IN THE HIGH COURT OF JUDICATURE AT MADRAS
HON’BLE MR. JUSTICE SENTHILKUMAR RAMAMOORTHY, J.
Novozymes – Appellant
Versus
Assistant Controller of Patents and Designs – Respondent
(T) CMA (PT) No. 33 of 2023 (OA/6/2017/PT/CHN)
Decided On : 20-09-2023
PATENTS - Phytase Variants - Section 3(d), Section 3(e) of the Patents Act, 1970 - The court analyzed the applicability of Section 3(d) and Section 3(e) of the Patents Act to the appellant's claims regarding phytase variants. It interpreted Section 3(d) as not limited to pharmaceutical substances, emphasizing that the enhancement of known efficacy could include improved thermostability. The court also clarified that Section 3(e) applies to compositions that do not exhibit synergistic properties beyond mere aggregation of their components. The court concluded that the claimed invention satisfies the requirements for patentability under Section 3(d) but upheld the rejection of composition claims under Section 3(e).
Fact of the Case:
The appellant challenged the rejection of their patent application for 'Phytase Variants with Improved Thermostability' by the respondent, which was based on Sections 3(d) and 3(e) of the Patents Act, 1970. The claims were rejected on the grounds that the invention was a known substance not patent-eligible under Section 3(d) and that the composition claims were merely admixtures under Section 3(e).
Finding of the Court:
The court found that the claimed invention of phytase variants did enhance known efficacy through improved thermostability, which is significant for its application in animal feed. However, it upheld the rejection of composition claims as they did not demonstrate synergy beyond the aggregation of properties of their components.
Issues: 1. Whether the claimed invention qualifies as a new form of a known substance under Section 3(d) of the Patents Act. 2. Whether the composition claims are patentable under Section 3(e) as they merely aggregate the properties of their components.
Ratio Decidendi: The court held that Section 3(d) applies to all known substances, not just pharmaceuticals, and that enhanced thermostability can constitute an enhancement of known efficacy. It also ruled that Section 3(e) requires evidence of synergy in composition claims, which was lacking in this case.
Final Decision: The court set aside the rejection of claims 1-7, allowing the patent application to proceed for those claims, while upholding the rejection of claims 8-11 under Section 3(e).
JUDGMENT :
SENTHILKUMAR RAMAMOORTHY, J.
Prayer: This Civil Miscellaneous Appeal filed under Section 117A of the Patents Act, 1970, prays (i) to allow the present appeal; (ii) pass an order setting aside the impugned order of the Respondent dated 15th November 2016 and pass an order granting a patent on Indian Patent Application No. 5326/CHENP/2008.
BACKGROUND
1. The appellant challenges the order dated 15.11.2016 of the respondent refusing to grant a patent in respect of Indian Patent Application No. 5326/CHENP/2008. The said application pertains to an invention that was originally titled as “Phytase Variants” and subsequently amended as “Phytase Variants with Improved Thermostability.” The amended claims of the appellant include the following:
2. The phytase of claim 1, wherein the phytase has improved thermostability indicated as residual activity determined by dividing a supernatant in two parts, one part is incubated for 30 minutes at 60° and the other part of 30 minutes at 5°C, following which the activity of both is determined on p-nitrophenyl phosphate at 37°C and pH 5.5, where the residual activity of the phytase is the activity of the sample having been incubated at 60°C divided by the activity of the same sample having been incubated at 5°C where the residual activity of the phytase is at least 105% of the residual activity of the reference phytase SEQ ID No. 2, measured in the same conditions.
..........
8. A composition comprising at least one phytase of claim 1:
(a) at least one fat soluble vitamin.
(b) at least one water soluble vitamin.
(c) at least one trace mineral.
9. The composition of claim 8 further comprising at least one enzyme selected from the following group of enzymes: amylase, phytase, phosphatase, xylanase, galactanase, alphagalactosidase, protease, phospholipase, and/or betaglucanase.
10. The composition of any one of claims 8-9 which is an animal feed additive.
11. An animal feed composition having a crude protein content of 50 to 800 g/kg and comprising the phytase of claim 1 or the composition of any one of claims 8-10.
2. By the impugned order, the claims were rejected primarily on the grounds that the claimed invention is in respect of a known substance which is not patent-eligible under Section 3(d) of the Patents Act, 1970 (the Patents Act) and that the composition claims (claims 8 to 11) fall within the scope of Section 3(e) of the Patents Act because the composition is a substance obtained by the mere admixture of ingredients. It is pertinent, in this regard, to notice and record that there is nothing in the impugned order that indicates that the claimed invention does not possess the attributes to qualify as an invention under Section 2(1)(j) of the Patents Act or that requisite disclosure was not made to work the invention.
CONTENTIONS
3. Oral arguments on behalf of the appellant were addressed by Ms. Vindhya S. Mani, learned counsel from M/s. Lakshmikumaran and Sridharan and on behalf of the respondent by Mr. Subbu Ranga Bharathi, learned Central Government Standing Counsel and Mr. Manoj Madhavan, Deputy Controller of Patents.
4. The first contention of Ms. Vindhya S. Mani was that Section 3(d) of the Patents Act applies only to pharmaceutical substances. In support of this contention, learned counsel relied upon the judgment of the Division Bench of this Court in Novartis AG vs. Union of India (Novartis DB), MANU/TN/1263/2007, particularly paragraph 12 thereof, wherein the Division Bench concluded that the first limb of Section 3(d) is referable only to the field of
The court allowed the amendment of claims at the appellate stage and found that the invention satisfied the criteria of inventive step.
The Controller must provide a reasoned decision on pre-grant opposition addressing all raised grounds, particularly under Sections 3(d) and 3(e), to ensure compliance with natural justice standards.
The court established that inventions based on traditional knowledge are not patentable if they do not demonstrate a significant inventive step beyond known properties.
A pre-grant opposition is in the nature of an aid to examination and is not an adversarial proceeding and thus no right of the Petitioner can be said to be violated so as to invoke the extraordinary ....
Enhanced bioavailability must be substantiated with data demonstrating enhanced therapeutic efficacy to meet patentability criteria under Section 3(d) of the Patents Act.
A patent rejection must be a reasoned order that explicitly analyzes prior art and demonstrates why a person skilled in the art would be motivated to combine teachings to arrive at the claimed invent....
The refusal of a patent application for a therapeutic drug composition based on the grounds of it being a method of treatment is erroneous; claims must be recognized as product claims, distinguishing....
The main legal point established in the judgment is that an amended patent claim must not broaden the scope beyond the originally filed claims and must demonstrate significant enhancement of therapeu....
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