F. HOFFMANN-LA ROCHE AG & ANR. vs NATCO PHARMA LIMITED

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* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ CS(COMM) 567/2024 & I.A. 33088/2024, I.A. 44310/2024, I.A. 44384/2024

F. HOFFMANN-LA ROCHE AG & ANR. …..Plaintiffs
Through: Mr. Pravin Anand, Ms. Shrawan Chopra, Ms. Prachi Agarwal, Mr. Devinder Rawat, Mr. Achyut Tewari, Mr. Aayush Maheshwari, Ms. Elisha Sinha, Ms. Krisha Baweja, Mr. N. Mahabir, and Ms. Archana Shanker, Advocates (M:8604633567)
versus

NATCO PHARMA LIMITED …..Defendant
Through: Mr. J. Sai Deepak, Sr. Adv. with Mr. Afzal B. Khan, Mr. Samik Mukherjee, Ms. Amrita Majumdar, Mr. Dominic Alvares, Mr. Avinash Kr. Sharma, and Mr. Sharad Besoya, Advocates (M: 7585965845)
Email: del.lit@majumdarip.com

CORAM:
HON’BLE MS. JUSTICE MINI PUSHKARNA
JUDGMENT
% 24.03.2025
MINI PUSHKARNA, J:

INDEX

S.No.
CONTENT
PARA NOs.
1.
Factual Matrix
1 – 9
2.
Submissions of the Plaintiffs
10 – 10.30
3.
Submissions of the Defendant
11 – 11.21
4.
Submissions of Intervener in Application, I.A. 44310/2024
12 – 12.5
5.
Submissions of Intervener in Application, I.A. 44384/2024
13 – 13.7
6.
Analysis and Findings
14 – 107
I
Finding on the Aspect of Prima Facie Case
15 – 82
A
Anticipation by Prior Publication – Section 64(1)(e) of the Patents Act
a. Statements Made in Foreign Jurisdictions
18 – 58
B
Issue of Obviousness – Section 64 (1)(f) of the Patents Act
59 – 71
C
Challenge qua Non Patentability – Section 64(1)(d) of the Patents Act
72
D
Issue of Misrepresentation – Section 64(1)(j) of the Patents Act
73 – 74
E
Ground with regard to non-compliance of requirements – Section 8 of the Patents Act
75 – 77
F
No presumption of validity of a Patent
78 – 79
G
Criteria at the time of considering an application for interim injunction and Prima Facie Case
80 – 82
II
Aspect of Balance of Convenience
83 – 100
III
Aspect of Irreparable Damage/Prejudice
101 – 103
IV
Public Interest
104 – 107
7.
Conclusion and Directions
108 – 111
I.A. 33088/2024
Factual Matrix:
1. The present suit has been filed alleging infringement of Patent No. IN 334397 (IN’397-Suit Patent/Species Patent). By way of the present application, the plaintiffs are seeking interim injunction for restraining the infringement of the Suit Patent, which is titled “COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY”.
2. The Suit Patent, which is a ‘Species Patent’ inter alia for the product ‘Risdiplam’, relates to compounds which are Survival Motor Neuron 2 (“SMN2”) used in the treatment of Spinal Muscular Atrophy (“SMA”). The Suit Patent is registered in the name of plaintiff nos. 1 and 2. The bibliographic details of the Suit Patent are as below:

3. The Suit Patent has a term of 20 years from 11th May, 2015, which expires on 11th May, 2035. There has been no pre-grant opposition, post-grant opposition or any revocation proceedings filed against the Suit Patent in India.
4. The US (“United States”) Patent No. 9,969,754 (“US’754”) is the corresponding patent to the Suit Patent. US Patent No. 9,586,955 (“US’955”) is the US Patent corresponding to the Patent Cooperation Treaty (“PCT”) application no. PCT/US2013/025292 published as WO 2013/119916 A2 patent (“WO’916 – International Genus Patent”). An application for Patent Term Extension (“PTE”) of US’955 has been filed before the United States Patent and Trademark Office (“USPTO”) on 02nd October, 2020. In Australia, the request for PTE has been accepted for its corresponding Australian Genus Patent No. 2013216870 (“AU’870”). Likewise, the plaintiffs have also been granted patent in Canada, i.e., CA 2863874 (“CA’874”), which corresponds to the International Genus Patent, WO’916. The corresponding patents to the Suit Patent have been granted in about 60 countries worldwide.
5. The Suit Patent claims a compound having an International Non-Proprietary Name (“INN”), ‘Risdiplam’, assigned by the World Health Organization, in the year 2018. It has the molecular formula – C22H23N7O, and has the following chemical structure:

6. Risdiplam is the Active Pharmaceutical Ingredient (“API”) in the plaintiffs’ commercial product, which is marketed in various countries worldwide, including, India, under the brand name, ‘EVRYSDI®’. Risdiplam is an oral prescription medicine indicated for the treatment of SMA in patients two months of age or older. SMA is a rare genetic neuromuscular disorder caused by the mutation of the Survival Motor Neuron 1 (“SMN1”) gene, leading to a deficiency of SMN protein, which affects motor nerve cells, diminishing the ability to walk, sit, eat and breathe.
7. The plaintiffs came across the listing of Risdiplam on the defendant’s website under the ‘APIs under development’ section. Further, investigation revealed that the defendant was preparing for commercial production of Risdiplam API. Moreover, the defendant was found to have filed a patent application bearing no. 202241055182 on 26th September, 2022 under the title, ‘Improved Process for the Preparation of Risdiplam and its Intermediates’ for manufacturing of Risdiplam. Thus, the present suit has been filed by the plaintiffs alleging infringement by the defendant of their rights in the Suit Patent.
8. During the hearing of the present application for interim injunction, two applications, I.A. 44310/2024 and I.A. 44384/2024, were filed on behalf of the interveners, for their impleadment/intervention.
9. Though, the said interveners were not impleaded, however, for the purposes of submissions on the aspect of public interest involved, this Court has allowed the two interveners in the present case, to make their submissions before this Court. The submissions of the interveners have been considered in furtherance to the powers inured in the Court by way of Rule 25 of the Delhi High Court Intellectual Property Rights Division Rules, 2021 and in light of the judgement of the Supreme Court in the case of Dr. Satyanarayana Sinha Versus S. Lal and Company (P) Ltd.1, wherein, the Supreme Court held as follows:
“xxx xxx xxx

10. In England also the Courts have taken the view that when the application is made by a party or by a person aggrieved the Court will intervene ex debito justitiae, in justice to the applicant, and when it is made by a stranger the Court considers whether the public interest demands its intervention. In either case it is a matter which rests ultimately in the discretion of the Court: (See R.v. Thames Magistrates’ Court, Exhibit p. Greenbaum). [(1957) 55 LGR 129 (Extracted in Yardley: Source Book of English Administrative Law, 1970, p. 228).]

