LAURUS LABS LIMITED vs UNION OF INDIA & ORS.

$~ (Original Side)
* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ CS(COMM) 76/2021, CC(COMM) 8/2021, I.A. 2298/2021
I.A. 2299/2021 & I.A. 13391/2021

PHARMACYCLICS LLC & ANR. ….. Plaintiffs
Through: Mr. Pravin Anand, Ms. Archana Shanker, Mr. Dhruv Anand, Ms. Udita Patro, Ms. Kavya Mammen, Ms. Sampurnaa Sanyal, Advs.

versus

HETERO LABS LIMITED & ORS. ….. Defendants
Through: Ms. Rajeshwari H., Adv. Mr. Harish Vaidyanathan Shankar, CGSC with Ms. S. Bushra Kazim & Mr. Karan Chibber, Advs.

+ W.P.(C)-IPD 3245/2021 & CM APPL. 9916/2021
LAURUS LABS LIMITED ….. Petitioner
Through:

Versus

UNION OF INDIA & ORS. ….. Respondents
Through: Ms. Rajeshwari H., Adv.Mr. Harish Vaidyanathan Shankar, CGSC with Ms. S. Bushra Kazim & Mr. Karan Chibber, Advs.
Mr. Pravin Anand, Ms. Archana Shanker, Mr. Dhruv Anand, Ms. Udita Patro, Ms. Kavya Mammen, Ms. Sampurnaa Sanyal, Advs. for Respondent No.2

+ CS(COMM) 709/2019, I.A. 18051/2019, I.A. 18491/2019, I.A. 3219/2020, I.A. 11421/2021, I.A. 11422/2021, I.A. 13388/2021, I.A. 13851/2021 & I.A. 16992/2021

PHARMACYCLICS, LLC & ANR. ….. Plaintiffs
Through: Mr. Sudhir Chandra, Senior Counsel with Mr. Pravin Anand, Ms. Archana Shanker, Mr. Dhruv Anand, Ms. Udita Patro, Ms. Kavya Mammen, Ms. Sampurnaa Sanyal, Advs.

versus

NATCO PHARMA LIMITED ….. Defendant
Through: Mr. G. Natray, Mr. Avinash Kumar & Mr. Ankur Vyas, Advs.

+ CS(COMM) 342/2020, I.A. 7332/2020, I.A. 7333/2020, I.A. 8761/2021, I.A. 10504/2021, I.A. 13390/2021, I.A. 15713/2021, I.A. 16039/2021 & I.A. 16040/2021

PHARMACYCLICS LLC & ANR. ….. Plaintiffs
Through: Mr. Dayan Krishnan, Senior Counsel with Mr. Pravin Anand, Ms. Archana Shanker, Mr. Dhruv Anand, Ms. Udita Patro, Ms. Sampurnaa Sanyal, Advs.

versus

BDR PHARMACEUTICALS INTERNATIONAL PVT LTD & ORS. ….. Defendants
Through: Mr. G. Natray, Mr. Avinash Kumar & Mr. Ankur Vyas, Advs.

+ CS(COMM) 451/2020, I.A. 9360/2020, I.A. 1906/2021 & I.A. 8742/2021

PHARMACYCLICS LLC & ANR. ….. Plaintiffs
Through: Ms. Manisha Singh, Mr. Abhai Pandey, Mr. Varun Sharma & Mr. Gautam Kumar, Advs.
Mr. Pravin Anand, Ms. Archana Shanker, Mr. Dhruv Anand, Ms. Udita Patro, Ms. Sampurna Sanyal, Advs.

Versus

SHILPA MEDICARE LIMITED & ANR. ….. Defendants
Through:

+ CS(COMM) 571/2020 & I.A. 12649/2020, I.A. 12650/2020 &
I.A. 13389/2021
PHARMACYCLICS LLC & ANR. ….. Plaintiffs
Through: Mr. Dayan Krishnan, Senior Counsel with Mr. Pravin Anand, Ms. Archana Shanker, Mr. Dhruv Anand, Ms. Udita Patro, Ms. Sampurnaa Sanyal, Advs.

versus

ALKEM LABORATORIES LTD ….. Defendant
Through: Mr. G. Natraj, Mr. Avinash Kumar & Mr. Ankur Vyas, Advs.

CORAM:
HON’BLE MR. JUSTICE C. HARI SHANKAR

J U D G M E N T
% 21.12.2023

1. This is a batch of six suits and one writ petition. The writ petition, filed by Laurus Labs Ltd (“Laurus” hereinafter) challenges judgment dated 29 September 2020 passed by the Intellectual Property Appellate Board (“the IPAB”). The suits allege infringement, by the respective defendants, of Indian Patent 262968 (IN’968, also referred to as “the suit patent”). The controversy, on merits, is identical in all the suits.

2. This judgment decides the applications for interim relief filed in the writ petition of Laurus and the six suits filed by Pharmacyclics LLC. They are IA 2298/2021 in CS (Comm) 76/2021, IA 9360/2020 in CS(COMM) 451/2020, IA 18051/2019 in CS (Comm) 709/2019, IA 7332/2020 in CS (Comm) 342/2020, IA 12649/2020 in CS (Comm) 571/2020 and CM APPL. 9916/2021 in W.P.(C) 3245/2021. For the sake of convenience, I am treating CS (Comm) 709/2019 as the lead case. The decision on IA 18051/2019 would apply, mutatis mutandis, to all other IAs. This is but obvious as the decision on the prayer for restraint against exploitation of the suit patent, whichever way it goes, would apply in rem, not in personam.

Facts

3. The suit patent, which is registered in favour of the Plaintiff 1, covers “Inhibitors of Bruton’s Tyrosine Kinase” and claims, in Formula 4, the drug Ibrutinib. Plaintiff 2, Johnson & Johnson Private Limited, an Indian affiliate of Janssen Biotech, Inc, is the exclusive licensee of Plaintiff 1. Ibrutinib is commercially sold by the plaintiffs under the registered trademark IMBRUVICA.

4. The present suit was instituted as a quia timet action, anticipating launch, in the market, by the defendants, of Ibrutinib, without any license from the plaintiff.

5. When this suit came up for preliminary hearing on 19 December 2019, the defendants submitted that they had already launched the infringing product in the market. In the circumstances, while issuing notice on the present application, this Court directed the defendants to disclose the date of commencement of marketing of Ibrutinib by them, and the quantum of sales of the said product effected till then. The defendants were also directed to file, before this Court, the sales of the impugned product as effected by them on a quarterly basis.

6. The plaintiff, however, filed IA 18491/2019, also under Order XXXIX Rules 1 and 2 of the Code of Civil Procedure, 1908 (CPC), disputing the defendants’ contention that the impugned product had been launched in the market. On 24 December 2019, this Court recorded the said submission and issued notice in IA 18491/2019, returnable for the date already fixed.

