Calcutta High Court
West Bengal Chemical Industries ... vs M/S. Gtz (India) Pvt. Ltd. & Ors on 25 June, 2024
IN THE HIGH COURT AT CALCUTTA
(Ordinary Original Civil Jurisdiction)
COMMERCIAL DIVISION
Present:
The Hon'ble Justice Krishna Rao
IA No. GA 1 of 2023
In
CS-COM 513 of 2024
(Old No. CS 116 of 2023)
West Bengal Chemical Industries Limited
Versus
M/s. GTZ (INDIA) Pvt. Ltd. & Ors.
Mr. Sarosij Dasgupta
Mr. Saunak Sarbajna
... For the petitioner.
Mr. Abhrajit Mitra, Sr. Adv.
Mr. Sayan Roychowdhury
Mr. Tanmoy Roy
Mr. Soumen Mukherjee
Mr. Aniket Chowdhury
... For the respondent no. 1.
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Hearing Concluded On : 08.04.2024
Judgment on : 25.06.2024
Krishna Rao, J.:
1. The petitioner is engaged in manufacturing and trading of Active Pharmaceutical Ingredients (herein after referred to as "API") and various organic chemicals since 1988. The petitioner being API Pharmaceutical manufacturing company which researches, produces, develops and markets its own pharmaceutical products and is focused on finding new pharmaceutical solutions and delivering high quality products, driving scientific excellence through its R&D and helping the people through its exports around the world.
2. In the present day, the petitioner has innovated treatments for Iron deficiency and Iron deficiency anemia through its innovative R&D in order to help the patients around the world suffering from severe and chronic diseases to lead better and healthier life. The petitioner's invention was granted patent being no. IN370845. The petitioner is the owner of the registered Indian Patent where FERRIC CARBOXYMALTOSE is protected under the said patent. The petitioner has also applied for a new invention which is an improved version of their mother patent, i.e. IN370845 as described with an application No. 20223302884 which is an 'IMPROVED FERRIC CARBOXYMALTOSE WITH LESS SIDE - EFFECTS OBTAINED COST - EFFECTIVELY.' Such patent was granted to the petitioner on 13th June, 2023 being patent No. 434424.
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3. The advantages associated with the petitioner's company inventions being IN370485 and IN434424 both of which are product by process patent and an Iron Replacement Therapy with low toxicity compared to the other therapies of the same footing. The petitioner had filed the granted specifications along with the claims of the suit patent before the Controller of Patent and after examining the same and being satisfied with the invention of the petitioner granted the said patents to the petitioner. The granted claim four of improved product by process for preparation of Ferric Carboxymaltose which has been granted to the petitioner being patent No. IN370845 is a product by process patent affirms that the petitioner has right as a patentee on a pharmaceutical composition for the treatment of iron deficiency by parental administration comprising more than 90% Ferric Carboxymaltose prepared by process as claimed in claim 1 having molecular weight of 82KDA with Iron content 34.55% and less than 10% Ferric Carboxymaltose component having molecular weight less than 10,000Da" and further the patent of addition to the said granted mother patent of the petitioner i.e. improved Ferric Carboxymaltose with less side effects obtained cost effectively which has been granted to the petitioner being patent no. IN434424 is also a product by process patent affirms that the petitioner has their right as a patentee over such granted patents.
4. The petitioner claims that the pharmaceutical composition is considered to be novel having the following characteristics: 4
a. Having molecular weight of 82KDA;
b. Iron content 34.55%; and
c. Less than 10% Ferric Carboxyl complex
molecular weight less than 10,000 D.a.
5. The petitioner reiterates that it had undertaken extensive R&D to develop novel "FERRIC CABOXYMALTOSE" improved in terms of efficacy and yield/purity produced by a novel and a cost-effective process and it has recently received approval for manufacturing and marketing of its novel and improved efficient "FERRIC CARBOXYMALTOSE" from the Drug Control on 18th November, 2021.
6. Sometimes on or around 12th December, 2022, the petitioner came to know that the Respondents have published a brochure wherein the Respondents had mentioned their product of similar nature, in or around the same time, the Respondent No.4, i.e. Mr. Atanu Ghosh, with the intention of selling the products manufactured by the respondent no.1, approached Abihakem International, who apparently shares years long business relationship with the petitioner. The respondent no.4 had vividly mentioned about a product namely Ferric Carboxy Maltose, which is a patented product of the petitioner. The authority concerned of Abihakem International informed the petitioner regarding such activity of the respondents which infringes the patent of the petitioner and with the intention to sell the infringing product in the market which would not only cause infringement of the patent but will also cause huge irreparable damage to the petitioner and the respondents in 5 their brochure have clearly mentioned the list of API including FERRIC CARBOXYMALTOSE.
7. The respondent no.4 was an Ex-employee of the petitioner company, the respondent no.5, was also an erstwhile employee of the petitioner and was deputed in the R&D section of the Petitioner Company, the respondent no.6 and the respondent no.8 were also employees of the petitioner company and was deputed in the Q&A section, and lastly the respondent no.7 is an ex-employee of the petitioner company and was posted in the purchase department of the petitioner company.
8. Learned Counsel for the petitioner submitted that any other party apart from the patentee himself or his lawful licensees or assignees does not have the right to exploit the patented process and /or manufacture the product having sameness with the product as has been claimed in claim no.4 of the patent Nos. IN370845 and IN434424. He submits that petitioner's suit patent is valid and subsisting from 31st March, 2017 in India and other patent of the petitioner being IN434424 has been granted to the petitioner on 13th June, 2023 while application filed in respect of the mother Suit Patent No. IN370845 under Section 11A of the Patents Act, 1970 was published on 5th May, 2017, no pre grant or post grant opposition was ever filed challenging this patent. The Suit patent IN370845 have been granted in favour of the petitioner in India on 30th June, 2021 and IN434424 have been granted to the petitioner on 13th June, 2023.
