VIFOR INTERNATIONAL LTD & ANR. vs DR REDDYS LABORATORIES LTD

* IN THE HIGH COURT OF DELHI AT NEW DELHI
% Judgment reserved on: 02 November 2023
Judgment pronounced on: 07 February 2024

+ FAO(OS) (COMM) 159/2023 & CM APPL. 39177/2023
VIFOR (INTERNATIONAL) LIMITED & ANR. .. Appellants
Through: Mr. Neeraj Kishan Kaul, Sr. Adv. with Mr. Pravin Anand, Ms. Vaishali Mittal, Mr. Rohin Koolwal, Mr. Hersh Desai, Ms. Ira Mahajan, Ms. Pritha Suri & Mr. Siddhant Chamola, Advs.

versus

MSN LABORATORIES PVT LTD & ANR. ….. Respondents
Through: Mr. G. Nataraj, Mr. Shashikant Yadav, Mr. Rahul B., Advs.
Mr. Chander M. Lall, Sr. Adv. with Mr. Kunal Vajani, Mr. Kunal Mimani, Mr. Shubhang Tandon, Mr. Prashant Alai Advs. for intervener – BDR Pharmaceuticals Pvt. Ltd.

+ FAO(OS) (COMM) 160/2023 & CM APPL. 39197/2023
VIFOR INTERNATIONAL LTD & ANR. ….. Appellants

Through: Mr. Sandeep Sethi, Sr. Adv. with Mr. Pravin Anand, Ms. Vaishali Mittal, Mr. Rohin Koolwal, Mr. Hersh Desai & Mr. Siddhant Chamola, Advs.
versus

CORONA REMEDIES PVT LTD & ANR. ….. Respondents

Through: Mr. G. Nataraj, Mr. Shashikant Yadav, Mr. Rahul B., Advs.
Mr. Kunal Vajani, Mr. Kunal Mimani, Mr. Shubhang Tandon, Mr. Prashant Alai, Advs. for intervener – BDR Pharmaceuticals Pvt. Ltd.
Ms. Rajeshwari H., Mr. Tahir AJ., Ms. Garima Joshi, Advs.

+ FAO(OS) (COMM) 161/2023 and CM APPL. 39201/2023
VIFOR INTERNATIONAL LTD & ANR. ….. Appellants

Through: Mr. Neeraj Kishan Kaul, Sr. Adv. with Mr. Pravin Anand, Ms. Vaishali Mittal, Mr. Rohin Koolwal, Mr. Hersh Desai, Ms. Ira Mahajan, Ms. Pritha Suri & Mr. Siddhant Chamola, Advs.

versus

DR REDDYS LABORATORIES LTD ….. Respondent

Through: Mr. G. Nataraj, Mr. Shashikant Yadav, Mr. Rahul B., Advs.
Mr. Kunal Vajani, Mr. Kunal Mimani, Mr. Shubhang Tandon, Mr. Prashant Alai, Advs. for intervener – BDR Pharmaceuticals Pvt. Ltd.

CORAM:
HON’BLE MR. JUSTICE YASHWANT VARMA
HON’BLE MR. JUSTICE DHARMESH SHARMA

J U D G M E N T

YASHWANT VARMA, J.

S. No.
Particulars
Paragraph Nos.

A.
PREFACE/ BRIEF INTRODUCTION
1-11
B.
ESSENTIAL FACTS
12-16
C.
CONTENTIONS OF VIFOR
17-61
D.
SUBMISSIONS OF MSN & DR. REDDY’S
62-77
E.
ARGUMENTS OF CORONA REMEDIES
78-82
F.
INTERVENORS’ STAND
83-96
G.
PRIOR INTERIM ORDERS AND OTHER ANCILIARY ISSUES
97-102
H.
SCOPE OF PRODUCT-BY-PROCESS
103-143
I.
GRANT AND INFRINGEMENT – DISSIMILAR STANDARDS?
144-168
J.
SUBSIDARY ISSUES
169-179
K.
EPILOGUE
180-182
L.
CARDINAL PRINCIPLES
183
M.
DETERMINATION
184-185

A. PREFACE/ BRIEF INTRODUCTION

1. These appeals have been preferred against the order dated 24 July 2023 passed by a learned Single Judge disposing of the interim injunction applications made in CS(COMM) Nos. 261/2021, 265/2021, 448/2022 & 450/2022 and refusing interim relief in terms as prayed for by the appellant. The present appeals stand restricted to the aforesaid order insofar as it operates upon CS(COMM) Nos. 261/2021, 265/2021 & 448/2022.
2. The appeals raise an issue of significant import, namely, product-by-process claims and their scope as liable to be construed under the provisions of the Patent Act, 19701. The respondents resisted the applications for grant of interlocutory injunction asserting that since the claim of the plaintiff/appellant was liable to be construed as a product-by-process claim, it would stand limited to the process alone. It is this principal ground which appears to have found favour with the learned Single Judge while dismissing the prayer for interim relief. The respondents also appear to have urged that the rule of novelty as applicable at the stage of grant would be irrelevant for the purposes of trying infringement allegations and the principles of claim construction alone would govern. The learned Judge has accepted the aforenoted twin submissions as addressed.
3. A reading of the impugned order would indicate that the learned Single Judge firstly found that in all actions alleging infringement, the primary question would be how the claims are to be interpreted and thus discern the scope of the patent. As per the learned Judge it is the claims which would define and be determinative of the allegation of infringement. This will be evident from paragraph 52 of the impugned order which is reproduced hereinbelow:
“52. A reading of Section 10(4)(a) leads to an inevitable conclusion that when a complete specification is filed to describe the invention, it is implicit that the applicant has fully and particularly described not only the invention and its operation but also the use and “method” by which it is to be performed and the monopoly on grant of patent is limited to the scope as defined by the claims. In this context, I may refer to the judgment of the Supreme Court in Novartis AG (supra), wherein it was emphasized that the scope of monopoly rights granted by means of a patent are in exchange for the disclosure of the invention and the scope cannot travel beyond the disclosure as that would negate the fundamental rule underlying the grant of patent. Relevant passage from Novartis AG (supra) is as follows:-

“118. The submissions of Mr Andhyarujina and Mr Subramanium are based on making a distinction between the coverage or claim in a patent and the disclosure made therein. The submissions on behalf of the appellant can be summed up by saying that the boundary laid out by the claim for coverage is permissible to be much wider than the disclosure/enablement/teaching in a patent.
119. The dichotomy that is sought to be drawn between coverage or claim on the one hand and disclosure or enablement or teaching in a patent on the other hand, seems to strike at the very root of the rationale of the law of patent. Under the scheme of patent, a monopoly is granted to a private individual in exchange of the invention being made public so that, at the end of the patent term, the invention may belong to the people at large who may be benefited by it. To say that the coverage in a patent might go much beyond the disclosure thus seem to negate the fundamental rule underlying the grant of patents.”
(emphasis supplied)

