J. Mitra and Co Pvt Ltd v Kesar Medicaments (2008)

Summary

“The plaintiff is stated to be a Private Limited Company engaged in the manufacture and sale of diagnostic kits and is also stated to be a holder of various patents, designs and trademarks in respect of its products.” Its “application (I.A. No. 11883 of 2006) under Order 39, Rules 1 and 2 and Section 151 of the Civil Procedure Code (hereinafter referred to as the ‘said Code’) is for the issuance of a temporary injunction restraining the defendants from infringing the plaintiff’s Patent No. 194638 dated 22nd September, 2006 in a suit for permanent injunction, rendition of accounts and damages.” (para 2) “The early detection of HCV is stated to be critical as there is no vaccine for the same.” (para 1) “It is claimed that the said device is a ‘fourth generation’ device which is stated to detect the antibodies if present for 10-15 days.” (para 4) “Such application post acceptance was notified in the Gazette on 20-11-2004 to which a pre-grant opposition was filed by defendant No. 2 on 21-03-2005. Such opposition was heard and dismissed vide order dated 23-08-2006 and finally the said patent was granted in favor of the plaintiff on 22-09-2006 as mentioned aforesaid.” (para 6) “Defendant No. 2 has contested the present suit filing a written statement and a counter-claim being CC 2196/2006 on 25.11.2006 for the revocation of the plaintiff’s patent no 194638 under Section 64 of the Patents Act, 1970 (hereinafter referred to as the ‘said Act’).” (para 13) “The invalidity of plaintiff’s patent No. 194638 is alleged on the grounds of prior publication, prior public knowledge and use in India, obviousness, not being an invention nor a patentable invention and lastly on the ground that the invention has not been sufficiently explained by the plaintiff.” (para 15)

The Court held that “the grant of a patent alone does not give rise to a presumption of validity of the patent notwithstanding the examination and inspection carried out by the Patent Controller” and that “The decision on the opposition application also does not imply the validity of the patent.” (para 49) It found that “Defendant no 2 cannot thus plead that they have been manufacturing a similar device since the year 1997 and that they had knowledge of the technology prior to the patent application of the plaintiff” (para 70), that “it cannot be said at least prima facie that the plaintiff’s device is anticipated by US patent Nos. 5006464 and 5541059” (para 79), and that “it would be not be permissible for the defendant to rely on different documents disclosing different components/features of the product to plead that the product of the patent is known.” (para 102) “In view of the aforesaid, I am of the view that the plaintiff has made out a prima facie case.” “The balance of convenience lies in favor of the plaintiff as the plaintiff’s patent cannot be permitted to be infringed.” (para 119) “Thus, the application of the plaintiff under Order 39 Rules 1 and 2 of the said Code is allowed and the defendants, their promoters, directors, servants, agents, dealers, distributors are retrained from manufacturing, selling, offering for sale or in any other manner dealing with the impugned product SIGNAL HCV or any other product violative of the plaintiff’s patent No. 194638. Parties are left to bear their own costs.” (para 120)

