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Novartis AG v. Natco Pharma LTD., 2019 SCC OnLine Del 9689

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0% found this document useful (0 votes)
53 views5 pages

Novartis AG v. Natco Pharma LTD., 2019 SCC OnLine Del 9689

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urvija2002
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SCC Online Web Edition, © 2024 EBC Publishing Pvt. Ltd.

Page 1 Tuesday, August 06, 2024


Printed For: Urvija Sharma, Vivekananda Institute of Professional Studies
SCC Online Web Edition: https://www.scconline.com
© 2024 EBC Publishing Pvt. Ltd., Lucknow.
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2019 SCC OnLine Del 9689 : (2019) 80 PTC 403 : (2019) 4 RCR
(Civil) 196

In the High Court of Delhi at New Delhi


(BEFORE PRATHIBA M. SINGH, J.)

Novartis AG and Another … Plaintiffs;


Versus
Natco Pharma Limited … Defendant.
CS (COMM) 229/2019 and I.As. 11304/2019, 11305/2019
Decided on August 20, 2019
Advocates who appeared in this case:
Mr. Hemant Singh, Ms. Mamta Jha, Mr. Ankit Arvind, Mr. Rohan
Krishnan & Dr. Shilpa Arora, Advocates (M : 9873603089)
Mr. Sanjeev Sindhwani, Sr. Advocate with Ms. Rajeshwari H., Mr.
Swapnil Gaur and Mr. Kumar Chitranshu, Advocates (M : 9897905254).
The Judgment of the Court was delivered by
PRATHIBA M. SINGH, J. (Oral):— The Defendant has filed two
applications - one under Order VII, Rule 11 CPC and the second one
under Order XXXIX, Rule 4 CPC seeking dismissal of the present suit
and vacation/suspension of the interim injunction operating in the
present case on the ground that the patent granted in favour of the
Plaintiffs has been revoked in the post grant opposition proceedings.
The Defendant relies on the order passed by the Deputy Controller of
Patents and Designs (hereinafter, ‘Controller’) on 16th August, 2019.
Ld. senior counsel for the Defendant has taken the Court through the
findings and shown that the Controller has arrived at a finding that the
compounds disclosed in the suit patent lack novelty in view of the
disclosures made in IN 240560 and IN 232653. The submission is that
in view of Section 62(2) of The Patents Act, 1970 the interim injunction
cannot be continued.
2. The Plaintiff - Novartis AG has filed the present suit seeking
permanent injunction, damages, rendition of accounts and delivery up
in respect of its granted patent, Indian Patent No. 276026 titled ‘Novel
Pyrimidine Compounds and Compositions as Protein Kinase Inhibitors’.
The case of the Plaintiff is that it has been granted the suit patent for a
novel and inventive compound Ceritinib which is a drug meant for
treatment of non-small cell lung cancer (NSCLC). The case of the
Plaintiff is that the said molecule, which forms part of the broader
group of 2, 4-diaminopyrimidines, is novel and inventive.
3. The suit patent was filed as a Patent Convention Treaty
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(hereinafter, ‘PCT’) application claiming priority since 2007, and was


granted on 28th September, 2015. The Defendant - Natco Pharma Ltd.
filed a post grant opposition within the statutory period under Section
25(2) of The Patents Act, 1970. The said opposition was initially
referred for the consideration of the Opposition Board, which gave a
report in favour of the Plaintiff. However, Natco Pharma thereafter filed
additional material and now the hearing in the post grant opposition
th
itself stands concluded, and the order was reserved on 10 April, 2019.
nd
4. The suit was first listed on 2 May 2019. While granting an
nd
interim order on 2 May, 2019, the Court had directed that the post
grant opposition wherein orders were reserved, be decided by the
Patent Office prior to the next date of hearing. Relevant portions of the
said order are set out below:
“15. The Court has heard both sides on the grant of ad-interim
relief. It is the admitted position that the post grant opposition is
now pending decision with the Patent Office and the question as to
whether the patent is to be maintained or not will be decided
therein. Thus, in so far as the validity of the patent itself is
concerned, this court would not like to make any observation at this
stage, so as to ensure that the post grant opposition is decided
without being affected by any observation which may be made by
this court.
16. The drug license for Natco Pharma's product, which is
marketed under the mark NOXALK (Ceritinib) was granted to the
Defendant in January, 2019, i.e. after the post grant opposition was
filed and the Opposition Board had made its recommendations.
17. The actual commercial launch has also admittedly been done
th
only on 20 March, 2019. Thus, during the period when the post-
grant opposition decision was yet to come, the Defendant has chosen
to commercially launch the product. While the Supreme Court in
Aloys Wobben (supra) held that the rights would be crystallized once
the post grant opposition is decided, launch of an allegedly infringing
product, prior to the said decision in the opposition by the entity
opposing the Patent, did not arise in the facts of the said case.
Section 48 of the Patents Act grants rights in favour of a patentee,
which are not affected during the pendency of a post-grant
opposition. Section 48 provides as under:
“48. Rights of patentees - Subject to other provisions contained
in this Act and the conditions specified in section 47, a patent
granted under this Act shall confer upon the patentee-
(a) where the subject matter of the patent is a product, the
exclusive right to prevent third parties, who do not have his
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consent, from the act of making, using, offering for sale, selling
or importing for those purposes that product in India
(b) where the subject matter of the patent is a process, the
exclusive right to prevent third parties, who do not have his
consent, from the act of using that process, and from the act of
using, offering for sale, selling or importing for those purposes
the product obtained directly by that process in India”