4. Laying emphasis on “claim construction” the learned Judge has made the following pertinent observations:
“61. The next question that posits is ‘why claim construction?’. As per Section 10 of the 1970 Act, claims define the scope of the patent and that in turn defines not just the boundaries of coverage of the invention, but also plays a pivotal role in determining the economic value of a patent. The broader the scope of invention, the larger the number of competing products or processes that will infringe the patent and consequently, larger would be its economic value. Subject to other provisions of the 1970 Act, grant of patent under the Act confers upon the patentee the exclusive right to prevent third parties from making, using, selling, importing or offering to sell, without the consent of the patentee, the patented product and where the subject matter of the patent is a process, from using the said process. Therefore, when the patentee sues the alleged infringer, patentee will endeavour to establish that the infringer’s product/process is within the scope of the patent of the patentee while the accused infringer will seek to carve out its product/process from the scope of the patented claims. Either way, the decision would have to be predicated on construing the claims and therefore the real challenge for adjudicating the claim of infringement of a patent will be to construe the scope of the claims. In the present case, since Defendants plead non-infringement of IN’536 predicating their case on difference in the respective processes, without prejudice to the argument of invalidity, it becomes imperative to construe the claims of Vifor in order to ascertain the actual scope of the claimed invention.”

5. The Court has ultimately and on merits proceeded to record the following conclusions:
“105. Upon a bare perusal of Article 69(1), it is luminously clear that the extent of protection conferred by a patent or a patent application shall be determined by the claims and any contra position to state that actual scope of enforcement of the claims of a patent can extend beyond what is defined by the claims, cannot be accepted. Additionally, in the Indian context, the Supreme Court in Novartis AG (supra), has clearly held that coverage cannot go beyond what is disclosed in the complete specification of the patent application and therefore, the stand adopted in the affidavit, if accepted, would strike at the very root of Indian Patent law. In any event, the applicability of the decision of the UK Supreme Court in Actavis v. Lily, [2017] UKSC 48, which concerned indirect infringement, is yet to be tested in the Indian context. In fact, for the sake of record, it may be noted that in Actavis (supra), emphasis has been laid on the limitations placed on a claim that a patentee chooses consciously at the time of drafting and filing the claims.”

6. Insofar as the subject patent and the nature of product-by-process claim is concerned, the learned Judge has firstly and on facts found that IN’536 was primarily a product-by-process claim. This is evident from the following observations as appearing in paragraph 60:
“60. Coming now to the second issue which directly concerns IN’536. Before moving to claim construction, it would aid to look at definitions in Black’s Law Dictionary, 8th Ed., wherein ‘product claim’ is defined as “a patent claim that covers the structure, apparatus or composition of a product” while ‘process claim’ is defined as “a patent claim that describes by steps what is done to the subject matter usually a substance in order to achieve a useful result.” ‘Product-by-process claim’ is defined as “a patent claim defining a product through the process by which it is made”. It is not Vifor’s claim that IN’536 is a process claim. To be categorised as a product claim, a product must be described by its composition and structure, both physical and chemical and not limited by a process. Claim 1 does not fit into the definition of ‘product claim’ and the limitations on obtaining FCM by a specified process defined in the said claim aligns it with a ‘product-by-process claim’. The reasons for this conclusion are adverted to in the later part of the judgment. Insistence of Vifor to treat Claim 1 as a product claim would, in fact, trigger issues of clarity and sufficiency of disclosure and will be hit by non-compliance of Section 10(5) of the 1970 Act, besides reducing the process terms to a dead letter, even when the process steps are the essence of the claims, both in quantitative and qualitative terms. Be it ingeminated that in an another suit being CS(OS) 1206/2015 filed by Vifor, Court permitted the Defendants to manufacture the water soluble iron carbohydrate complex using a different process which did not infringe the patent of the Plaintiff and this, in my view, recognizes that IN’536 is a product-by-process patent, else the Court would have injuncted the Defendants, since in a product patent the process is irrelevant. Relevant extract of the order dated 16.09.2015 is as follows:
“It may be noted that once the plaintiff has a registered patent, defendants cannot use the subject matter of the patent and can only use a process of manufacture which does not infringe the patent of the plaintiff for manufacture of the water-soluble iron carbohydrate complex. It may be noted that learned senior counsel for the defendants states that defendants are not and do not intend to violate the plaintiff’s patent and the defendants claim to be using a different process which is not the subject matter of plaintiff’s patent.”
(emphasis supplied)

7. Drawing from the guiding principles culled out in F. Hoffmann-La Roche Ltd. & Anr. Vs. Cipla Ltd.2, the learned Judge has come to the following conclusion:
“67. Claim 1 thus refers to the product followed by description of the sequence of using aqueous solution of oxidation product of one or more maltodextrins in an alkaline pH in the presence of a specified oxidizing agent i.e. aqueous hypochlorite solution, where the end product i.e. iron carbohydrate complexes have a defined average molecular weight and the limitation to the product by the process is prima facie evident. Stand of Vifor that the claim as drafted is a product claim and/or that even with the limitation of the process, the claim leads to a product claim only, would render the description of the claim with a detailed and a specific process meaningless and otiose. Therefore, prima facie IN’536 is a product-by process claim and monopoly will be limited to the product obtained by the specific process in the claims, going by the first principles delineated in F. Hoffmann-La Roche Ltd. & Anr. (supra), that claims define the territory or scope of protection.”

8. While holding against the appellants, the Court also negated the arguments which were addressed on the basis of Claim 1 using the expression “obtainable from”. While rendering findings on this aspect, the Court appears to have drawn from the principles enunciated by the High Court of England and Wales in Hospira UK Limited vs. Genentech Inc.3 and other well-known treatise to come to the conclusion that the description of a product by way of a process of manufacture would limit the scope of the patent. The aforesaid view though not explicitly stated, appears to rest on the decision rendered by the United States Court of Appeals for the Federal Circuit in Atlantic Thermoplastics Co., Inc. V. Faytex Corporation4 and Abbott Laboratories v. Sandoz5.
9. The learned Judge had also observed that since iron carbohydrate complexes were already known, the invention forming part of IN’536 resided in the specified process alone. This is evident from the following observations as appearing in paragraph 71 of the impugned decision:
“71. As rightly contended by the Defendants, there is an admission by Vifor that use of iron carbohydrate complexes is known and a water-soluble iron (III) hydroxide sucrose complex is a frequently and successfully used preparation. It is stated that the problem to be solved by the present invention is to provide an iron preparation which is especially to be applied parenterally and can be easily sterilized as the known parenterally applicable preparations on the basis of sucrose and dextran were only stable at temperatures up to 100oC, which made sterilization difficult. It is categorically asseverated in the complete specification that present invention is a process for producing iron carbohydrate complexes wherein one or more ‘maltodextrins’ are oxidized in an aqueous solution at an alkaline ‘pH’ using ‘aqueous hypochlorite solution’ and further that when one maltodextrin is applied, the DE value is between 5 and 20 and when mixture of several maltodextrin is applied, the DE value of the mixture lies between 5 and 20 and the DE value of each individual maltodextrin contained in the mixture lies between 2 and 40. Given the admission of Vifor in the complete specification that iron carbohydrate complexes were already known, the only prima facie conclusion that this Court can reach is that the purported invention resides in preparing iron carbohydrate complexes with maltodextrin as the starting material and/or the step of oxidation using the specified oxidizing agent i.e. aqueous hypochlorite solution. In fact, what Vifor overlooks in making the submission that the process is inconsequential, is that the characteristic properties that it claims in FCM, distinguished from the prior art, are a direct result of the process used by Vifor, an admission that it makes during the prosecution of the patent application and is glaringly evident in the complete specification. Therefore, the scope of Claim 1 of IN’536 is limited to a product obtained through a specific process feature identified therein and cannot cover any and all processes that may be used by a third party to produce FCM and it is thus held that Claim 1 is a product-by-process claim and not a pure product claim.”

