G.P. Mittal, J.
I.A. No. 5908/2013 (Order XXXIX Rules 1 and 2 CPC) and I.A. No. 5417/2013 (Order VII Rules 10 and 11 CPC) in CS (OS) No. 678/2013
1. By virtue of this application, the Plaintiff seeks an ad interim injunction restraining the Defendants, their agents, etc. from manufacturing, selling, offering for sale, advertising or directly or indirectly dealing in the product Linezolid manufactured in a manner so as to result in infringement of the Plaintiff''s registered patent IN213062 (IN ''062) and the registered patent IN213063 (IN ''063).
2. The Plaintiff filed the suit with the averments that the processes for preparation of Linezolid as disclosed in the prior art were tedious and cumbersome in as much as (i) the prior art processes involve use of highly flammable and dangerous reagents like n-butyl lithium in hexanes; (b) handling of n-butyl lithium is very difficult at lab scale and in commercial scale operations; (c) the reaction between N-carbobenzyloxy-3-fluoro-4-morpholinyl aniline and (R)-glycidyl butyrate in tetrahydrofuran in the presence of n-butyl lithium/hexane should be performed at extremely low temperatures (-780C to -160C) under very strict control of reaction conditions; processes involving extremely low temperatures are undesirable for large-scale operations since they require special equipment and an additional reactor, adding to the cost, thereby making the processes commercially unviable; (d) the processes require longer reaction time and the yield and purity of the product obtained is very low; (e) the processes involve the use of highly toxic and expensive reagents like benzyl chloroformate, sodium azide and (R)-glycidyl butyrate, Palladium on Carbon; (f) the processes involve the use of tedious and cumbersome procedures like prolonged reaction time periods, multiple process steps, column chromatographic purifications, multiple isolation/re-crystallizations etc; (g) the processes involve the use of multiple and excess amounts of hazardous solvents like n-hexane, heptanes, dioxane and tetrahydrofuran; (h) the processes involve the use of highly toxic reagents like phosgene, pyridiium p-toluenesulfonate; (i) methods involving column chromatographic purifications are generally undesirable for large-scale operations, thereby making the processes commercially unfeasible; (j) the overall processes generate a large quantity of chemical waste which is difficult to treat etc.
3. It is the case of the Plaintiff that in an effort to develop a more economical, safe and commercially viable process for preparation of Linezolid, the Plaintiff developed novel processes involving novel intermediates that have been patented vide IN ''062 and IN ''063.
4. The novelty and inventive steps of IN ''063 as claimed by the Plaintiff are as under:-
"(i) Alleged use of R-Epichlorohydrin and N, N-Carbonyldiimidazole as a key starting materials for first time in synthesis of Linezolid to obtain compound called CHFA-compound IV;
(ii) Production of novel intermediate compound called CHFA;
(iii) Carbonylating CHFA with carbonylating agent N, N-carbonyldiimidazole) to obtain Zodiac-4 as key intermediate;
(iv) Reacting Zodiac-4 with potassium phthalimide to produce Compound of Formula-VII (phthalimidomethyl oxazolidinone compound), which is further converted to Linezolid;"
5. Similarly, novelty and inventive steps of IN ''062 are:-
"(i) Reacting CHFA with Potassium phthalimide to obtain PHPFMA (Compound of Formula-IV);
(ii) PHPFMA is a novel intermediate;
(iii) Carbonylating PHPFMA with carbonylating agent N, N-carbonyldiimidazole to obtain amino methyl phthalimide, which is converted to Linezolid;"
6. It is urged that novel intermediate compounds claimed in the suit patents "N-[3-Chloro-2-(R)-hydroxypropyl]-3-fluoro-4-morpholinyl-anlaniline" (CHFA) (claimed in Claims 18 and 19 of IN ''063) and "N-3 [Phthalimido-2-(R)-hydroxypropyl]-3-fluoro-4 (morpholinyl) aniline" (PHPFMA) (claimed in Claims 23, 24 and 25 of IN ''062) are exclusively formed/generated and used in the processes for the production of Linezolid as claimed in the suit patents whereas those intermediates are not formed (indeed, there is no possibility of them forming) in the prior art processes for preparing Linezolid. The structural formulae of these two claimed intermediate compounds "N-[3-Chloro-2-(R)-hydroxypropyl]-3-fluoro-4-morpholinylaniline" (CHFA) and "N-[3-Phthalimido-2-(R)-hydroxypropyl]-3-fluoro-4-(morpholinyl) aniline" (PHPFMA) are being extracted below for the sake of clarity and convenience:
Novel Intermediate Compounds Claimed in the Subject Suit patents:
Thus, the presence of any of the aforesaid compounds in the final product (Linezolid) would be indicative of the fact that the said product has been prepared by using the patented processes of the Plaintiff.
