In May 2023, the UK Court of Appeal upheld the invalidity of Bristol-Myers Squibb’s Apaxiban patent for lacking “plausibility”. But how does this finding interact with the position of relevant laws in India? Responding to this question, we are pleased to bring to you this guest post by Amit Tailor, discussing whether the “plausibility” requirement is embedded within the Patent Act. Amit is a postgraduate in Pharmaceutical Sciences from National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar (Mohali) and LL.B. from Faculty of Law, Maharaja Sayajirao University of Baroda (MSU), Vadodara. He has also completed his graduation in Pharmacy from MSU, Vadodara. Amit is a registered Patent Agent and is currently part of IP litigation team at Sun Pharmaceuticals. Amit also writes poetry at amittailor.kavi (Instagram), અમિત ટેલર (Facebook) and at http://www.amittailor.com. His previous posts can be found here. Views expressed here are those of the author’s alone.
‘Plausibility’ and Admissibility of Post-Published Data in India
By Amit Tailor
Plausible or plausibility is not a purely legal term or concept. (i) “Likely to be true, or possible to believe”, (ii) “seeming reasonable or probable” or (iii) “how likely it is to be true”, are some of the general definitions for ‘plausible’ or ‘plausibility’. There is nothing express that may directly relate plausibility to patents (para 58 & 92). The term ‘plausibility’ became a ‘hotly debated’ issue, in IP and patent community in recent past, when a UK Court revoked a patent related to a drug substance on the ground (amongst others) that the patent (specification) does not disclose ‘enough’ that would make it plausible (for the skilled person to believe) that the drug would have (any) useful activity as suggested by the specification (and/or claims). “… a patentee is required to demonstrate that the specification discloses some scientific reason why the implied assertion of efficacy in the patent claim is true. Whilst experimental data is not necessarily required, a bare assertion or mere possibility of therapeutic efficacy is not enough.” (Plausibility Hurdle…). Soon thereafter another decision was pronounced on the similar issue, this time from EPO’s Enlarged Board of Appeal (G2/21) wherein the Board set the standard for the EPO that – “a patentee may rely upon post-filed evidence in support of a technical effect if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention.”(G2/21: Post File…).
Plausibility ‘Embedded’ in the Patents Act?
These decisions from Europe would force one to check the corresponding position and relevant jurisprudence, if any, in India, under the Indian Patents Act (The “Patents Act” or the “Act”). Plausibility may not have been debated and/or argued in India literally as ‘plausibility’, most probably, because the term ‘plausible’ or ‘plausibility’ is not expressly found in the Act. But, that does not mean that ‘plausibility’ can be ruled out completely as an ‘issue’ under the Act, (at least not from the judgments discussed herein).
The ‘plausibility’ issue was apparently under discussion or consideration before the IPD of Delhi High Court in Ischemix Llc vs The Controller, wherein the Court commented that “13. … the patent specification, itself, ought to contain some data and results of lab experiments which demonstrate enhancement of efficacy…” and “16. … any benefit of placing reliance on data filed after the priority date … would be permissible subject to the same having a basis in the complete specification.”.
So, the use of expressions like “the patent specification, itself, ought to contain some data and results” and “subject to the same having a basis in the complete specification”, by Ischemix, hints that the Court was indicating requirements of disclosure under Indian Patents Act similar to those discussed by the above European decisions like ‘encompassed’ or ‘embodied’ by the original disclosure.
Post-Published Data: Admissibility & Reliance Thereon
Ischemix specified that imposing the above requirements for the complete specification that, ‘some’ data should be present in the specification itself to demonstrate technical advancement, and any additional post-published data shall be admissible if it finds basis in the complete specification; is in line with another decision from the same Court in AstraZeneca vs Intas. Relevant operating part from AstraZeneca, in turn, relied on another European decision – an England and Wales High Court (Patents Court) Decision in Generics (UK) vs Yeda Research (cited by Plaintiff therein). Generics (UK) held that –
“[post-published data/evidence] can only be relied upon to confirm the existence of a technical effect which is plausible in the light of the specification and the skilled person’s common general knowledge, and not to establish the existence of a technical effect for the first time.”