10. The Court has also held in favour of the respondents upon finding that they used an oxidizing agent distinct from the one spoken of in the product-by-process claim of the appellant. Presumably, drawing inspiration from the decisions in Hospira UK Limited, Kirin Amgen Inc. & Ors. V. Hoechst Marion Roussel Limited & Ors.6, Atlantic Thermoplastics and Abbott Laboratories the learned Judge came to conclude that the aspect of novelty would be relevant only for the purposes of patentability and not insofar as infringement analysis is concerned. The aforesaid conclusion too is founded on an appreciation of the views as expressed in the aforenoted decisions.
11. At the very outset it becomes pertinent to note that the suit patent expired on 20 October 2023 and thus after we had commenced final hearing on these appeals on 04 September 2023. Parties had continued oral submissions thereafter. However and more importantly and as learned counsels appearing for respective sides urged, the impugned decision represents a significant view taken on product-by-process claims and would have wide ramifications on how such claims are construed by courts in pending and future litigation. Undisputedly, the subject itself has directly arisen for consideration before a court in India for the first time. The judgment assailed before us is also likely to impact the ultimate view that may be taken not only in the suit from which the present appeals emanate but also others which are pending. The appellants had also submitted that the refusal of injunction would also impact their claim for deposit of profits from sales made by the respondents. In our considered opinion, the importance of the issues which were canvassed coupled with the fact that the questions posited requires us, as the first High Court of the country, to enunciate the law with respect to product-by-process claims merits the appeal being considered on merits notwithstanding the expiry of the suit patent. This more so since, and as would be evident from the ultimate conclusions recorded by us, the learned Judge appears to have manifestly erred in enunciating the principles which must govern the interpretation of such claims. There thus exists adequate justification to proceed further upon this appeal.
B. ESSENTIAL FACTS
12. In order to appreciate the challenge which stood raised in the subject suits, we deem it apposite to notice the following essential facts. The appellants claim to be part of the Vifor Pharma Group of Companies founded in 2008 and originally forming part of the erstwhile Galenica Group of Companies established in 1927 in Switzerland. IN’536 is described to be an invention used for intravenous treatment of iron deficiency and iron deficiency anaemia, when oral iron preparations are rendered ineffective. According to the appellants, Ferric Carboxymaltose7, which is the International Non-proprietary Name8 accorded to the product in dispute, was formulated to meet the requirement of an intravenous iron therapy which would be non-toxic, easily administrable in a variety of clinical conditions and capable of being quickly sterilized. According to the appellants, the preparations in the prior art, and which were based on sucrose and dextran were stable upto temperatures of 100oC which made sterilization difficult. The appellants would contend that there was a necessity to develop an iron preparation which would be free of the noticed adverse effects attached to treatments known in the prior art. FCM which according to the appellants is in a sense a water soluble complex, enables higher dosing of upto 1000 mg iron possible and can be easily administered by way of an intravenous injection within less than 15 minutes. It was the case of the appellants in the suit that IN’536 is a novel water soluble iron carbohydrate complex of iron and oxidation product comprising of one or more maltodextrins.
13. The bibliographic details of IN’536 and which have also been noticed by the learned Judge are extracted hereinbelow:-
Patent Application No.
947/KOLNP/2005
Title of the Invention
Water soluble iron carbohydrate complex and a process for producing water soluble iron carbohydrate complex
Date of Filing
24th May, 2005
International filing date
20th October 2003
(filed as PCT/EP2003/011596, published as WO/2004/037865)
Date of publication (Section 11A)
22nd September, 2005
Date of priority
23rd October, 2002 (DE 10249551.1)
Date of grant
25th June, 2008
Date of publication of grant (Section 43)
27th June, 2008
Date of Expiry
20th October 2023

14. The case of the appellant/ plaintiff in the suit was that IN’536 is principally a product claim and which can also be acknowledged as being a product-by-process claim, a practice which is common and well known in claim drafting. They also appear to have placed before the learned Judge detailed figures of sales of FCM in India right from 2017 to 2019. It was their contention that the suit patent has had corresponding counterparts issued in 57 jurisdictions across the globe since its priority date. It was further asserted that neither the suit patent nor any of its foreign counterparts had been successfully assailed in either pre or post grant opposition or in any other legal proceedings. Insofar as the suit patent is concerned it was asserted that the patent had also not been challenged or questioned in pre-grant opposition in India.
15. Undisputedly although the suit patent was applied for in 2003, it came to be granted only in 2008. Regulatory approval to FCM was granted to the second appellant in India in 2011. Although the suit patent has admittedly expired upon completion of its full term of 20 years on 20 October 2023, it was the case of the appellant that they were able to exploit the monopoly flowing from the grant of the suit patent for 12 of its 20 year term. Before the learned Single Judge the appellants had also placed a tabular statement of the various suits instituted by it to protect IN’536 and the various interim and final orders granted thereon. Those particulars as placed before the learned Single Judge are reproduced hereinbelow:-
S.
NO.
PARTICULARS OF THE MATTER
STATUS
ORDER
DATE
ORDERS
1.
CS(OS) 2282/2011
VIFOR (INTERNATIONAL)
LTD. VS. D. MOHAN RAO & ORS. (SYMED LABS)
Disposed of
16.09.2011
Interim
Injunction

09.09.2015
Disposed of
(Undertaking)
2.
CS(OS) 4005/2014
VIFOR (INTERNATIONAL)
LTD. VS. MOHAN RAM &
ANR.
(MAXYCON HEALTH CARE
PVT. LTD.)
[Later CS(COMM) 712/2018
VIFOR (INTERNATIONAL)
LTD. & ANR. VS. MAXYCON
HEALTH CARE PRIVATE
LIMITED & OTHERS]
Disposed of
22.12.2014
Interim
Injunction

12.04.2018

Decreed
(Permanent
Injunction and
Damages)
3.
CS(OS) 4038/2014
VIFOR (INTERNATIONAL)
LTD. VS. NIKUNJ GOSWAMI
& ANR.
Disposed of
24.12.2014
Interim
Injunction

03.09.2015
Settlement
4.
CS(OS) 1179/2015
VIFOR (INTERNATIONAL)
LTD. VS. SURENDER
KUMAR TANEJA & ORS.
(INTAS
PHARMACEUTICALS LTD.)
Disposed of
24.12.2014
Interim
Injunction

