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Landmark Judgment on Section 3(i), Amendments, Synergy & Inventiveness Sub-Test

LexOrbis India


Since the creation of the new IP Division in the Delhi High Court, the interpretation of the Indian Patents Act, 1970 (the “Act”) is gaining momentum, and dark and ambiguous corners of legal text are being explained by the Indian Courts. On the one hand, a large proportion of appeals has been disposed on account of non-adherence to the natural justice principle (i.e., procedural lapses or non-speaking orders) in the first-stance proceedings at the Indian Patent Office (IPO), resulting in the remand of these cases back to IPO. On the other hand, a few judgements enlighten us on crucial law points and liberal teachings of patent provisions. The latter class is the focal attraction for the purpose of the instant article, in which we analyze a recent judgement of the Delhi High Court that dives deep into the merits of the case/ appeal and offers a complete re-hearing of law and facts along with re-appreciation of evidence and extends a rare opportunity of making amendments at the appellate stage.

Let us now unveil the layers of the crisp and pin-pointed verdict of the Delhi High Court in Societe Des Produits Nestle SA v Controller of Patents (2023/DHC/000774) that propounds progressive glimpses on multiple counts – non-patentability, scope of amendments, synergistic effect, and inventive step analysis. For the sake of clarity, Nestle or Appellant or Applicant will be used interchangeably and Controller or Respondent or IPO will have the same connotation. 

Subject Invention

The applicant filed a patent application bearing the title “Composition for use in the Prophylaxis of Allergic Disease” in 2018. The composition comprised an ω-6 fatty acid DGLA for use in prophylaxis of allergic disease in an offspring of a mammalian subject, comprising administration of the composition to said subject pre-pregnancy and/or during pregnancy and/or during lactation. Also, the composition comprised certain ω-3 fatty acids, which could either be DHA or EPA or even a combination of DHA and EPA. Thus, the applicant’s invention was a composition comprising DGLA, DHA and/or EPA. It was further disclosed that the administration of this composition yields technical advancement or effect of reduction of allergies in the offspring of a mammalian subject (including humans). Data on technical/synergistic effects was illustrated through examples and figures. The total claims as originally filed were fourteen (Claim Set 1).

IPO’s Proceedings and Controller’s Impugned Order

The First Examination Report (FER) raised, inter alia, the substantive objection of non-patentability u/s 3(i) of the Act, which bars a ‘method of treatment’ from patentability. In response to FER, the applicant amended the claims and limited them to five (Claim Set 2). Still, the Controller retained Section 3(i) objection in the hearing notice. Post-hearing, the applicant filed the written submission along with further amendments having only three claims (Claim Set 3). The Controller held that amended claims were not permissible u/s 59 and rejected the patent application on the ground of non-patentability u/s 3(i) and lack of inventive step and synergy.

The applicant assailed the Controller’s refusal order by filing an appeal where the High Court examined each of the contention placed before it, and the following five issues were addressed:

  1. First-ever judicial scrutiny of “method for treatment” exclusion clause

The non-patentability objection u/s 3(i) was pivotal in the whole case and it was dealt with first by the Court. The Controller’s objection was that the claims of patent application were directed towards a “method for treatment of the human body”. To overcome the objections of the patent office, in Claim Set 3 the appellant removed the phrase “for use in prophylaxis of allergic disease in an offspring of a mammalian subject, comprising administration of the composition to said subject pre-pregnancy and/or during pregnancy and/or during lactation” and retained ‘composition’ only. The appellant argued that amended claims were towards a ‘composition’ and not towards a ‘method of treatment’ and covered by a claim as originally filed. Therefore, the appellant submitted that the finding of the IPO that claims relate to a ‘method of treatment’ was wholly erroneous. The Respondent reiterated that claims defined medicinal use in terms of the method of treatment/ prophylaxis, which is barred u/s 3(i).

Interpretation and Claim Construction

The Court assessed the applicability of Section 3(i) to the subject invention. In the context of the instant case, the Court read the text of the said provision as follows:

“(i) 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”

Thus, it was held that any claim directed towards a process for the prophylaxis or prophylactic treatment of human beings to render them free of disease is not patentable as per the Act.

Claim construction is the process in which courts interpret the meaning and scope of an invention’s claims. Construing the claims is a critical step in determining the outcome of patent disputes. In the present case, the Court construed that the subject claims were directed towards a composition, comprising DGLA, EPA and DHA, which had been developed for the purpose of using the same in the prophylactic treatment of allergic diseases. It would mean that the said composition was useful in preventing or reducing the risk of the development of allergies. The Court clarified that the expression “composition comprising DGLA directed towards treatment” was used only for defining the composition and not directed towards a method of treatment. The Court held that all three claim sets were in respect of the composition and not directed towards a method of treatment.

  1. Amendment of Claims due to wrong application of law by the IPO

The Controller rejected the claims on account of expanding the scope of the claims. The appellant amended claims from “a composition comprising DGLA for use in prophylaxis of allergic disease” (Set 1 or 2) to “a composition comprising DGLA” (Set 3). It can be noted, previous claims contained both “composition” and “method features” and amended claims contained only “composition”. In Controller’s wisdom, and rightly so, while amending claims, original scope of claims stood enlarged – a purpose-related product claim became a general claim over the composition.