7. The defendants, in their written statement filed by way of response to the plaint, did not dispute the fact that they were intending to launch Ibrutinib in the market. They, however, invoked Section 107(1)1 read with Section 642 of the Patents Act, 1970, to question the validity of the suit patent on the ground of prior publication, anticipation and lack of obviousness in view of the disclosure, in Patent WO 2005/037836, of the compound (1-[(3R)-3-[8-amino-1-(4-penoxyphenyl)-imidazo [1,5-a] pyrazin-3-y]-1-piperidinyl]-2-propen-1-one). As such, this Court proceeded to frame issues on 7 February, 2020, including, among them, issues regarding the validity of the suit patent in the light of the objections regarding anticipation by prior claiming, publication and obviousness, raised by the defendants.

8. During the pendency of the suit, a post-grant opposition, filed against the suit patent by Laurus Labs Ltd (“Laurus” hereinafter), was allowed by the Joint Controller of Patients & Designs (“the Joint Controller”), resulting in revocation of the suit patent. In the circumstances, the defendants moved IA 3219/2020 under Order VII Rule 11 of the CPC, seeking rejection of the plaint. This Court was, however, informed on 6 March 2020 that the plaintiffs had preferred an appeal against the decision of the Joint Controller, to IPAB. In the circumstances, this Court adjourned the matter, instead of dismissing it.

9. Thereafter, during the pendency of these proceedings, the aforenoted appeal (OA/46/2020/PT/DEL) came to be allowed by the IPAB by its judgment dated 29 September 2020.

10. A primary contention, advanced by learned Senior Counsel for the plaintiffs – primarily by Mr. Dayan Krishnan – is that, once the validity of the suit patent thus stands upheld by the IPAB, a prima facie case against exploitation of the suit patent by the defendants exists.

11. It would be appropriate to examine this contention at the outset, before proceeding to the rival submissions on merits as, if a view regarding the validity of the suit patent has already been taken by the IPAB, and the challenge to the present suit, by the defendants, is only on the ground of invalidity of the suit patent, Mr. Dayan Krishnan may be correct in his submission that a case for interim injunction is made out even for that reason alone – unless, of course, this Court decides to stay the IPAB order. Before, however, proceeding to the order of the IPAB, and its impact on the present application, a brief view of the rival stands, on merits, is necessary.

12. So far as the plaintiffs are concerned, it contends that, as the suit patent is valid and subsisting and claims Ibrutinib, and as Ibrutinib is, admittedly, manufactured and sold by the defendants under various brand names, the defendants are infringing the suit patent.

13. The PCT application for the invention titled “Inhibitors of Bruton’s Tyrosine Kinase”, claiming the drug Ibrutinib was initially filed by Plaintiff 1 on 28 December 2006. The suit patent, therefore, claims priority from US 60/826720 (US’ 720) dated 22 September 2006 and US 60/828590 (US’590) dated 6 October 2006. The National Phase Application in India was filed on 12 March 2009 and the suit patent came to be granted on 25 September 2014. The suit patent is valid for 20 years w.e.f. 28 December 2006 and is, therefore, due to expire only in 2026.

14. Relevant passages from the “field of the invention”, “background of the invention” and “detailed description of the invention” may be reproduced thus:

“[0002] Described herein are compounds, methods of making such compounds, pharmaceutical compositions and medicaments containing such compounds, and methods of using such compounds and compositions to inhibit the activity of tyrosine kinases.

[0003] Bruton’s tyrosine kinase (Btk), a member of the Tec family of non-receptor tyrosine kinases, is a key signalling enzyme expressed in all hematopoietic cells types except lymphocytes and natural killer cells, Btk plays an essential role in the B-cell signaling pathway linking cell surface B-cell receptor (BCR) stimulation to downstream intracellular responses.”

“[0005] Described herein are inhibitors of Bruton’s tyrosine kinase (Btk). Also described herein are irreversible inhibitors of Btk. Further described are irreversible inhibitors of Btk that form a covalent bond with a cysteine residue on Btk. Further, described herein are irreversible inhibitors of other tyrosine kinases. wherein the other tyrosine kinases share homology with Btk by having a cysteine residue (including a Cys 481 residue) that can form a covalent bond with the irreversible inhibitor (such tyrosine kinases are referred herein as “Btk tyrosine kinase cysteine homologs”). Also described herein are methods for synthesizing such irreversible inhibitors, methods for using such irreversible inhibitors in the treatment of diseases (including diseases wherein irreversible inhibition of Btk provides therapeutic benefit to a patient having the disease). Further described are pharmaceutical formulations that include an irreversible inhibitor of Btk.

[0006] Compounds described herein include those that have a structure of any of Formula (A), Formula (B), Formula (C), or Formula (D) and pharmaceutically acceptable salts, solvates, esters, acids and prodrugs thereof. In certain embodiments, isomers and chemically protected forms of compounds having a structure represented by any of Formula (A), Formula (B), Formula (C), or Formula (D) are also provided.

Detailed description-

“[00163] The methods described herein include administering to a subject in need a composition containing a therapeutically effective amount of one or more irreversible Btk inhibitor compounds described herein. Without being bound by theory, the diverse roles played by Btk signalling in various hematopoietic cell functions, e.g. B-cell receptor activation, suggests that small molecule Btk inhibitors are useful for reducing the risk of or treating a variety of diseases affected by or affecting many cell types of the hematopoetic lineage including, e.g., autoimmune diseases, heteroimmune conditions or diseases, inflammatory diseases, cancer (e.g., B-cell proliferative disorders), and thromboembolic disorders. Further, the irreversible Btk inhibitor compounds described herein can be used to inhibit a small subset of other tyrosine kinases that share homology with Btk by having a cysteine residue (including a Cys 481 residue) that can form a covalent bond with the irreversible inhibitor. See, e.g., protein kinases in FIG, I. Thus, a subset of tyrosine kinases other than Btk are also expected to be useful as therapeutic targets in a number of health conditions.

[00164] In some embodiments, the methods described herein can be used to treat an autoimmune disease, which includes, but is not limited to, rheumatoid arthritis, psoriatic arthritis, osteoarthritis, Still’s disease, juvenile arithritis, lupus, diabetes, myasthenia gravis, Hashimoto’s thyroiditis, Ord’s thyroiditis. Graves’ disease Sjogren’s syndrome, multiple selerosis, Guillain-Barre Syndrome, acute disseminated encephalomyelitis, Addison’s disease, opsoclonus-myoclonus syndrome, ankylosing spondylitisis, antiphospholipid antibody syndrome, aplastic anemia, autoimmune hepatitis, coeliae disease. Goodpasture’s syndrome, idiopathic thrombocytopenic purpura, optic neuritis, scleroderma, primary biliary cirrhosis. Reiter’s syndrome, Takayasu’s arteritis, temporal arteritis. warm autoimmune hemolytic anemia, Wegener’s granulomatosis, psoriasis, alopecia universalis, Behcet’s disease, chronic fatigue, dysautonomia. endometeriosis, interstitial cystitis, neuromyotonia, scleroderma, and vulvodynia.