03.09.2015
Decreed
(Permanent
Injunction)
5.
CS(OS) 1489/2015
VIFOR (INTERNATIONAL)
LTD. VS. SANJAY PATEL &
ANR.
(NIKSAN
PHARMACEUTICAL)
Disposed of
21.05.2015
Interim
Injunction

06.10.2016

Settlement
6.
CS(OS) 1488/2015
VIFOR (INTERNATIONAL)
LTD. VS. GAGAN SINGH &
ANR.
(AVANSCURE
PHARMACEUTICALS
PRIVATE LIMITED)
Disposed of
21.05.2015
Interim
Injunction

10.04.2018
Decreed
(Undertaking)

7.
CS(OS) 4083/2014
VIFOR (INTERNATIONAL)
LTD. VS. MR.
DHARMENDRA VORA &
ANR.
(EXIM PHARMA)
Disposed of
29.07.2015
Interim
Injunction

07.11.2017

Decreed
(Permanent
Injunction and
Damages)
8.
CS(COMM) 1548/2016
VIFOR (INTERNATIONAL)
LTD. VS. MR. G. SANU NAIR
& ORS.
(NEOFALCON LIFE
SCIENCES AND HEALTH
BIOTECH LIMITED)
Disposed of
24.11.2016
Interim
Injunction

18.01.2018
Settlement
9.
FAO(OS) (COMM) 146/2016
VIFOR (INTERNATIONAL)
LIMITED VS. UDEET
JEEGUL BANKER & ORS.
(MANUS AKTEEVA
BIOPHARMA)
Disposed of
23.12.2016
Interim
Injunction

12.01.2017
Decreed
(Undertaking)
10.
CS(COMM) 214/2017
VIFOR (INTERNATIONAL)
LTD. VS. MR. VISHAL N.
JAJODIA & ORS.
(SWATI SPENTOSE AND
ALCON BIOLIFESCIENCES)
Disposed of
21.03.2017
Interim
Injunction

15.09.2017
Settlement
11.
CS(COMM) 417/2017
VIFOR (INTERNATIONAL)
LTD. VS. JIGEN
BIPINCHANDRA SHAH &
ANR.
(JIGS CHEMICALS)
Disposed of
31.05.2017

Interim
Injunction

09.05.2018
Interim
Injunction

20.12.2018
Decreed
(Undertaking)
12.
CS(OS) 4079/2014
VIFOR (INTERNATIONAL)
LTD. VS. SUNILA RAIZADA
& ANR.
(PUNEET
PHARMACEUTICALS)
Disposed of
24.12.2014
Interim
Injunction

23.04.2015

Settlement
13.
CS(COMM) 1680/2016
VIFOR (INTERNATIONAL)
LTD. VS. SUVEN LIFE
SCIENCES LTD.
Pending trial
ongoing
23.12.2016
Defendant
ordered to be
bound by the
undertaking
given under S107A of the
Patents Act

19.11.2018
Defendant
agreed to be
bound by the
undertaking
dated
23.12.2016 to
be continued
till the
disposal of the
suit
14.
CS(COMM) 1206/2015
VIFOR (INTERNATIONAL)
LTD. VS. MR. PANKAJ
RAMANBHAI PATEL &
ANR.
(ZYDUS CADILA)
Pending trial
ongoing
16.09.2015
Interim
Injunction
15.
CS(COMM) 565/2017
VIFOR (INTERNATIONAL)
LTD. VS. MANASI MEHTA &
ORS.
(LA RENON HEALTHCARE)
Pending trial
ongoing
31.07.2019
(framing
issues)

No injunction
order as suit
for non-infringement
already filed
prior to suit
for infringement –
issues framed
and parties
directed to
expedited trial.
Interim
Application
still pending.
16.
CS(COMM) 261/2021
VIFOR (INTERNATIONAL)
LTD. & ANR. VS. MSN
LABORATORIES PVT. LTD.
& ANR.
Pending recently
filed
01.06.2021
Undertaking
not to infringe
17.
CS(COMM) 264/2021
VIFOR (INTERNATIONAL)
LTD. & ANR. VS. UNIJULES
LIFE SCIENCES LTD. &
ANR.
Disposed of
02.06.2021
Interim
Injunction

11.03.2022
Settlement

18.
CS(COMM) 265/2021
VIFOR (INTERNATIONAL)
LTD. & ANR. VS. DR.
REDDY’S LABORATORIES
LTD.
Pending recently
filed
02.06.2021
Undertaking
not to infringe
19.
CS(COMM) 335/2021
VIFOR (INTERNATIONAL)
LTD. & ANR. VS. ALEMBIC
PHARMACEUTICAL LTD.
Disposed of
28.07.2021
Undertaking
not to infringe

26.11.2021
Settlement

20.
CS(COMM) 210/2022
VIFOR (INTERNATIONAL)
LTD. & ANR. VS. HETERO
HEALTHCARE LIMITED &
ANR.
Pending recently
filed
05.04.2022

interim
Injunction

16. Insofar as the claims themselves are concerned, it was contended by the appellants that Claim 1 is a product claim for FCM which was merely described by reference to an illustrative process. It was their submission that Claim 1 is an independent product claim while Claims 2 to 6 embody illustrative processes for the making of FCM. It was this stand which was reiterated before us in these appeals with it being argued that FCM is a new and novel man-made product which was unknown in the prior art.
C. CONTENTIONS OF VIFOR
17. Both Mr. Kaul, learned senior counsel as well as Mr. Anand, learned counsel appearing in support of the appeals had taken us through the claims to drive home their submission that FCM and the claims made in respect thereof clearly answered the description of a product-by-process claim. The appellants also drew our attention to the ‘Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals’ as formulated by the Indian Patent Office9 to submit that a product-by-process claim is not unknown in the Indian patent system. It was submitted that patentability of a product-by-process claim, as the IPO holds, rests fundamentally on the product itself and is not dependent upon a method of production. Those guidelines, it is pertinent to note also drew strength from an order of the erstwhile Intellectual Property Appellate Board10 which had held that product-by-process claims must define a novel and unobvious product and not be limited by its description in the form of a process. We deem it appropriate to extract the relevant parts of the guidelines hereinbelow:
“7.9 Product-by-process claims:
A claim to a product obtained or produced by a process is anticipated by any prior disclosure of that particular product per se, regardless of its method of production. In a product-by-process claim, by using only process terms, the applicant seeks rights to a product, not a process. The IPAB held in ORDER No. 200/2012 “…….product-by process claims must also define a novel and unobvious product, and that its patentability cannot depend on the novelty and unobviousness of the process limitations alone. Therefore, the patentability of a product by process claim is based on the product itself if it does not depend on the method of production. In other words, if the product-by-process claim is the same as or obvious from a prior product, the claim is un-patentable even if the prior art product was made by a different process. Accordingly the product by process claim must define a novel and unobvious product and the patentability in such claim cannot depend on the novelty and un-obviousness of the process limitation alone”. Therefore, in product-by-process claims, the applicant has to show that the product defined in process terms, is not anticipated or rendered obvious by any prior art product. In other words the product must qualify for novelty and inventive step irrespective of the novelty or inventive step of the process”