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9. The petitioner says that the respondents had no investments in the R&D and have simply published followed the published document to derive the improved FERRIC CARBOXYMALTOSE and IMPROVED FERRIC CARBOXYMALTOSE WITH LESS SIDE -EFFECTS OBTAINED COST EFFECTIVELY and with the malafide intention to hamper the enthusiasm and create financial disruptions to the innovator R&D investments. The petitioner has issued a legal notice to the respondents calling upon the respondents to refrain from continuing such illegal acts. On receipt of the notice, initially, the respondent requested the petitioner to allow one month time to give proper reply to the desist notice but the petitioner refused to grant time and on 2nd March, 2023, the respondents sent reply denying all the assertions and accepted that they are manufacturing and/or trading of various products including FERRIC CARBOXYMALTOSE based product, which they every lawful right to do so, although the respondents are not patentee and the respondents had accepted the same in the said letter.
10. The petitioner says that the respondents had adopted impugned process for the preparation of FERRIC CARBOXYMALTOSE and IMPROVED FERRIC CARBOXYMALTOSE WITH LESS SIDE EFFECTS OBTAINED COST EFFECTIVELY which are same as that of the petitioner which violates the process for preparation of FERRIC CARBOXYMALTOSE granted under the Patent No. IN 370845 and the process for preparation of IMPROVED FERRIC CARBOXYMALTOSE WITH LESS SIDE-EFFECTS OBTAINED COST EFFECTIVELY granted 7 under the Patent No. IN434424 to the petitioner and the same is dishonest abinitio.
11. The petitioner says that the unauthorized manufacture and commercialization of the said infringing product by respondents have been affecting the business of the petitioner wherein incurring huge loss of two crores and above which cannot be calculated in monetary terms unless and until full and final disclosures are made by the respondents.
12. The petitioner says that by virtue of grant of Patent No. IN370845 and IN434424, the petitioner under Section 48 of the Patents Act, 1970 has the exclusive right to prevent others from using, making, selling, offering for sale and/or importing for those purposes the product protected by the said Patent and also has the right to prevent others from using the process protected by the said Patent from using, offering for sale, selling or importing from those purposes a product obtained directly from the purposes by the said patent. He submits that the petitioner patent is a product by process patent hence it includes both the products and process simultaneously.
13. Learned Counsel for the petitioner relied upon the judgment reported in MANU/DE/2777/2023 (Vifor (International) Ltd. and Ors. -vs- J.B. Chemicals and Pharmaceuticals Limited) and submitted that in the said case also the plaintiff has prayed for interim relief and the Delhi High Court has granted interim relief to the petitioner. 8
14. Learned Counsel for the respondents submits that the respondent no.1 was established in the year 1973 and from 1985 has been into manufacturing Industrial Chemicals. The respondent no.1 has been marketing their products not only in India, but also in various countries in the world. The respondent no.1 has decided to expand their operation in Pharmaceutical Sector and intended to start manufacturing, selling and/or trading in Active Pharmaceutical Ingredients (API) as well as final pharmaceutical products derived therefrom including but not limited to Ferric Carboxymaltose, Iron Isomaltoside, Ferric Derisomaltose, Iron(III) Hydroxide Polymaltose, Ferric Maltol, Methylfolate Nicoraldil etc.
15. The respondents say that on receipt of the legal notice from the petitioner, the respondent no.1 has examined the Patent No. IN370845 which appears to be frivolous, and is not an invention which has been granted by the concerned authorities without proper application of mind and in violation of various established proposition of patent law, which is not tenable in a judicial review process. He submits that it has also been found that the Patent IN370845 does not protect the product "Ferric Carboxymaltose" per se.
16. The respondent says that Patent No. IN370845 relates to a Process of Preparation of Ferric Carboxymaltose (FCM), which is a known iron complex that consists of a ferric hydroxide core stabilized by a carbohydrate shell, which allows for control delivery of Iron to target tissues. It is submitted that several companies manufacture and sell 9 Ferric Carboxymaltose as the Active Pharmaceutical Ingredient (API) and/or injectable formulation of API Ferric Carboxymaltose. The names of such manufacturers include but are not limited to Dr. Reddy's Laboratories, Global Calcium, Weefsel pharma, Trumac Health Care, Kavya Pharma, Medzeel Life Sciences etc.
17. The respondents say that Ferric Carboxymaltose is not a novel product and has also been unequivocally acknowledged by the petitioner in their "written submission" dated 16th June, 2021 before the Patent Authorities in respect of patent no. IN370845. He submits that as Ferric Carboxymaltose is a known compound, any product per se claim thereon in any patent is devoid of novelty and the petitioner do not and cannot have any patent right or monopoly over the same.
18. The respondents say that the claims of both the patents do not involve any inventive step, having regard to what was publicly known or publicly used in India or what was published in India or elsewhere before the priority date of the claim and Section 2(1)(ja) of the Patents Act,1970 defines "Inventive Steps." The complete specifications of both the patents do not sufficiently and fairly describe the invention and the method by which it is to be performed, that is to say, that the description of the method or the instructions for the working of invention as contained in the complete specifications are not by themselves sufficient to enable a person in India possessing average skill in, and average knowledge of, the art to which the invention relates, to work the invention, and/ or that they do not disclose the best 10 method of performing the same which was known to the applicant for the patents and for which he was entitled to claim protection.