7. It is averred that Defendant no. 1 is a limited company based in India and is dealing in the manufacture and supply of both active pharmaceutical ingredients (APIs) and finished doses forms of various pharmaceutical formulations while Defendant no. 2 is its subsidiary. It is averred that Defendant no. 1 is engaged in the manufacture and sale of Linezolid in finished dosages forms (tablets) and I.V. injections whereas Defendant no. 2 is engaged in manufacturing, purchase and sale of Linezolid API/bulk drug.
8. It is the case of the Plaintiff that sometime in December, 2012, the Plaintiff learnt that the Defendants were manufacturing Linezolid in finished doses forms and I.V. injections and selling them under the brand name ''LIZOLID'' in the open market. The Plaintiff obtained three samples of Linezolid manufactured by the Defendants (bearing Batch Nos. 081200672, 05121501 and 05120995) and analysed the same using the High Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS) method. The samples disclosed the presence of PHPFMA and Zodiac-4, which are the key intermediates in the Linezolid manufacturing processes as claimed in the suit patents IN ''062 and IN ''063.
9. Thus, the Plaintiff concluded that the Defendants were infringing the Plaintiffs suit patents.
10. Therefore, the Plaintiff sent a legal notice dated 02.01.2013 to Defendant no. 1 complaining about infringement of the suit patents. Defendant no. 1 issued a response dated 17.01.2013 denying any infringement activity.
11. During the pendency of the suit, the Plaintiff obtained two fresh samples bearing Batch Nos. 081200550 dated May, 2012 and 05122366 dated September, 2012 and upon testing, the three compounds/markers of the Plaintiff being CHFA, PHPFMA and Zodiac-4 were detected in scientifically and statistically significant levels in every sample of the Defendants. It is the case of the Plaintiff that the three samples from various batches which were got tested by the Plaintiff in its own lab were also submitted for further testing in a renowned independent scientific laboratory i.e. the Indian Institute of Chemical Technology (IICT), a Central Government Organisation which also confirmed presence of earlier said three molecules (CHFA, PHPFMA and Zodiac-4), which were exclusive to the Plaintiffs patented processes.
12. It is thus, averred that the Plaintiff who has expended huge amount, effort, time and money in developing and inventing the patented processes is entitled to protect the same and the Defendants are liable to be injuncted from manufacturing, selling, offering for sale etc. the API Linezolid manufactured in a manner so as to result in infringement of the Plaintiffs registered patents IN ''062 and IN ''063.
13. The Plaintiff claims jurisdiction of this Court to entertain and try this suit on the ground that the Defendants are doing business within the territorial jurisdiction of this Court; they also have their branch office at Najafgarh Road Industrial Area, Moti Nagar, New Delhi. It is stated that the Defendants are also carrying on their business in general and in the unfinished products in New Delhi through M/s. Diksha Medicos, 1956, Outrem Line, Kingsway Camp, New Delhi and M/s. Safdarjung Medicos, Shop No. 5, Near Metro Station, Safdarjung Hospital Gate no. 2 (Opp. AIIMS), New Delhi.
14. The Defendants have contested the suit by way of filing a written statement to the plaint and reply to the injunction application stating that the processes as well as the intermediates claimed in the suit patents are not the novel. It is averred that intermediates obtained in the process of manufacture of Linezolid as claimed by the Plaintiff has been known in the pharmaceutical industry for a long time prior to the Plaintiffs alleged development of the process or the intermediates. Thus, it is averred that the suit patents are liable to be revoked on the grounds as set out in the counter claim filed by the Defendants.