18. In order to appreciate the submissions which were addressed in this respect, we also reproduce the claims as appearing on the record hereinbelow:
“WE CLAIM
1. Water soluble iron carbohydrate complexes obtainable from an aqueous solution of iron (111) salt and an aqueous solution of the oxidation product of one or more maltrodextrins using an aqueous hypochlorite solution at a pH-value within the alkaline range, where, when one maltodextrin is applied, its dextrose equivalent lies between 5 and 20, and when a mixture of several maltodextrins is applied, the dextrose equivalent of the mixture lies between 5 and 20 and the dextrose equivalent of each individual maltodextrin contained in the mixture lies between 2 and 40, wherein the obtained iron complexes have an average molecular weight of 80 kDa to 400 kDa.
2. A process for producing an iron carbohydrate complex as claimed in c1aim 1 wherein one or more maltrodextrins are oxidized in an aqueous solution at an alkaline pH-value using an aqueous hypochlorite solution and the obtained solution is reacted with an aqueous solution of an iron (111) salt, “wherein, when one maltodextrin is applied, its dextrose equivalent lies between 5 and 20, and when a mixture of several maltodextrins is applied, the dextrose equivalent of the mixture lies between 5 and 20 and the dextrose equivalent of each individual maltodextrins contained in the mixtures lies between 2 and 40.
3. A process as claimed in claim 2, wherein the oxidation of the maltodextrin or the maltodextrins is carried out in the presence of bromide ions.
4. A process as claimed in claim 2 or 3, wherein the iron (111) chloride is used as the iron (111) salt.
5. A process as claimed in claims 2, 3 or 4, wherein the oxidized maltrodextrin and the iron (111) salt are mixed to form an aqueous solution having a pH-value so low that no hydrolysis of the iron (Ill) salt occurs, whereafter the pH is raised to 5 to 12 by the addition of a base.
6. A process as claimed in any of claims 3 to 5, wherein the reaction is carried out at a temperature of 15°C up to boiling point for 15 minutes up to several hours.
7. A medicament containing an aqueous solution of an iron carbohydrate complex as claimed in claim 1 or 2 or obtained in accordance with any of claims 3 to 6.
8. A medicament as claimed in claim 7 formulated for parenteral or oral application.
9. Water-soluble iron carbohydrate complex as claimed in claim 1 for therapy or prophylaxis of iron deficiency.”

19. Mr. Kaul learned senior counsel laid emphasis on the fact that the respondents had not assailed the validity of the suit patent before the learned Judge nor had they addressed any submissions which may have cast a cloud on the novelty or inventive step comprised in FCM. It was also submitted that it was on consideration of the novel and inventive attributes of FCM which led to the World Health Organization11 according an INN for the product. It was their contention that INNs’ are only allocated to new products and processes. Reliance in this regard was placed on certain authoritative texts, relevant extract whereof are reproduced hereunder:
Guide to EU Pharmaceutical Regulatory Law (7th Edition) – Sally Shorthose
“[6] Naming the Product
Choosing an appropriate and acceptable product name is an important precursor to the application process.
The active substance is named according to the INN designated by the World Health Organisation (WHO) or using the relevant chemical name. During clinical trials, the manufacturer applies to the WHO for an INN if the active substance does not already have one. The application form allows the applicant to suggest three names in order of preference (the WHO provides general principles for guidance in devising INNs, based on the use of stems). A consultation committee considers the selected names, and the one accepted name is published.
The name of the medicinal product itself may either be a single, ‘invented’ name (trade name) or a common or scientific name, usually the INN of the active substance (s), accompanied by a trademark or the name of the Marketing Authorisation holder. For applications using the CP, guidance on invented names and the procedure for submitting them for acceptance is available on the EMA website.”

Pharmaceuticals Biotechnology and the Law (2nd Edition) – Trevor Cook
“Non-proprietary names
14.6 The full chemical name for a medicinal product is usually long and complex and it has been recognised that its use is not desirable for proper communication in medicine and the labelling and promotion of pharmaceuticals. Indeed most biological molecules are of such complexity that they cannot be given a chemical name in the conventional sense. There is thus a need for a relatively simple name by which a particular pharmaceutical is referred to, but one which is not a trade mark, so that for example the drug as sold by others than the original patentee can be identified after patent expiry. Thus the practice has developed of providing drugs with at least two names other than their full chemical name; one, a non-proprietary, or generic, name which is free for all to use in respect of the drug in question and the other a brand name specific to each manufacturer which that manufacturer registers as a trade mark and which he has the exclusive right to use. For example, VIAGRA is Pfizer’s trade mark for the erectile dysfunction drug the generic name of the active moiety for which is sildenafil, but the full chemical name for which moiety is 4-[2-ethoxy-5-(4-methy;piperazin-1-yl)sulfonyl-pheyl]-0-methyl-7-propyl-3,5,8,9-tetrazabicyclo [4.3.0] nona-3,7,10-trien-2-one. Sildenafil has other utilities, and thus REVATIO is Pfizer’s trade mark for the same active moiety, but as formulated and supplied for the treatment of pulmonary arterial hypertension. Once patent protection for sildenafil expires it will be possible for others to trade in sildenafil not of Pfizer’s manufacture, and to call it this, but they will still not be able to use Pfizer’s trade marks for it.”
Pharmaceutical, Biotechnology, and Chemical Inventions: World Protection and Exploitation (Volume II) – Duncan Bucknell
“Generic names
92.6.13 After obtaining a CAS Registry Number, the inventor must apply for a generic name. Multiple organizations standardize generic, non-proprietary drug names through an application process and a naming classification system based on pharmacological or chemical relationships. The American Medical Association (AMA), the United States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA) co-sponsor the US Adopted Names Council, which assigns a United States Adopted Name (USAN) to pharmaceuticals marketed in the United States. The USAN Council works in conjunction with the International Non-proprietary Name Expert Committee of the World Health Organization (WHO), which assigns an International Non-proprietary Name (INN) globally recognized as public property. The USAN and INN and the USAN designations are considered generic per se and cannot be trade marked or otherwise prohibited from being used by competitors. A proposed USAN may be rejected in view of its similarity to existing trade marks. If a proposed USAN is adopted, it is entered into the USP Pharmacopeia Dictionary of USAN and International Drug Names and the CAS database. In the United States, before a new drug application (NDA) can be filed with the FDA, a USAN is required.”

Evergreening Patent Exclusivity in Pharmaceutical Products – Frantzeska Papadopoulou
“2.3.5. The Name of the Product
One of the prerequisites for the commercialisation of a pharmaceutical product is being awarded an appropriate name. The name of the active substance will be the international non-proprietary name (INN) designated by the World Health Organization. Thus, if the active substance does not have a name, the product owner should apply for one from the WHO. The applicant should provide three alternatives to be considered by the consultation committee. The chosen name will be published by the WHO. The name of the active substance may be either an invented name or the name of a chemical substance.”

