| CITATION | 15th November 2016 |
| DATE OF JUDGMENT | 20th September 2023 |
| COURT | Madras high court |
| APPELLANT | Novozymes |
| RESPONDENT | Assistant controllers of patents and designs |
| BENCH | Justice Senthil Kumar Ramamoorthy |
SUMMARY
In the following case an appeal was filed under section 117A of Patents Act 1960 to pass order and set aside n the following case of novozymes v assistant controllers of patents and designs an appeal was filled under section 117A of the Patents act 1970 to pass and order to set aside the challenged order of Appellant Controller of patents and design dated 15 November 2016. The case goes around an invention entitled Phytase Variants which was subsequently changed to phytase variants with improved thermostability. Justice Senthil kumar Ramoorthy J while setting aside challenged order claiming made rejection and provided with two essential statements-:
- It was established that the term “known substance” in Section 3(d) applies to biochemical substances as well
- The composition claims 8 to 11 were deemed to fall under Section 3(e) because the composition was considered a substance resulting from the mere combination of ingredients.
INTRODUCTION:
In the following case the major question was can there be reconciliation between the science of biochemical and the realm of section 3(d) in the Indian Patents Act. The court provided a constructive interpretation of the same making understand the chemical substances that fall under the purview of section 3(d). Further justice moorthy invoked the doctrine of “ejusdem generis” which refers to of the same kind. The court set aside the Indian Patents Office(IPO) order partly and ultimately ruled that section 3(d) does apply to the biochemical substances but the explanation to 3(d) doesn’t apply to claimed intervention. Therefore novozymes appeal to be accepted by the court. In this case the court depended upon the division bench and the apex court’s verdict in Novartis AG, to arrive at a conclusion.
BACKGROUND:
The case evaluates the scope of section 3(d) of IPO particularly concerning the patentability of procedures creating variations of proteins. The appellant novozymes had impugned the IPO order in which claims were rejected on the basis that claimed invention in claim 1 and 3 relating to phytase variant with improved thermostablity is a known substance and not a patent eligible under section 3(d). Further claims 8-11 fall within scope of section 3(e) as composition is an admixture of ingredients.
FACTS OF THE CASE
- In the case appellant challenged the order dated 15 November 2016 wherein respondent refused to grant patent. The application relates to invention that was originally titled “Phytase Variants” was changed to Phytase Variants with improved thermostability
- the claims made by the appellant were rejected majorly on the basis that the claimed invention in Claims 1 and 2 relating to the phytase variant with improved thermostability is a known substance not patent eligible under section 3(d)
- It was claimed that the claims 8 to 11 falls under section 3(e) as the composition is a mere admixture
- A composition involving at least one phytase of claim 1
- Comprising at least one fat soluble vitamin
- The composition of 8 further comprising at least one enzyme selected from amylase, phytase, phosphatase
ISSUES ARISED:
The major issues involved in this case move around the interpretation of section 3(d) and section 3(e) of Indian Patents Act.
Section 3(d) – Does the term “known substance” in section 3(d) applies only to pharmaceutical substances or does it include other biochemical substances like phytase?
Section 3(d) – whether enhanced thermostability should be considered an improvement of efficiency?
Section 3(e) – Does this section apply only to compositions formed by sum of known ingredients, or can it be applied to composition claims for substances with individual components that meet patent requirements?
APPELLANT’S ARGUMENTS
- The appellant novozymes argued that section 3(d) was not restricted to pharmaceutical products and that biochemical substances like phytase fall under it the contentions were supported by division bench
- Novozymes contended that improved thermostability improves the efficiency of phytase as it enables easier production and storage in pellet form.
- It also exclaimed that section 3(e) doesn’t apply unless the substance is obtained by a admixture of known ingredients
- Ms Vindhya S. Mani questioned that section 3(d) enables the grant of a patent to develop a new form of known substance. To bring attention at the same she brought attention at example 8 of complete specification relating to temperature stability
- She even contended section 3(e) applies to independent claims and not dependent claims, by referring to claim 8 which points to composition comprising at least one fat soluble vitamin. At least one water soluble or trace of mineral. As the major ingredient is phytase of claim 1 section 3(e) is invalid.
RESPONDENT’S CONTENTIONS
- In response, the respondent claimed that section 3(d) of patents act uses the expression “known substance” and not pharmaceutical substance”. hence, section 3(d) is not restricted to pharmaceutical products and as phytase is a biochemical substance it falls under section 3(d)
- Further it was argued that a new form of substance is not patent-eligible unless it leads to enhancement of known efficacy of substance.
- The counsel under section 3(e) claimed that claim 8 that ingredients other than phytase are not provided and composition claim is not patent-eligible unless it previews synergy of ingredients.
JUDGEMENT
The honorable Madras High Court in case Nozymes V. Assistant Controllers of Patents and Designs while partly maintaining the challenged order clarified that section 3(d) of patents act 1970 is not confined only to pharmaceutical substances but also biochemical substance like phytase. The court relied upon a landmark judgment on section 3(d) in Novartis AG v. Union of India concerning the chronic myeloid leukemia.They determined that enhanced efficacy for biochemical substances can extend beyond increased enzymatic activity, specifically where factors like better thermostability leads to easier production.The court also ruled that section 3(e) of the act includes all claims involving compositions, even those incorporating major ingredients, heightening the difficulty of patent acquisition.
Further court didn’t find that the invention claimed fell within the scope of 3(d) and the principle of “ejusdem genris” was invoked in this case.The court even held that even a marginal improvement in efficacy could lead to patentability requirement.The Court maintained the Respondent’s refusal decision not to grant claims 8-11 under section 3(e) of the Act due to the absence of evidence that the composition was more than the sum of its parts.
In the case it was clarified that Section 3(d) of the Act applies to biochemical inventions and that the enhancement of efficacy should be examined broadly.It also expands the application of section 3(e) to all composition claims and raises the bar for patentability in this regard.
ANALYSIS
In this case involving section 3(d) and section 3(e) of patents act it is clear that these sections were not restricted to pharmaceutical substances but also to biochemical products leading to increased patent eligibility.
Further the judgment provides an insight that improved efficiency for biochemical substances provides enhanced thermostability and also provides flexibility in ensuring patentability of applications including enzymes and other substances. Also it gives a glance of section 3(e) of patent act where it was assured that it applies not only to compositions formed by summing up of known ingredients but where the composition adds value beyond the individual component
CONCLUSION
Therefore in all this case is a precedent for patenting of biochemical components and composition claims. It provides a purview on interpretation of important and unique sections of Patents Act.
The following case would help provide and offer opportunities for innovations in the field of biochemistry and other scientific fields.
REFRENCES
https://ksandk.com/newsletter/novozymes-vs-assistant-controller-of-patents-designs/
https://patentblog.kluweriplaw.com
Article by: Vrishti Arora, Amity Law School Noida(ALSN), Intern at Legal Vidhya
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