Madras High Court
Regeneron Pharmaceuticals vs Controller Of Patents And Designs on 22 October, 2024
(T)CMA(PT) No.191 of 2023
IN THE HIGH COURT OF JUDICATURE AT MADRAS
CORAM
DATED : 22.10.2024
THE HONOURABLE MR.JUSTICE K.KUMARESH BABU
(T)CMA(PT) No.191 of 2023
Regeneron Pharmaceuticals, Inc,
777 Old Saw Mill River Road,
Tarrytown, NY 10591, USA. … Appellant
Vs
Controller of Patents and Designs,
Government of India, Patent Office,
Intellectual Property Rights Building,
GST Road, Guindy,
Chennai- 600 032. … Respondent
PRAYER:- This Civil Miscellaneous Petition has been filed under 117-A of
the Indian Patents Act, 1970 seeking direction to set aside the impugned
order dated 16 December 2020 issued by the Respondent and to grant the
patent in respect of the appellant's Application No.1554/CHENP/2013 in
accordance with the provisions of the Act and the Rules.
For Appellant : Mr.Shivathanu. Mohan,
for M/s.De Penning and De Penning,
For Respondent : Mr.A.R.Sakthivel SPC
ORDER
This instant appeal has been filed to set aside the impugned order
dated 16.12.2020 issued by the respondent and to grant the patent in respect
of the Appellant's Application No.1554/CHENP/2013 in accordance with the
provisions of the Act and the Rules.
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2. Heard Mr.Shivathanu. Mohan, learned counsel appearing for M/s.De
Penning and De Penning, counsel for the Appellant and Mr.A.R.Sakthivel,
learned counsel appearing on behalf of the respondent.
3. Mr.Shivathanu. Mohan, learned counsel appearing on behalf of the
appellant would submit that the application filed by the appellant under
Section 15 of the Act had been rejected by the respondent holding that the
amendment sought for in the Patent application, if entertained would amount
to change the entire scope of invention and hence, the claim could not be
entertained. The other reason given by the respondent is that it attracts
Section 3(b) of the Patents Act and therefore such amendment cannot be
permitted to be made. He would submit that such views were expressed by
the respondent in a pre-grant hearing, the appellant had in extensio made
submissions that there has been no change in the specifications or the
substances that had been disclosed. He would submit, what was the original
claim based on the specifications and the substance disclosed was not
comprehensive and hence, what was sought to be amended was only to the
claim based on the specifications and the substances that had already been
disclosed. Therefore, the amendment that is sought for would not fall within
the ambit of Section 59 which would deny the amendment.
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4.He would submit that in the examination Report with regard to
Section 3(b), the applicant had specifically made a statement that it would be
for the benefit of the human kind. However, while rejecting the claim under
Section 3(b), the Authority had held that such modification of genetic identity
of the animal would cause them suffering without any substantial, medical or
other benefit to men or women. The said finding according to him is without
application of mind that too in the light of the specific statement of the
appellant that such genetic modification is for the benefit of the humanity. He
had also relied upon the judgment of the Hon'ble Delhi high Court as well as
the judgment of this Court and contended that such rejections is without the
application of mind and hence would have to be interfered with and remit the
matter back to the respondent for being decided by any other Controller other
than the Controller who had passed the order.
5. Mr.A.R.Sakthivel, learned counsel appearing on behalf of the
respondent would submit that no materials have been placed before the
respondent to come to an conclusion that the subject invention namely the
modifying the genetic identity of the animal would be beneficial to the
mankind. He would further submit that the amendment that is sought for
would squarely fall within the mischief of Section 59 and the amendment that
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is sought for by the appellant cannot be entertained. Hence, he would seek
dismissal of the appeal as being devoid of merits.
6. I have considered the submissions made by the learned counsels
appearing on either side and perused the materials available on record before
this Court.
7. It is seen from the impugned order that the respondent had rejected
the application on two grounds as follows,
(a)Holding that the amendment could not be
allowed as per the Section 59 of the Patents Act.
(b)The amendment is not patentable as per the
Section 3(b) of the Patents Act.