15. It is averred that the Plaintiff has alleged PHPFMA as a novel intermediate compound in Indian Patent IN ''062 and has based the suit on the alleged presence of PHPFMA with Zodiac-4 in the products of the Defendants. It is the case of the Defendants that scrutiny of the proceedings of the European Patent office pertaining to EP1768967 corresponding to Indian Patent IN ''062 has revealed that the Plaintiff had specifically not patented and had disclaimed PHPFMA as a novel intermediate and reference to PHPFMA has been deleted from the claims of the said European Patent which clearly establishes that PHPFMA is not a novel intermediate as claimed by the Plaintiff.
16. It is urged that the Plaintiff and Defendant no. 1 had long standing business relationship since the year 2003 and Defendant no. 1 was granted the drug license to manufacture and sell Linezolid API in 2002 and it has been selling ''Linezolid'' tablets in open market to the knowledge of the Plaintiff since then.
17. It is claimed that the suit filed by the Plaintiff and the prayer of ad interim injunction is misconceived as mere presence of Zodiac-4 and PHPFMA in the final product of the Defendants cannot be indicative of infringement of the Plaintiffs patents as these compounds can be found even if other processes of prior art are followed for manufacturing Linezolid.
18. It is further the case of the Defendants that the Plaintiff has not filed the analysis report of its own product and on analysis of the Plaintiff''s Linezolid, the intermediates CHFA, PHPFMA and Zodiac-4 were not found when tested by the Defendants. It is averred that the Defendants have made huge investment and set up plant and machinery and are already manufacturing Linezolid API by their own process for at least twelve years to the knowledge of the Plaintiff without any objection having been raised by the Plaintiff.
19. The veracity of the Plaintiff''s claim is also questioned on the ground that in the pre-suit lab reports, presence of CHFA was not found whereas in post-suit analysis, suddenly CHFA was also deducted in the product of the Defendants.
20. It is thus, stated that the onus of proof on the Plaintiff to prove infringement was not shifted upon the Defendants under Section 104-A of the Patents Act, 1970. The Defendants, have therefore, prayed for dismissal of the injunction application for want of any prima facie case, balance of convenience or irreparable loss and injury to the Plaintiff.
21. In the replication, the existence of prior commercial relationship between the Defendants and the Plaintiff has not been denied. At the same time, it has been stated that a few sporadic invoices filed by the Defendants to show that they had purchased insignificant quantity of Linezolid API from the Plaintiff is of no consequence when the Defendants'' utilisation of Linezolid API is believed to be approximately 4000 kgs. per month, whereas total sale of Linezolid API by the Plaintiff to the Defendants over a period of ten years since 2003 is only 2816 kgs.
22. In order to succeed for grant of injunction, the Plaintiff has to show that it has a good prima facie case, the balance of convenience lies in its favour and that if injunction sought for is not granted, it will suffer an irreparable loss and injury.
23. Before adverting to the facts with regard to the infringement of the Plaintiffs patented process, the Plaintiff will have to prima facie satisfy that this Court has territorial jurisdiction to entertain the present suit. In this regard, the Plaintiff has not only stated that the Defendants are functioning from their branch office at Najafgarh Road but has also given the names of two distributors through whom the pharmaceutical preparation manufactured through the patented processes is being sold by the Defendants in New Delhi.
24. Although the Defendants have denied the jurisdiction of this Court to entertain the present suit, but at the same time it has not been disputed that Defendant no. 1 has its branch office at Najafgarh Road within the jurisdiction of this Court. It has also not been disputed that the pharmaceutical preparation allegedly manufactured through the claimed patented processes is being sold by the Defendants through their distributors in New Delhi as alleged in the plaint. What has been stated by the Defendants is that the alleged cause of action could only relate to manufacture of Linezolid API and since the Defendants did not have any manufacturing facility at New Delhi, this Court will not have jurisdiction to entertain and try the suit.