What the court decided

1. The WHO report. “I am of the view that the fact of the plaintiff’s 4th generation product being mentioned in the WHO Report in which the product has been evaluated and its sensitivity and specificity noted is certainly one of the factors to be taken into account by this Court.” (para 28)
2. Procedure. Appeals before 2 April 2007. “While it is the plea of the plaintiff that appeals under Section 117A of the said Act can be filed only against orders under Section 25 of the said Act, it may be noticed that prior to the amendment of the said Act vide the Patents Amendment Act, 2005, to the provisions inter alia of Section 117A(2), which came into force from 2.04.2007, appeal could be brought against any order of the Controller under Section 25. Be that as it may, these aspects are to be considered by the Appellate Court.” (para 37)
3. The international examination report. “The PCT preliminary examination report indicates that claims 1-13 of the plaintiff lack an inventive step but are novel and can be considered industrially applicable.” “Article 35(2) of the PCT states that the International Preliminary Report would not contain any statement on the patentability or unpatentability of the claimed invention according to any national law.” “The said International Preliminary Examination Report thus cannot be said to have much bearing in considering the validity of the patent.” (para 42)
4. No presumption from grant. Following Bishwanath Prasad Radhey Shyam v Hindustan Metal Industries and Standipack Private Ltd. and Ors. v. Oswal Trading Co. Ltd and Ors., the Court held: “It is well settled as held in the decisions in Bishwanath Prasad Radhey Shyam and Standipack Private Ltd. cases (supra) that the grant of a patent alone does not give rise to a presumption of validity of the patent notwithstanding the examination and inspection carried out by the Patent Controller and the validity of the patent can be challenged in infringement proceedings on the same grounds on which revocation can be claimed under Section 64 of the said Act. Section 13(4) of the said Act provides inter alia, that the examination and investigation conducted shall not be deemed in anyway to warrant the validity of the patent. The decision on the opposition application also does not imply the validity of the patent.” (para 49)
5. The Controller’s order and the opposition. “Although the examiner looks into various aspects and makes a rigorous examination of the patent application and opposition thereto, in view of the decisions in Bishwanath Prasad Radhey Shyam and Standipack Private Ltd cases (supra), the order of the patent controller granting the patent and the decision on the opposition cannot of itself give rise to a presumption of validity of the patent notwithstanding the investigation and examination made and the same can be challenged.” (para 51)
6. Age and working of the patent. Of National Research Development of India v Delhi Cloth & General Mills Co (1979), AIR 1980 Delhi 132, considered in Telemecanique & Controls v Schneider Electric Industries (2001), the Court held: “Insofar as the decision in M/s National Research Development Corporation of India case (supra) is concerned while the actual user and duration of the patent may be one of the factors that may be taken into account, I am of the view that that factor alone cannot give rise to a presumption of validity of the patent. This Court would thus have to look into the merits of the case of the plaintiff as also the defense put forth by the defendant.” (paras 50–51)
7. The defendant’s earlier technology. “The device thus currently being manufactured by defendant No. 2 cannot be said to be the same as the one in respect of which licenses were sought in 1997.” “The agreement with AccuDx also does not refer to the combination of antigens now being used by the said defendant. Defendant no 2 cannot thus plead that they have been manufacturing a similar device since the year 1997 and that they had knowledge of the technology prior to the patent application of the plaintiff.” (para 70)
8. The prior US patents. “The plaintiff’s device does not contain a septum and the manner of flow therein is not a directed flow.” (para 77) “There is thus no mixture of antigens used as is used in the plaintiffs device. The construction of the device also appears to be different from that of the plaintiff’s device.” (para 78) “Thus, it cannot be said at least prima facie that the plaintiff’s device is anticipated by US patent Nos. 5006464 and 5541059.” (paras 77–79)
9. Products of third parties. “Thus, the product of the plaintiff is different from the products being manufactured by third parties referred to being Murex Anti-HCV, the UBI-HCV test, INNOTEST HCV AbIV and ... which contain different components from that of the plaintiffs product and are Elisa tests and cannot be said to be anticipated by the said products.” (para 96)
10. Mosaicing. Following Bilcare v Amartara (2007), the Court held: “Insofar as the aspect of mosaicing is concerned, the legal position as set out in the judgment in Billcare Ltd. case (supra), it would not be a defense to show that the various components in the patented product are known separately. The combination of such components may be patentable.” (para 101) “Thus, it would be not be permissible for the defendant to rely on different documents disclosing different components/features of the product to plead that the product of the patent is known. None of the documents relied on by defendant No. 2 in the present matter really anticipate all the components of the plaintiff’s product.” (paras 101–102)
11. Working before the application. “Section 30 of the said Act exempts the communication of the invention either to the government or a person authorised by the Government for the investigation of the invention or its merits from challenge on the ground of anticipation.” (para 107) “The batch of HCV Tri-dot 4th Generation evaluated by the WHO evaluated was manufactured in November 2000 which is after the date of the patent application. There is no other material on record which shows that the 4th Generation HCV Tri-dot was being manufactured by the plaintiff prior to the date of the patent application. Thus, it cannot be said from the material on record that the plaintiff has worked the impugned product prior to the date of the application.” (paras 107–108)
12. Sufficiency of the specification. “The specification prima facie appears to have sufficiently explained the various components of the device and the impact of the said components/features.” (para 112)
13. The Gillette defence. Of Shri Ravi Raj Gupta v. Acme Glass Mosaic Industries 56 (1994) DLT 673 and the judgment of Lord Moulton reproduced by the Court, it held: “where it is shown that the act complained of is what was disclosed in a prior publication, which can be relied on against the validity of the patent, and no patentable or substantial alteration has been made in respect thereof, there is a good defense. As far as the documents relied on by defendant No. 2 are concerned,the same do not prima facie indicate that the product of the plaintiff is obvious or was anticipated.” “They do not appear to be based on the US Patents or the products of third parties relied on by the plaintiff.” (para 115)
14. Whether the products differed. “There is no sufficient explanation forthcoming as to the effect of the differences in the number of drops of the wash buffer, sample and colloidal gold added during the various stages of the test nor as to the effect of the number of coatings and nature of mixture used or as to how these differences make the two devices or the process different.” “Thus, a finding cannot be reached on the submissions made at this stage that the product of defendant No. 2 is distinct from that of the plaintiff.” (para 118)
15. Prima facie case and the injunction. “In view of the aforesaid, I am of the view that the plaintiff has made out a prima facie case.” “The use of patent being limited, irretrievable prejudice will be caused to the plaintiff if interim orders are not granted. The balance of convenience lies in favor of the plaintiff as the plaintiff’s patent cannot be permitted to be infringed.” (para 119) “Thus, the application of the plaintiff under Order 39 Rules 1 and 2 of the said Code is allowed and the defendants, their promoters, directors, servants, agents, dealers, distributors are retrained from manufacturing, selling, offering for sale or in any other manner dealing with the impugned product SIGNAL HCV or any other product violative of the plaintiff’s patent No. 194638.” (paras 119–120)