xxx xxx xxx”
(Emphasis Supplied)

Submissions of the Plaintiffs:
10. On behalf of the plaintiffs, the following submissions have been made:
10.1 The defendant has admitted infringement, since the defendant has admitted that it is in the process of launching Risdiplam.
10.2 The defendant’s entire case is based on the WO’916, being International Genus Patent pertaining to the Suit Patent. The defendant has simply based their entire case on account of the statements made in other jurisdictions regarding the PTEs. However, none of the statements made overseas by the plaintiffs, amount to an admission of any nature that WO’916 specifically discloses Risdiplam.
10.3 The Suit Patent is an old patent filed in the year 2016 and claiming priority since the year 2014. The patent is still valid and subsisting, having been granted in the year 2020. Further, the corresponding patents to the Suit Patent that have claims directed to the specific compound Risdiplam have been granted in more than 60 countries, and the same have not been revoked/invalidated in any jurisdiction.
10.4 The fact that an INN has been granted, shows that it is a new chemical entity, as INN naming is only available for new compounds. International Search Authority (“ISA”) has held the Suit Patent to be novel and non-obvious after considering WO’916.
10.5 The defendant has simply based their entire case on account of the statements made in other jurisdictions regarding the PTE. In its arguments, the defendant did not refer to prior art document, WO’916 or the patent in question to determine patentability requirements.
10.6 The Suit Patent enjoys a strong presumption of validity, and the defendant has clearly failed in establishing any challenge to the validity of the Suit Patent. In view of the fact that the Suit Patent is prima facie valid, an infringement is admitted, the plaintiffs are entitled to an injunction against the defendant.
10.7 The plaintiffs have developed a new drug which is the only oral drug for SMA in the world, and expenditure in development of a new molecule as done by the plaintiffs, is highly exorbitant, whereas, companies which create generic versions, like the defendant, bear minimal costs for Research & Development (“R&D”). Therefore, a balance is necessary between the interests of the innovators and the generic medicines industry.
10.8 The plaintiffs have voluntarily provided a heavy price reduction and discounts to the Government of India for the cause of SMA patients in India.
10.9 The defendant is a habitual infringer, as there are multiple law suits filed against them in which injunctions have been granted. They have also breached undertakings and paid damages in settlements.
10.10 A Person of Ordinary Skill in the Art is an ordinary person, and not an expert, as alleged by the defendant. Tests to determine obviousness and insufficiency are all from the perspective of A Person of Ordinary Skill in the Art, and not an expert. Therefore, the defendant’s understanding of A Person of Ordinary Skill in the Art is incorrect.
10.11 There has been no evergreening in the present case. Evergreening does not apply to new compounds and it is very clear that Risdiplam is a new compound.
10.12 Risdiplam cannot be anticipated or rendered obvious on the basis of WO’916. The International Genus Patent, WO’916, does not specifically disclose Risdiplam and no one can find Risdiplam as a specific example in WO’916. A Person of Ordinary Skill in the Art, not being aware of Risdiplam without hindsight, cannot recognise that Risdiplam would be the product.
10.13 The lead candidate chosen from WO’916 was the compound RG7800, as disclosed therein. However, RG7800 was later stopped due to retinal toxicity, but it was reasonable for A Person of Ordinary Skill in the Art to select RG7800 based on WO’916. Therefore, comparing the structures of the failed compound, i.e., RG7800, with that of Risdiplam, one can easily see the difference in the same, hence demonstrating that Risdiplam was a new invention.
10.14 There was no novelty/anticipation challenge by the Indian Patent Office (“IPO”) during the prosecution of the Suit Patent, despite the fact that WO’916 was looked into by the Patent Office. Moreover, WO’916 was specified in the description of the Suit Patent. Thus, both, the IPO and the ISA, as well as all of the authorities over 60 jurisdictions where the Species Patent has been granted, were specifically aware of the said document. Thus, WO’916 has been considered in multiple jurisdictions and no jurisdiction regarded the same as anticipating the Species Patent or Risdiplam.
10.15 Suit Patent is not obvious on the basis of WO’916, as alleged by the defendant. At the priority date of the Suit Patent, A Person of Ordinary Skill in the Art, would have no basis for selecting a particular compound, as alleged by the defendant. There is no teaching for A Person of Ordinary Skill in the Art, to narrow down to the compound of formula from various Markush Structures. The defendant has miserably failed to provide reasons for A Person of Ordinary Skill in the Art to perform the various steps of selecting and modifying the compound and the multiple substituents to arrive at Risdiplam. Thus, the defendant’s contentions are purely based on hindsight and on reverse engineering, i.e., after having knowledge of the structure of Risdiplam from US’955, the defendant has tried to reverse engineer to arrive and represent Risdiplam from the disclosure of WO’916.
10.16 Coverage is not the same as disclosure. Disclosure is a question of fact and must be clear and unambiguous. It cannot be implied, inferred or deemed, and is best discovered by looking at the genus patent itself. Further, for a new chemical entity, disclosure must involve identification of the compound such as by its molecular formula, molecular structure, chemical formula or International Union of Pure and Applied Chemistry (“IUPAC”) name.
10.17 The International Genus Patent is not theoretical, as at the very least 835 compounds have been exemplified for the same and each one can be a subject matter of further research.
10.18 The test for infringement is not the same as the test of invalidation. The test for infringement is whether the accused product or method falls within the scope of the patent claims. For invalidity, the test is disclosure, whether the product or method is specifically disclosed by the prior art.
10.19 Risdiplam is a new chemical entity. Therefore, Section 3(d)2 of the Patents Act, 1970 (“Patents Act”) will not apply to the present case. For Section 3(d) to apply, the defendant must demonstrate that there was a known substance that had been isolated and synthesised, whose properties were known. Section 3(d) would apply only if Risdiplam was known, and the plaintiffs applied for a new salt for the same.
10.20 Reliance on plaintiffs’ statements in applications for PTEs is completely misplaced and legally untenable. Statements made during prosecution of foreign applications are irrelevant, as they are in response to unique patentability requirements overseas. Whether Risdiplam is disclosed in WO’916 or not, must be arrived at by looking at the said document alone. Any subsequent statements made by any party, cannot decide or alter the scope of the patent claims or interpret the patent specification. Further, subsequent statements made by any party or the patentee cannot decide or alter the scope of the patent claims or interpret the patent specifications, especially, when the statement made was much after the priority date.
10.21 The context in which statements for grant of PTEs have been made, are completely different and cannot be termed as an admission on any account. Further, if the statements made in the other jurisdictions amounted to admission of disclosure, the novelty would be destroyed in this country and in the other jurisdictions, which cannot be the intent of the plaintiffs.
10.22 It is trite law that an admission must be unequivocal and unambiguous. Further, none of the statements made by the plaintiffs in the various PTE applications ever mentioned in any manner, that the Risdiplam product was specifically disclosed in the International Genus Patent, nor A Person of Ordinary Skill in the Art would find specific disclosure of Risdiplam molecule from the International Genus Patent. Moreover, in all these jurisdictions, the Genus and the Species Patents both co-existed and if there had been anticipation, then the Species Patents would not have been granted in these countries. Therefore, the law on admissions is subservient to a verifiable fact.
10.23 It is wrong for the defendant to construe on the basis of law suit in USA against the defendant, that Risdiplam is specifically disclosed, merely owing to the coverage under the International Genus Patent.
10.24 On the aspect of Public Interest, it is to be considered that the drug in question is used for treating a life-threatening disease, which is a rare disease.
10.25 There are between 7000-8000 rare diseases and about 95% of rare diseases have no approved treatment. Therefore, there is equally an overwhelming public interest in protecting a patent for a rare disease. Further, the expenditure and time invested by the plaintiffs in R & D ought to be protected. The plaintiffs have spent billions of dollars on clinical trials, which were carried out on a global scale.
10.26 The patents have a limited life of 20 years. Therefore, if a generic manufacturer is allowed to manufacture the patented drug of the plaintiffs, then companies would be dissuaded from investing in R & D.
10.27 Plaintiffs are already giving the drug in question to the Government at heavily discounted rates. Therefore, to say that a patent creator is not entitled to protection would be destructive. The plaintiffs have spent many years on research, whereas, no development cost has been incurred by the defendant. The investment of the defendant is nothing, except in manufacturing the drug in question, if allowed by this Court.
10.28 The motive of the defendant is to only make profits by imitating the plaintiffs, which has to be seen in proportion to the investment made by the defendant, which is only for the proposed manufacture and not for R & D. On the other hand, the plaintiffs have to recoup their costs and investments on R & D and clinical trials, held globally.
10.29 In the case of Master Arnesh Shaw Versus Union of India, W.P.(C) 5315/2020, which was a Public Interest Litigation, the plaintiffs themselves came forward to provide the drug in question to the Government at heavily discounted rate. Further, 486 patients suffering from SMA in India, are enrolled with the plaintiffs under the Patient Assistance Program.
10.30 Allowing the defendant to manufacture would be overarching public interest, as public interest also lies in protecting the patentee. If patent rights are not protected, then the companies will not put in efforts for invention and discovery of new compounds for treatment of diseases. The defendant cannot make crime out of profitability. The larger public interest demands protection of patents, especially, in cases of drugs for rare diseases. Generic manufacturers, like the defendant, have put in no effort on clinical trials or development costs.
Submissions of the Defendant:
11. On behalf of the defendant, the following submissions have been made:
11.1 The plaintiffs have resorted to evergreening and unlawful PTE in India, by applying for a species patent, instead of an Indian Genus Counterpart to US’955/WO’916, which would have expired in 2033. By applying for a species patent in India, the plaintiffs have secured an unlawful PTE of two years in India under the garb that Risdiplam is not specifically disclosed by the International Genus Patent, although admittedly covered by the same. Thus, the present is a case of International Genus Versus Indian Species.
11.2 The plaintiffs have attempted to shift the focus of the case from the question of evergreening and patent validity to the worth of the product, Risdiplam and in labelling of defendant as a ‘habitual infringer’.
11.3 Interim injunction cannot be granted for the asking in suits for alleged patent infringement. The said position applies with greater rigor to suits relating to pharmaceutical patents. The Patents Act does not bestow presumptive validity on a patent, even if it has been granted pursuant to a failed pre-grant opposition, or even if it survives a post-grant opposition. As held in catena of judgments, given the absence of presumptive validity of a patent, Courts must deny grant of interim injunction if the defendant establishes a credible challenge to patent validity.