Section 59 of the Patents Act had been considered by the Hon'ble Delhi
High Court in a judgment made in Allergan Inc Vs The Controller of Patents
reported in 2023/DHC/000515 dated 20.01.2023. The case therein was that
the appellant therein had originally sought for the method in which the
implants were to be used and subsequently, wanted to modify the patent for
the implants. The said claim was rejected by the Authority against which the
appeal had been filed. After analysing the facts of the case, the Hon'ble Delhi
High Court held that the amendment to the claims should be made by
considering the complete specifications of the pre-amended claims and not
merely textually cabined reading of the pre-amended claims themselves
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dehors complete specification. For better appreciation, the relevant paragraph
of the said order is extracted hereunder:-
35.The question which is before this Court, for the
present, is whether the appellant should be completely
foreclosed from seeking a patent in respect of the said
implants merely because the original application, as
filed by the appellant, sought a patent not for the
implants but for the method in which the implants were
to be used, whereas the amended claims seek patents
for the implants themselves, rather than the method of
their usage, even if all details of the implants, and
every particular of the amended claims stand
completely disclosed in the complete specifications
accompanying the original claims.
36.Any such view, in my considered opinion, would be
completely contrary to the very ethos of the Patents Act,
as well as the most elementary principles of patent
claim construction. Bishwanath Prasad Radhey
Shyam19 spoke thus, on patent claim construction, vis-
à-vis the complete specifications:
“43. As pointed out in Arnold v. Bradbury23 the
proper way to construe a specification is not to read
the claims first and then see what the full
description of the invention is, but first to read the
description of the invention, in order that the mind
may be prepared for what it is, that the invention is
to be claimed, for the patentee cannot claim more
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than he desires to patent. In Parkinson v. Simon24
Lord Esher, M.R. enumerated that as far as
possible the claims must be so construed as to give
an effective meaning to each of them, but the
specification and the claims must be looked at and
construed together.
44. The learned trial Judge precisely followed this
method of construction. He first construed and
considered the description of the invention in the
provisional and complete specifications and then
dealt with each of the claims, individually.
Thereafter, he considered the claims and
specifications as a whole, in the light of the evidence
on record.”
(Emphasis supplied)
The principle was enunciated, with even greater
precision, in the judgement of the Division Bench of
this Court authored by S. Ravindra Bhat, J. (as he then
was), in the following passage from Merck Sharp &
Dohme Corporation v. GlenmarkPharmaceuticals 25:
“48. At this juncture, the Court notes that: -
“the construction of claims is not something that
can be considered in isolation from the rest of the
specification, Claims are intended to be pithy
delineations of the scope of monopoly, and they are
drafted in light of the much more detailed text of the
description. A specification must be read as a
whole, just as any document is. It must moreover be
read as having been addressed to a person
acquainted with the technology in question. So it
must take account of that person's state of
https://www.mhc.tn.gov.in/judis knowledge at the time.”
(see, Cornish, Llewelyn and Aplin, Intellectual
Property, Seventh Ed, Sweet and Maxwell, pages
182-3).”
(Italics in original; underscoring supplied)
37. Dichotomizing the claims and the accompanying
specifications is, therefore, contrary to the most
fundamental canons of patent law. That, however, is
precisely what the Court would be lending its
imprimatur to, were it to accept the interpretation that
Mr Vaidyanathan seeks to place on Section 59(1).
38. This is not a case in which there is a wide
divergence between the claims for which the patent had
originally been sought, and the claims as amended
subsequently. The amended claims were in respect of
the very same implants for the method of use of which
the original claims have been filed. Every detail of the
implants, as contained in the amended claims, was in
fact disclosed in the original claims as filed. This is
apparent from the tabular statement in para 22 supra.
In fact, the complete specifications, holistically read,
clearly indicate that the appellant was effectively
claiming both the implants as well as their method of
use as its inventions.
39. The question is, therefore, whether, in such
circumstances, this Court should uphold the decision of
the learned Controller to throw out, at the very
threshold, the application of the appellant, on the
https://www.mhc.tn.gov.in/judis ground that the amended claims were not within the
scope of the originally filed claims.