What the court did not decide

“The impact of such difference in manner of flow is not clear and would have to be examined during the course of the trial.” (para 77) Of the research documents, “i am of the view that sufficient material has been placed on record by the parties for a prima facie consideration of the case. These aspects may thus be considered during the trial.” (para 40) “Needless to say, any observations made herein will not affect the final adjudication of the case.” (paras 40, 77, 121)

Subsequent treatment

• Explained — In F Hoffmann-La Roche v Cipla (2008) the Delhi High Court recorded that “The Court held (in para 51) that the order of grant of patent, or rejecting pre-grant opposition cannot itself give rise to a presumption of validity of the patent, and the Court would have to look into the merits of the case of the plaintiff as well as the defense put forth by the defendant.” and that “The court, in Para 102, held, after discussing the rival contentions, that it would be impermissible for the defendant to rely on different documents disclosing different features of the product, that the product of the patent is known. Such ‘mosaicing’ is not a valid defense.” It added that “The court did not however, discuss whether the patented product or the infringing goods had any life saving or such like element; it was not concerned with the interpretation of Section 3(d).” (para 62)
• Followed — In Sandeep Jaidka v Mukesh Mittal (2014) the Delhi High Court reproduced paragraph 51 of this judgment on the absence of any presumption of validity (para 25).
• Followed — In Nocil v Finorchem (2026) the Calcutta High Court held, citing this judgment, that “Insofar as the aspect of mosaicing is concerned, the legal position is clear, it is not permissible for the respondent no. 1 to rely on different citations to plead that the process of the patent is known.” (para 20)