19. The respondent says that the claims of the impugned patent are not supported by the specification. The statement in claim 4 does not have any support whatsoever in the specification. Claim 4 of the impugned patent directed to a "Product by Process" claim. i.e. a claim to a pharmaceutical composition of ferric carboxymaltose produced by a process of claims 1-3, is not allowable in India as 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. He submits that in other words the product must qualify for novelty and inventive step irrespective of novelty or inventive step of the process.
20. The respondents says that the claim 4 of the impugned patent No. IN 370845 is not patentable under the provision of Section 3(e) of the Patents Act, 1970 as it defines a single component ferric carboxymaltose composition for parenteral application. He submits that the Patent No. IN 370845 are also not patentable under the provisions of Section 3(d) of the Patents Act, 1970 as it fails to disclose any improved efficacy of the claimed Ferric Carboxymaltose Composition over known ferric carboxymaltose and the process of manufacturing thereof is mere use of a known process.
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21. The respondents say that the claims as claimed in Patent no. IN 434424 cannot and could not be granted as the ferric carboxymaltose complex/ composition claimed in 1-6 of the claim of the said patent is not novel and is well known to the public and also from claim 4 of the main patent no. IN 370845. He submits that the modification contemplated in the Patent No. IN 434424 over the main patent 370845 is only in the oxidation steps of maltodextrin. Oxidation of maltodextrin was carried out by using citric acid in 370845, the said oxidation in 434424 is carried by using ozone gas, which is a colourable imitation based on common general knowledge.
22. The respondents says that the 'Pharmaceutical Composition' of claim 1 of 434424, in a product by process format, is nowhere supported in the specification either in the descriptive part or in the working examples of 'preparation of ferric carboxymaltose'.
23. The said Ferric Carboxymaltose is not a novel product, since it is a known compound, it is also a widely known fact that the general process of preparation of ferric carboxymaltose consists of reacting ferric salt such as ferric hydroxide and oxidised maltodextrin. The patents claimed by the petitioner does not involve any inventive steps, having regard to what was publicly known or publicly used in India.
24. Each and every step of claim 1 of the impugned patent 370845 is known from the published documents. Particularly, iron salt can be encapsulated in maltodextrin and stabilized by citric acid in infant milk 12 formulation for oral delivery of iron for iron deficiency treatment is known from the Article- Iron Absorption from Two Milk Formulas Fortified with Iron Sulfate Stabilized with Maltodextrin and Citric Acid by Fernando Pizarro, Manuel Olivares, Eugenia Maciero, Gustavo Krasnoff, Nicolas Cócaro and Diego Gaitan, in the journal Nutrients 2015, 7, 8952-8959; which was received: 12 August 2015; Accepted: 19 October 2015; Published: 30 October 2015 i.e. prior to the filing date of the impugned patent.
25. The respondent further submits that the reaction of FeCls and NaOH although is not supported anywhere in the specification, the said reaction to produce ferric hydroxide is even known to elementary chemistry students. In the impugned claim 1 of patent 370845 Petitioner has claimed to use only a new cross-linking agent for maltodextrin viz. citric acid. I say that selection of citric acid as cross- linking agent of maltodextrin is devoid of any uniqueness, as cross- linkage of various starches including maltodextrin is very well known long before the impugned invention was conceptualized sometime in 2017 inter alia at least from the article Thermal Crosslinking of Maltodextrin and Citric Acid. Methodology to Control the Polycondensation Reaction under Processing Conditions published in Polymers & Polymer Composites, Vol. 24, No. 8, 2016 and the reaction scheme of claim 1 of 370845 of oxidizing maltodextrin with citric acid and reacting the oxidized maltodextrin with ferric hydroxide to produce ferric carboxymaltose, is not workable as citric acid is in fact a reducing 13 agent and not an oxidizing agent as falsely claimed, and therefore no oxidation of maltodextrin is possible.
26. Under the above mentioned circumstances, the respondent no.1 has initiated an application/petition for revocation against patent Nos. 370845 and 434424, before this Court on 17th May, 2023 and 13th June, 2023 subsequently, being I.P.D.P.T.A. 115 of 2023 and I.P.D.P.T.A. 35 of 2023.
27. Learned Counsel for the respondent in support of his cases has relied upon the following judgments:
i. Vifor (International) Limited & Anr. v. MSN Laboratories Pvt. Ltd. & Anr., reported in FAO(OS) (COMM) 159/2023 & CM APPL. 39177/2023.
ii. Bistol-Myers Squibb Holdings Ireland v. Mylan Laboratories Limited reported in MANU/AP/1932/2014.
iii. Vifor (Internation) Ltd. and Ors. v. J.B. Chemicals and Pharmaceuticals Limited reported in MANU/DE/2777/2023.
iv. Sandeep Jaidka v. Mukesh Mittal and Ors.
reported in MANU/DE/1157/2014.
v. Franz Xaver Huemer v. New Yash Engineers reported in MANU/DE/--15/1997.
vi. TVS motor Company Limited v. Bajaj Auto Limited reported in MANU/TN/0976/2009.
14vii. Garware-Wall Ropes Ltd. v. Techfab India ad Ors.
reported in MANU/GJ/0272/2008.
viii. Boots Pure Drug Co. (India) Ltd. v. May & Baker, Ltd. reported in MANU/WB/0212/1947.
ix. Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries reported in MANU/SC/0255/1978.
x. Bayer Healthcare LLC v. NACTO Pharma Limited reported in CS (COMM) 343/2019 & I.As.
8878/2019, 9685/2019, 1178/2022 and Bayer Healthcare LLC v. MSN Laboratories Private Limited reported in CS (COMM) 660/2022 & I.As.
15573/2022, 15574/2022, 1432/2023,
1848/2023.