[00165] In some embodiments, the methods described herein can be used to treat heteroimmune conditions or diseases, which include, but are not limited to graft versus host disease, transplantation, transfusion, anaphylaxis, allergies (e.g., allergies to plant pollens, latex, drugs, foods, insect poisons, animal hair, animal dander, dust mites, or cockroach calyx), type I hypersensitivity, allergic conjunctivitis, allergic rhinitis, and atopic dermatitis,

[00166] In further embodiments, the methods described herein can be used to treat an inflammatory disease, which includes, but is not limited to asthma, inflammatory, bowel disease, appendicitis, blepharitis, bronchiolitis. bronchitis, bursitis, cervicitis, cholangitis, cholecystitis, colitis, conjunctivitis, cystitis, dacryoadenitis, dermatitis, dermatomyositis, encephalitis, endocarditis, endometritis, enteritis, enterocolitis, epicondylitis, epididymitis, fasciitis, fibrositis, gastritis, gastroenteritis, hepatitis, hidradenitis suppurativa, laryngitis, mastitis, meningitis, myelitis myocarditis, myositis. nephritis, oophoritis, orchitis, osteitis, otitis, pancreatitis, parotitis, pericarditis, peritonitis, pharyngitis, pleuritis, phlebitis, pneumonitis, pneumonia, proctitis, prostatitis, pyelonephritis, rhinitis, salpingitis, sinusitis, stomatitis, synovitis, tendonitis, tonsillitis, uveitis, vaginitis, vasculitis, and vulvitis.

[00167] In yet other embodiments, the methods described herein can be used to treat a cancer, e.g. B-cell proliferative disorders, which include, but are not limited to diffuse large B cell lymphoma, follicular lymphoma, chronic lymphocytic lymphoma, chronic lymphocytic leukemia. B-cell prolymphocytic leukemia, lymphoplasmacytic lymphoma/Waldenström macroglobulinemia, splenic marginal zone lymphoma, plasma cell myeloma, plasmacytoma, extranodal marginal zone B cell lymphoma, nodal marginal zone B cell lymphoma, mantle cell lymphoma, mediastinal (thymic) large B cell lymphoma, intravascular large B cell lymphoma, primary effusion lymphoma, burkitt lymphoma/leukemia, and lymphomatoid granulomatosis.

[00176] The Btk inhibitor compounds described herein are selective for Btk and kinases having a cysteine residue in an amino acid sequence position of the tyrosine kinase that is homologous to the amino acid sequence position of cysteine 481 in Btk. See. e.g. kinases in FIG. 1. Inhibitor compounds described herein include a Michael acceptor moiety.

[00181] Irreversible Btk inhibitor compounds can used for the manufacture of a medicament for treating any of the foregoing conditions (e.g. autoimmune diseases, inflammatory diseases, allergy disorders, B-cell proliferative disorders, or thromboembolic disorders).

[00183] In one embodiment, the irreversible Btk inhibitor compound selectively and irreversibly inhibits an activated form of its target tyrosine-kinase (e.g. a phosphorylated form of the tyrosine kinase). For example, activated Btk is transphosphorylated at tyrosine 551. Thus, in these embodiments the irreversible Btk inhibitor inhibits the target kinase in cells only once the target kinase is activated by the signalling events.

[00184] Described herein are compound of any of Formula (A), Formula (B), Formula (C), or Formula (D). Also described herein are pharmaceutically acceptable salts, pharmaceutically acceptable solvates, pharmaceutically active metabolites and pharmaceutically acceptable prodrugs of such compounds. Pharmaceutical compositions that include at least one such compound or a pharmaceutically acceptable salt, pharmaceutically acceptable solvate, pharmaceutically active metabolite or pharmaceutically acceptable prodrug of such compound, are provided. In some embodiments, when compounds disclosed herein contain an oxidizable nitrogen atom, the nitrogen atom can be converted to an N-oxide by methods well known in the art. In certain embodiments, isomers and chemically protected forms of compounds having a structure represented by any of Formula (A), Formula (B), Formula (C), of Formula (D) are also provided.”

15. Formulae (A) to (D), to which para 00184 makes reference, were thus provided in the complete specifications:

16. Ibrutinib is claimed in Claim 1 of the suit patent. Its chemical structure is , and its IUPAC/chemical name is l-[(R)-3-[4-Amino-3-(4-phenoxyphenyl)- 1H-pyrazolo [3,4-d]pyrimidin-1-yl] piperidin-1-y1]prop-2-en-l-one.

17. That the defendants in these suits manufacture and sell – or intend to manufacture and sell – Ibrutinib, is not in dispute. That they do so without any licence or authority from the plaintiffs is also not in dispute. As in many such cases, the defendants do not plead that their acts are not, strictly speaking, infringing of the suit patent. They rely, instead, on Section 107(1) read with Section 64 of the Patent Act. Their defence is, therefore, predicated on alleged invalidity of the suit patent.

18. As already noted, the invalidity of the suit patent is, however, not being tested for the first time. Laurus filed a post grant opposition before the Indian Patent Office (IPO), seeking revocation of the suit patent on 24 July 2019.

19. By order dated 4 March 2020, the Joint Controller allowed the post grant opposition and revoked the suit patent as obvious to an ordinary person skilled in the art and, therefore, as lacking any inventive step vis-à-vis prior art. That order was, however, set aside by the IPAB vide judgment dated 29 September 2020.

20. As the defendants are contesting these suits only on the ground of invalidity of suit patents, and the validity of the suit patents stands affirmed by the judgment dated 29 September 2020 of the IPAB, Mr. Dayan Krishnan, learned Senior Counsel appearing for some of the plaintiffs, argues that a prima facie case ipso facto stands made out in the plaintiffs’ favour.

21. This submission is contested by Mr. J. Sai Deepak, who led arguments on behalf of defendants, on the ground that the Chairman of the IPAB, who authored the judgment dated 29 September 2020, was not competent to hold office. He was, according to Mr. Sai Deepak, coram non judice.

22. The tenure of the Chairman of the IPAB, he submits, had expired on 21 September 2019 and he was continuing to hold office on the basis of certain interim orders passed by the Supreme Court. The Supreme Court ultimately held, vide judgment dated 27 November 2020 read with clarification dated 12 February 2021, that the tenure of the Chairman of the IPAB in fact had ended on 21 September 2019. Thus, submits Mr. Sai Deepak, all orders passed by the learned Chairman after 21 September 2019 were non est. Mr. Dayan Krishnan, in response to this submission, invokes the de facto doctrine. Mr. Sai Deepak, never the man to cede an inch where there exists a case worth contesting, submits that the de facto doctrine is not applicable in the facts of this case.

23. For the purposes of the present application, which only requires this Court to examine the issue prima facie, I am certainly not inclined to revisit the findings of the IPAB. To the extent the IPAB has upheld the validity of the suit patent, a prima facie case must be held to exist in favour of the plaintiff. This, however, is undoubtedly subject to the submission of Mr. Sai Deepak that the judgment of the IPAB is null and void as the learned Chairman was not competent to hold office. That aspect would be dealt with by and by.

24. If, however, Mr. Sai Deepak has advanced any submissions, assailing the validity of the suit patent, beyond those which were considered by the IPAB, those submissions undoubtedly have to be taken into consideration.

25. Thus, primary issues arise for examination before me, which may be framed thus:

(i) What is the value of the judgment dated 29 September 2020 passed by the IPAB ? Is it null and void, as Mr. Sai Deepak would seek to contend, or is it saved by the de facto doctrine, as submitted by Mr. Dayan Krishnan?

