F Hoffmann-La Roche v Cipla (2012)

Summary

“Two plaintiffs, namely, F. Hoffmann-La Roche Ltd. and OSI Pharmaceuticals Inc., have filed the suit for permanent injunction restraining infringement of patent, rendition of accounts, damages and delivery up” (para 1), the patent being in respect of “a small drug molecule medically termed as a” “Human Epidermal Growth Factor Type-I/Epidermal Growth Factor Receptor” “inhibitor which is popularly known as” “Erlotinib” (para 3). The interim injunction “application of the plaintiffs was dismissed vide order dated 19th March, 2008” (para 14), the appeal “was also dismissed” (para 15), and the Supreme Court requested “the learned Single Judge dealing with the Civil Suit to conclude the trial as expeditiously as possible” (para 16). The issues framed included “Whether the manufacture, marketing and sale of ERLOCIP by defendant is infringing the plaintiffs’ Indian Patent 196774?” and “Whether the Indian Patent 196774 is liable to be revoked on the grounds raised in written statement and counter- claim of the defendant?” (para 17)

The Court held that “no ground of obviousness or lack of inventive step under Section 64 (1) (f) of the Patents Act is made out due to the inability of the defendant to discharge the onus casted upon it” (para 110), and that “the impugned patent is not hit by Section 3(d) of the Patents Act.” (para 125) It held that “the ground of violation of Section 8 read with Section 64(1)(m) is made out. However, still there lies a discretion to revoke or not to revoke” (para 156), and exercised it: “Therefore, I exercise the discretion in this matter by not to revoke the patent.” (para 196) On infringement, “in the absence of the discharge of onus of proof by the plaintiffs which was independently lied upon them, the plaintiffs have not been able to establish the infringement of the IN'774 on balance of the probabilities.” (para 285) “In the result, both, the suit” ... “and the counter claim” ... “are dismissed. No order as to costs.” (para 303)