28. To decide the issue whether the plaintiff is entitled to get an order of injunction, the following provisions of the Patents Act, 1970 are relevant:
"Section 2(1), Definitions and interpretation.--
(j), "invention" means a new product or process involving an inventive step and capable of industrial application;
(ja)"inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art;
(o) "patented article" and "patented process" means respectively an article or process in respect of which a patent is in force;
Section 3, What are not inventions.-
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d), the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation.--For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;
(e), a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance;
Section 10, Contents of specifications.-- (4) Every complete specification shall--
(a) fully and particularly describe the invention and its operation or use and the method by which it is to be performed;
(b) disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection; and
(c) end with a claim or claims defining the scope of the invention for which protection is claimed;
(d) be accompanied by an abstract to provide technical information on the invention: Provided that--
(i) the Controller may amend the abstract for providing better information to third parties; and 16
(ii) if the applicant mentions a biological material in the specification which may not be described in such a way as to satisfy clauses (a) and (b), and if such material is not available to the public, the application shall be completed by depositing the material to an international depository authority under the Budapest Treaty and by fulfilling the following conditions, namely:--
(A) the deposit of the material shall be made not later than the date of filing the patent application in India and a reference thereof shall be made in the specification within the prescribed period;
(B) all the available characteristics of the material required for it to be correctly identified or indicated are included in the specification including the name, address of the depository institution and the date and number of the deposit of the material at the institution;
(C) access to the material is available in the depository institution only after the date of the application of patent in India or if a priority is claimed after the date of the priority; (D) disclose the source and geographical origin of the biological material in the specification, when used in an invention.
Section 13, Search for anticipation by previous publication and by prior claim.--
(4) The examination and investigations required under section 12 and this section shall not be deemed in any way to warrant the validity of any patent, and no liability shall be incurred by the Central Government or any officer thereof by reason of, or in connection with, any such examination or investigation or any report or other proceedings consequent thereon.17
Section 25, Opposition to the patent -
(d) that the invention so far as claimed in any claim of the complete specification was publicly known or publicly used in India before the priority date of that claim. Explanation.--For the purposes of this clause, an invention relating to a process for which a patent is claimed shall be deemed to have been publicly known or publicly used in India before the priority date of the claim if a product made by that process had already been imported into India before that date except where such importation has been for the purpose of reasonable trial or experiment only;
Section 48, Rights of patentees.--Subject to the 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 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.
Section 64, Revocation of patents.--
(1) Subject to the provisions contained in this Act, a patent, whether granted before or after the commencement of this Act, may, be revoked on a petition of any person interested or of the Central Government by the Appellate Board or on a counter-claim in a suit for infringement of the 18 patent by the High Court on any of the following grounds , that is to say--
(a) that the invention, so far as claimed in any claim of the complete specification, was claimed in a valid claim of earlier priority date contained in the complete specification of another patent granted in India;
(b) that the patent was granted on the application of a person not entitled under the provisions of this Act to apply therefor:
(c) that the patent was obtained wrongfully in contravention of the rights of the petitioner or any person under or through whom he claims;
(d) that the subject of any claim of the complete specification is not an invention within the meaning of this Act;
(e) that the invention so far as claimed in any claim of the complete specification is not new, having regard to what was publicly known or publicly used in India before the priority date of the claim or to what was published in India or elsewhere in any of the, documents referred to in section 13:
(f) that the invention so far as claimed in any claim of the complete specification is obvious or does not involve any inventive step, having regard to what was publicly known or publicly used in India or what was published in India or elsewhere before the priority date of the claim:
(g) that the invention, so far as claimed in any claim of the complete specification, is not useful;
(h) that the complete specification does not sufficiently and fairly describe the invention and the method by which it is to be performed, that is to say, that the description of the method or the 19 instructions for the working of the invention as contained in the complete specification are not by themselves sufficient to enable a person in India possessing average skill in, and average knowledge of, the art to which the invention relates, to work the invention, or that it does not disclose the best method of performing it which was known to the applicant for the patent and for which he was entitled to claim protection;
(i) that the scope of any claim of the complete specification is not sufficiently and clearly defined or that any claim of the complete specification is not fairly based on the matter disclosed in the specification;
(j) that the patent was obtained on a false suggestion or representation;
(k) that the subject of any claim of the complete specification is not patentable under this Act;
(l) that the invention so far as claimed in any claim of the complete specification was secretly used in India, otherwise than as mentioned in sub-section (3), before the priority date of the claim;
(m) that the applicant for the patent has failed to disclose to the Controller the information required by section 8 or has furnished information which in any material particular was false to his knowledge;
(n) that the applicant contravened any direction for secrecy passed under section 35 or made or caused to be made an application for the grant of a patent outside India in contravention of section 39;
(o) that leave to amend the complete specification under section 57 or section 58 was obtained by fraud.20
(p) that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention;
(q) that the invention so far as claimed in any claim of the complete specification was anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere.
(2) For the purposes of clauses (e) and (f) of sub-
section (1)--,
(a) no account shall be taken of personal document or secret trial or secret use; and
(b) where the patent is for a process or for a product as made by a process described or claimed, the importation into India of the product made abroad by that process shall constitute knowledge or use in India of the invention on the date of the importation, except where such importation has been for the purpose of reasonable trial or experiment only.
(3) For the purpose of clause (1) of sub-section (1), no account shall be taken of any use of the invention--
(a) for the purpose of reasonable trial or experiment only; or;
(b) by the Government or by any person authorised by the Government or by a Government undertaking, in consequence of the applicant for the patent or any person from whom he derives title having communicated or disclosed the invention directly or indirectly to the Government or person authorised as aforesaid or to the Government undertaking; or 21
(c) by any other person, in consequence of the applicant for the patent or any person from whom he derives title having communicated or disclosed the invention, and without the consent or acquiescence of the applicant or of any person from whom he derives title.