25. I am not inclined to agree with the submission raised on behalf of the Defendants. If the Defendants are selling their product in a particular area, the Court having jurisdiction over the area will have territorial jurisdiction to entertain the suit. Reference in this connection may be made to
26. Apart from claiming that there was nothing novel in the process patents IN ''062 and IN ''063 of the Plaintiff, the Defendants have claimed that way back in the year 2002, Director General, Health Services, Government of India permitted the Defendants to manufacture Linezolid. It is true that by a letter dated 01.04.2002, Defendant no. 1 was granted a drug licence to manufacture Linezolid IV injections and subsequently, by a letter dated 02.04.2003, Commissioner, Food and Drug Control Administration allowed Defendant no. 1 to manufacture certain drudges including Linezolid. However, it may be noted that these licences simply permitted Defendant no. 1 to manufacture Linezolid and Linezolid IV. The Defendants could have either manufactured Linezolid by prior art processes or could have purchased Linezolid API from the market to manufacture the licensed product. Therefore, mere grant of licence by letter dated 01.04.2002 and its renewal is of no consequence and subsequent grant of licence by the commission is also of no consequence.
27. It is urged by the learned Senior Counsel for the Defendants that the claim made by the Plaintiff is contradictory inasmuch as the initial test report did not disclose the presence of CHFA while suddenly presence of CHFA was found in the same sample tested post filing of the written statement by the Defendants. The learned Senior Counsel for the Defendants has urged that CHFA, PHPFMA and Zodiac-4 being in public domain, no inference can be drawn that presence of these compounds in a particular product is indicative of the infringement of the suit patents.
28. It is true that presence of CHFA is not claimed in the initial test report when the suit was filed by the Plaintiff. However, it is possible that the test for detection of CHFA was not done. In any case, in the opinion of the Plaintiff, presence of PHPFMA and Zodiac-4 itself in the samples (belonging to the Defendants) made the Plaintiff conclude that the Plaintiff''s patented processes in IN ''062 and IN ''063 have been infringed by the Defendants. It may be noted that the Plaintiff does not possess any patent in respect of Linezolid API. It claims only process patents to manufacture Linezolid API by IN ''062 and IN ''063 because the prior art processes were tedious and cumbersome and the manufacture cost was much higher than the cost of manufacture of Linezolid by the process patents. I have already extracted earlier the inventive steps of IN ''062 and IN ''063 in paras 4 and 5 of this order. The Plaintiff has in the patent processes stated as to how R-Epichlorohydrin and N, N-Carbonyldiimidazole are synthesised to obtain CHFA-compound 4. Thereafter, in IN ''063, a different process is used and in IN ''062, another process is used to obtain Linezolid. However, the Defendants have not disclosed their process of manufacturing Linezolid API. But, at the same time, they say that they have not used the Plaintiffs process to obtain Linezolid. In Raj Prakash v. Mangat Ram Chowdhary and Ors., AIR 1979 Del. 1, a Division Bench of this Court held that the simplest way to find out if a process patent has been infringed is to compare the process of the Plaintiff with the process of Defendant and a person would be guilty of infringement if he makes what is in substance the equivalent of the patented article. In para 25 of the Report, the Division held as under:
"(25) The patented article or where there is a process then the process has to be compared with the infringing article or process to find out whether the patent has been infringed. This is the simplest way and indeed the only sure way to find out whether there is piracy. This is what was done in the hair-pin case above-referred lo, and is. Indeed, always done. Unessential features in an infringing article or process are of no account. If the infringing goods are made with the same object in view which is attained by the patented article, then a minor variation does not mean that there is no piracy. A person is guilty of infringement if he makes what is in substance the equivalent of the patented article. Some trifling or unessential variation has to be ignored. There is a catena of authority in support of this view. We need not cite all those cases which were brought to our notice at the Bar. Suffice it to quote the words of Lord Denning, M.R. in Beecham Group Limited v. Bristol Laboratories Ltd. and another, 1967(16) R.P.C. 406:-
"THE evidence here shows that in making hetacillin in the United States the defendants use a principal part of the processes which are protected here by the English patents. The importation and sale here is prima facie an infringement. There is a further point. A person is guilty of infringement if he makes what is in substance the equivalent of the patented article. He cannot get out of it by some trifling or unessential variation.............. On the evidence as it stands, there is ground for saying that hetacillin is medically equivalent to ampicillin. As soon as it is put into the human body, it does after an interval, by delayed action, have the same effect as ampicillin. In these circumstances, I think there is a prima facie case for saying there was an infringement. The process is so similar and the product so equivalent that it is in substance the same as ampicillin."