20. According to Mr. Kaul, the allotment of an INN to FCM by WHO additionally lends credence to the assertion of the appellant of FCM being a novel product and thus liable to be acknowledged as such, irrespective of the description of one of the possible methods of its production in the claimed document.
21. It was further submitted that an identical challenge to the foreign counterpart of FCM before the European Patent Office12 came to be rejected on 14 September 2016. Our attention was drawn to the following conclusions which were arrived at by the EPO in this respect:
“The Opposition Division finds that claim 1 as granted does not extend beyond the content of the application as filed. In the original claim 1 from the parental application (D26) the expression “obtainable from” is used. This expression shows clearly that the subject-matter of the claim and the application is not only a water-soluble iron–carbohydrate-complexes, which have the same essential features (a weight average molecular weight Mw of 80 kDa to 400 kDa and a ligand from oxidation products from maltodextrin) but can be obtained by other processes. The process as described in general in original claim 1 and the description (from page 2, Line 33 to page 7, Line 7) indeed allows to obtain an oxidized maltodextrin at a depolymerisation degree which finally allows to obtain iron(III)-carbohydrate complexes with an weight average molecular weight Mw of 80 kDa to 400 kDa. For a person skilled in the art it is clear that the oxidation method of the maltodextrin is not decisive when the complex has the molecular weight as defined in granted claim 1. There are further processes which a person skilled in the art might apply that also allow for this, as for instance the so-called “TEMPO process” as cited in the application (see page 3, line 33 to page 4, line 5) and as described in D9. The Opposition Division is thus of the opinion that the expression “of thus obtained complexed” on page 7, line 9 does not refer to the entire production process of the complex as described on page4, line 25 to page 7, line 2 in the earlier application (D26) and that the feature “a weight average molecular weight of 80 kDa to 400 kDa) (page 7, lines 9-14) is disclosed separately form this special process and accordingly also separately form the rest of the paragraph (lines 4 to 8). The molecular weight of a compound is clearly a product feature, which characterizes a product and which is not depending on process for production. Even in case that the final product has further features which are depending on the process chosen for maltodextin oxidation directly, it remains that the molecular weight is the indispensable and sufficient feature of the water-soluble iron-oxidized maltodextrin-complex, and that it is thus the essential feature of the invention (see table, comparative examples on page 16). The various product features cited in the paragraph on page 7, lines 4 to 17 do not relate to each other. The process for the production of the complex is not substantial for the invention; the application of the oxidation product of a maltodextrin as lignd and the weight average Mw of the complex are the essential features of the invention (see page, lines 6 to 8, comparative example on page 16, table). Consequently, cancellation of a process feature from claim 1 (“obtainable from …… involved single maltodextrins at 2 to 40”) and replacement by these two product features (“on basis of oxidation products of maltodextrins” and a weight Mw of the complex of 80 kDa to 400 kDa) does not violate the Guidelines H-V 3.1.”
22. Proceeding further along this line the appellants also referred to the examination report drawn by the IPO in the course of the examination process and is dated 10 October 2007 which had cited certain prior arts in support of the objection of lack of novelty and inventive step. Our attention was also drawn to the detailed response dated 19 December 2007 which was submitted by the appellant and which had at that stage itself distinguished each of the cited prior arts on the basis of the novel characteristics of FCM. It was submitted that it was only when the response of the appellants came to be accepted by the IPO that the suit patent came to be granted.
23. Mr. Kaul submitted that under Section 2(1)(j) the Act the word ‘invention’ has been defined to mean a ‘product’ or a ‘process’. Our attention was also invited to Section 48 of the Act and which confers the right upon a patentee to injunct infringers both in respect of a patented product or process. It was the submission of learned senior counsel that a product-by-process is essentially a product claim drafted in a particular style and on account of the difficulty of describing large molecules. It was submitted that notwithstanding the product having been described in fuller detail in process terms, the same would not detract from the product itself being novel and unobvious. It was submitted that product-by-process claims when found to be directed to a product per se would confer a monopoly not merely on the process as disclosed but on the product itself. It was submitted that the guidelines framed in this respect and alluded to hereinabove follow a position identical to that of the EPO and which would be evident from the following guidelines of the EPO:
“4.12 Product-by-process claim
A claim defining a product in terms of a process is to be construed as a claim to the product as such. The technical content of the invention lies not in the process per se, but rather in the technical properties imparted to the product by the process. Claims defining plants or animals produced by a method including a technical step which imparts a technical feature to a product constitute an exception in so far as the requirements of Art. 53(b) as interpreted by Rule 28(2) are concerned. The exclusion under Rule 28(2) regarding plants and animals exclusively obtained by means of an essentially biological process does not apply to patents granted before 1 July 2017 nor to pending patent applications with a filing date and/or a priority date before 1 July 2017.
If a technical feature of a claimed plant or animal, e.g. a single nucleotide exchange in the genome, can be the result of both a technical intervention (e.g. directed mutagenesis) and an essentially biological process (a natural allele), a disclaimer is necessary to delimit the claimed subject-matter to the technically produced product (see examples in G?II, 5.4.2.1 and G?II, 5.4). If, on the other hand, the feature in question can unambiguously be obtained by technical intervention only, e.g. a transgene, no disclaimer is necessary. For the general principles governing disclaimers see H?V, 4.1 and H?V, 4.2.
If the process through which the claimed plant or animal is defined does not impart identifiable and unambiguous technical features to the plant or animal, e.g. the genetic information present in the genome, the claim directed to a plant or animal lacks clarity.
Claims for products defined in terms of a process of manufacture are allowable only if the products as such fulfil the requirements for patentability, ineralia that they are new and inventive, and it is impossible to define the claimed product other than in terms of a process of manufacture. A product is not rendered novel merely by the fact that it is produced by means of a new process. The claim may for instance take the form “Product X obtainable by process Y”. Irrespective of whether the term “obtainable”, “obtained”, “directly obtained” or an equivalent wording is used in the product-by-process claim, it is still directed to the product per se and confers absolute protection upon the product.
As regards novelty, when a product is defined by its method of manufacture, the question to be answered is whether the product under consideration is identical to known products. The burden of proof for an allegedly distinguishing “product-by-process” feature lies with the applicant, who has to provide evidence that the modification of the process parameters results in another product, for example by showing that distinct differences exist in the properties of the products. Nevertheless, the division needs to furnish reasoned argumentation to support the alleged lack of novelty of a product-by-process claim, especially if this objection is contested by the applicant.”