(4) Without prejudice to the provisions contained in sub-section (1), a patent may be revoked by the High Court on the petition of the Central Government, if the High Court is satisfied that the patentee has without reasonable cause failed to comply with the request of the Central Government to make, use or exercise the patented invention for the purposes of Government within the meaning of section 99 upon reasonable terms.
(5) A notice of any petition for revocation of a patent under this section shall be served on all persons appearing from the register to be proprietors of that patent or to have shares or interests therein and it shall not be necessary to serve a notice on any other person.
Section 146, Power of Controller to call for information from patentees.--
(1) The Controller may, at any time during the continuance of the patent, by notice in writing, require a patentee or a licensee, exclusive or otherwise, to furnish to him within two months from the date of such notice or within such further time as the Controller may allow, such information or such periodical statements as to the extent to which the patented invention has been commercially worked in India as may be specified in the notice.
(2) Without prejudice to the provisions of sub- section (1), every patentee and every licensee (whether exclusive or otherwise) shall furnish in such manner and form and at such intervals (not being less than six months) as may be prescribed statements as to the extent to which the patented 22 invention has been worked on a commercial scale in India.
(3) The Controller may publish the information received by him under subsection (1) or sub section (2) in such manner as may be prescribed."
29. The following principles applicable to consideration of an application seeking interim injunction:
a. Section 107 of the Patents Act, 1970 provides that in any suit for infringement of a patent, every ground on which the patent may be revoked under Section 64 of the Act shall be available as a ground for defence.
b. The fact that the patent is old, that is, granted a long time back, and/or that there was no challenge to the same prior to its grant or thereafter, are not relevant circumstances. There is no presumption on the validity of the patent.
c. The defendant, in opposition to the prayer for interim relief made by the plaintiff, is only to show vulnerability of the patent in question. The defendant is not to prove actual invalidity of the patent.
30. The first invention of the plaintiff was "Improved process for preparation of Ferric Carboxymaltose".
Field of the invention was relates to improved, cost effective process for preparation of water soluble ferric carboxy maltose with reduced impurity suitable for preparation of medicament without involving further purification.
The background of invention was:
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Ferric carboxymaltose is a stable, non- dextran iron complex of ferric hydroxide core stabilized by a carbohydrate shell, Ferric Carboxymaltose is commercially available in market under the brand name Ferinject® and is administered intravenously in single dosses to treat iron deficiency anemia.
US2006/0205691 discloses a process for water soluble iron-
carbohydrate complexes comprising reacting aqueous solution of iron (III) salt and aqueous solution of one or more oxidation products of maltodextrin. The oxidation of maltodextrin is carried out using aqueous hypochlorite solution at a pII-value within the alkaline range.
The drawback of the process is that it involves the use of large amount of toxic ferric chloride and sodium carbonate generating a large quantity of undesired sodium chloride and unacceptable impurities of sodium carbonate resulting in poor quality of iron (III)-carbohydrate complex.
US20120214986 discloses a process for preparation of iron (III) carboxymaltose complex wherein a mixture of one or more maltodextrins, ferric hydroxide and water are heated and the resulting iron maltodextrin complex is oxidized using aqueous sodium hypochlorite solution to yield iron (III) carboxymaltose.
WO2016151367 describes a process for preparation of iron (III) carboxymaltose complex which include reacting aqueous solution of iron (III) salt with aqueous solution of oxidation product of at least one 24 maltodextrin. The oxidation of maltodextrin is carried out in presence of catalyst and phase transfer catalyst in alkaline medium.
The processes in the art require catalysts, phase transfer catalysts for performing oxidation of maltodextrin which add to the manufacturing cost. The use of sodium hypochlorite as the oxidizing agent lead to formation of undesired chlorinated by products. The processes in the art thus suffer from the drawbacks of formation of inorganic impurities such as metal bromides, chlorides and carbonates which impact the yield and purity of iron(II)-carboxymaltose.
The problem to be solved by the present invention is to reduce the impurity formation and provide ferric carboxymaltose which will be suitable for preparation of medicament without involving further purification. Also, the preparation to be provided by the present invention should provide ferric carboxymaltose which is stable, less toxic, avoids dangerous anaphylactic shocks that can be induced by dextran so as to enable a high applicable dosage of ferric carboxymaltose.
The present inventors were of the view that the drawbacks of the prior art processes can be resolved on the basis of oxidation products of maltodextrin using citric acid which functions both as mild oxidizing and cross linking agent. Maltodextrin individually and independently polymerize using citric acid as cross-linkage agent under mild conditions and the resultant polymers obtained are hydrophilic, forming 25 helical inclusion complexes thereby exhibiting larger capability to solubilize in Water.
SUMMARY OF THE INVENTION:
In accordance with the above, the present invention provides simple, cost effective process for preparation of ferric carboxy maltose in good yield and purity comprising:
i. adding maltodextrin of dextrose equivalent in the range of 10- 20 to the suspension of ferric hydroxide with sodium chloride level not more than 45ppm and the chloride content not more than 2.5%w/w;
ii. adding citric acid to the solution of step (i) in an amount of 0.4 to 1.2 equivalent of one aldehyde group per molecule of maltodextrin oxidized followed by heating; iii. adjusting the pH in the range of 7.0-8.0 using ammonia; iv. filtering and drying to obtain water soluble ferric carboxy maltose.