However, the Court found that the amendments were made by the appellant only on account of an objection raised by the Patent Office u/s 3(i) to delete features related to “method of treatment”. As already discussed above, the 3(i) objection was held untenable by the Court for all the claim sets (1/2/3) in the first place. Thus, the erroneous application of 3(i) on the part of IPO led to an undesirable amendment on part of the Appellant. Once the eclipse of 3(i) was removed by the Court, the appellant was granted liberty to pursue the previously filed claims in appellate proceedings. Accordingly, the appellant filed the final amended claims (set 4) before the Court and resorted back to the previously filed claims (purpose-limited composition). The High Court allowed the final amendments (Set 4), which were now fully covered u/s 59.

  1. Question of Law – Can the High Court direct for Amendment?

When the High Court directed the appellant to file a final set of claims to be considered before it, the Respondent IPO strongly objected that there was no provision in the Act that permits High Court to allow any amendment. The Court addressed the issue – of whether an amendment can be allowed at the stage of appeal or not.

Section 57(3) shows that an amendment application can be made even after the grant of the patent. Section 58(1) shows that an amendment to the specification can be allowed in the proceedings before the High Court at the stage of revocation of a patent. Thus, there is no specific bar in the Act for amendment at the appellate stage so long as amended claims are not inconsistent with the earlier claims as originally filed.

The Court held that it is a settled position of law that an appeal is a continuation of the proceedings of the original court. The appellate jurisdiction involves a re-hearing on the law as well as on facts. Thus, the High Court, sitting in appeal and considering the issue of grant of the patent, should necessarily have the same powers as given to the Controller u/s 15, which includes the power to require amendment.

  1. Synergy – What and How much data is sufficient?

As the subject invention was a composition of three ingredients (DGLA, EPA and DHA), the synergistic effect u/s 3(e) was required to be demonstrated – an interaction between two or more drugs that causes the total effect of the drugs to be greater than the sum of the individual effects of each drug. The Controller submitted that sufficient data was not supplied to show synergism as the application lacks data on the individual effects of each component (when each component is used alone). It was objected that data on one important parameter (IL4) showed the result effect of DGLA alone but lacked the result of effect of DHA alone and EPA alone.

The Court observed that said data provided a comparison between IL4 values of the control group, DGLA alone, fatty acid mix of DHA and EPA and the claimed composition. The reduction of IL4 held a synergistic effect of the claimed composition. The synergistic case of the appellant was also duly supported by data from five other parameters. The Court reaffirmed that it was not necessary to disclose all conceivable ways of operating the invention. If the best method known to the patentee is disclosed, it is sufficient.

  1. Exemplary Inventive Step Analysis

The Controller held that prior art (D1 & D2) evidence rendered the invention obvious. The Court carried out a step-by-step inventive step analysis as per the test laid down in Roche v Cipla 2016 (65) PTC 1 (Del). D1 was considered the closest prior art, but it was completely silent on ω-3 fatty acids (DHA & EPA), whereas the subject composition was a mixture of DGLA (ω-6 fatty acid) and DHA & EPA (both ω-3 fatty acids). As D2 was aimed at an entirely different purpose, i.e., for combating dyslexia or inadequate night vision, not to prophylaxis allergies, D2 was teaching away, and there would be no benefit if D2 was combined with D1. The Court held that if these differences between the prior art and subject invention were “obvious to try”, then the same would have been attempted by now, especially considering old-aged prior art (both almost 20 years old).

In addition to the main technical test, the Court also applied the non-technical secondary test in the obviousness analysis. It was held that the age of prior art is a relevant consideration for determining if the subject matter of patent application would be obvious to a skilled person. The Court emphasized that the subject application was showing technical advancement over the considerably old prior art which was a clear indicator of non-obviousness.

On examining all grounds as discussed above, the Court allowed the appeal and the application proceeded for the grant. 

Conclusion

With respect to Section 3(i), scant rulings of erstwhile quasi-judicial IPAB and only tangential judicial remarks were available. Section 3(i) is also multi-pronged (medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment). The Nestle verdict thoroughly shed light on one aspect of this provision viz., prophylactic treatment. The finding is vital – the use of expression the ‘treatment’ in the claims may not render a claim falling u/s 3(i). In the Indian landscape, Section 3(i) is perceived as one of the major hurdles for patentability and interpretation provided, in this case, could have a bearing on a large number of pharmaceutical and biotechnological applications.

In an appeal challenging the refusal of grant of a patent, questions of facts need to be re-examined comprehensively, and therefore, a liberal view must be taken with respect to the amendment of claims. The amendment of purpose-limited product claims to general product claims would clearly be in the teeth of Section 59. However, the amendments falling outside the scope of Section 59, due to the wrong application of non-patentability, can be remedied by the High Court at the appellate stage.

The Nestle pronouncement is not only a pro-patentability decision but also a model guidance for IPO. Patent Office should update its procedure, guidelines, and manual to incorporate relevant ratios of this judgement, particularly the liberal stand on ‘method of treatment’ exclusion and excellent textbook application of the Roche inventive test and time-factor secondary test. It would curb variation in IPO practice.

 

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