24. It was submitted that the overarching aspect of patentability even if they be placed as product-by-process claims has been universally acknowledged and accepted right from the time when the EPO rendered its decision in International Flavors & Fragrance Inc.13 Reliance was placed on the following passages from that decision:
“7. Inventions fall either into the category of products, e.g. articles, devices or materials, or of processes, e.g. methods of preparing a product, or using an article, or obtaining a result. Nevertheless, the invention defined in the claims for products or for processes must all be novel, inventive and industrially applicable according to Article 52(1). Whilst a process may well be novel and deserves full protection in view of its inventiveness, the same may not be true for its product if that is known or obvious in the light of the state of the art. Notwithstanding this, the special protection provided by Article 64 (2) EPC extends even to products which are not themselves inventions. According to the submissions of the appellants, the protection provided by “product-by-process” claims should go beyond the limits of “direct products” in Article 64(2) and ought to be equal to that enjoyed by products which are claimed per se, with no restriction to the details of their preparation. This, irrespective of the fact that the product protected in this manner may not represent an invention at all, as such.
8. The Guidelines for Examination in the EPO (C.III. 4.7b) allows claims for products defined in terms of a process of manufacture provided the products themselves fulfil the requirements for patentability. This may well be the only way to define certain natural products or macromolecular materials, of unidentified or complex composition which have not yet been defined structurally. Nevertheless, before such claims are allowable their patentability as products must be established since such definition is in lieu of the normal definition by structure.
9. The appellants referred to German law in this respect and alleged that product-by-process claims had also been validly granted in cases where the product itself was not patentable. The evidence submitted in this respect by Dr. Goddar refers to Benkard 7. Ed. page 353 and 355. It is clear that the statements there relate to the question of direct product protection for processes under §9(2)(3) of the Patent Law which is analogous to Article 64(2) EPC. It is apparent that the submitted Opinion is silent about the more relevant entries in the same textbook (e.g. Benkard, 7. Ed. §1.14 on page 124, 86 on pages 158 and 159, and 88(dc) on page 159) where it is clearly indicated that a claim to a patentable product is allowable as long as neither the structure nor the physical characteristics of the material are known. This is based on the appropriate decisions of the Supreme Court and the Federal Patent Court (“Trioxan” B1PMZ, 1971, 73, pp. 374-33; BPatGE-20, pp. 20-25, 1 BGHZ 57,1.). There is no suggestion in the attached documents that unpatentable products could be expressly claimed in this manner.
10. An earlier decision of the Board already established that “the effect of a process manifests itself in the result, i.e. in the product in chemical cases, together with all its internal characteristics and the consequence of its origin, e.g. quality, yield and economic value”. (“Gelation/Exxon” T 119/82, 12.12.1983). Although problems may be recognised in processes known in the state of the art which are then removed by appropriate modifications or by an altogether different approach, the effect of such measures en route ultimately manifests itself in the technical and economic characteristics of the product, the real purpose of the exercise. Whilst some features of such end-effects may be drawn into the definition of the process for reasons of clarity and of conciseness, the product is in consequence of the invention, without being the invention itself, which is rather the novel interaction represented by the process in such cases. Any attempt to claim the in itself non-inventive product by means of product-by-process claims is claiming the mere effects instead. Whilst reliance on the provisions on Article 64(2) EPC may nevertheless provide protection beyond the invention in processes leading to known or patentable products alike, this should not be afforded for both kinds of product themselves on the same footing, irrespective of their character. This must therefore be rejected as unjustified and contrary to the requirements of Article 52 (1) and 84 EPC. The Board takes the view that in order to minimise uncertainty, the form for a claim to a patentable product as such defined in terms of a process of manufacture (i.e. “product-by- process claims”), should be reserved for cases where the product cannot be satisfactorily defined by reference to its composition, structure or some other test- able parameters.
11. The Board has seriously considered the well known fact that both “omnibus” and “product-by-process” claims were commonly admitted in the United Kingdom, one of the member states of the Convention. Nevertheless, it is also important to note that in no other member state have they gained acceptance beyond a manner of claiming structurally undefinable product inventions, and there appears to be no room under the Articles or Rules of the Convention to admit such claims on the basis of practice in a single Contracting State. Since the appeal is unsuccessful as regards the issues under con- sideration, the refund of the appeal fee must be rejected.”
25. Mr. Kaul further submitted that a selective and partial consideration of the decisions rendered by the House of Lords in Kirin Amgen, and the High Court of England and Wales in Hospira UK Limited has led the learned Judge to erroneously hold that product-by-process claims were recognized or held to be limited by process terms. Mr. Kaul submitted that the learned Judge failed to appreciate the observations as rendered in Kirin Amgen wherein it was held that where a product is identical to one which is known, the mere adoption of a new process of manufacture would not confer novelty on it. It was submitted that the House of Lords had clearly held that if a product were known and not novel it would clearly not be entitled to patent protection. It was submitted that the learned Judge also failed to appreciate the accepted distinction which is recognized to exist between the phrases “obtained by” on the one hand and “obtainable by” or “obtainable from” and which was even acknowledged in Kirin Amgen and Hospira UK Limited. It was submitted that the conclusion ultimately arrived at by the learned Judge also failed to bear in mind that in both Kirin Amgen and Hospira UK Limited. the product in question were already known in the prior art. This was submitted in the context of the erythropoietin hormone in Kirin Amgen being found to be naturally occurring and Trastuzumab in Hospira UK Limited being already known. It is in the aforesaid backdrop that Mr. Kaul had urged that the learned Judge has clearly erred in holding that product-by-process claims have been held to be limited by process terms in the decision of Kirin Amgen and Hospira UK Limited.
26. It was then submitted that the aspect of limitation and which appears to have found favour with the learned Judge essentially flows from the findings returned by the majority in Abbott Laboratories. The decision of the Federal Court was assailed and criticized on various grounds. It was firstly submitted that the holding in Scripps Clinic Research Foundation vs. Genentech Inc Scripps Clinic & Research Foundation14 had held the field till it came to be departed from in Atlantic Thermoplastics. It was submitted that the learned Judge has rested her conclusions relating to the scope and ambit of product-by-process claims on an en banc ruling of a divided Federal Court. It was submitted that out of a Bench comprising of eleven justices, a scathing minority opinion came to be penned by three members of the Bench. It was urged that a reading of the minority opinion would unerringly point towards the en banc Court ignoring settled and binding precedent. It was the submission of Mr. Kaul that the en banc Court ruling in Abbott Laboratories had overruled a century worth of precedent and propounded a novel rule of process terms acting as limitations when viewed in the context of infringement actions. According to Mr. Kaul if patentability be an inviolable feature of a valid patent granted under the Act, there would exist no justification to draw a distinction between patentability and infringement. According to learned senior counsel, the test of invention and novelty would apply with equal force to both actions, namely, a challenge to validity as well as one for infringement.
27. The primary challenge which the appellants raised against the impugned order was also based on the assertion that the learned Single Judge had visibly failed to either notice or deal with its submissions relating to the novelty of FCM and the inventive qualities of that product especially when the same had never been questioned or assailed by the respondents. It was submitted by Mr. Kaul that in the entire judgment the learned Single Judge has abjectly failed to consider whether FCM was known in the prior art. It was submitted that quite apart from the fact that a dispute in that respect having never been raised by the respondents, the prior art which was cited on their behalf in the three suits carried no whisper of FCM. Reliance in this respect was also sought to be placed upon what was ascribed to be a clear admission on the part of MSN Laboratories and as reflected from the recordal of facts by the learned Judge in para 21:-
“21. By virtue of provision of Section 48 of the 1970 Act, upon grant of IN’536, Vifor has acquired exclusive right to prevent third parties, who do not have its consent, from using, making, offering for sale or importing and selling the product FCM, which is protected by IN’536 or the product obtained directly from the process protected by IN’536 in India. FCM is a product covered directly under IN’536 and has definite and unique characteristic features, such as average molecular weight between 80 kDa and 400 kDa and manufacture by any unauthorized entity of a product which exhibits the same characteristics, would amount to infringement of IN’536, by virtue of Section 48 of the 1970 Act. Defendant No.1/MSN in CS(COMM) 261/2021 is manufacturing the product FCM protected by IN’536, which is evident from its Patent Application No.201841012945. MSN’s patent application mentions US patent corresponding to IN’536 as the earliest literature where FCM was disclosed and MSN has also sought approval from Indian Authorities for building capacity to manufacture large quantities of FCM. Evidently, this is being undertaken with the aim of launching an infringing version of FCM in the near future, albeit Vifor has already filed pre-grant opposition to the patent application of MSN. As can be seen from the website of the Defendant, MSN’s product under the brand FEINJ is FCM, a water-soluble iron carbohydrate complex with a molecular weight of approximately 150 kDa, which is between 80 kDa and 400 kDa.”