31. In order to appreciate the submissions of the parties, the claims of the petitioner is as follows:
WE CLAIM:
(a) A pharmaceutical composition obtained from process of synthesis sourced from ozone oxidised Maltodextrin of varied 26 dextrose equivalent 10-15. comprisingferric carboxymaltose wherein not more than 10% of the ferrie Carboxymaltose having molecular weight more than 250kDa, less than 10% of ferric Carboxymaltose having molecular weight less than 10kDa and the rest of ferric carboxymaltose falls within the range of 70kDa-
250kDa) average reolecular weight, more espetor 70kDa 250kvity of feric Carboxymaltose within the molecular weight of 70kDa-250kDa having average monitor weight 82.50kDa.
(b) The pharmaceutical composition as claimed in claim 1 wherein the polymer Chain is uniformly distributed justifying the uniformity of the molecular distribution.
(c) The pharmaceutical composition as claimed in claim 1 having polydispersity index in the range of 1.38-1.99, preferably 1.48.
(d) The pharmaceutical composition as claimed in claim 1 wherein the dimer content is less than 2.
(e) The pharmaceutical composition as claimed in claim 1 having solubility in the range of 50-150 mg/ml, preferably 120mg/ml having therapeutic efficacy in treatment of iron deficiency.
(f) The pharmaceutical composition as claimed in claim 1 which having negligible amount of ferrous content less than 1%.
(g) (i) A process for synthesis of pharmaceutical composition as claimed in claims 1or 5 comprising of the following steps: (a) 27 preparing Ferric hydroxide cake reacting ferric chloride with sodium carbonate;
(ii) Preparing oxidized maltodextrin using ozone gas for desried time and at desired temperature;
(iii) Reacting ferric hydroxide cake with oxidized maltodextrin at desired temperature and for desired time.
(h) The process of synthesis as claimed in claim 7 where the pharmaceutical composition is derived by addition of ammonia in the reaction mass at desired time and temperature and further cooled at room temperature and subsequently added ammonia at pH 7.
(i) The process of synthesis as claimed in claim 7 where the derived pharmaceutical composition is allowed to settle for 1 hour and spray dried.
32. Second Invention of the plaintiff was: Improved Ferric Carboxymaltose with less side-effects obtained cost-effectively.
Field Invention of the plaintiff was: The present invention is directed to advancement in the development and improved ferric carboxymaltose synthesis of improved ferric carboxymaltose with less toxicity, desired polydispersity index and better solubility and less ferrous content and consistent average molecular weight which is 28 suitable for treatment of iron deficiency through both oral as well as parental route through a cost-effective process. Background of the 2nd Invention of the plaintiff was as follows:
"Iron carbohydrate complexes are Intravenously administered for the treatment of iron deficiency (anaemia) as iron replacement therapies for the patients with serious clinical consequences.
US FDA has approved several iron-
carbohydrate complexes for treatment of iron deficiency that are used intravenously in serious clinical conditions. For example, Iron-gluconate, Iron-sucrose (Venofer), low molecular weight Iron- dextran, high molecular weight Iron-dextran, Iron- Isomaltoside, Ferumoxytol, Ferric Carboxymaltose.
However, the approved iron-carbohydrate complex shows side-effects including but not limited to anaphylactic shocks.
This is because of the lack of stability usually caused due to non-transferrin bound iron, ferrous ion and labile iron content, toxicity in the product and presence of undesired molecular weight.
Polymers can be characterized by a variety of definitions for molecular weight including the number average molecular weight/number of molecule (Mn), the weight average molecular weight (Mw), the size average molecular weight (Mz), or the viscosity molecular weight (Mv).
The Gel permeation chromatography and Size- Exclusion chromatography tests for molecular weight conducted wherein the most prominent peaks determines the molecular weight of majorly distributed molecules along with polymer chains. Further, the average molecular weight is determined on the prominent peaks which are a characteristic of iron carbohydrate complex.
Synthesis of iron-carbohydrate complexes used for the treatment of iron defidency are known and described in the art. However, the major 29 challenge during the synthesis is to get appropriate molecular weight to retain the stability thus lesser side-effects of iron-carbohydrate complex. For long, dextran and non-dextran complexes have been used to treat iron deficiency with quite some serious side effects resulting from low molecular weights (dimer) than the appropriate molecular weight which affected the physio-chemical stability of the Iron complex.
US7612109, US20120214986A1, WO2016151367A, US20210155651A1 disclosed a process for water-soluble ferric carbohydrate complexes obtained by oxidation of maltodextrin followed by coupling with iron (III) chloride. Maltodextrin contained in the mixture lies between 2 and 40 dextrose equivalents which resulted in water soluble iron carbohydrate complex having an average molecular weight of 80,000 to 400,000 Daltons.
It is evident from published methods that the ferric carbohydrate complexes prepared from dextrin having a varying dextrose equivalents unit. Broadly, it involved two steps or in situ one step processes where both require the oxidation of maltodextrin and coupling with iron salts. The oxidation methods Include sodium hypochlorite with without sodium bromide, hydrogen peroxide, sodium hypochlorite + hydrogen peroxide, sodium tungstate etc. In the second stage, iron salts were used for coupling to yield ferric carboxymaltose. The maltodextrins were used with varying dextrose units ranging from 5 to 20 DE which gave varying molecular weights of ferric carboxymaltose. All the processes in the previous art suffer from the following drawbacks, formation of iron carbohydrate complexes with inconsistent average molecular weight and iron content, formation of undesired chlorinated by-products such as chlorides, metal bromides, and carbonates. Thus, generating a large quantity of chemical waste which is difficult to treat and hence, unsuitable for the commercial scale. The dextrin with varying dextrose equivalents used in the reported methods can be obtained according to the literature methods. However, the methods used various combinations of dextrin's from 5 to 20 DE which 30 significantly affect the average molecular weight of the ferric carboxymaltose.