11.4 Courts have gone to the extent of holding that the issue of patent validity can be raised even in a counter claim to a suit for infringement or as a defence against infringement, without necessarily filing a counter claim. Nevertheless, the defendant has filed a counter claim, however, at the interim stage, the ‘vulnerability’ of the Suit Patent should be considered, and not its ‘invalidity’, hence, it is not necessary to even file a counter claim at this stage.
11.5 Both, the International Genus Patent, WO’916, and Indian Species Patent, IN’397, relate to the compounds for the treatment of the same condition, namely, SMA. Therefore, WO’916 is not a random document that is being selected for assessment of the patentability/validity of the IN’397. Thus, statements made by the plaintiffs in any other jurisdiction are relevant towards the question of validity or vulnerability of Suit Patent.
11.6 The plaintiffs have misrepresented and made material suppression before the Patent Office with respect to the International Genus Patent.
11.7 On account of non-filing of the Indian Genus Patent, Risdiplam has fallen in public domain in India, notwithstanding the grant of the Species Patent.
11.8 Although patent rights are territorial in nature, the Patents Act itself recognizes the relevance of findings of Foreign Patent Offices in relation to a family of patents. Admissions made either during the prosecution of a patent application or post the grant of the patent by the applicant/patentee, are relevant in every jurisdiction in relation to the same subject matter, whether in the form of genus patent or a species patent. The Indian Suit Patent is a Species Patent of WO’916 and relates to the very same set of compounds, which are meant to address the same conditions, i.e., SMA. Consequently, all statements/admissions made by the plaintiffs/patentee, in any jurisdiction in relation to WO’916 and other Genus counterparts, are relevant for the assessment of the patentability of the Indian Species Suit Patent.
11.9 The Supreme Court and this Court in several cases relied on ‘foreign admissions’ as the basis for rejection of patent applications and denial of interim injunction.
11.10 During the pendency of the present suit, the plaintiffs have instituted a suit for infringement in US before the United States District Court against the defendant herein, alleging infringement of the US Genus Patent, US’955 and US Species Patent, US’754, in respect of Risdiplam. By filing the said suit, the plaintiffs have validated the defendant’s contention that the International Genus Patent of the plaintiffs is capable of being asserted against third parties for the very same product, Risdiplam. Consequently, a genus patent which can be asserted/enforced against the third parties for infringement, can equally be used by such third parties as prior art to challenge the validity of a subsequent/species patent, which admittedly claims the same product.
11.11 The plaintiffs secured the PTE for US’955 Genus Patent through express admission that Risdiplam is a new drug whose discovery is traceable to the US Genus Patent. Thus, at the interim stage, the plaintiffs cannot take a contrary position to secure an interim injunction.
11.12 In case of Grouped Claim/Markush Claim, the Patents Act requires only fair disclosure and not express or specific disclosure. By requiring only fair and not specific disclosure, the Act permits a few examples to be presented in the disclosure on an illustrated basis, without necessarily limiting the scope of claims only to such examples. Markush Claim, which is based on a common inventive step, need not be supported by examples which relate to every embodiment within that claim. Therefore, a Markush Claim and the disclosure of the patent are co-extensive, and the scope of Markush Claim is not limited by or to the specific examples contained in the patent specifications, thereby, allowing benefit of the provision to both the patentee and third parties, such as the defendant.
11.13 The issue of Coverage Versus Disclosure, has been settled by the Supreme Court in the case of Novartis AG Versus Union of India and Others3, which is also covered by several decisions of this Court. Thus, there is no distinction between coverage or claim in the Species Patent and disclosure in the International Genus Patent.
11.14 Even in foreign jurisdictions, the law is that if the prior art discloses a species falling within the claimed genus, then, the species patent cannot be granted. Thus, by plaintiffs’ admissions towards the coverage of WO’916/US’955 extending to Risdiplam and claiming infringement of the US Genus Patent, the plaintiffs have put themselves in a position of the Species Patent being susceptible to invalidity.
11.15 A species/selection patent can be granted despite the grant of a genus patent, only if it is demonstrated that the species patent has significant technical advancement and enhanced therapeutic efficacy over the genus patent. The species patent must disclose substantial advantage over the genus patent/prior art in the specification. However, the Suit Patent fails to disclose any such advantage over the International Genus Patent.
11.16 All the substituent specifically mentioned in Claim 1 of the Suit Patent, are disclosed in the International Genus Patent. Any modifications or substitutions which result in the same chemical and physical properties, and are necessary to arrive at the compounds claimed in the Suit Patent from the compounds disclosed in the International Genus Patent, are routine and predictable by a person skilled in the art, being disclosed in prior art itself. This could include modification to functional groups, side chains or other structural elements, which are commonly employed in medicinal chemistry.
11.17 Even though it has been admitted by the plaintiffs that the International Genus Patent discloses Risdiplam, the complete specification of Suit Patent fails to present any comparative data showing technical advancement or enhancement of therapeutic efficacy over the International Genus Patent.
11.18 Risdiplam cannot enjoy any protection in a later filed Species Patent, whose novelty is destroyed by the plaintiffs’ own prior published genus patent family.
11.19 The plaintiffs are not adequately working the patent in India. The plaintiffs are not manufacturing Risdiplam in India, and only importing the same in India, whereas, the defendant will be manufacturing the drug in India.
11.20 The intent of the plaintiffs is to monetize the said invention, and in such cases if the plaintiffs succeed, monetary damages are adequate compensation, and interim injunction should not be granted in such cases. The drug is not accessible or affordable to regular patients and the plaintiffs have failed to make the drug accessible and affordable.
11.21 When a big gap exists in the price of the plaintiffs’ drugs and the defendant’s drugs, balance of convenience will be in favour of the defendant, subject to the defendant establishing a credible challenge to the validity of the patent. The defendant intends to make the product available at a price that is nearly 80-90% lesser than the plaintiffs’ price.
Submissions of Intervener in Application, I.A. 44310/2024:
12. On behalf of the intervener, Ms. Purva Mittal, in application being I.A. 44310/2024, it has been submitted as follows:
12.1 The intervener, Ms. Purva Mittal, is a patient diagnosed with the rare genetic disease of SMA, in which muscles throughout the body are weakened because nerve cells in the spinal cord and brainstem do not work properly.
12.2 The intervener is undergoing treatment at LNJP Hospital, New Delhi. She has been recommended Risdiplam, but is unable to start treatment with the drug, as the price thereof, is exorbitant and completely unaffordable. The average/approximate cost for one year’s treatment is around Rs. 1,48,00,000/- (One Crore Forty-Eight Lacs) per year, which is highly unaffordable.
12.3 The spirit of considering public interest while granting injunction, is reflected in the jurisprudence that has developed in India, as well as in other countries. Furthermore, in cases of life saving drugs, public interest is a critical factor.
12.4 SMA is a debilitating disease and there is no cure for the same. The plaintiffs claim to run a Patient Assistance Program, which is meant to assist patients and provide drugs at an affordable price. However, from a study done by the plaintiffs on its Patient Assistance Program, Risdiplam was made available to only 75 patients in India in 2023. If any person, such as the defendant, is able to manufacture the drug and make it available at an affordable price, in such a case, public interest would have to outweigh the need for grant of injunction.
12.5 Since injunction is an equitable remedy and public interest is an important factor in the grant of injunction, this Court should consider this aspect in the overall scheme before granting any injunction.
Submissions of Intervener in Application, I.A. 44384/2024:
13. On behalf of the intervener, Ms. Seba P.A., in application being, I.A. 44384/2024, it has been submitted as follows:
13.1 The applicant is living with the rare, life threatening progressive neuromuscular genetic disease, SMA. She is vitally interested in increasing access to treatment for SMA, including, the drug Risdiplam, for herself and for thousands of others in the country diagnosed with the rare disease, which is not easily accessibly on account of the patent monopoly that allows the plaintiffs to have dominant position and charge an exorbitant price for the drug, Risdiplam.
13.2 The applicant had approached the High Court of Kerala, wherein, by an order dated 23rd February, 2024 in W.P. (C) No. 43275 of 2023, the Court directed that the medicine be procured for the applicant from the one time amount of Rs. 50 Lacs available under the National Rare Disease Policy. Consequently, the Kerala Government had procured 18 bottles, which the applicant has received. She will receive another 6 bottles in the next three months, which will exhaust the said threshold limit of Rs. 50 Lacs. Thereafter, without affordable access, the applicant would be left without treatment.
13.3 In a patent suit, public interest in terms of availability and accessibility of the drug, is a relevant factor to grant or to refuse the injunction.
13.4 The price under Roche’s Patient Support Program in India, is also unaffordable. Patients pay Rs. 12.5 Lacs for 2 bottles and get 3 bottles free. Thus, patients get 5 bottles for Rs. 12.5 Lacs, and for a patient weighing 20 Kilograms (“Kgs”) or more, needing 30 bottles a year, will still pay over Rs. 30 Lacs.
13.5 The high cost of the drug Risdiplam, the only approved drug in India, is leading to challenges in making it available and accessible to all patients diagnosed or undiagnosed with SMA in India.
13.6 The Government of India has launched National Policy for Rare Diseases, 2021, for the treatment of patients with rare diseases, whereby, the rare diseases have been categorized. Provision for financial support of upto Rs. 50 Lacs for patients suffering from rare disease has been introduced. However, considering the high cost of patented medicines such as Risdiplam, the said provisions of the Government will be inadequate unless generic competition for lowering prices by local manufacturing is introduced.
13.7 The Court ought to balance the public interest, and the constitutionally protected right to health of patients and balance them against the exorbitant price of the drug.
Analysis and Findings:
14. I have heard learned counsels for the parties and have perused the record.
I. Finding on the Aspect of Prima Facie Case:
15. In the present suit, the defendant has challenged the validity of the Suit Patent primarily on the following grounds:
a. Section 64(1)(e)4 – The invention so far as claimed in any claim of the Suit Patent is not new, having regard to what was published in India or elsewhere before the priority date in any of the documents referred to in Section 135 of the Patents Act.
b. Section 64(1)(f)6 – The invention claimed in Suit Patent 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.
c. Section 64(1)(d)7 – The subject of any claim of the Suit Patent is not an invention.
d. Section 64(1)(j)8 – The patent was obtained on a false suggestion or representation.
e. Section 64(1)(m)9 – Non-compliance of requirements under Section 810 of the Patents Act.
16. It is to be noted that the defendant has primarily argued on the aspect of invalidity of the Suit Patent on various grounds, as mentioned above, and the aspect regarding non-infringement of the Suit Patent has not been pressed at the time of arguments.
17. Thus, each ground raised by the defendant is being considered separately, herein below.
A. Anticipation by Prior Publication – Section 64(1)(e) of the Patents Act:

18. According to Sections 2(1)(l)11 and 13(2) of the Patents Act, India follows a principle of absolute novelty with strict novelty requirements. As per the definition of ‘new invention’, stipulated in Section 2(1)(l) of Patents Act, only those inventions or technology which are not anticipated by publication in any document or used in the country or elsewhere in the world, before the date of filing of patent application with complete specification, can be considered as a new invention. This is to say that there are no other prior published documents claiming a priority date earlier than the date on which an application for the invention in question is filed, on the basis of which, an invention can be anticipated. Accordingly, only an invention that has not already become a part of the public domain, affecting the novelty of the invention in question, can be considered as a new invention. Thus, as per the law of the land, anticipatory publications extend to those published anywhere in the world. It is relevant to note here that in the present case, the anticipatory documents cited by the defendant, i.e., the International Genus Patent, WO’916 and its corresponding US Patent, US’955, are patent applications published internationally, without claiming any patent protection in India, having a priority date earlier than the Suit Patent.
19. In India, the test or approach for determining anticipation has evolved and has been consolidated by a Coordinate Bench of this Court in a recent decision, LAVA International Limited Versus Telefonaktiebolaget LM Ericsson12. The test for determining anticipation, (which is one of the material factors while dealing with the issue of novelty), as drawn in the said judgement, is as under:
(i) Understanding of the Claims of the Invention,
(ii) Identifying Relevant Prior Art,
(iii) Analysing the Prior Art,
(iv) Determination of Explicit and Implicit Disclosures,
(v) Assessment of material differences while considering the entire scope of the claims,
(vi) Verifying Novelty in light of Comprehensive Scope and Specific Combination of Claimed Elements,
(vii) Documentation of the Analysis and Novelty Determination.
20. Thus, keeping in view the aforesaid approach, this Court has proceeded to analyse as to whether any credible challenge has been raised by the defendant towards vulnerability of the Suit Patent.
21. The present suit alleges infringement of IN’397, a Species Patent (Suit Patent). The Suit Patent relates to a compound of formula (I) and methods for their preparation, which are potentially useful in treating or preventing SMA. The plaintiffs assert their rights on the compound ‘Risdiplam’, which according to the plaintiffs, is ‘covered and claimed in the Suit Patent’.
22. The chemical name of Risdiplam is, 7-(4,7-diazaspiro [2.5] octane-7-yl)-2-(2,8dimethylimidazo[1,2-b] pyridazin-6-yl)-4H-pyrido[1,2-a] pyrimidin-4-one, which has the molecular formula – C22H23N7O.
23. At this juncture, to understand the scope of the claims, a reference is made to the granted claims of the complete specification. Claim 1 of the Suit Patent, that discloses the compound of formula (I), which is the basic structure of the species claimed in the Suit Patent, is reproduced as under:

24. Thus, upon examination of the above, as per the Markush Structure in Claim 1 of the Suit Patent, the following is manifest:
24.1 ‘R1’ could be alkyl groups that contain between one and seven carbon atoms (C1-7).
24.2 ‘R2’ could be Hydrogen or alkyl group with C1-7.
24.3 ‘R3’ could be Hydrogen or alkyl group with C1-7.
24.4 ‘A’ could be a heterocyclic compound containing Nitrogen.
25. From the Markush Claim 1 of the Suit Patent and the substitutions proposed in the dependent claims, the derivation of Risdiplam, as per the plaint, is reproduced here under for clarity:
“xxx xxx xxx

23. Risdiplam can be derived from the Markush claim 1 as follows:

xxx xxx xxx”
26. From the claims asserted by the plaintiffs in the Suit Patent and the illustrations given therein, especially, Example Compound 20, it is the categorical case of the plaintiffs that the compound Risdiplam is explicitly disclosed and covered in the Suit Patent.
27. It is relevant to note that the plaintiffs have a Species Patent, i.e., US’754, in US, corresponding to the Suit Patent. Further, it is to be noted that prior to the aforesaid US Species Patent, US’754, the plaintiffs have also obtained a Genus Patent, i.e., US’955, in US, which corresponds to the International Genus Patent, WO’916. This International Genus Patent of the plaintiffs published internationally as WO’916, has been cited as prior art by the defendant. The defendant has challenged the validity of the Suit Patent, which is a species patent, inter alia on the basis of anticipation of Risdiplam compound by prior publication in the International Genus Patent.
28. Therefore, the moot question is whether Risdiplam is explicitly or implicitly disclosed in the International Genus Patent, which has been cited as prior publication/prior art, by the defendant.
29. In this regard, it would be apposite to refer to the submissions made in the written statement filed on behalf of the defendant, with respect to the compound of formula (I) being disclosed in the International Genus Patent, wherein, it has been stated as follows:
“xxx xxx xxx

34. The subject matter of the Suit Patent relates to a compound of formula (I), and methods for their preparation. It is submitted that WO ‘916 Patent (D1) discloses in para [00959] a compound of Formula-(IIa1);

35. The comparison of the compound claimed in the Suit Patent and disclosed in WO ‘916 Patent is provided below:

xxx xxx xxx”
45. ……….
g. WO ‘916 at Page No: 37 and 38, paragraph [00215] discloses Markush structure (IIa1)

Wherein R2 is heteroaryl selected from imidazo[1,2- b]pyridazinyl; wherein, each instance of heteroaryl is optionally substituted with R6 and R7 substituents.