28. It was pointed out by learned counsels that MSN Laboratories had throughout conceded and admitted to manufacturing FCM, a fact which is evident from its own patent application. It was submitted that the said patent application itself referred to the US patent corresponding to IN’536 as the earliest literature where FCM was disclosed. It was submitted that the learned Single Judge has committed a manifest illegality in proceeding on the basis that the invention resided in the use of iron carbohydrate complexes which were already known. Our attention was specifically drawn to para 71 in this respect. Both Mr. Kaul and Mr. Anand vehemently submitted that iron carbohydrate complexes are not FCM. It was their submission that similarly hydroxide sucrose complexes are also not FCM. It was their contention that the learned Single Judge failed to bear in mind that the invention was claimed in FCM which was undisputedly a novel product and which had ultimately led to it being accorded an INN. It was submitted that FCM is a complex macromolecule capable of being described only by the way in which it was made. It was the contention of the appellant that a reading of the claims would indicate that the invention was a water-soluble iron carbohydrate complex having the following essential features: (a) an iron (III) core; (b) an oxidized maltodextrin as ligand; and (c) average molecular weight in the range of 80-400 kDa.
29. We were apprised that the priority application in respect of the suit patent was filed on 23 October 2002. This was followed by the filing of the Patent Cooperation Treaty15 application on 20 October 2003. It was submitted that while the appellant was conscious of the invention of a new product, on the date when it filed its patent application, it was impossible for it to describe the product without referring to the process used for its manufacture. However, according to the appellant, this would clearly not diminish from FCM being accepted and acknowledged as a product per se. For the purposes of novelty, reliance was also placed on the International Preliminary Examination Report drawn by the World Intellectual Property Organization16 the relevant extract whereof reads as follows:
“In light of the documents cited in the international search report, it is considered that the invention as defined in the claims meets the criteria mentioned in Article 33(1) PCT, i.e., it appears to be novel and to involve an inventive step.”

30. It was submitted that it was only thereafter that the appellant commenced clinical trials and approached the WHO for the assignment of an INN. The INN FCM was thereafter assigned to the appellants in March 2008. Without prejudice to the above, the appellants submitted that the stand as struck by the respondents is clearly contradictory when one views the information of MSN Laboratories which itself acknowledges and admits that the product proposed to be manufactured by it was a FCM injection. It was additionally pointed out that the patent application of MSN Laboratories itself not only discloses that its proposed product was FCM an iron replacement product in para 10, it also makes an unabashed reference to the corresponding US patent of the appellant being US patent no. 7612109 B2. Paras 10 and 25 of MSN Laboratories’ patent application are reproduced hereunder:
“10. Ferric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III) hydroxide 4(R)-(poly-(1-4)-O- -a-D-glucopyranosyl)-oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate. The relative molecular weight is approximately 150 000 Da.

xxxx xxxx xxxx

25. US Patent No. 7612109 B2 herein after referred as “US’109” discloses Water-soluble iron carbohydrate complexes (ferric carboxymaltose complexes) obtainable from an aqueous solution of an iron (III) salt, preferably iron (III) chloride, and an aqueous solution of the oxidation product of one or more maltodextrins using an aqueous hypochlorite solution.”

31. The appellants on facts also questioned the stand of the respondents who had contended that since they were using a different oxidising agent the allegation of infringement would not be made out. It was submitted in this regard that the respondents have sought to incorrectly convey the impression that the use of an oxidising agent was the inventive characteristic of FCM. This according to the appellants is a submission addressed in ignorance of Claim 1 using the expression “obtainable from”. Our attention was also drawn to line 25 of the specifications of the suit patent where the appellant had clearly accepted and acknowledged that it would be possible to use any other oxidation system. It was in the aforesaid backdrop that learned counsels argued that the mere tweaking of the manufacturing process and substituting the oxidising agent would not absolve the respondents from the allegation of infringement.
32. The appellants also questioned the arguments advanced by the respondents and revolving around the DE value of FCM. It was pointed out that some of the respondents had urged that since the DE value of maltodextrin had been clearly specified, a product which obtained a DE value outside the range defined by the appellant would constitute evidence of the product not being infringing. It was pointed out to us that Corona Remedies had admitted that they used starched hydrolysis products with a DE value of 25-27 as the carbohydrate ligand and not oxidized maltodextrins. It was on this basis that Corona Remedies had claimed that their final product would not fall within the scope of Claim 1 of the suit patent. It was submitted that if this position were treated to be correct then Corona Remedies could not possibly title its product as being FCM.
33. We were informed that the appellants had placed voluminous technical literature before the learned Single Judge and which had established that maltodextrins could have a DE value upto 96. It was submitted that Claim 1 of the suit patent itself had spoken of maltodextrins of upto a DE value of 40 being possible. It was in the aforesaid backdrop that Mr. Kaul contended that the learned Judge has clearly erred in proceeding on the premise that maltodextrins with a DE value range of 2-20 was an essential facet of the process of manufacturing FCM. The findings in this respect were additionally assailed on the basis of the U.S. Markman Hearing order in which maltodextrins were accepted as being unbound by a DE value limitation. The relevant extracts of the aforesaid order are reproduced hereinbelow:
“IT IS this 28th day of June, 2021, ORDERED and DECLARED that the Disputed Claim Terms are construed as follows:
Disputed Claim Term
Construction
“maltodextrin”
“a mixture of saccharides of variable length composed of chains of D-glucose units connected primarily by ? (1?4) glycosidic bonds”

34. The principal bone of contention before the learned Single Judge clearly appears to have been the scope and extent of product-by-process claims and the principles deducible from the decisions in Kirin Amgen, Hospira UK Limited and Abbott Laboratories. Insofar as Abbott Laboratories is concerned while the respondents sought to draw sustenance from the judgment rendered by the majority of the Court, the appellants had commended for the consideration of the learned Single Judge the view as expressed by the minority. The reliance on the aforenoted foreign precedents a