(ii) Has Mr. J. Sai Deepak advanced any contention beyond those which were considered by the IPAB, which make out a prima facie case for denial of interlocutory injunction as sought by the plaintiffs ?

26. Re. Issue (i) – Value of the judgment of the IPAB and applicability of the de facto doctrine

26.1 On 21 September 2019, Manmohan Singh, J., the Chairman of the IPAB, demitted office on completion of his tenure.

26.2 The International Association for Protection of Intellectual Property (“the IAPIP”) preferred WP (C) 1439/2019 before the Supreme Court. The writ petition was tagged with other writ petitions which challenged the constitutional validity of the Tribunal, Appellate Tribunal and other Authorities (Qualification, Experience and other Conditions of Service of Members) Rules, 2020 (“the 2020 Rules”), headed by WP (C) 804/2020 (Madras Bar Association v. U.O.I.). That batch came to be disposed of, by the Supreme Court, by judgment dated 27 November 20203.

26.3 During the pendency of the said proceedings, the tenure of all incumbent members of all tribunals was continued by interim orders passed by the Supreme Court from time to time – particularly order dated 16 September 2020 – till 31 December 2020.

26.4 MA 2219/2020 was filed by the IAPIP in WP (C) 1439/2019, praying that, till a new Chairperson of the IPAB was appointed, Manmohan Singh, J. be permitted to continue as Chairman. In other words, the IAPIP sought extension of the interim orders earlier passed, which came to an end on 31 December 2020, till a new Chairperson was appointed to the IPAB.

26.5 MA 2219/2020 was dismissed, by the Supreme Court, by judgment dated 12 February 20214. The opening paragraph of the judgment is, however, of significance:
“This judgement will dispose of an application by which directions are sought that till a new chairperson of the Intellectual Property Appellate Board (hereinafter referred to as “the board” or “IPAB”) is appointed, the incumbent (whose tenure had been extended by interim orders of this court, up to 31.12.2020) should continue to function as Chairperson.”
(Emphasis supplied)

As already noted, the judgment ultimately dismissed MA 2219/2020.

26.6 The Supreme Court, in its judgment dated 12 February 2021, noted the fact that Manmohan Singh, J., had continued to function as Chairman of the IPAB under various interim orders passed from time to time in Madras Bar Association. Specific notice is taken, in para 5 of the judgment, of the order dated 16 September 2020, thus:
“5. Learned Counsel relied upon the said judgment. It was argued that the orders made by this Court during the pendency of that case, till final judgment, i.e. dated 27th of November, 2020 protected the tenures of all incumbent tribunal members and their chairpersons. Specific reliance was placed upon the order dated 16th September 2020, which had extended the tenure of office of all incumbent members of all tribunals, to 31st December, 2020. The applicant also urged that it is essential that there is continuity and that taking into consideration the workload of the board, it is absolutely essential that it is headed by a properly qualified chairperson.”

26.7 Clearly, the Supreme Court, in its judgment dated 12 February 2021, did not expressly undo the effect of its interim orders, passed in Madras Bar Association, extending the tenure of the incumbent members of all tribunals till 31 December 2020, or set the clock back.

26.8 What, then, is the status of orders passed by Manmohan Singh, J., as Chairman of the IPAB, between 21 September 2019 and 31 December 2020? The order dated 29 September 2020, on which the plaintiffs in these suits relies, is one such order.

26.9 Mr. Dayan Krishnan submits that all such orders are saved by the de facto doctrine. He relies on Gokaraju Rangaraju v. State of A.P.5 He submits that the Supreme Court, while rendering its judgment dated 12 February 2021 in International Association for Protection of Intellectual Property, was well aware of the fact that the tenure of Manmohan Singh, J. had been continued under orders passed by the Supreme Court itself. It did not pass any orders nullifying all judicial acts done by Manmohan Singh, J., during the period of such continuance. The de facto doctrine squarely applies in such a case. Its application is excepted only to a usurper or an intruder, and Manmohan Singh, J., obviously was neither. The applicability of the doctrine was not excepted in a case in which the incumbent demitted office on superannuation. Mr. Dayan Krishnan cited, in this context, paras 3, 4, 7 and 13 of a judgment of the High Court of Patna in Sunity Pandey v. Sri Kant Prasad Shrivastava 6.

26.10 Mr. Sai Deepak contends that all the orders passed by Manmohan Singh, J., during the aforesaid twilight period perish with the judgment dated 31 December 2020. According to him, every judicial order passed by Manmohan Singh, J. after 21 September 2019 has been rendered null and void. The Supreme Court having held, in its judgment dated 12 February 2021, that Manmohan Singh, J’s term of office as Chairman of the IPAB had come to an end on 21 September 2019, and having not passed any orders protecting judicial acts done by Manmohan Singh, J., thereafter, all such acts stand nullified. He places especial reliance on para 23 of the judgment in International Association for Protection of Intellectual Property, which reads thus:
“23. Another argument urged by the applicant was that the Finance Act, 2017 had inserted Section 89A of the TM Act, (introduced by Section 161 of the former Act) which states that the tenure of office and maximum age of retirement would be governed by the terms of the said Finance Act and, consequently, the pre-existing tenure and age limits did not apply. Undoubtedly, the purport of Section 89A was to overbear or supersede the pre-existing age and tenure limits (the existing tenure and age limits have been indicated in Section 86 of the TM Act). However, the Finance Act merely stipulates the potential maximum age limits and tenure limits. In the case of Chairpersons, the maximum age limit prescribed was seventy years (by virtue of second proviso to Section 184[1]). However, by virtue of the first proviso to Section 184(1), members or chairpersons could be appointed “for such term as specified in the Rules made by the Central Government but not exceeding five years from the date on which he enters upon his office”. Thus, the outer limit of the tenure was five years. As noticed earlier, the Central Government had fixed the tenure of chairperson of the board to be three years. By the time this Rule was held unconstitutional, the tenure of the incumbent holding office of chairperson, of the board ended, on 21.09.2019. The final judgment in Rojer Mathew, could not have per se been applied to the facts of this case. The applicant’s contentions in this regard are of no avail; it is after the judgment in Madras Bar Association (supra) that the tenure has been mandated to be five years. It is to be noticed that even the 2020 Rules did not prescribe the maximum tenure; it rather confined the tenure to four years. In the facts of this case, even if that were to be applied-assuming such a course to be available, the four-year period too ended on 21.09.2020. It is important to notice that the changes brought about in the tenure and age limits were not only through the Schedule to the Finance Act, 2017, but also through its substantive provisions-Sections 156 to 182.5 These provisions introduced changes relating to tenure and age limits for members and chairpersons of 19 tribunals (including the Income Tax Appellate Tribunal; Securities Appellate Tribunal, Competition Commission of India, CESTAT, Railway Claims Tribunal, Central Administrative Tribunal, Debt Recovery Tribunal, Debt Recoveries Appellate Tribunals, the IPAB-i.e. the Board, in this case, etc.). All these provisions, much like Section 89A of the TM Act, aligned Parliamentary intention to legislate uniform tenure limits and maximum age for members and chairpersons. Therefore, Section 89A is only part of the entire legislative design. However, that has no bearing on the circumstances of the present case.”