In order to avoid the variations and to maintain the consistency of the product stability, the present invention which further improves the IN370845 through a robust and novel oxidation process have been used which gives consistency in the product average molecular weight throughout all the batches.
The improved process makes an improvement in the final product having high solubility, better polydispersity index, uniform distribution of the complex which is suitable for injectables having less side-effects.
33. The claim of the plaintiff is the Second Invention was as follows:
WE CLAIM:
"1. A pharmaceutical composition obtained from process of synthesis sourced from ozone oxidised Maltodextrin of varied dextrose equivalent 10-15, comprising ferric carboxymaltose wherein not more than 10% of the ferric Carboxymaltose having molecular weight more than 250kDa, less than 10% of ferric Carboxymaltose having molecular weight less than 10kDa and the rest of ferric carboxymaltose falls within the range of 70kDa-
250kDa) average molecular weight, more specifically the majority of ferric Carboxymaltose within the molecular weight of 70kDa-
250kDa having average molecular weight 82.50kDa.
2. The pharmaceutical composition as claimed in claim 1 wherein the polymer chain is uniformly distributed justifying the uniformity of the molecular distribution.31
3. The pharmaceutical composition as claimed in claim 1 having polydispersity index in the range of 1.38-1.99, preferably 1.48.
4. The pharmaceutical composition as claimed in claim 1 wherein the dimer content is less than 2.
5. The pharmaceutical composition as claimed in claim 1 having solubility in the range of 50-150 mg/ml, preferably 120mg/ml having therapeutic efficacy in treatment of iron deficiency
6. The pharmaceutical composition as claimed in claim 1 which having negligible amount of ferrous content less than 1%.
7. A process for synthesis of pharmaceutical composition as claimed in claims 1 or 5 comprising of the following steps: (a) preparing Ferric hydroxide cake reacting ferric chloride with sodium carbonate;
(b) Preparing oxidized maltodextrin using ozone gas for desired time and at desired temperature;
(c) Reacting ferric hydroxide cake with oxidized maltodextrin at desired temperature and for desired time.
8. The process of synthesis as claimed in claim 7 where the pharmaceutical composition is derived by addition of ammonia in the reaction mass at desired time and temperature and further 32 cooled at room temperature and subsequently added ammonia at pH 7.
9. The process of synthesis as claimed in claim 7 where the derived pharmaceutical composition is allowed to settle for 1 hour and spray dried.
ABSTRACT TITLE: IMPROVED FERRIC CARBOXYMALTOSE WITH LESS SIDE- EFFECTS OBTAINED COST-EFFECTIVELY Development and process of synthesis of better soluble Ferric carboxymaltose attaining desired molecular weight, PDI, high solubility, uniform distribution of the complex through an improved process with less contamination effects for treatment of iron deficiency with less anaphylactic shock. The advanced process of synthesis involves less time taking and preservative free oxidation process by use of ozone.
34. In the case of Vifor (International) Limited and Anr. (Supra), the Division Bench of the Delhi High Court held that:
"A. A product-by-process claim is an amalgam which ―straddles the otherwise recognised distinction between products and process patents per se. A product-by-process patent is founded on a claim relating to a novel product whose unique attributes are sought to be explained by reference to its manufacturing process. These patents owe their genesis to cases where new products could not be fully described by their structure compelling the patent applicant to rely upon and refer to the process features.
C. Product-by-process claims are foundationally referable to a novel or unobvious 33 product and the patentability of that product not being dependent upon the mere novelty of the process adopted. A product is not rendered novel merely by virtue of the fact that it is produced by a new process, because if novelty is claimed only in respect of a process, it would be treated and granted as a process patent.
G. The contention that process features serve as a limitation during infringement proceeds on the incorrect and untenable premise that notwithstanding the product being novel, it must be presumed that the patentee sought and claimed protection only over the process and thus the same acting as a limitation. More fundamentally, such an interpretation ignores the undisputed fact that such a claim may in fact have been recognised at the stage of grant as a novel product.
H. Product-by-process claims pertain to a product which is novel and inventive and unknown in the prior art. It would thus remain a product which would fall within the ambit of Section of 48(a). The difficulty in discerning the scope of such claims would not constitute a valid basis to deprive a true invention of the protection which the Act confers. It would be incorrect to rule that product- by-process claims must be inevitably curtailed by process terms.
I. Product-by-process claims, although employing process terms, are fundamentally concerned with an inventive product and the reference to a process being only to aid in explaining the novel attributes of a new product unknown in the prior art. Thus, it would be unjust and incorrect to prune down a claim pertaining to such a patent as being confined to merely a process. That would clearly be doing violence to well established tenets of claim construction. According such an interpretation firstly proceeds on the premise that notwithstanding the product being novel, it must be presumed that the patentee sought and claimed protection only over the process and thus the same acting as a limitation. More fundamentally, that interpretation commands us to ignore the undisputed fact that such a claim may in fact have been recognised at the stage of grant as a novel product.34
O. A process claim and the extent of protection that can be claimed in respect thereof would have to draw colour and content from Section 48(b) and which embodies the phrase "obtained directly by that process". We would thus draw and acknowledge the existence of a distinction between "obtained by" and "obtainable by" language embodied in the claim. The words "obtainable by"
would appear to convey a descriptive process by which the claimed product could be manufactured or produced. However, that process in itself need not and invariably be the inventive element of the patent.