29. It may be noted that the instant case does not relate to infringement of any product. It relates to the infringement of the patent processes. Presence of CHFA, PHPFMA and Zodiac-4 is a strong indicator of the fact that the Plaintiff''s patented processes have been used because the Defendants have not come forward explaining the process which they have used to obtain Linezolid API.
30. The Plaintiff has obtained test reports not only from its own lab but also from independent labs, like Dr. Reddy''s Lab and Indian Institute of Chemical Technology (IICT).
31. In the case of
"7. Turning to the first three issues which embody the questions in controversy between the parties on the merits of the present case, it may be stated that issues Nos. 1 and 2 relate to the subject of infringement, whilst issue No. 3 relates to the question of the validity of the plaintiffs'' patent No. 58716. I will proceed to deal with the question of infringement which is the subject matter of issues Nos. 1 and 2. It was contended by Mr. Mistreat for the defendants that the plaintiffs have led no evidence on issue No. 1 and they must therefore, fail on that issue, as well as on issue No. 2 which is consequential thereto. Mr. Mistreat contention was that there is nothing in the evidence on record to show that the manufacture of Uni-Tolbid tablets or Tolbutamide by defendants Nos. 1 and 3 was carried out by using the processes mentioned in the plaintiffs patent No. 58716 and the plaintiffs have, therefore, not proved the alleged infringement of the said patent by defendants Nos. 1 and 3, the onus in regard to which lay on the plaintiffs. It is true that, as stated by Halbury, (3rd edn.) Vol. 29 p. 106 para 218, the onus as to infringement lies on the plaintiff. In the Canadian Patent Act there is a specific statutory provision viz., Section 41(2), which lays down that in an action for infringement where the invention relates to the production of a new substance, any substance of the same chemical composition and constitution shall, in the absence of proof to the contrary, be deemed to have been produced by the patented process which it is alleged to be an infringement. Though there is no corresponding provision in the Indian Patents and Designs Act, I see no reason why a presumption to the same effect should not be drawn by the me against the defendants in the present case under the general provisions contained in S. 114 of the Indian Evidence Act, since it is admitted by the defendants that it is the very drug Tolbutamide, in respect of which the plaintiffs have obtained their patent No. 58716, that they have prepared and sold. Moreover, though the general burden of establishing the case of infringement undoubtedly rests on the plaintiffs as laid down in the statement from Halsbury mentioned above which is in accordance Act, the burden of proving a particular fact viz., the process by which Tolbutamide is being prepared by the defendants would be on the defendants, since that is fact "especially" within their knowledge within the terms of Section 106 of the Indian Evidence Act. It is impossible for the plaintiffs to know by what precise process Tolbutamide is being prepared by the defendants and it is precisely to that sort of a case that S. 106 is intended to apply. The defendants have not led any evidence whatsover in regard to the same. That, however, is not all. The first question that arises is, what is the infringement complained of by the plaintiffs in the present suit in the opening sentence of para 4 of the plaint it is no doubt stated in very wide terms that the first defendants have infringed the plaintiffs'' said patent No. 58716. That averment is not limited to infringement of any particular claim or claims in the plaintiffs said patent. In the following sentence of the said paragraph, however, it is stated that the first defendants have manufactured, prepared and sold Uni-Tolbid tablets or Tolbutamide manufactured in accordance with or by the use of the invention disclosed in the complete specification of the plaintiffs'' said patent "and claimed in claims 1 and 11". It is not necessary for me to decide on a construction of the said paragraph of the plaint whether the latter averment should be read as restricting the general averment with which the said paragraph opens, as contended by Mr. Mistreat for the defendants, in view of the fact that Mr. Blanco White has conceded that, on the suit as framed, the infringement that has been complained of is infringement only of claims Nos. 1 and 11 of the plaintiffs'' said have argued this case throughout on that footing, and I must therefore, proceed to deal with the same on the basis that the infringement complained of is infringement only of claims Nos. 1 and 11 of plaintiffs'' said patent.