In view of the above, the core structure having an imidazo[1,2-b]pyridazine-2-yl-pyrido [1,2-a] pyrimidine of formula (I) is also clearly disclosed in WO ‘916 (prior art).

xxx xxx xxx”

30. Thus, it is the case of the defendant that the core structure of the compound of formula (I) in the Suit Patent is disclosed in the International Genus Patent under the compound of formula (IIa1). As per the defendant, the compounds of formula, as claimed in Claim 1 of the Suit Patent, IN’397, i.e., Risdiplam, is disclosed in the International Genus Patent, from the teachings as contained in the complete specification of the International Genus Patent.
31. On the aspect of disclosure, this Court notes the stand of the plaintiffs, as given in its rejoinder to the reply of the defendant to the interim application, wherein, it has been stated as follows:
“xxx xxx xxx

126. …..

The genus patent claims a genus of compounds to which Risdiplam belongs, but does not specifically claim Risdiplam, nor does the specification of the genus patent specifically disclose Risdiplam. …….

xxx xxx xxx”
(Emphasis Supplied)

32. Reading of the aforesaid clearly shows that it is the categorical stand of the plaintiffs that the International Genus Patent does not specifically disclose Risdiplam, while the International Genus Patent claims a genus of compounds to which the Risdiplam belongs. Thus, it is an admitted position that the International Genus Patent and the Species Patent relate to the very same product, namely, Risdiplam. In this background, the question arises as to the gap between the coverage and disclosure.
33. On this aspect, it would be fruitful to refer to the judgment of the Supreme Court in the case of Novartis AG Versus Union of India and Others13, wherein, the Supreme Court, has held as follows:
“xxx xxx xxx

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.

xxx xxx xxx

124. Chisum on Patents: A Treatise on the Law of Patentability, Validity, and Infringement (Vol. 3-6-2007) in chapter “Adequate Disclosure” notes:
“§ 7.03. — The enablement requirement

Since 1790, the patent laws have required that the inventor set forth in a patent specification sufficient information to enable a person skilled in the relevant art to make and use the invention.

The ‘invention’ that must be enabled is that defined by the particular claim or claims of the patent or patent application. This is consistent with the general principle of patent law that the claim defines the invention for purposes of both patentability and infringement.”

xxx xxx xxx

134. However, before leaving Hogan [Hogan, In re, 559 F 2d 595 (CCPA 1977)] and proceeding further, we would like to say that in this country the law of patent, after the introduction of product patent for all kinds of substances in the patent regime, is in its infancy. We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skilful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.

xxx xxx xxx”
(Emphasis Supplied)

34. It is established law that disclosure can be either explicit or implicit/inherent in nature. The concept of implicit/inherent disclosure is now a widely settled principle, both in India and internationally. Reference may be made to judgment of this Court in the case of Bayer Healthcare LLC Versus NATCO Pharma Limited 14, wherein, it has been considered as follows:
“xxx xxx xxx

63. In the Manual of Patent Office Practice and Procedure, published by the office of the Controller General of Patents Design and Trademarks, it is stated that a generic disclosure in the prior art may not necessarily take away the novelty in a specific disclosure. The onus of proving that the ‘applied for’ patent is not anticipated by prior art is on the applicant. In its ‘Guidelines For Examination of Patent Applications in the Field of Pharmaceuticals’, it is stated as under:

“1. Often broad (generic) patent claims are drafted covering a family of a large number (sometimes thousands or millions) of possible compounds. The so-called ‘Markush claims’ refer to a chemical structure with plurality of functionally equivalent chemical groups in one or more parts of the Compound. The Markush claims are drafted to obtain a wide scope of protection encompassing a large number of compounds whose properties might not have-been tested, but only theoretically inferred from the equivalence with other compounds within the claim. Quite often the Markush claims generate confusion regarding the novelty, non-obviousness and industrial applicability of a group of compounds covered within the sald Markush formula. Also, the Markush claims may invoke the question of sufficiency and plurality of distinct group of inventions surrounding such claims.”

64. It further states that in case of Markush formulae, it is to be checked from the prior art whether compounds disclosed specifically in the prior are of such structure so that they can unambiguously take away the novelty of the compound(s) in the subsequent patent. If the compounds of prior art disclosed specifically do not take away the novelty of the compounds in question, then the generic disclosure in the prior art may still be cited for the purpose of inventive step.

65. It further explains the concept of ‘implicit disclosure’ and ‘inherent anticipation’, as under:—

“7.4 Implicit disclosure: The lack of novelty must normally be clearly apparent from the explicit teaching of the prior art. However, since the prior art is read through the eyes of the person skilled in the art, the implicit features of a document may also be taken into account for determining novelty. Thus, if the person skilled in the art would read a disclosure as including a particular feature without it being specifically mentioned, it would be considered an implicit feature of that disclosure and lack of novelty may be implicit in the sense that, in carrying out the teaching of the prior document, the skilled person would inevitably arrive at a result falling within the terms of the claim. Therefore, if the said prior art discloses the claimed subject-matter in such implicit manner that it leaves no doubt in the mind of examiner as to the content of the prior art and the practical effect of its teaching, an objection regarding lack of novelty should be raised.

7.5 Inherent anticipation: Sometimes the prior art may inherently disclose the subject matter of an invention. In one case before the IPAB, it was held that” patent is invalid for anticipation if a single prior art reference discloses each and every limitation of the claimed invention. The prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating prior art. It is not necessary that inherent anticipation requires that a person of ordinary skill in the art at the time would have recognized the inherent disclosure. But it is necessary that the result is a necessary consequence of what was deliberately intended in the invention”.”

xxx xxx xxx”
(Emphasis Supplied)

35. Similarly in Schering Corporation Versus Geneva Pharmaceuticals, INC. & Others15, United States Court of Appeals, Federal Circuit, has dealt the same principle in detail. The relevant extract from the judgement is reproduced here below:
“xxx xxx xxx

[5] This court recognizes that this may be a case of first impression, because the prior art supplies no express description of any part of the claimed subject matter. The prior art ?233 patent does not disclose any compound that is identifiable as DCL. In this court’s prior inherency cases, a single prior art reference generally contained an incomplete description of the anticipatory subject matter, i.e., a partial description missing certain aspects. Inherency *1379 supplied the missing aspect of the description. Upon proof that the missing description is inherent in the prior art, that single prior art reference placed the claimed subject matter in the public domain. This case does not present the issue of a missing feature of the claimed invention. Rather, the new structure in this case, DCL, is not described by the prior ?233 patent.

Patent law nonetheless establishes that a prior art reference which expressly or inherently contains each and every limitation of the claimed subject matter anticipates and invalidates. See, e.g., EMI Group N. Am., Inc., v. Cypress Semiconductor Corp., 268 F.3d 1342, 1350 (Fed.Cir.2001) (“A prior art reference anticipates a patent claim if the reference discloses, either expressly or inherently, all of the limitations of the claim.”); Verdegaal Bros., Inc. v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed.Cir.1987) (“A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.”). In these prior cases, however, inherency was only necessary to supply a single missing limitation that was not expressly disclosed in the prior art. This case, as explained before, asks this court to find anticipation when the entire structure of the claimed subject matter is inherent in the prior art.

