[This guest post is authored by Amit Tailor. 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 with penname “કાચબો” [Kācabō – meaning tortoise/turtle] at kavi_kachbo (Instagram), કાચબો (Facebook) and at http://www.amittailor.com. His previous posts can be found here.]
The IP Division of the Delhi HC, in November-2022, heard an appeal from a Controller’s order rejecting a patent application under sections 3(i), 3(e), 59 and 2(1)(ja) of the Patent Act. While deciding the appeal, the Hon’ble Court made a few observations with respect to claims relating to method of treatment falling within the ambit of Sec. 3(i), and presence of the expressions like ‘for the treatment of’’ or ‘for use in the treatment of’, in the claim; and the impact thereof on the claim scope and claim amendments under section 59. The facts of the case and the observations of the Hon’ble Court are discussed herein. [Societe Des Produits Nestle SA vs The Controller 2023/DHC/000774 delivered in February-2023, Appeal from the rejection of Patent Application No.201817040811]
The Application and Amendments
A PCT application was filed with practically 3 sets of claims –
- A Compound for use in a Medical Condition comprising administering the compound to a Subject In Need (the “Compound for Use” claims);
- A Composition comprising the Compound for use in the Medical Condition, comprising administering the composition to a Subject in Need (the “Composition for Use” claims); and
- A Method of Treatment of the Medical Condition comprising administering the Compound, or a Composition comprising the Compound, to a subject in need (the “Method of Treatment” claims).
The National Phase Application in India was also filed with the same set of claims (pdf) (the “Original Claims”).
In response to the Examination report the “Compound for Use” and the “Method of Treatment” claims were deleted, while the “Composition for Use” claims were amended to describe additional components of the composition and their relative concentration therein(pdf). Later in response to a hearing notice, the claims were further amended to delete the reference to the ‘Medical Condition’ and the ‘administering’ language to read as – A Composition comprising the Compound and additional components and their relative concentration therein (pdf). [The “Composition with Components” claims].
The Controllers Order
The Controller after reviewing the post-hearing submissions, rejected the application with the “Composition with Components” claims on three broad grounds (pdf) –
- the Original Claims were related to the ‘Method of Treatment’ [of Human Body] falling within the ambit of non-patentable subject matter u/s 3(i);
- the amendments entered were not permissible u/s 59, because they would alter the scope of the claims. The Original Claims(“Composition for Use” claims) contained both the ‘composition’ and ‘method’ features, while the amended claims contained only the ‘composition’ feature, thereby expanding the scope of the claims and making them unallowable u/s 59. [I have discussed in detail the Sec. 59 and allowable claim amendments therein, a two part post at SpicyIP]; and
- The data submitted by the applicant for the claimed composition did not demonstrate ‘synergism’. The applicant failed to provide data comparing the individual effects of each active ingredient with that of the combinations thereof to establish synergy. Therefore, the claims are not inventive u/s 2(1)(ja) and would also fall within the ambit of non-patentable subject matter u/s 3(e).
‘Treatment’ Means Only the ‘Method of Treatment’?
On appeal, the Hon’ble Court addressed the three issues one-by-one, starting with Sec. 3(i), which reads as – “any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products”
The Court, first, made it ‘clear’ that any claim directed towards a process for prophylaxis[diagnosis, therapy or any other] treatment of human beings [or animals] would fall within the ambit of Sec 3(i) and would not be patentable; and then went on to determine what would be (rather, what would not be) a ‘Method of Treatment’ u/s 3(i).
Citing erstwhile IPAB in the University of Miami case, the Hon’ble Court suggested that mere use of the expression ‘treatment’ in the text of a claim does not render it a method claim falling within the ambit of Sec. 3(i). The expression ‘for the treatment’ [of a medical condition] can be a way of defining the composition [or the product] itself, with which it is used, and in no way, it can be a method to be performed by a physician for treatment of a disease.
By using the cited language “The expression “composition for the treatment” has been used in the preamble of many claims which have been granted…There are plenty of compositions claimed wherein the composition is defined in the preamble with the disease/condition that is being treated with the composition” [emphasis added], the Hon’ble Court appears to indicate that the expressions like ‘for the Treatment of a Medical Condition’ or ‘for Use in the Treatment of a Medical Condition’ may be considered as a part of claim preamble instead of claim body; and as a definition defining the type of invention of the preamble and not as purpose limiting element of the claim body.