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11. It may be stated that the formula shown in Figure 6 is the formula of Tolbutamide. As already stated above, in view the admitted position, in the suit as framed, I am concerned in this case only with claims Nos. 1 and 11 which are in respect of what may be called ''process patents", but I have thought it appropriate to refer incidentally to claim No. 22 also, in which the patent claimed is of the substances resulting from the processes comprised in those claims and in the other claims that claim No. 1 is the main claim which covers compounds obtained by the chemical reaction specified therein, either directly to form a urea linkage, or indirectly to form a linkage readily convertible into urea linkage. It is the plaintiffs'' case that claim No. 11 falls within the latter part of claim No. 1, in so far as it deals with the processes by which thioureas are converted to the corresponding urea linkage by being treated with agents eliminating sulphur, the radicals R and R. 1 having for the purpose of claim No. 11 the same limitations in regard to the number of Carbon atoms as they are required to have for the purposes of claim No. 1. In my opinion, that is the proper construction of claims Nos. 1 and 11 and the proper position, therefore, is as stated by Mr. Blanco White, that claims Nos. 1 and 11 must stand or fall together and that if claim No. 11 is infringed, claim No. 1 must necessarily be infringed. It may be mentioned that Tolbutamide is one of the compounds which the plaintiffs claim to have prepared by the processes patented by them in their said patent No. 58716 which would in addition, comprise numerous other compounds which could also be prepared by those processes. Since the case of the first defendants in paragraph 4 of their Written Statement is that they are preparing the compound Tolbutamide by the process of desulphurisation of benzene-sulphonyl thioureas with Hydrogen peroxide, in order to prove their case of infringement what the plaintiffs have to prove is that the process of synthesising the compound Tolbutamide by desulphurisation of benzenesulphonyl thioureas with Hydrogen peroxide is a process which would fall within claim No. 11. Mr. Mistreat has stated that he does not contest the proposition that it makes no difference for the purpose of the present case whether the defendants purchase thiourea, or prepare it themselves. Mr. Blanco White is, in my opinion, right when he contends that claim No. 11 is as a matter of plain language,-and that us how a claim should be construed as stated in the passage from Halsbury-referred to earlier wide enough to include desulphurisation of thioureas by any chemical substance, including Hydrogen peroxide which the defendants claim to use. Since claim No. 11 is unambiguous in its terms it would not, in my opinion, be right to seek to construe it by reference to anything stated in the body of the specification Ex. A. Mr. Balnco White has rightly contended that in view of the admissions made by the defendants in their Written Statement in the present case, it became unnecessary for the plaintiffs to lead any evidence at all to prove infringement on the part of the defendants. As stated in Section 58 of the Indian Evidence Act, facts which are admitted need not be proved. The admissions on which Mr. Blanco White has relied are to be found in paragraph 4 of the Written Statement of the first defendants, which has been adopted by the third defendant in its Written Statement. Those admissions are: (1) that the thioureas used as the starting material in their process is the very starting material mentioned in claim No. 11 of the plaintiffs'' patent; though there is a formal denial, the Written Statement itself shows that, in point of fact, it is the same; (2) that the defendants have been synthesising their drug by the process mentioned in the second defendants'' patent No. 64323, which consists of the preparation of substituted benzensulphonyl ureas from the corresponding substituted benzenesulphonyl-thioureas by desulphurization with Hydrogen peroxide; (3) that the drug which is the end product is Tolbutamide which the defendants have been synthesizing and selling; and (4) that Tolbutamide is one of a class of sulphonyl ureas. In my opinion, there can be no doubt that these facts admitted on the pleadings are sufficient to show that claim No. 11 in the plaintiffs'' specification (Ex. A) is necessarily infringed by the defendants. Claim No. 1 covers both the direct as well as the indirect methods of manufacture of sulphonyl ureas. The fact that, as Dr. Aumuller has deposed, the plaintiffs in practice adopt the direct method in the production of Tolbutamide for sale is immaterial. The question is not as to the method actually followed by the plaintiffs, but is whether the method followed by the defendants, which is an indirect method, is covered by any of the claims in the plaintiffs'' patent. Even a cursory look at claim No. 11 is sufficient to show that it is wide enough to cover all methods of eliminating sulphur from thioureas, whether the desulphurisation is effected, by means of Hydrogen peroxide, or by the use of any other substance. Whether claim No. 11, so widely worded, is valid in law is a totally different question which will be dealt with by me separately at the appropriate place later on. Suffice it to say that from the facts admitted in the pleadings, the conclusion that claim No. 11 has been infringed by the defts. must follow and that in view of those admissions it was unnecessary for the plaintiffs to lead any evidence to prove infringement on the part of the defendants. As claim No. 11 is comprised in the wider claim contained in claim No. 1, it must follow that claim No. 1 has also been infringed by the defendants. I would, therefore, answer issues Nos. 1 and 2 in favour of the plaintiffs."
