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1 - 10 of 24 (0.44 seconds)Novartis Ag vs Union Of India & Ors on 1 April, 2013
97. We are unable to concur with the reasoning of the learned Single
Judge to the extent that it accepts that there is a gap between coverage
and disclosure. The learned Single Judge also referred to Novartis v.
UoI1, supporting the said view. However, a plain reading of the said
judgment indicates to the contrary. The relevant extract of the said
decision is set out below:
Merck Sharp & Dohme Corporation & Anr. vs Glenmark Pharmaceuticals Ltd. on 7 October, 2015
90. We may at this stage also refer to observations made by the
Division Bench of this Court in Merck v. Glenmark2 in respect of the
defence raised on account of the challenge raised by Merck Sharp and
Dohme in respect of its patented product "Sitagliptin" (genus patent)
having Indian Patent No. 209816 on account of utility and lack of
industrial applicability. The Court rejected the contention that the suit
patent, Sitagliptin (the genus patent) did not disclose utility. The Court
noted that the claim referred to an active ingredient, which results in
13
K.D. TRIPATHI, ESSENTIALS OF MEDICAL PHARMACOLOGY 55-55 (Jaypee Brothers
Medical Publishers (P) Ltd. 7th ed. 2013)
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RAWAL
Signing Date:26.04.2024 FAO(OS) (COMM) 178/2021 Page 70 of 86
therapeutic effect. It was contemplated that the said active ingredient
(Sitagliptin molecule) would be combined with a carrier of some form.
However, the said carrier would be inert and of no therapeutic value. It
is also relevant to note that in that case, the respondent had also
contended that since, Sitagliptin simpliciter cannot be administered, it
had no real application. This is the mirror image of the contentions
advanced on behalf of Novartis in this case. The same being that since,
ELT (free acid) cannot be administered, as it is not soluble, ELT-O must
necessarily be considered as one enhancing therapeutic efficacy, as
without the pharmaceutical salt (Olamine), ELT would not be available
to the body for any therapeutic effect.
Astrazeneca Ab & Anr. vs Alkem Laboratories Limited on 2 November, 2020
109. Thus, in both cases, Merck v. Glenmark2 and the decision of the
Division Bench in Astrazeneca AB and Anr. v. Intas Pharmaceuticals
Limited9, the interim orders were passed on the basis that the genus
patent covered the product in question. In the former case, the interim
injunction was granted, and in the latter, it was denied. We do not find
the said decisions to be conflicting, as contended by Mr Hemant Singh.
Section 48 in The Patents Act, 1970 [Entire Act]
Section 8 in The Patents Act, 1970 [Entire Act]
F. Hoffmann-La Roche Ltd, Switzerland ... vs Cipla Ltd., Mumbai Central, Mumbai on 7 September, 2012
46. In the present case, the learned Single Judge held that even if a
prima facie ground for revocation is made out, revocation is not
automatic as the patent authority retains discretion not to revoke the
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RAWAL
Signing Date:26.04.2024 FAO(OS) (COMM) 178/2021 Page 46 of 86
patent if not absolutely necessary. And, the vulnerability to revocation
must also be adjudged on the same standard. The learned Single Judge
also concluded that this standard is therefore, high rather than low. It
was further observed that the credible challenge occupies a higher
pedestal than challenge, which is merely worthy of consideration. The
learned Single Judge held that "When an infringer seeks to defend
infringement on the ground that the patent he infringes is invalid, the
onus, to prove such invalidity heavily lies on him. This standard has to
be met, when applying the principle of "credibility"". The standard as
articulated in the impugned judgement is in clear variance with the
decision of the Division Bench of this court in F. Hoffmann-LA Roche
Ltd. & Anr. v. Cipla Ltd.7. In the said case, the Division Bench had
expressly rejected the contention that the defendant has a heavy burden
to discharge as it has to establish a stronger prima facie case. It is
apparent that in the present case, the learned Single Judge has applied a
higher standard for examining whether a credible challenge to the
validity of a patent is made out, than as explained by the Division
Bench. In effect, the learned Single Judge has read in a presumption as
to the validity of the patent, where none exists. Obviously, a challenge
to a patent, that is insubstantial, would be wholly insufficient to resist
an order of interdiction. However, if a prima facie ground of revocation
is made out, the threshold standard of credible challenge is met
notwithstanding the discretion vested with the patent authority in regard
to revocation of the patent. The fact that the patent authority may have
the discretion not to revoke the patent despite a ground for the same
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RAWAL
Signing Date:26.04.2024 FAO(OS) (COMM) 178/2021 Page 47 of 86
being established, is not a relevant consideration for granting an interim
injunction restraining the infringement of a patent on the ground that
the defendant has not met the threshold standard of a credible challenge
to the validity of the patent, if a prima facie ground for revoking the
patent is made out.