26.11 According to Mr. Sai Deepak, the de facto doctrine applies only where the office of the incumbent itself is disbanded by operation of law and not in case such as the present in which the incumbent was wrongfully (as is specifically alleged, in writing, in para 4(c)(viii) of the consolidated written submissions of Mr. Sai Deepak) continuing in office beyond superannuation, contrary to the law. In the present case, he submits, the post of Chairperson IPAB was disbanded after the issuance of the judgment dated 24 September 2020. Mr. Sai Deepak also cites Central Bank of India v. Bernard7, which excepts the applicability of the de facto doctrine to a usurper in office. A person who continues in office after retirement, he submits, is a usurper. Mr. Sai Deepak also places reliance on the judgments of the High Court of Patna in Sunity Pandey and Shrikant Prasad Shrivastava v. State of Bihar 8.

26.12 To my mind, the issue is elementary. It would be preposterous to hold that the continuance in office of Manmohan Singh, J., which was in accordance with interim orders passed by the Supreme Court in Madras Bar Association, was “wrongful”, or that he was holding office as a “usurper”. Compliance with orders passed by the Supreme Court cannot be regarded as wrongful. The submission, of Mr. Sai Deepak, that a person who continues in office after retirement does so as a usurper, and that his continuance in office is illegal, mistakes the wood for the trees. As a general principle, it may be unexceptionable; but, in a case in which the person continues in office under orders passed by a judicial forum – in this case, none less than the Supreme Court – he is, quite obviously, neither a usurper, nor continuing illegally, or even wrongfully, in office.

26.13 De hors the de facto doctrine and its applicability, the judgment dated 12 February 2021 in International Association for Protection of Intellectual Property clearly observes that the interim orders of the Supreme Court in Madras Bar Association extended the tenure of incumbent members of all tribunals, including the Chairman, IPAB. The import is obvious. The interim orders of the Supreme Court were not intended at gratuitously permitting the members of the tribunals to continue in office, subject to the final outcome of the petitions. Their tenures were extended. “Tenure” is defined by the Supreme Court in Dr L.P. Agarwal v. U.O.I.9 and Yashwant Singh Kothari v. State Bank of Indore10 as the “term during which an office is held”. The situation was clarified still further in Dr P. Venugopal v. U.O.I.11:
“ “Tenure” means a term during which the office is held. It is a condition of holding the office. Once a person is appointed to a tenure post, his appointment to the said post begins when he joins and it comes to an end on the completion of tenure unless curtailed on justifiable grounds. Such a person does not superannuate, he only goes out of the office on completion of his tenure.”
(Emphasis supplied)

Extension of tenure, therefore, ipso facto implies extension of the tenure during which the incumbent holds office. Where such extension is by orders passed by the Supreme Court, he obviously holds office under authority of law. By no means is he a usurper.

26.14 Besides, the de facto doctrine, as explained in Gokaraju Ramaraju, also concludes the controversy. The Supreme Court held thus, in the said decision:

“4.  We are unable to agree with the submissions of the learned Counsel for the appellants. The doctrine is now well-established that “the acts of the officers de facto performed by them within the scope of their assumed official authority, in the interest of the public or third persons and not for their own benefit, are generally as valid and binding, as if they were the acts of officers de jure (Pulin Behari v. King-Emperor12). As one of us had occasion to point out earlier “the doctrine is founded on good sense, sound policy and practical expedience. It is aimed at the prevention of public and private mischief and the protection of public and private interest. It avoids endless confusion and needless chaos. An illegal appointment may be set aside and a proper appointment may be made, but the acts of those who hold office de facto are not so easily undone and may have lasting repercussions and confusing sequels if attempted to be undone. Hence the de facto doctrine” (vide Immedisetti Ramkrishnaiah Sons v. State of A.P.13).

5.  In Pulin Behari , Sir Asutosh Mookerjee, J. noticed that in England the de facto doctrine was recognised from the earliest times. The first of the reported cases where the doctrine received judicial recognition was the case of Abbe de Fontaine14 decided in 1431. Sir Asutosh Mookerjee noticed that even by 1431 the de facto doctrine appeared to be quite well known and, after 1431, the doctrine was again and again reiterated by English Judges.

6.  In Milward v. Thatcher15, Buller, J. said:
“The question whether the judges below be properly judges or not, can never be determined, it is sufficient if they be judges de facto. Suppose a person were even criminally convicted in a Court of Record, and the Recorder of such Court were not duly elected, the conviction would still be good in law, he being the judge de facto.”

7.  In Scadding v. Lorant16, the question arose whether a rate for the relief of the poor was rendered invalid by the circumstance that some of the vestry men who made it were vestry men de facto and not de jure. The Lord Chancellor observed as follows:
“With regard to the competency of the vestry men, who were vestry men de facto, but not vestry men de jure, to make the rate, Your Lordships will see at once the importance of that objection, when you consider how many public officers and persons there are who were charged with very important duties, and whose title to the office on the part of the public cannot be ascertained at the time. You will at once see to what it would lead if the validity of their acts, when in such office, depended upon the propriety of their election. It might tend, if doubts were cast upon them, to consequences of the most destructive kind. It would create uncertainty with respect to the obedience to public officers and it might also lead to persons, instead of resorting to ordinary legal remedies to set right anything done by the officers, taking the law into their own hands.”

8.  Some interesting observations were made by the Court of Appeal in England in Re James17  (An Insolvent). Though the learned Judges constituting the Court of Appeal differed on the principal question that arose before them namely whether “the High Court of Rhodesia” was a British Court, there did not appear to be any difference of opinion on the question of the effect of the invalidity of the appointment of a judge on the judgments pronounced by him. Lord Denning, M.R., characteristically, said:
“He sits in the seat of a judge. He wears the robes of a judge. He holds the office of a judge. Maybe he was not validly appointed. But, still, he holds the office. It is the office that matters, not the incumbent…. So long as the man holds the office, and exercises it duly and in accordance with law, his orders are not a nullity. If they are erroneous they may be upset on appeal. But, if not, erroneous they should be upheld.”
Lord Denning then proceeded to refer to the State of Connecticut v. Carroll18 decided by the Supreme Court of Connecticut, Re Aldridge19 decided by the Court of Appeal in  New Zealand and Norton v. Shelby County20 decided by the United States Supreme Court. Observations made in the last case were extracted and they were:
“Where an office exists under the law, it matters not how the appointment of the incumbent is made, so far as the validity of his acts are concerned. It is enough that he is clothed with the insignia of the office, and exercises its powers and functions…. The official acts of such persons are recognised as valid on grounds of public policy, and for the protection of those having official business to transact.”

9.  Scarman, L.J., who differed from Lord Denning on the question whether the High Court of Rhodesia was a British Court appeared to approve the view of Lord Denning, M.R. in regard to the de facto doctrine. He said:
“He (Lord Denning) invokes the doctrine of recognition of the de facto judge, and the doctrine of implied mandate or necessity. I agree with much of the thinking that lies behind his judgment. I do think that in an appropriate case our courts will recognise the validity of judicial acts, even though they be the acts of a judge not lawfully appointed or derive their authority from an unlawful Government. But it is a fallacy to conclude that, because in certain circumstances our courts would recognise as valid the judicial acts of an unlawful court or a de facto judge, therefore, the court thus recognised is a British Court.”