What the court decided

1. Inventive step under section 2(ja). “On the bare reading of the aforementioned Sections, it is clear that the definition of” “inventive step” “nowhere accords any differential treatment to any particular type of invention.” (para 41) “These are conjunctive requirements u/s 2(ja) which means that not merely there should be a technical advancement in the invention but at the same time, it should not be obvious to the person skilled in art.” (para 43) “Consequently, what follows from the above discussion is that as per the provision of Patents Act there is nothing which is indicative of the fact that any stricter approach is to be followed while testing the patents relating to chemical compounds” (paras 41–44)
2. The Bishwanath Prasad test. “If the answer comes in affirmative, then certainly the said invention under challenge is anticipated by the prior art or in other words, obvious to the person skilled in art as a mere workshop result and otherwise it is not. The said view propounded by Hon’ble Supreme Court in Biswanath Prasad (supra) holds the field till date” (para 50). “Therefore, it is proper and legally warranted to apply the same very test for testing the patent; be it any kind of patent.” (paras 50–51)
3. Foreign tests of obviousness. “However, the said test laid down by the Courts either in Europe or in US cannot be as a matter of natural consequence applied in the Indian context on the mere insistence of the parties.” (para 52) “Till the time it is not done so, it cannot be said that the test of American Courts and European Courts may be applied when it comes to adjudicate the obviousness of Indian Patents.” (paras 52, 57)
4. Obviousness of a selected compound. “Therefore, after analyzing the aforenoted events, the following material facts are essentially required to be established by the counterclaimant:” “The selection of the impugned invention is taken from the examples of the known prior art.” “That the selected invention is not far removed from the known range illustrated in the example. Rather, the same is closer to the known range.” “That the selection area is not on the basis of any purpose of the inventor and is merely an arbitrary picking up the compound.” (para 66)
5. Standard of proof. “It is well settled principle of law that the onus of proof in the revocation proceedings is akin to the principle of onus of proof involved in the civil cases which is on balance of probabilities.” (paras 67, 69)
6. Structural similarity not enough. “If the chemical compounds are held to be obvious on the basis of mere perusal and appearance of the structures and assuming that the slight change here and there is inconsequential without a positive evidence medically and clinically as to how the said reaction is immaterial, then several novel compounds can be declared obvious by such exercise and the same shall affect the research process adversely.” “Resultantly, no ground of obviousness or lack of inventive step under Section 64 (1) (f) of the Patents Act is made out due to the inability of the defendant to discharge the onus casted upon it.” (paras 90, 110)
7. Section 3(d) and obviousness distinguished. “It is one thing to say that the Patent lacks the inventive step in as much as the same is obvious to the person skilled in art as the same may amount to workshop result which is per se not patentable. However, it is another thing to say the patent is a new form of the old substance which is pre-existing. The line may be blurred between the two but there lies a subtle difference.” (para 121)
8. The section 3(d) challenge. “In the present case, though the defendant has stated in the affidavit that there was a preexisting patent of EP'226, but the defendant at the same time could not provide any positive evidence as to whether the suit patent coincides with the said compound which was the subject matter of EP'226 or new form of what is contained in EP'226.” (para 122) “However, considering the evidence as to efficacy differences, it can still be inferred that the plaintiffs’ patent is not hit by Section 3(d).” (paras 122–125)
9. The scope of section 8. “On the conjoint reading of both the above Sections, it is clear that there is a mandatory provision provided u/s 8” (para 131). “It is also seen from the reading of said Section that Section 8(1) covers within its sweep not merely the applications which are being prosecuted at the time of filing of patent, but also the other applications which are filed subsequently during the time when the prosecution before the Indian Patents Office is underway.” (para 137) “Therefore, the Court seized of with the revocation u/s 64(1)(m) will examine the question of disclosure or non disclosure as envisaged u/s 8 must confine itself to the enquiry which is permissible u/s 8” (paras 131–141)
10. Same or substantially the same invention. “It is also pertinent to mention that what is the requirement of law u/s 8 is the disclosure in respect of same or substantially the same invention which may subsume within its ambit the inventions which are substantially the same but may have slight difference here and there” (para 151). “It appears at this stage from the attending circumstances that the disclosure was not made and the said Section was in fact violated by the patentee and therefore the ground contained in Section 64(1)(m) is made out.” (paras 151, 154)
11. Discretion not to revoke. “The said discretion exists by use of the word” “may” “under Section 64 of the Act. Thus, solely on one ground of non-compliance of Section 8 of the Act by the plaintiffs, the suit patent cannot be revoked.” (para 156) “Applying the said principle of law, it is clear the usage of the word” “may” “under Section 64 confers a discretion of widest amplitude upon rectification Court which is evident from the language of the Section.” (paras 156, 196)
12. Approbate and reprobate. “In the light of the said stand taken by the defendant, I find that the discretion tilts in favour of the plaintiffs and against the defendant” (para 199). “It is equally well-settled that the party cannot be allowed to approbate or reprobate at the same time” (para 200). “Therefore, the defendant is not entitled to relief of cancellation or revocation of the Patent” (paras 199–203)
13. False suggestion and the prosecution history. “So far as the improper examination of the patent as a ground is concerned, there is no need for any specific mention of the said expression is covered in the grounds of revocation when there is a ground of revocation in para-4 which provides that the patent is obtained on false suggestion and representation” (para 172). “The Court can surely look into the deeper aspects of the patent including its prosecution history which may reveal that the patent ought not to have been granted due to the representations of the plaintiffs before the patent office” (paras 172, 174)
14. Construction where the product varies. “I find the said tests appears to be correct so far as it relates to simplicitor infringement cases where the impugned product is straightaway subsumed in the claimed portion of the invention without anything else in the said product.” (para 230) “To sum up this discussion on Catnic (supra) and Merck (supra), at this stage, it is relevant to note the aforementioned observations of the Courts and also the test which is that in the cases where the product contains further variants or reacted versions of the compounds claimed in the patent, not merely the claim in the specification is relevant but also all the facts correlating the said invention with that of the role of such variant or reactant are also important” (paras 230, 247–248)
15. The patentee’s independent onus. “It is seen that the onus is on the plaintiffs to show that the said product of the defendant corresponds with the patent claim which is subject matter of IN'774. The said onus is an independent to that of what position defendant’s take in the proceedings.” (para 249) “I think the said indirect route does not discharge the burden of the plaintiffs which is independent and upon the plaintiffs.” (paras 249, 279)
16. Infringement not proved. Among the circumstances listed, “On the purposive construction of the claim of the suit patent IN'774 as per Catnic approach, it has been found that the plaintiffs never intended to cover the Polymorphic version B of the said compound under IN'774” and “The plaintiffs’ failure to examine the product of the defendant’s clinically” (para 286). “In these circumstances, in the absence of the discharge of onus of proof by the plaintiffs which was independently lied upon them, the plaintiffs have not been able to establish the infringement of the IN'774 on balance of the probabilities.” (paras 285–286)
17. The later United States patent. “In view of the abovementioned discussion, I hold that the defendant has proved that the plaintiffs’ subsequent US'221 patent contains the admission on the part of the plaintiffs that claim No.1 of the suit patent is a mixture of two Polymorph A&B and US'229 patent has an effect on the suit patent of the plaintiffs.” (para 299)
18. Procedure. Disposition. “In view of my findings arrived at on issue No.1, the plaintiffs are not entitled for permanent injunction” (para 287), and “The prayer of damages to the plaintiffs is accordingly rejected.” (para 288) “In the result, both, the suit” ... “and the counter claim” ... “are dismissed. No order as to costs.” (paras 287–288, 303)

What the court did not decide

“There are other submissions advanced by the parties relating to the impact of the public interest on the grant and non grant of the relief of permanent injunction. Likewise, the plaintiffs have advanced the submissions as to the grant of the damages and costs. I find that the said submissions do not warrant discussion in view of the finding arrived by me in relation to issue no. 1” (para 301)

Subsequent treatment

• Appealed — In Cipla v F Hoffmann-La Roche (2015) the Division Bench of the Delhi High Court held that “The correct test of infringement in this case is to map Cipla product against the Roche’s patent claims, which we find has not been done by the learned Single Judge” (para 109), found “no reason to revoke the suit patent for non-compliance of Section 8 under Section 64(1) (m) of the Patents Act” (para 129), set aside the dismissal of the suit and ordered accounts (para 183).
• Explained — In Merck Sharp and Dohme v Glenmark Pharmaceuticals (2015) the Division Bench of the Delhi High Court reproduced passages from paras 131 to 138 of this judgment on “The nature of disclosure required under the Section 8/64(1)(m) regime” (para 73).