40. A hyper-technical view, in that regard, in my
opinion, would not be justified, given the philosophy
behind the Patents Act. If, indeed, the implants are
inventive, the appellant, as the claimed inventor, ought
to be given a chance to have the implants patented. If,
however, the learned Controller finds, on examination,
that the implants are not inventive or stand otherwise
disentitled to a patent under the Patents Act for any
reason whatsoever, the appellant"s application would
naturally stand disallowed. The application cannot,
however, be thrown out without examination at the very
threshold.
41. Referring back to Section 59(1), what the Section
proscribes is permitting of an amendment of the claim
where the amended claim would not fall wholly within
the scope of the pre-amended claim. Interestingly, even
this last part of Section 59(1) uses two expressions. It
states that “no amendment of a complete specification
shall be allowed, the effect of which would be … that
any claim of the specification as amended would not
fall wholly within the scope of a claim of the
specification before the amendment.” What the Section
compares, therefore, is the amended claim with the
scope of the pre-amended claim. Where the amended
claim does not fall within the scope of the pre-amended
claim, the amendment would not be allowed.
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42. The exact ambit of the scope of a claim in a
patent has been the subject of judicial decisions, to
which I have already adverted. As I have already
noted, the claims and complete specifications in a
patent have to be read together and as a whole. The
claims have to be understood in the light of the
complete specifications. They form an integrated whole,
and cannot be treated as two distinct parts of one
document. The claim by itself, and de hors the complete
specifications which accompany it, cannot convey, to
the Court, the exact scope of the claim.
43. The very use of the expression “scope of a claim” in
the concluding part of Section 59(1) would, therefore, in
my considered opinion and keeping in mind the avowed
purpose of the Patents Act, require taking into
consideration the complete specifications of the pre-
amended claim, and not merely a textually cabined
reading of the pre-amended claims themselves, de hors
the complete specifications.
8. In the present case, based upon the specifications and the disclosed
substances, the appellant had originally claimed the patent of the mouse, cell
and the usage of mouse. However, by the amended claim, he sought patent to
the method of making a genetically modified mouse, an antigen binding
protein, a targeting vector, a nucleic acid construct. There has been no change
in the specification or the substances disclosed. However, the respondent
herein had only considered the original claim and the amended claim dehors
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the complete specification that was before it. Such a decision is squarely
covered by the judgment of the Hon'ble Delhi High Court extracted supra,
which also, I am in concurrence too. Hence, the reasons attributed by the
respondent to reject the claim of the appellant under Section 59 of the Act
cannot be countenanced.
9. Similarly, based upon the examination Report, the appellant had
indicated in his response that such genetical modification in a mouse would
be beneficial to the human kind. The same had been briefly recorded by the
respondent in his order. The recording of such statement clearly indicates that
there has been a claim made by the appellant that the subject matter of the
invention is actually beneficial to the humanity in terms of medical research.
However, the reasoning assigned by the respondent that there has been no
substantial medical or other benefit to mankind in genetically modifying post
is against his own recording of statement of facts.
10. In view of the aforesaid findings and reasonings, I am inclined to
interfere with the impugned order in the present appeal. In fine,
i) the order dated 16.12.2020 made by the respondent is set aside and
the application for the amendment is directed to be reconsidered by the
respondent.
ii) in order to preclude the possibility of predetermination, an officer
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other than the officer who issued the impugned order shall undertake
reconsideration.
iii) After providing a reasonable opportunity to the appellant, a
reasoned decision shall be issued within a period of four months from the
date of receipt of a copy of this judgment.
iv) It is made clear that no opinion is being expressed herein on the
merits of the application for grant of patent.
22.10.2024
Gba
Index : Yes/ No
Speaking Order/ Non-speaking Order
Copy to:
Controller of Patents and Designs,
Government of India, Patent Office,
Intellectual Property Rights Building,
GST Road, Guindy,
Chennai- 600 032.
https://www.mhc.tn.gov.in/judis
K.KUMARESH BABU,J.
GBA
22.10.2024
https://www.mhc.tn.gov.in/judis