10.  The de facto doctrine has received judicial recognition in the United States of America also. In  State v. Gardner (Cases on Constitutional Law by McGonvey and Howard, Third Edition, p. 102) the question arose whether the offer of a bribe to a City Commissioner whose appointment was unconstitutional was an offence. Bradbury, J. said:
“We think that principle of public policy, declared by the English courts three centuries ago, which gave validity to the official acts of persons who intruded themselves into an office to which they had not been legally appointed, is as applicable to the conditions now presented as they were to the conditions that then confronted the English judiciary. We are not required to find a name by which officers are to be known, who have acted under a statute that has subsequently been declared unconstitutional, though we think such officers might aptly be called de facto officers.”

11.  In Norton v. Shelby County21 Field, J., observed as follows:
“The doctrine which gives validity to acts of officers de facto whatever defects there may be in the legality of their appointment or election is founded upon considerations of policy and necessity, for the protection of the public and individuals whose interests may be affected thereby. Offices are created for the benefit of the public, and private parties are not permitted to inquire into the title of persons clothed with the evidence of such offices and in apparent possession of their powers and functions. For the good order and peace of society their authority is to be respected and obeyed until in some regular mode prescribed by law their title is investigated and determined. It is manifest that endless confusion would result, if in every proceeding before such officers their title could be called in question.”

12.  In Cooley’s Constitutional Limitations, Eighth Edition, Volume 2, p. 1355, it is said:
“An officer de facto is one who by some colour or right is in possession of an office and for the time being performs its duties with public acquiescence, though having no right in fact. His colour of right may come from an election or appointment made by some officer or body having colorable but no actual right to make it; or made in such disregard of legal requirements as to be ineffectual in law; or made to fill the place of an officer illegally removed or made in favour of a party not having the legal qualifications; or it may come from public acquiescence in the qualifications; or it may come from public acquiescence in the officer holding without performing the precedent conditions, or holding over under claim of right after his legal right has been terminated; or possibly from public acquiescence alone when accompanied by such circumstances of official reputation as are calculated to induce people, without inquiry, to submit to or invoke official action on the supposition that the person claiming the office is what he assumes to be. An intruder is one who attempts to perform the duties of an office without authority of law, and without the support of public acquiescence.
No one is under obligation to recognise or respect the acts of an intruder, and for all legal purposes they are absolutely void. But for the sake of order and regularity, and to prevent confusion in the conduct of public business and in security of private rights, the acts of officers de facto are not suffered to be questioned because of the want of legal authority except by some direct proceeding instituted for the purpose by the State or by some one claiming the office de jure, or except when the person himself attempts to build up some right, or claim some privilege or emolument, by reason of being the officer which he claims to be. In all other cases the acts of an officer de facto are as valid and effectual, while he is supposed to retain the office, as though he were an officer by right, and the same legal consequences will flow from them for the protection of the public and of third parties. There is an important principle, which finds concise expression in the legal maxim that the acts of officers de facto cannot be questioned collaterally.”

13.  In Black on Judgments it is said:
“A person may be entitled to his designation although he is not a true and rightful incumbent of the office, yet he is no mere usurper but holds it under colour of lawful authority. And there can be no question that judgments rendered and other acts performed by such a person who is ineligible to a judgeship but who has nevertheless been duly appointed, and who exercises the power and duties of the office is a de facto judge, and his acts are valid until he is properly removed.”

14.  The de facto doctrine has been recognised by Indian courts also. In Pulin Behari  Sir Asutosh Mookerjee, J. after tracing the history of the doctrine in England observed as follows:
“The substance of the matter is that the de facto doctrine was introduced into the law as a matter of policy and necessity, to protect the interest of the public and the individual where these interests were involved in the official acts of persons exercising the duties of an office without being lawful officers. The doctrine in fact is necessary to maintain the supremacy of the law and to preserve peace and order in the community at large. Indeed, if any individual or body of individuals were permitted, at his or their pleasure, to collaterally challenge the authority of and to refuse obedience to the Government of the State and the numerous functionaries through whom it exercised its various powers on the ground of irregular existence for defective title, insubordination and disorder of the worst kind would be encouraged. For the good order and peace of society, their authority must be upheld until in some regular mode their title is directly investigated and determined.”

15.  In P.S. Menon v. State of Kerala22  a Full Bench of the Kerala High Court consisting of P. Govindan Nair, K.K. Mathew and T.S. Krishna-moorthy Iyer, JJ., said about the de facto doctrine:
“This doctrine was engrafted as a matter of policy and necessity to protect the interest of the public and individuals involved in the official acts of persons exercising the duty of an officer without actually being one in strict point of law. But although these officers are not officers de jure they are by virtue of the particular circumstances, officers, in fact, whose acts, public policy requires should be considered valid.”

16.  In the judgment under appeal Kuppuswami and Muktadar, JJ., observed:
“Logically speaking if a person who has no authority to do so functions as a judge and disposes of a case the judgment rendered by him ought to be considered as void and illegal, but in view of the considerable inconvenience which would be caused to the public in holding as void judgments rendered by judges and other public officers whose title to the office may be found to be defective at the later date. Courts in a number of countries have, from ancient times evolved a principle of law that under certain conditions, the acts of a judge or officer not legally competent may acquire validity.”

17.  A judge, de facto, therefore, is one who is not a mere intruder or usurper but one who holds office, under colour of lawful authority, though his appointment is defective and may later be found to be defective. Whatever be the defect of his title to the office, judgments pronounced by him and acts done by him when he was clothed with the powers and functions of the office, albeit unlawfully, have the same efficacy as judgments pronounced and acts done by a judge de jure. Such is the de facto doctrine, born of necessity and public policy to prevent needless confusion and endless mischief. There is yet another rule also based on public policy. The defective appointment of a de facto judge may be questioned directly in a proceeding to which he be a party but it cannot be permitted to be questioned in a litigation between two private litigants, a litigation which is of no concern or consequence to the judge except as a judge. Two litigants litigating their private titles cannot be permitted to bring in issue and litigate upon the title of a judge to his office. Otherwise so soon as a judge pronounces a judgment a litigation may be commenced for a declaration that the judgment is void because the judge is no judge. A judge’s title to his office cannot be brought into jeopardy in that fashion. Hence the rule against collateral attack on validity of judicial appointments. To question a judge’s appointment in an appeal against his judgment is, of course, such a collateral attack.