Because inherency places subject matter in the public domain as well as an express disclosure, the inherent disclosure of the entire claimed subject matter anticipates as well as inherent disclosure of a single feature of the claimed subject matter. The extent of the inherent disclosure does not limit its anticipatory effect. In general, a limitation or the entire invention is inherent and in the public domain if it is the “natural result flowing from” the explicit disclosure of the prior art. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 970 (Fed.Cir.2001); see also In re Kratz, 592 F.2d 1169, 1174 (CCPA 1979) (suggesting inherent anticipation of a compound even though the compound’s existence was not known).

In reaching this conclusion, this court is aware of In re Seaborg, 51 C.C.P.A. 1109, 328 F.2d 996 (CCPA 1964). In that case, this court’s predecessor considered claims drawn to an isotope of americium made by nuclear reaction in light of a prior art patent disclosing a similar nuclear reaction process but with no disclosure of the claimed isotope. The court reversed a United States Patent and Trademark Office rejection of the claims for lack of novelty. This court’s predecessor found that the prior art process did not anticipate the claims because the process would have produced at most one billionth of a gram of the isotope in forty tons of radioactive material, i.e., the isotope would have been undetectable. Id. at 998–99 (“[T]he claimed product, if it was produced in the Fermi process, was produced in such minuscule amounts and under such conditions that its presence was undetectable.”). In this case, DCL forms in readily detectable amounts as shown by the extensive record evidence of testing done on humans to verify the formation of DCL upon ingestion of loratadine.

[6]. This court sees no reason to modify the general rule for inherent anticipation in a case where inherency supplies the entire anticipatory subject matter. The patent law principle “that which would literally infringe if later in time anticipates if earlier,” Bristol–Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1378 (Fed.Cir.2001), bolsters this conclusion.

Similarly, “if granting patent protection on the disputed claim would allow the patentee to exclude the public from practicing the prior art, then that claim is anticipated.” Atlas Powder, 190 F.3d at 1346. “The *1380 public remains free to make, use, or sell prior art compositions or processes, regardless of whether or not they understand their complete makeup or the underlying scientific principles which allow them to operate. The doctrine of anticipation by inherency, among other doctrines, enforces that basic principle.” Id. at 1348. Thus, inherency operates to anticipate entire inventions as well as single limitations within an invention.

Turning to this case, the use of loratadine would infringe claims 1 and 3 of the ?716 patent covering the metabolite DCL. This court has recognized that a person may infringe a claim to a metabolite if the person ingests a compound that metabolizes to form the metabolite. See Hoechst–Roussel Pharms., Inc. v. Lehman, 109 F.3d 756, 759 (Fed.Cir.1997) (“[T]he right to exclude may arise from the fact that when administered, [the accused product] metabolizes into another product … which Hoechst has claimed.”); see also Zenith Labs., Inc. v. Bristol–Myers Squibb Co., 19 F.3d 1418, 1421– 22 (Fed.Cir.1994) (stating that a compound claim could cover a compound formed upon ingestion). An identical metabolite must then anticipate if earlier in time than the claimed compound.

The record shows that the metabolite of the prior art loratadine is the same compound as the claimed invention. Claims 1 and 3 are compound claims in which individual compounds are claimed in the alternative in Markush format. DCL is within the scope of claims 1 and 3. Because the prior art metabolite inherently disclosed DCL, claims 1 and 3 are anticipated and invalid. In other words, the record shows that a patient ingesting loratadine would necessarily metabolize that compound to DCL. That later act would thus infringe claims 1 and 3. Thus, a prior art reference showing administration of loratadine to a patient anticipates claims 1 and 3.

C.

This court next examines whether Schering’s secret tests of loratadine before the critical date placed DCL in the public domain. Before the critical date, Schering only tested loratadine in secret. Thus, according to Schering, “DCL was not publicly used, or described in any printed publication, until after February 15, 1983, the critical date for the ?716 patent under 35 U.S.C. § 102(b).” Schering thus argues that DCL did not “exist” in the public domain such that DCL could be prior art against the ?716 patent.

[7] Anticipation does not require the actual creation or reduction to practice of the prior art subject matter; anticipation requires only an enabling disclosure. In re Donohue, 766 F.2d 531, 533 (Fed.Cir.1985). Thus, actual administration of loratadine to patients before the critical date of the ?716 patent is irrelevant. The ?233 patent suffices as an anticipatory prior art reference if it discloses in an enabling manner the administration of loratadine to patients.

[8] Thus, this court examines whether the ?233 patent contains an enabling disclosure of DCL. A reference may enable one of skill in the art to make and use a compound even if the author or inventor did not actually make or reduce to practice that subject matter. Bristol–Myers, 246 F.3d at 1379; see also In re Donohue, 766 F.2d at 533 (sustaining an anticipation rejection over a reference disclosing a compound and other references disclosing sufficient information to make that compound). Indeed, information arising after the critical date may show that the claimed subject matter, as disclosed in a prior art reference, “was in the public’s possession.” Bristol– Myers, 246 F.3d at 1379 (citing In re Donohue, 766 F.2d at 534).

……..

xxx xxx xxx”
(Emphasis Supplied)

36. Accordingly, it is evident that as per law of the land, disclosure can be implicit/ inherent, and there is no stringent rule that it ought to be explicit in nature. Thus, if from the prior art, it can be inferred that there is disclosure, though implicit/ inherent, that would be a valid ground for challenging the validity of a patent.
37. It is also pertinent to mention here that the plaintiffs have filed a suit for infringement against the defendant herein, in US, alleging infringement by the defendant of the US Genus Patent, US’955, on the ground that the defendant is planning to launch Risdiplam, which infringes the said Genus Patent. Thus, by plaintiffs’ own showing, Risdiplam is disclosed in the US Genus Patent, US’955 (Corresponding Patent to the International Genus Patent, WO’916) and the right of the plaintiffs in the said Genus Patent is capable of being enforced with respect to claims of infringement towards the compound Risdiplam. The plaintiffs on account of this fact, cannot as per convenience, agitate their claims in different jurisdictions for different patents of the same family, and thereafter assert non-disclosure of Risdiplam in the International Genus Patent, when it comes to the Suit Patent.
38. In this regard, reference may be made to the judgment of this Court in the case of Astrazeneca AB and Others Versus P. Kumar and Another16, wherein, it has been held as follows:
“xxx xxx xxx