19. Considering that this is a drug for treating non small cell lung
cancer (NSCLC), stopping the sale of the Defendant's products which
are already manufactured would not benefit the patient community
in any manner. Thus, the drugs already manufactured by the
Defendant under the mark NOXALK (Ceritinib) are allowed to be sold
during the pendency of the hearing in the application under Order 39
Rule 1 and 2 CPC and till further orders of this Court. However, Natco
Pharma, having been well aware of the fact that the patent stood
granted and the fact that the post grant opposition was pending
adjudication, ought not to have launched the product while the
decision was pending in the Patent Office. Accordingly, the
Defendant is restrained from carrying out any fresh manufacturing of
pharmaceutical preparations comprising of the active pharmaceutical
ingredient (API) ‘Ceritinib’ till the next date.

22. It is further directed that a copy of this order be sent to
Controller General of Patents, Designs and Trade Marks with a
request that the order on the post grant opposition, which is now
stated to be reserved may be passed by the Patent Office before the
next date of hearing before this Court so that this Court may have
the benefit of the decision of the Patent Office.”
5. However, on the next date, the Court was informed that no orders
had been passed in the post grant opposition proceedings. Thus, on the
th
next date, i.e., 11 July 2019, directions were issued as under:
th
“3. Though arguments were heard on 10 April, 2019 by the
Controller General in the post-grant opposition, even on 11th July,
2019, there are no orders passed by the Controller General. This is
detrimental to the timely adjudication of opposition matters which is
not permissible. Accordingly, the Controller General shall now go
ahead and proceed to pass orders in the post-grant opposition within
a period of one month from today. No further filing shall be done by
either party.”
6. By way of the present applications, the Defendants have informed
the Court that the order in the post-grant opposition proceeding has
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since been passed on 16th August 2019 and the patent has been
th
revoked. A perusal of the said order dated 16 August 2019 passed by
the Controller shows that, after examining the matter, it has been held
that the suit patent lacks Novelty and the patent has thereafter been
revoked. Once a patent is revoked, a suit for infringement of the patent
itself would not be maintainable. However, Mr. Hemant Singh, ld.
counsel, submits that the order passed in the post grant opposition
proceedings has been appealed against by the Plaintiffs and the same
was listed before the Intellectual Property Appellate Board (hereinafter,
‘IPAB’) on 19th August, 2019. On the said date, the IPAB has directed
st
that the matter be listed on 21 August, 2019 at 2 : 30 PM. He
accordingly requests that no order be passed till 22nd August, 2019,
which is the next date before Court in this matter.
7. Though the appeal is stated to have been filed by the Plaintiffs
th
immediately after the passing of the order dated 16 August 2019,
rights in a patent are only for the life of a patent which remains granted
and has not been revoked. The manner in which patent rights operate
is that they are merely statutory rights and there are no common law
rights in patents. Patent infringement actions are maintainable only in
respect of granted and live patents.
8. The fact that no infringement action is maintainable in respect of
an unregistered or revoked patent is further clear from a reading of
Section 62(2) and Section 11A(7) of The Patents Act, 1970. Even if a
patent is not renewed, no infringement action would lie. Similarly, once
the patent is published, no infringement action can be filed till the
patent is granted, though damages can be sought with effect from the
date of publication. Thus, the continuation of an injunction, even for a
day, would not be permissible once the patent is revoked. Considering
th
the development, i.e., the passing of the order dated 16 August,
2019, revoking the patent, the interim order restraining the Defendant
from carrying out any fresh manufacturing of pharmaceutical
preparations comprising of the API ‘Ceritinib’, as directed vide order
dated 2nd May 2019, stands suspended.
9. The Plaintiffs are, however, granted liberty to seek appropriate
orders if any orders are passed in favour of the Plaintiffs by the IPAB, in
the appeal preferred by them. Accordingly, I.A. under Order XXXIX
Rule 4 CPC is disposed of. I.A. under Order VII Rule 11 CPC be listed
on the next date.
10. List on 22nd August, 2019, i.e., the date already fixed.
11. Dasti under signature of the Court Master.
———
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