32. Although there is no admission as to the presence of the compounds CHFA, PHPFMA and Zodiac-4 by the Defendants in their product, but in view of the various lab reports placed on record by the Plaintiff including the report produced from IICT, it shall be concluded that presence of CHFA, PHPFMA and Zodiac-4 was detected in the samples of the Defendants'' products tested by these laboratories.
33. It is urged by the learned Senior Counsel for the Defendants that although the Plaintiff has placed on record the lab reports in respect of the Defendants'' samples, but at the same time the Plaintiff has not filed any report in respect of its own production. That, in my view, is totally unnecessary. The Plaintiff has explained in detail the processes used by it and has also obtained the patents IN ''062 and IN ''063. Even if some of the Linezolid API is manufactured by the Plaintiff by prior art processes, that will not nullify the Plaintiffs claim if the Plaintiff had valid patent processes.
34. It is very strenuously urged by the learned Senior Counsel for the Defendants that the Plaintiff has concealed material facts from this Court because the Plaintiff had abandoned and disclaimed PHPFMA as a novel intermediate during the prosecution of the European Patent no. 1768967 (corresponding to the Indian Patent no. 213062). It is thus, argued that the claim of exclusivity of the Plaintiff to the compound PHPFMA is misleading. It is further urged that the Plaintiff has suppressed longstanding business relationship of supply of Linezolid by the Plaintiff to Defendant no. 1 since the year 2003. Defendant no. 1 was granted a drug licence in the year 2002 and it has been selling Linezolid in the open market to the knowledge of the Plaintiff since then. It is urged that the Plaintiffs plea of presence of CHFA, PHPFMA and Zodiac-4 in the same sample of the Defendants'' product is also completely contrary to the Plaintiffs own contention that Zoidac-4 is formed in manufacture of Linezolid by use of process of IN ''063 and PHPFMA is formed in manufacture by use of process of IN ''062. It is argued that the Plaintiff seeks injunction by seeking parity with two other similar suits filed against Optimus Pharma and Sharon Bio-Medicine without disclosing that for the same patent, the intermediate alleged to be novel in those suits were different i.e. Zoidac-4. It is also averred that the factum of validity of the suit patents was also challenged in the cases of Optimus Pharma and Sharon Bio-Medicine by filing counter-claims and non disclosure of the same is another material suppression which will disentitle the Plaintiff from grant of an ad interim injunction. Thus, relying on the judgments in
35. The business relationship between the Plaintiff and Defendant no. 1 has not been disputed. The learned counsel for the Plaintiff has pointed out that during a period of ten years, Defendant no. 1 had intermittently purchased only 2816 kgs. of Linezolid API from the Plaintiff. In my view, omission to refer to the purchase of Linezolid API by Defendant no. 1 from the Plaintiff is totally inconsequential. Rather, the same strengthens the case of the Plaintiff that Defendant no. 1 was purchasing Linezolid API from the Plaintiff to prepare finished dosages of the pharmaceutical preparation because the Defendants had not found it feasible to manufacture Linezolid API of their own. The Plaintiff obtained the process patents IN ''062 and IN ''063 w.e.f. December, 2007. The Defendants have not given the sale figures of the finished dosages and quantum of manufacture of Linezolid API since the year 2003. In the circumstances, an inference can be raised that although initially the Defendants purchased Linezolid API from the Plaintiff and others, later they started manufacturing Linezolid API themselves by using the suit patented processes.