Did Claims Relate to ‘Method of Treatment’?
After determining what would (not) be a ‘Method of Treatment’ claim, the Court reviewed the rejected set of claims – the “Composition with Components” claims, and expressed their views that the claims were related to a Composition comprising a Compound and some additional components and not to any method of treatment. Therefore, the claims would not fall within the ambit of Sec 3(i).
However, the Hon’ble Court, expectedly in light of the above determination, went on to read the claims before the amendment – the “Composition for Use” claims, as directed towards Composition and not a Method of Treatment.
Amendments and ‘Scope Expansion’ u/s 59
On the issue of allowability of the amendments, the Hon’ble Court noted that the L’d Controller read the Original – “Composition for Use” claims, as purpose-limited product claims; and thereby the amended claims(the product claims for the Composition)were determined as enlarging the scope of it, hence rejected u/s 59. However, under above the determination of what is not a method claim, the Hon’ble Court declared that the said amendment from “Composition for Use” claims to “Composition’ claims does not alter or expand the scope of the claim from a “Composition” and therefore allowable u/s 59.
However, after determining that the “Composition with Components” claims are not method claims u/s 3(i) and the amendment from “Composition for Use” claims to “Composition with Components” claims is not the change of scope u/s 59, the Hon’ble Court, at this stage, went on to allow the claims to be restored back to the pre-amendment stage, i.e. with the expression ‘for use in the treatment of a Medical Condition’. However, a comment by the Hon’ble Court while doing so is to some extent problematic – “since the appellant is resorting back to the previously filed Claim, the same is fully covered under Section 59 of the Act.”
As I have discussed the in my earlier post (here at SpicyIP) an amended claim must fall wholly within the scope of a claim before the amendment, i.e. the amended claim is subsumed in the claim before the amendment, but the reverse would not be true. Therefore, the comment of the Hon’ble Court with respect to resorting back to the previously filed claims, in isolation, would be contrary to the express mandate of Sec 59; but when viewed in conjugation with the other findings of the Court that – i) the “Composition for Use” claims are not method claims but product claims; ii) there is no change of scope in amending the claims from “Composition for Use” claims to “Composition Claims”; and that iii) the applicant deleted the language ‘for use in the treatment of a Medical Condition’ to overcome the objection u/s 3(i) which the Court later determined not sustainable; restoring back from “Composition” Claims to “Composition for Use” Claims for the specific facts of the case would be covered u/s 59.
Comments on the Sufficiency of Data are Problematic
On the issue of Sec 3(e), the L’d Controller remarked that the technical data submitted by the Applicant in support of the claimed composition was insufficient to demonstrate any synergism between different components of the composition. But the Hon’ble Court commented that “the [applicant] has provided extensive experimental data in the specification showing the synergistic effect when compared to the individual.”
Such a comment from the Hon’ble Court may set a problematic precedence in this area of patent jurisprudence in India. The patent examiners and the controllers, are technically qualified in the field of the invention that they are examining, and therefore, the Patent Office can be considered to have the necessary technical expertise to review or analyse the scientific data presented before them and draw technical inferences thereon. When a competent authority having the necessary technical expertise has opined that the submitted data is insufficient to meet the requirements of relevant provisions of the Act, the Appellate Court cannot reverse the finding merely based on arguments of a legal counsel without taking help and support from a competent independent scientific expert in the field of the invention.
Without going into the veracity of the opinion of the L’d Controller with respect to sufficiency and relevancy of the data; considering the highly technical nature of the data involved, it would have been more appropriate had the Hon’ble Court taken the assistance of an independent scientific expert, u/s 115 of the Patent Act, rather than relying merely on the counsel arguments to decide on a technical matter.
The Court while setting aside the rejection made the observations that – Mere use of the expression ‘treatment’ in the text of a claim does not render it a method claim falling within the ambit of Sec. 3(i). The expressions like ‘for use’ or ‘in the treatment of’ may be considered as a part of the claim preamble and inclusion or exclusion thereof from the claim language may not alter the scope of it. Thereby the Hon’ble Court not only allowed the “Composition with Components” claims u/s 3(i), but allowed the applicant to reintroduce the expression ‘for use in the treatment of’ in the claims, as well. The Hon’ble Court also determined that the data submitted in support of inventiveness is sufficient and allowed the claims for the composition under sec 3(e) also.