72. As noted above, the facts here show that the plaintiffs have been showing working of IN 229 through TICAGRELOR to the Controller of Patents while filing Form 27. The plaintiffs have filed proceedings for breach of IN 229 when the drug in question was TICAGRELOR in USA. These are important facts which have a material bearing on the issue as to whether TICAGRELOR is disclosed in IN 229 and is known and anticipated. The plaintiffs were obliged to have revealed the full facts in the plaint. This is especially so, keeping in view the fact that Micro Labs Ltd. had already filed an application for revocation of the suit patents before IPAB in 2015 where various grounds were urged including the fact that the suit patents are disclosed and covered in IN 229. The said petition clearly states that the compounds as disclosed in IN 907 and IN 984 are known and anticipated in light of IN 229 and could have been developed by a person skilled in the art. There is clear omission of the plaintiff to mention these materials and important facts in the plaint.
73. The above facts, in my opinion, show that the claim of the plaintiff that TICAGRELOR is not disclosed in IN 229 and is not anticipated is subject to a strong challenge by the defendant. This is so on account of the admissions which prima facie the plaintiff have not been able to explain properly. This is also shown on account of the conduct of the plaintiff as noted above.

xxx xxx xxx”
(Emphasis Supplied)

39. Likewise, the Division Bench of this Court in the case of Astrazeneca AB and Another Versus Intas Pharmaceutical Ltd.17, has held that when a party has pleaded infringement of its genus patent, while claiming a species patent, at the stage of consideration of interim application, the same has to be treated as an admission that the invention in question was known while obtaining the genus patent. Thus, it has been held as follows:
“xxx xxx xxx

21. In our opinion, with respect to one invention, there can be only one patent. The appellants/plaintiffs herein however, while claiming one invention only i.e. DAPA, are claiming two patents with respect thereto, with infringement of both, by the respondent(s)/defendant(s). The same alone, in our view, strikes at the very root of the claim of the appellants/plaintiffs and disentitles the appellants/plaintiffs from any interim relief.

xxx xxx xxx”

34. The words ‘Markush’, ‘Genus’, ‘Species’, do not find mention in the Patents Act. We thus proceeded to examine, whether in the Indian statutory regime, what the counsel for the appellants/plaintiffs has argued, is permissible i.e. of a patent being first granted of “a core structure” and/or of a formula, only “generally describing the molecules, rather than detailing each and every molecule covered by the formula” and thereafter a second patent being granted detailing each and every molecule. The counsel for the appellants/plaintiffs referred to Section 10(5) in this regard.

xxx xxx xxx

39. Rather, according to the arguments of the counsel for the appellants/plaintiffs, IN 147 was with respect to mere discovery of a scientific principle or formulation of an abstract theory or was a mere presentation of information and qua which under Sections 3(c) and 3(n) respectively, no patent could be granted. However, not only was the patent obtained but also infringement thereof claimed in the suits from which these appeals arise, admitting DAPA to be the new product subject matter of IN 147. If IN 147 did not disclose DAPA and specifications thereof did not describe DAPA or the best method of industrially manufacturing DAPA, there could be no infringement of IN 147 from the action of the respondent(s)/defendant(s) making and selling medicines/drugs with DAPA as ingredient thereof. The provisions afore noticed of the Patents Act, in our view, do not permit a patent to be granted with respect to the important stage in the inventive process and at which stage there is no product capable of industrial application, even if having technical advancement as compared to the existing knowledge. The appellants/plaintiffs on the other hand, as aforesaid, not only claimed patent IN 147 at the “breakthrough” stage, when according to them DAPA was not even known but even after obtaining patent IN 625 with respect to DAPA, by suing the respondent(s)/defendant(s) have pleaded infringement of IN 147 also. At least at this stage the same has to be treated as an admission of DAPA being known while obtaining IN 147.

xxx xxx xxx

46. In our opinion, a single formulation as DAPA, is incapable of protection under two separate patents having separate validity period. The appellants/plaintiffs, in their pleadings, are not found to have pleaded the difference, save for pleading that DAPA was discovered by further research. From the field of the invention subject matter of the two patents being verbatim same, at this stage, it also appears that there is no enhancement of the known efficacy, within the meaning of Section 3(d) of the Act, between the product subject matter of IN 147 and the product subject matter of IN 625.

47. To hold, that an inventor, merely on the basis of his work, research, discovery and prior art, but which has not yielded any product capable of commercial exploitation, is entitled, by obtaining patent thereof, to restrain others from researching in the same field, would in our view, not be conducive to research and development and would also be violative of the fundamental duties of the citizens of this country, enshrined in Article 51A of the Constitution of India, to develop the scientific temper and a spirit of inquiry. The same will enable busy bodies to, by walking only part of the mile, prevent others also from completing the mile.

xxx xxx xxx”
(Emphasis Supplied)

40. Another important factor that bears consideration by this Court is the fact that at least four lead inventors are common to the International Genus Patent and the Suit Patent, which is the Indian Species Patent. Reference may be made to the details of the inventors of the Suit Patent and the International Genus Patent, which is reproduced, herein under:

International Genus Patent – WO’916
Suit Patent – IN’397
Inventors
Ratni Hasane; Green Luke;
Naryshkin Nikolai;
Weetall Maria L;
Qi Hongyan;
Choi Soongyu;
Dakka Amal;
Karp Gary Mitchell;
Narasimhan Jana;
Turpoff Anthony A;
Welch Ellen;
Woll Matthew G;
Yang Tianle;
Zhang Nanjing;
Zhang Xiaoyan;
Zhao Xin;
Pinard Emmanuel

Ratni, Hasane; Green, Luke;
Naryshkin, Nikolai A;
Weetall, Maria L.

41. In this regard, the Division Bench in the case of Astrazeneca AB Versus Intas Pharmaceutical Limited (DB)18, has held as follows:
“xxx xxx xxx

29. It cannot be lost sight of, that the inventor of both, IN 147 and IN 625 and/or of US equivalents thereof was/is the same. The said inventor, as compared to a third person, was best placed to know the inventive step i.e. technical advancement in the invention subject matter of IN 625, over that of the earlier invention subject matter of IN 147. However, in the description of field of invention of IN 625, neither any technical advancement or difference in efficacy of the new products subject matter thereof over the product subject matter of IN 147 is mentioned nor any economic significance of the new invention claimed. Once the inventor himself, while writing and seeking the patent, has not mentioned so, the subsequent claims of the assignee of the patent, in this regard, at least at the stage of judging prima facie case, cannot be accepted and have to be necessarily put to trial.

30. The tests of “obvious to a person skilled in the art” and “anticipation by publication” and “use before the date of filing of patent application with complete specification”, in the context of an earlier patent and its specifications, in our view, have to be different, when the inventor of both is the same. The counsel for the appellants/plaintiffs has argued, that owing to delays in obtaining approvals of Drug Regulators in different jurisdictions, for marketing of a new drug/medicine, after obtaining patent with respect thereto, results in the inventor/patentee being not able to enjoy the exclusivity granted under the Patent Laws to the inventor/patentee, for the full term of the patent. However merely because there are such delays, would not be a reason for the Court to give to the patent a longer life than provided in the statute. The