos. 5698/2024, 5699/2024 & 5700/2024 upheld the judgment passed by the learned Single Judge and was pleased to hold as under:-

“22. It is also material to note that unlike the Trade Marks Act, 1999, where grant of a trademark leads to a presumption of its validity; grant of patent does not lead to any statutory presumption as to its validity. Thus, if a defendant raises a credible challenge to the validity of the patent, the same is relevant for deciding whether any interim orders restraining the defendant rom using the patent in question, is warranted.

23. In the present case, the Court had noted that patents corresponding to the suit patent had been invalidated in various countries. In Japan, it had been refused after a trial. As noted above, there is no dispute that the appellant’s applications for grant of patent corresponding to the suit patent had been rejected in various countries. The patent has been invalidated in some of the countries as noticed above.
24. The respondent had entered appearance to contest the grant of interim relief and had relied upon the decisions rendered in other jurisdiction, refusing and/or invalidating the patent corresponding to the suit patent. In the given circumstances, the Court concluded that the defendants did have a credible challenge to the validity of the suit patent. The triple test
25. Apart from the prima facie case, the learned Single Judge had also found that the balance of convenience was in favour of the appellant.

According to the appellant, it had licensed the suit patent to an enterprise in India and the third parties in US, Japan and Australia for incorporating the same in their respective earphones. The appellant had also sought damages, which were quantified at 2 crores, on account of alleged infringement of its suit patent. If the appellant succeeds in its action, the appellant can be compensated in terms of money. However, if it was found that the patent was invalid, a grant of injunction restraining the respondent from using the same would have unfairly prejudice the respondent by interdicting its current business. In the given circumstances, the learned Single Judge, after existence of prima facie case, balance of applying the triple test- convenience, and irreparable injury – rejected the appellant’s application for interim relief.

26. In Wander Ltd. v. Antox India (P) Ltd.: 1990 Supp SCC 727, the Supreme Court had held as under:

“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.”

27. In the present case, we are unable to accept that the learned Single Judge’s exercise of discretion in declining the interim relief is arbitrary, or in ignorance of settled principles of law. Thus, no interference in the impugned judgment is warranted.
28. The appeal is unmerited and, accordingly, dismissed. All pending applications are also disposed of.”
29. A perusal of these two judgments demonstrates that firstly there exists High Court of Delhi Rules Governing Patent Suits, 2O22 and in terms of these Rules, it is mandatory that a plaint in an infringement action, shall, inter alia, include the details of orders, if any passed by any Indian or International Court or Tibunal, upholding or rejecting the validity of the suit patent or a patent which is for the same or substantially the same invention. Not only this, a perusal of the judgment passed by the learned Single Judge of Delhi High demonstrates that therein the plaintiff mislead the Court by mentioning in the plaint that in respect of some of the countries, where the suit patent has either been revoked, refused, abandoned or lapsed have been shown as either pending or granted. It is in the backdrop of this factual matrix that the learned Single Judge adjudicated on the issue of the plaintiff not approaching the Court with clean hands, which findings of the learned Single were upheld by the Hon’ble Division Bench.
30. Coming to the facts of this case, firstly there are no such Rules governing Patent Suits as far as this Court is concerned. In other words, there are no Patent Rules framed by the High Court, in terms whereof, in a suit for infringement, it is mandatory for the plaintiff to disclose details of orders, if any, passed by any Indian or International Court or Tribunal, upholding or rejecting the validity of the suit patent or a patent which is for the same or substantially the same invention. Now, coming to the provisions of Order XI, Rule 1 of the Code of Civil Procedure, as amended by the Commercial Courts Act, 2015, the plaintiff has a duty to file those documents which are adverse to the case of the plaintiffs. This Court is of the considered view that in the case of infringement of a patent, primarily, the facts to be demonstrated by the plaintiff before the Court are that there is a registered patent in favour of the plaintiffs, which is being infringed by the defendant. If with regard to registration of that particular patent in India, certain facts stand concealed, then obviously that issue can be considered to be of significance, but the non-disclosure of the factum of the invalidation of the corresponding patent of the plaintiff-Company by the Court of China, cannot be said to be so significant so as to either make this Court believe that this itself renders the subject patent vulnerable or this amounts to concealment of material facts by the plaintiffs. Non-disclosure of the fact that a corresponding patent of the Company, after its registration, was invalidated in China, cannot be said to be such a serious lapse or concealment, of a material fact, so as to call upon this Court to hold that the plaintiffs have not approached the Court with clean hands. In fact, the factum of the suit patent being successfully registered in 70 other countries has not been denied by the defendant. It is also not in dispute that each country has different Set of Laws as far as registration of patents is concerned and registration of a patent by a country gives life to that patent within the jurisdiction of that country only. Even, during the course of arguments, it could not be disputed that registration or invalidation of a patent by a particular country in general has no effect on the registration or invalidation of the same patent in some other country, for the reason that registration and invalidation of patent is governed by the law of that particular country.
31. The contention of the defendant that grant of interim would cause irreparable loss to the Society and in view of the price difference between the product of the plaintiffs and the defendant, no interim be granted to the plaintiffs, can also be not accepted. In the considered view of this Court, the plaintiffs and the defendant are commercial rivals. A commercial rival against whom there is an allegation of infringement of patent cannot be allowed to raise the plea of public interest, in view of the fact that there are enough checks and balances in the Patents Act, 1970 itself to cater the public interest.
32. Chapter XVI of the Patents Act deals with Working of Patents, Compulsory Licences and Revocation and Chapter XVII thereof deals with Use of Inventions for Purposes of Government and Acquisition of Inventions by Central Government. In circumstances of national emergency or in circumstances of extreme urgency and in the case of public non-commercial use, the provisions provided in these Chapters can be resorted to by the Central Government in larger public interest, but fact of the matter remains that this has not been done by the Central Government as far as the subject patent is concerned.

37.        In the backdrop of the above discussion, this Court holds that the plaintiffs have been able to prove a prima facie case in their favour alongwith balance of convenience, because on one hand, there is a duly registered subject patent with a successful commercial run in favour of plaintiff No. 1, whereas, on the other hand, defendant does not have any registered patent pertaining to the infringing product. Besides this, in view of the fact that the defendant is manufacturing and selling the infringing product by infringing the suit patent and without the consent of the plaintiffs, therefore, in case the defendant is not restrained from doing so during the pendency of the suit, it obviously will cause irreparable loss to the plaintiffs.

Citation: Boehringer Ingelheim Int’l GmbH v. Eris Lifesciences Ltd., COMS No. 09 of 2023, COMS No. 02 of 2024 (H.P. May 30, 2024). Available at: http://indiankanoon.org/doc/9167022/, Visited on: 05/06/2024.

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