18.  We do not agree with the submission of the learned Counsel that the de facto doctrine is subject to the limitation that the defect in the title of the judge to the office should not be one traceable to the violation of a constitutional provision. The contravention of a constitutional provision may invalidate an appointment but we are not concerned with that. We are concerned with the effect of the invalidation upon the acts done by the judge whose appointment has been invalidated. The de facto doctrine saves such acts. The de facto doctrine is not a stranger to the Constitution or to the Parliament and the legislatures of the States. Article 71(2) of the Constitution provides that acts done by the President or Vice-President of India in the exercise and performance of the powers and duties of his office shall not be invalidated by reason of the election of a person as President or Vice-President being declared void. So also Section 107(2) of the Representation of the People Act, 1951 (43 of 1951) provides that acts and proceedings in which a person has participated as a member of Parliament or a member of the legislature of a State shall not be invalidated by reason of the election of such person being declared to be void. There are innumerable other Parliamentary and State legislative enactments which are replete with such provisions. The twentieth amendment of the Constitution is an instance where the de facto doctrine was applied by the constituent body to remove any suspicion or taint of illegality or invalidity that may be argued to have attached itself to judgments, decrees, sentences or orders passed or made by certain District Judges appointed before 1966, otherwise than in accordance with the provision of Article 233 and Article 235 of the Constitution. The twentieth amendment was the consequence of the decision of the Supreme Court in Chandra Mohan v. State of U.P23 that appointments of District Judges made otherwise than in accordance with the provisions of Articles 233 and 235 were invalid. As such appointments had been made in many States, in order to pre-empt mushroom litigation springing up all over the country, it was apparently thought desirable that the precise position should be stated by the constituent body by amending the Constitution. Shri Phadke, learned Counsel for the appellants, argued that the constituent body could not be imputed with the intention of making superfluous amendments to the Constitution. Shri Phadke invited us to say that it was a necessary inference from the twentieth amendment of the Constitution that, but for the amendment, the judgments, decrees etc. of the District Judges appointed otherwise than in accordance with the provisions of Article 233 would be void. We do not think that the inference suggested by Shri Phadke is a necessary inference. It is true that as a general rule the Parliament may be presumed not to make superfluous legislation. The presumption is not a strong presumption and statutes are full of provisions introduced because abundans cautela non nocet (there is no harm in being cautious). When judicial pronouncements have already declared the law on the subject, the statutory reiteration of the law with reference to particular case does not lead to the necessary inference that the law declared by the judicial pronouncements was not thought to apply to the particular cases but may also lead to the inference that the statute-making body was mindful of the real state of the law but was acting under the influence of excessive caution and so to silence the voices of doubting Thomases by declaring the law declared by judicial pronouncements to be applicable also to the particular cases. In Chandra Mohan case this Court had held that appointments of District Judges made otherwise than in accordance with Article 233 of the Constitution were invalid. Such appointments had been made in Uttar Pradesh and a few other States. Doubts had been cast upon the validity of the judgments, decrees etc. pronounced by those District Judges and large litigation had cropped up. It was to clear those doubts and not to alter the law that the twentieth amendment of the Constitution was made. This is clear from the Statement of Objects and Reasons appended to the Bill which was passed as Constitution (20th Amendment) Act, 1966. The statement said:
“Appointments of District Judges in Uttar Pradesh and a few other States have been rendered invalid and illegal by a recent judgment of the Supreme Court on the ground that such appointments were not made in accordance with the provisions of Article 233 of the Constitution…. As a result of these judgments, a serious situation has arisen because doubt has been thrown on the validity of the judgments, decrees, orders and sentences passed or made by these District Judges and a number of writ petitions and other cases have already been filed challenging their validity. The functioning of the District Courts in Uttar Pradesh has practically come to a standstill. It is, therefore, urgently necessary to validate the judgments, decrees, orders, and sentences passed or made heretofore by all such District Judges in those States….”

19.  In our view, the de facto doctrine furnishes an answer to the submissions of Shri Phadke based on Section 9 of the Criminal Procedure Code and Article 21 of the Constitution. The judges who rejected the appeal in one case and convicted the accused in the other case were not mere usurpers or intruders but were persons who discharged the functions and duties of judges under colour of lawful authority. We are concerned with the office that the Judges purported to hold. We are not concerned with the particular incumbents of the office. So long as the office was validly created, it matters not that the incumbent was not validly appointed. A person appointed as a Sessions Judge, Additional Sessions Judge or Assistant Sessions Judge, would be exercising jurisdiction in the Court of Session and his judgments and orders would be those of the Court of Session. They would continue to be valid as the judgments and orders of the Court of Session, notwithstanding that his appointment to such Court might be declared invalid. On that account alone, it can never be said that the procedure prescribed by law has not been followed. It would be a different matter if the constitution of the court itself is under challenge. We are not concerned with such a situation in the instant cases. We, therefore, find no force in any of the submissions of the learned Counsel.”

26.15 The overarching consideration of public interest has, therefore, to inform the interpretation and application of the de facto doctrine. The Supreme Court did not limit or restrict, in any way, the discharge of functions by the members of the various tribunals whose tenures were extended. The orders passed by Manmohan Singh, J., in his capacity as the Chairman of the IPAB, between 21 September 2019 and 31 December 2020, were, therefore, passed under lawful colour of authority, as he continued to hold office in accordance with the directives of the Supreme Court. Applying Gokaraju, therefore, the de facto doctrine clearly legitimizes them.

26.16 Besides the fact that Mr Sai Deepak’s stand is, even in law, not correct, acceptance of his contention would result in a situation of chaos, as every judicial decision taken by Manmohan Singh, J., for the entire period of nearly a year and a quarter after 21 September 2019 would stand invalidated. The law frowns on interpretations which consign the legal position to a state of flux or uncertainty. Given the fact that he was functioning as Chairman under orders of the Supreme Court, there is no justification to invalidate all judicial acts performed by him during the said period. Doing so would also, in my view, be perilously in the teeth of Article 144 of the Constitution of India, which requires all civil and judicial authorities in the territory of India to act in aid of the Supreme Court. The intent of the Supreme Court in allowing members of the tribunals to continue in office was obviously to ensure that the administration of justice continued unimpaired. It would ill behove this Court, therefore, to hold that all judicial acts of such members, during the period of their continuance in office, are invalid and non est.

26.17 Mr. Sai Deepak’s contention that the consequence of the judgment dated 12 February 2021 in International Association for Protection of Intellectual Property was that all judgments and orders passed by Manmohan Singh J. after 21 September 2019 were rendered non est cannot, therefore, be accepted.

26.18 The plaintiffs are, therefore, within its rights in relying on the IPAB judgment dated 29 September 2020. The extent to which the said judgment would further the case of the plaintiffs has, of course, to be assessed.

27. The order dated 4 March 2020 of the Joint Controller

27.1 To understand the objections raised by Laurus to the validity of the suit patent before the Joint Controller, it is first necessary to understand the chemical structure of Ibrutinib itself. The chemical structure of Ibrutinib comprises four distinct moieties, as under:

27.2 Ibrutinib may, therefore, be regarded as comprising a core 4-amino pyrazolo pyrimidine moiety – which the plaintiffs call the Ibrutinib “nucleus” – with the following three substituents at positions 1, 2, 3 and 4 (in the structure shown above):
(i) N at position 1 attached to the N-1 piperidine ring with the Michael acceptor attached to the N on the piperidine ring,
(ii) an unattached N at position 2,
(iii) a phenoxy phenyl group attached to the C at position 3, and
(iv) an amino group -NH2 attached to the C at position 4.