Based on this guidance, AstraZeneca declared that –
“30.4 … post priority date evidence … to show technical advance can only be taken into account to confirm the existence of technical effect which is found embedded in the specification … and is capable of being understood by a skilled person having common general knowledge and not to rely upon the same to establish its effect for the first time”. (Emphasis supplied)
Relying on said operating part of AstraZeneca, Ischemix directed the Controller to hear the matter afresh taking into consideration all the data brought, or to be brought, on record; ‘emphasising’ that – “16. … any benefit of placing reliance on data filed after the priority date of the subject patent application would be permissible subject to the same having a basis in the complete specification”
Said operative parts of the two decisions speaks for themselves for reading of ‘plausibility’ requirements and treatment of post-published data in India.
Plausibility & Patentability
All of the three European decisions (two discussed in the opening paragraph and one cited in AstraZeneca) and the two Indian decisions – AstraZeneca and Ischemix, may relate to different underlying subject matter and different kinds, volumes and types of technical data; and to some extent with different purposes and contexts in which they were presented, and were to be considered. Still one common issue can be identified that can bind them all together, and that is – all of them involved provision and/or admissibility of technical data generated and/or published after the priority date of the invention; and whether, and to which extent, reliance can be placed thereon.
In AstraZeneca the post-published data was being relied upon to establish technical advancement, i.e. inventiveness, u/s 2(1)(ja); while in Ischemix the post-published data was being relied upon to establish enhanced efficacy u/s 3(d). Though the issue of admissibility of post-published data was involved in both of them, the underlying provisions of the act and the relevant inquiries thereunder were different. However, both of them can still be associated with one or the other factor for the determination of patentability.
Therefore, it would be safe to say that the two decisions are at harmony with each other on a common and broader issue of – admissibility of post-published data for determination of patentability.
Full-and-Particular Disclosure Standard – Root of Plausibility?
Ischemix relies upon AstraZeneca, and AstraZeneca relies upon Generics (UK), to buttress their respective positions on disclosure requirements, but surprisingly, none of them clearly and unequivocally provides under which provision of the Act, such requirements have been imposed. However, such inquiry may be premised on Section 10, read with Sections 2(1) and 2(1)(ja), of the Act.
Sec 10, Clause (1) requires that every specification, whether provisional or complete, shall describe the invention; and Clause (4), sub-clause (a) requires that every complete specification shall fully and particularly describe the invention and its operation or use and the method by which it is to be performed. Section 2(1) defines ‘invention’ as “a new product or process involving an inventive step and capable of industrial application” and Section 2(1)(ja) defines ‘inventive step’ as “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”
When definitions of invention and inventive step are read together with Clause (1), and especially Clause 4(a), of Section 10, than it may be read as – the complete specification shall describe the invention in such full and particular manner that the feature of the invention, that involves technical advancement or economic significance or both, is also fully and particularly described along with its operation or use and the method by which it is to be performed.
Additionally, the relevant clause of Sec 3(d) reads as “a new form of a known substance which does not result in the enhancement of the known efficacy of that substance (is not an invention within the meaning of this Act)”. Accordingly, if the same is also read in consonance with above reading of Sec. 10(1), 10(4), 2(1) and 2(1)(ja), than the full-and-particular disclosure related to enhancement of efficacy of known substance may also be required to be provided within the specification as filed.
Co- and Post- filed Evidence, Admissibility and Relevance: Summary
Though, the Act does not expressly provide any provision for plausibility, and that none of the two recent judgements from the High Court expressly provides any basis for the same in the Act; some implied basis for plausibility, as provided by the Court, may be found in Sec. 10(1), 10(4), 2(1) and 2(1)(ja); and likewise in Sec 3(d).
The relevant operating parts of AstraZeneca and Ischemix, their guidance on requirement of disclosure in specification, and admissibility of post published evidence can be summarised as follows –
- specification as filed should contain some data and experimental results
- post-published data can be placed on record to support patentability;
- (however) reliance can be placed on post-published data only to confirm the existence of a technical effect which is found embedded in the specification; or say otherwise – there is at least a clue of the technical advancement, or at least a seed of that nature had been planted, in the specification on its priority date;
- and said alleged technical effect should be capable of being understood by a person, having common general knowledge in the field of the invention, that such technical effect is so embedded or seeded in the specification as filed;
- post-published data cannot be relied upon to establish the technical advancement (or enhanced efficacy) for the first time; and
- post-published data, if any, upon which a party wishes to rely, should be brought on record before the final date of oral hearing.
(Disclaimer from the Author: This work is purely an academic exercise to compile and summarise, in general, relevant operating parts of the cited judgements and their reliance on precedences. This does not represent final or binding views of the author on any of the issues discussed and this cannot be attributed, in any way, with the present, past or future employers of the author.)