R. Ultimately, a product-by-process claim would have to meet the test of pertaining to a novel and inventive product as opposed to a process. It will thus be wholly incorrect to abridge or truncate a product-by-process claim to fall within the ambit of Section 48(b). In our considered opinion as long as the product-by-process claim pertains to a product which is novel and inventive and unknown in the prior art it would remain a product which would fall within the ambit of Section of 48(a).
Z. We find that whether it be a question of validity or infringement, the patentability of a product can always be assailed irrespective of the process terms. In fact, if a defense of invalidity were to be raised in a suit for infringement, it would be open for a defendant to assert that the patent has been wrongly granted either on the ground of a lack of novelty or otherwise being unpatentable. This in light of the right unambiguously conferred by Section 107. Such a challenge would itself be addressed upon the product itself. That challenge would not rest upon the process terms at all. It would be incumbent upon such a defendant to prove that the claim does not relate to a novel or inventive product and that assertion would clearly not be influenced by the mere recitation of the process terms.
AA. Therefore, and in our considered opinion, a product-by-process claim would necessarily have to be examined on the anvil of a new and unobvious product irrespective of the applicant having chosen to describe the invention by referring 35 to a process of manufacture. The mere adoption of the product-by-process format would not result in a novel product being downgraded to Section 48(b) of the Act. It would inevitably have to be tested on principles enshrined in Section 48(a). Mere usage of process terms cannot be accepted as limiting nor is there any justifiable rationale to accept the advocated distinction between validity and infringement. If the rule of necessity were to compel the applicant to submit an application embodying a product-by-process claim, there would appear to be no justification to stultify the extent of protection.
184. We accordingly allow the present appeals and set aside the impugned judgment dated 24 July 2023. While an interim injunction would not be warranted at this stage, the suit proceedings may be taken forward bearing in mind the legal position as enunciated above. We also leave it open to the appellants to press their claim for deposit of percentage of sales at the appropriate stage and subject to further orders being passed in the pending suits. All rights and contentions of respective parties in that respect are kept open."
35. In the present case, from the advertisement of the petitioner, it is evident that the petitioners purportedly produce and offer for sale generic ferric carboxymaltose, which is known in every respect and nothing to do with the patent protection. The product in their own admission has a CAS No., which is universal identifier of known chemical molecules, is the same 9007-72-1 as that disclosed by the National Library of Medicines data. The petitioner has submitted a statutory declaration under Section 146 of the Patents Act, 1970 and Rule 131 under Form 27 for the financial Year 2020-2021 wherein it is stated that "The patented invention has not worked for further research 36 and development to scale it in commercial account". And for financial year 2022-2023 it was not worked due to "ongoing marketing strategy".
36. In the case of FDC Limited and Ors. (Supra), the Madras High Court held that:
"29. Considering the facts and circumstances of the present case, I am of the view that the following guidelines may be taken into consideration by the trial courts, while dealing with similar matters and before granting ex parte ad interim injunction:
i) Where the plaintiff and the primary defendant are residing outside the State and their identity, addresses etc., are easily known;
ii) Where sales of the offending products are not on a commercial scale;
iii) If the grant of injunction is going to result in closure operation/business of the defendant. If the ex parte injunction has an all India operation and not just within the state;
iv) Where the dispute involves patent/trade mark issues, the trial court should carefully peruse the certificates, offending marks etc.,
v) An ex parte injunction should not be granted in cases where no evidence or proof of infringement has been filed by the plaintiff;
vi) In the patent cases, the trial court has to carefully note the distinction between a product patent and a process patent. If the plaint alleges violation of process patent, then ex parte injunction should be granted unless the plaintiffs have adduced the evidence of an independent scientists/other technical expert who has tested the plaintiff's and defendant's product and arrived at an independent finding as to the identity of the processes used. In 37 process patent cases, opportunity must be given to the defendant to explain how their process does not constitute infringement within the meaning of "Section 104A" of the Patent Act."
37. In the present case, the petitioner has not produced any materials on record of any scientist or any technical expert who tested the petitioner and the defendant product and arrived at a finding to the identity of the process used. The Andhra Pradesh High Court in the case of Bristol - Myers Squibb Holdings Ireland (supra) also relied upon the judgment of FDC Limited and Ors. (supra), has rejected the interim prayer.
38. As per the case of the defendant, the defendant's company established in the year 1973 and has been into manufacturing industrial chemicals from the year 1985 to till date and has been marketing its products over last 37 years not only in India but also in various other countries. Now the defendant company has decided to venture into Pharma Industry with emerging market potential which includes "Ferric Carboxymaltose (Injectable Grade).
39. The claim of the plaintiffs is that, the process of the plaintiff and the defendant are same, the plaintiff is having patent and the plaintiff is to be protected. The defendant has no patent. The plaintiff says that as long as patent remains, the patent of the plaintiff is to be protected. Section 48 sub-divided in sub-sections i.e. 48(a) and 48(b). Section 48(a) relates to the right of the patentee when the patent is for a product. Section 48(b) relates to the right of the patentee when the 38 patent is for a process. The plaintiff does not have any right over Ferric Carboxymaltose composition per-se, thus Section 48(a) is not applicable in the case of the plaintiff.
40. In the background of the invention of the plaintiff, the plaintiff has mentioned that the Ferric Carboxymaltose is commercial available in the market under the brand name Ferinject®.
41. Considering the above, this Court finds that the petitioner has not made out any prima facie case for grant of interim injunction in favour of the petitioner. As regard the balance of convenience and irreparable damage, the other two important ingredients/ test to be made by the petitioner for grant of interim injunction, in my opinion, the plaintiff has failed.
42. In view of the above, G.A. No. 1 of 2023 is thus dismissed.
(Krishna Rao, J.)