36. As far as the Defendants'' contention that PHPFMA is not a novel intermediate as held in European Patent no. 1768967 is concerned, PHPFMA was affirmed to be a novelty by U.S. Patent Office (USPO) and compound claims for PHPFMA was granted to the Plaintiff in Claims 64 to 66 of U.S. Patent no. 7429661 B2. It is contended that the Plaintiff had also reserved its right by filing a divisional petition in respect of claims no. 42 and 41 (which inter alia is PHPFMA) during the prosecution of EP 967. However, the divisional application could not be filed within the deadline by the Plaintiff and hence, the same in law cannot be construed as the Plaintiff having disclaimed the patent claim over the novelty of PHPFMA. It is further urged by the learned counsel for the Plaintiff that claims no. 1 to 41 of European Patent no. 17681967 and claims no. 1 to 63 of U.S. Patent no. 7429661 cover the process of preparation of Linezolid using the novel intermediate compound PHPFMA. It is also urged that IN ''062 contains both claims for PHPFMA which is the relevant patent sought to be injuncted from being infringed in the present proceedings and the same was granted on 19.12.2007 in India i.e. sixteen months prior to the grant of EP ''967 and therefore, the contention that the Plaintiffs application with regard to IN ''062 was registered on a false representation is erroneous. Thus, I tend to agree with the Plaintiff. In my view, there cannot be said to be any suppression or much effect of EP 1768967 on the suit patents IN ''063 and IN ''062.
37. As far as presence of PHPFMA and Zodiac-4 in the same sample of Linezolid if manufactured according to either of the processes disclosed in the suit patents is concerned, it is urged by the learned counsel for the Plaintiff that owing to the unity of the starting compounds and the reagents in the two patents and the easy substitutability of the steps involved in both, it is a scientifically possible result that traces of the compounds used as intermediates in one process are also found when the other process is used. I have also considered the factum of challenge of the suit patent by Optimus Pharma and Sharon Bio-Medicine in the counter claims filed in the earlier suits. The same, in no case, will amount to suppression of material facts so as to disentitle the Plaintiff to the equitable relief of ad interim injunction. The Plaintiff very well disclosed filing of the suit against the earlier said two companies and obtaining an injunction order against them. The Plaintiff has obtained process patents IN ''063 and IN ''062 in the year 2007. Admittedly, challenge to the patent processes of IN ''063 and IN ''062 was not made either by Optimus Pharma or Sharon Bio-Medicine before filing of the suits against them. Similarly, the Defendants also did not lay any challenge or applied for revocation of the Plaintiff''s patents before filing of the instant suit. In view of the non-challenge for six long years and particularly when the Defendants themselves were purchasing Linezolid API from the Plaintiff, it will be difficult to say at this stage that there is any good ground of challenge to the Plaintiff''s patent.
38. There is no dispute about the proposition of law that validity of a patent can be challenged in a Court (Microsoft Corpn. v. 141 Ltd. Partnership Et Al, 564 US (2011),
39. It is urged by the learned Senior Counsel for the Defendants that grant of interlocutory injunction is a discretionary relief and the same ought not be granted if damages are efficacious remedy. Reliance is placed on
40. However, it may be noted that monopoly over the patent is the reward of the inventors. The inventor spends a lot of time and money in inventing a product or a process. As stated earlier, the Plaintiffs patents are subsisting since the year 2007. In view of foregoing discussion and facts and circumstances, I am convinced that the Plaintiff has got good prima facie case in its favour. In my view, protection to the patent processes ought to be granted to the Plaintiff as damages will not be an efficacious remedy. Thus, there will be irreparable loss and injury because of the long uninterrupted use of patents, the balance of convenience also lies in favour of the Plaintiff.
41. In view of foregoing discussion, I hereby grant an ad interim injunction restraining the Defendants, through their officers, directors, agents and distributors from manufacturing, selling, offering for sale, advertising or directly or indirectly dealing in the production of Linezolid manufactured in a manner so as to result in infringement of the Plaintiffs registered Patents IN ''063 and IN ''062 till the disposal of the suit.
42. It may be mentioned that the observations made hereinabove are only tentative and opinion made for the disposal of the application under Order XXXIX Rules 1 and 2 CPC and the same shall not be taken as an expression of my opinion on the merits of the case.
43. The applications stand disposed of.
44. List before the Joint Registrar on 19th February, 2015.
