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8. The suit was filed on 15th January, 2008. Along with the suit the plaintiffs filed an application under Order XXXIX Rule 1 Code of Civil Procedure 1908 (CPC), I.A. No. 642/2008, seeking ad-interim injunction restraining the defendant from infringing the plaintiffs patent in respect of Tarceva (Erlotinib).The two important points to be noted at this stage are that the plaintiffs asserted in the plaint that plaintiff No.2 was granted a patent for Tarceva (Erlotinib) jointly with Pfizer Products Inc. It was stated that the certificate bearing patent No. 196774 dated 23rd February, 2007 recorded in the Register of Patents on 6th July, 2007 pertained to Erlotinib Hydrochloride which was marketed as Tarceva. Secondly, in the plaint no details of the specification of the aforementioned patent or the x-ray diffraction of the product (tablet) Tarceva or the defendant‟s Erlocip was indicated. Plea of the defendant in its written statement to the injunction application

Defendant's application under O VII R 11 CPC seeking dismissal of the Suit

21. On 30th January, 2008 the defendant filed an application I.A. No.1272/2008 before the learned Single Judge seeking dismissal of the suit. The thrust of this application was that the defendant had discovered that the plaintiffs had made two further applications for grant of patent in respect of the same chemical compound for a different crystal form which was termed by the plaintiffs as B- polymorph. The first application was filed on 14th May, 2002 and published first on May 20, 2005 and thereafter re-published on 23rd February, 2007. In the said application priority was claimed over three US applications one of which was U.S.‟221. The second application which was filed on May 13, 2002 and published on 20th May, 2005 claimed priority over three US applications one of which was U.S.‟221. It was pointed that the suit patent had claimed priority over U.S.‟498 published on 5th May, 1998. A reference was made to the statements made by the plaintiffs in U.S.‟221 which showed that the Indian patent No.196774 was in relation to the hydrochloride compound in the form of mixture of polymorphs A and B which was known to the plaintiffs way back in the year 2000 since this corresponded to U.S.‟498 which was granted in 1998 itself. However, this fact was never stated in the application made before the Patent Controller. Since the admitted position of the plaintiffs was that patent No.196774 was not a preferred form for manufacture of tablets, the defendant was curious to know how the plaintiffs were still importing and selling tablets of the said Hydrochloride compound under the brand "Tarceva". It sought to determine the actual crystalline structure of the tablets and accordingly purchased some manufactured in August 2006 from the local market. The x-ray diffraction data of Tarceva sold in India showed that it was "B-Polymorph of the Hydrochloride". This was confirmed by the defendant‟s expert Mr. Manish G. Gangrade who performed the technical evaluation. On an analysis of the X-ray diffraction pattern he came to the follwoing conclusion: "Tarceva tablets are wholly B polymorph of the hydrocholoride salt of N-(3-ethynylphenyl)-6, 7 bis(2-methoxyethoxy)-4-quinazolinamine. I further say that the X-ray powder diffraction of Tarceva clearly goes to show that it is not A polymorph or a mixture of A and B polymorph but is wholly B polymorph of the said compound."

27. In this appeal, one of the significant issues posed by the defendant, which has a bearing on whether the plaintiffs have made out a prima facie case for grant of injunction, is that the specification for the suit patent (i.e. patent No.196774 corresponding to U.S.‟498) showed that it was in respect of Erlotinib Hydrchloride Polymorphs A+B which was on their own showing an unstable form which could not be administered as such. It was contended that the case of the plaintiffs themselves was that it was Polymorph B which was the more stable form of the compound which could be administered in the tablet form. The x-ray diffraction pattern of the tablet Tarceva showed that it corresponded to Polymorph B for which the plaintiffs did not yet hold a patent. Their application for the grant of patent for Polymorph B was pending consideration. It was submitted that therefore not even a prima facie case was made out by the plaintiffs since they were seeking an injunction against the defendant in respect of a drug for which they did not yet hold a patent. Moreover, this fact had been suppressed by the plaintiffs both before the Controller of Patents as well as in the suit. On this sole ground injunction ought to have been refused.

41. Reverting to the case on hand, what is significant is that when the plaintiffs filed their suit in this Court they was fully aware of the fact that Polymorph B was the more stable form of Erlotinib Hydrochloride. For marketing it in the tablet form, it was Polymorph B, which would be relevant. The plaintiffs knew that a separate application for grant of patent for Polymorph B had been made and obtained in the USA. They knew that in the USA while being granted that patent (which although an exercise in evergreening is stated to be permissible there), it was claimed that the closest prior art U.S.‟498 was for treatment of lung cancer in general not NSCLC in particular. The enhanced efficacy was sought to be thus justified. In short their case was that on its own strength Polymorph B of Erlotinib Hydrochloride deserved an exclusive patent on the ground of inventiveness and enhanced efficacy, non-obviousness and non-teaching by any prior art. Clearly the applications made by the plaintiff before the Controller of Patents for grant of patent in respect of Polymorph B was on the same lines. It is indeed in intriguing why the plaintiffs did not chose to be candid with this Court in making a full disclosure of all the above facts in its plaint. There can be no manner of doubt that had these facts fully disclosed in the plaint and the entire specification of the patent held by the plaintiff together with X-ray diffraction data of Tarceva and Erlocip filed along with the plaint, it is possible that the plaintiff may have had difficulty in showing that the patent held by it (No.196774) covered Tarceva as well. In other words, the Court would have had to first be convinced that the plaintiffs held a patent for the product which was marketed as Tarceva and further that the product of the defendant had a x-ray diffraction data which matched Tarceva as well as the compound which was a combination of Polymorphs A and B and not Polymorph B alone.