27.3 The post grant opposition filed by Laurus was allowed by the Joint Controller, vide his order dated 4 March 2020, on the ground that Ibrutinib was obvious to a person skilled in the art from the prior art documents cited by Laurus and was, therefore, lacking in inventive step.

27.4 Laurus predicated its challenge to the suit patent on clauses (b), (e), (f) and (g) of Section 25(2)24 of the Patents Act, by alleging that Ibrutinib is lacking in novelty, lacking in inventive step, not patentable by virtue of Section 3(d) and insufficiently described in the complete specifications of the suit patent.

27.5 The Joint Controller rejected the challenge predicated on clauses (b), (f) and (g) of Section 25(2), but upheld the challenge bsed on clause (e). He held, therefore, that Ibrutinib was lacking in any inventive step – in other words, that it was “obvious” to a person skilled in the art – from the prior art cited by Laurus.

27.6 The rejection, by the Joint Controller, of the challenge of Laurus predicated on clauses (b), (f) and (g) of Section 25(2) was never challenged.

27.7 The challenge under Section 25(2)(c) was premised on the following prior art documents:
(i) WO2002/080926 (WO’926),
(ii) US 2004/0006083 (US’083),
(iii) WO 2004/100868 (WO’868),
(iv) Andrew F. Burchatet et al, Bioorganic & Medicinal Chemistry, 2002, 12 (Andrew et al 2002), and
(v) Robert A. Copeland, Evaluation of Enzyme Inhibitors in Drug Discovery, 2005.

27.8 Regarding the prior art documents cited by Laurus, Laurus’ submissions, and the findings of the Joint Controller, were as under:

(i) Re. WO2002/080926 (WO’926)

Laurus contended that this patent described various protein tytrosine kinase inhibitors and that the preferred compounds in the patent were those in which, on the core 4-amino pyrazolo pyrimidine moiety, the phenoxyphenyl moiety was substituted at the third and the piperidine moiety was substituted at the first place. Some relevant compounds were cited thus:

(ii) Re. US 2004/0006083 (US’083):

This patent was also stated to disclose various tyrosine kinase inhibitors, including potential Btk inhibitors. They all had the 4-amino-pyrazolo-[3,4] pyrimidine core with substitutions at positions 1 and 3, to result in Ibrutinib like compounds. The following relevant compounds were disclosed by this patent:

(iii) Re. WO 2004/100868 (WO’868) and Andrew F. Burchatet et al, Bioorganic & Medicinal Chemistry, 2002, 12 (Andrew et al 2002)

These, too, were stated to disclose a patent with the 4-amino-pyrazolo-pyrimidine core, with many of the disclosed compounds containing phenoxyphenyl based with piperidine or other heterocyclic substitutions. The compounds were stated to show significant Lck inhibitory activity.

(iv) Re. Robert A. Copeland, Evaluation of Enzyme Inhibitors in Drug Discovery, 2005 (“Copeland”, hereinafter)

Laurus contended that Copeland disclosed, which was said to disclose irreversible enzyme inactivators, and contained the requisite teaching to instruct a person skilled in the art to attach the Michael receptor to the N-piperidinyl moiety.

27.9 The Joint Controller noted, in the opening paragraphs of his discussion on the aspect of inventive step in the suit patent vis-à-vis prior art, that the contention of the plaintiffs that all the compounds disclosed in the prior art patents were Lck inhibitors, and not Btk inhibitors, was correct. However, the prior art had to be seen as a whole, and all prior arts referred to the proteins as under the general tyrosine kinase family. The Joint Controller placed reliance on the following recital in the complete specifications of the suit patent:
“Further described are irreversible inhibitors of Btk that form a covalent bond with a cysteine residue on Btk. Further described herein are irreversible inhibitors of other tyrosine kinases, wherein the tyrosine kinases share homology with Btk by having a cysteine residue (including a Cys 481 residue) that can form a covalent bond with the irreversible inhibitor (such tyrosine kinases are referred herein as “Btk tyrosine kinase cysteine homologs”).

[0163] Further, the irreversible Btk inhibitor compounds described herein can be used to inhibit a small subset of other tyrosine kinases that share homology with Btk by having a cysteine residue (including a Cys 481 residue) that can form a covalent bond with the irreversible inhibitor. See e.g. protein kinases in FIG. 1. Thus, a subset of tyrosine kinases other than Btk are also expected to be useful as therapeutic targets in a number of health conditions.

[0039] In another aspect are methods for modulating, including irreversibly inhibiting the activity of Btk or other tyrosine kinases, wherein the other tyrosine kinases share a homology with Btk by having a cysteine residue (incuding a Cys 481 residue) that can form a covalent bond with at least one irreversible inhibitor described therein, in a mammal comprising administering to the mammal at least once an effective amount of at least one compound having the structure of any of Formula (A), Formula (B), Formula (C) or Formula (D).”

Figure 1, referred to in para [00163] of the complete specifications is the following:

27.10 The Joint Controller observed that, in Figure 1, the plaintiff had shown how Btk protein had homology with other tyrosine kinases including Lck. As such, the plaintiff itself appeared to state, in the complete specifications of the suit patent, that the suit patent was claiming inhibitor compounds which not only inhibited Btk but could also be expected to inhibit other homologous tyrosine kinases of which Lck was one. The crystalline structure of Btk was known. Btk contained a cysteine residue in its ATP binding domain/kinase domain. As Lck and Btk admittedly had similar structures with cysteine residue, the notion that Lck inhibitors were likely to act as Btk inhibitors was not without any basis. As such, the submission of the plaintiff that Lck and Btk were totally unrelated and that prior art regarding Lck was required to be rejected was not acceptable, as it was contrary to the complete specifications of the suit patent. Laurus was, therefore, entitled to rely on prior are pertaining to compounds which acted as Lck inhibitors.

27.11 Andrew et al 2002 described compounds with the 4-amino-pyrazolo-[3,4] pyrimidine core, which were synthesised and evaluated as Lck inhibitors. The Joint Controller referred to the following examples of two such compounds:

Compound 1 Compound 2

27.12 Of these, Compound 1 had the pyrrolopyrimidine core whereas Compound 2 had the pyrazolopyrimidine core. In each case, the core had N-methyl piperazine appended to a cyclohexyl group at position 1 and the phenoxy-phenyl moiety at position 3. Studies conducted by Laurus indicated that Compound 2 was more therapeutically effective than Compound 1. This was because the phenoxy-phenyl moiety position at 3 occupied the lipophilic pocket in the Lck protein ribose thereby increasing potency. Thus, Compound 2 was found to be more efficacious. As there were only two such compounds in Andrew et al 2002, there was no reason why a person skilled in the art would not select the more efficacious Compound 2 which had a pyrazolopyrimidine core. Similarly, the placement of the phenoxy-phenyl moiety at position 3 was also logical for a person skilled in the art, as it was shown to be beneficial and responsible for increasing potency.

27.13 The Joint Controller, therefore, opined that a person looking to make an effective compound would, therefore, be expected to retain the phenoxy-phenyl moiety on the pyrazolopyrimidine core. He further observed that Andr