In a dispute involving patent to a biological process indicator, the Intellectual Property Appellate Board (‘IPAB’) recently set aside the Assistant Controller of Patents & Designs’ Order rejecting the patent to ‘A BIOLOGICAL PROCESS INDICATOR, KIT COMPRISING IT AND IN VITRO METHOD OF VALIDATING A TREATMENT PROCESS’[1]. The Controller had refused the patent on the grounds that the claims were not novel or inventive in light of the cited prior art, claims were not patentable under Section 3(c) and 3(d) of the Patents Act, 1970 (‘Act’), in vitro methods as recited in the claims were not supported by the description, and that the claims indirectly attracted Section 3(i) of the Act.

It is pertinent to mention that besides the objections against novelty and inventive step of the claims which the Assistant Controller (‘Respondent’) had waived in the hearing notice but revived in the impugned order, the objections under Section 3(d) and the lack of support for method claims were raised for the first time only in the impugned order.

Objection under Section 3(c)

Section 3(c) of the Act states that, ‘the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature is not an invention.’

The Respondent in the impugned order had held that the biological process indicator defined in claims 1-10 of the patent application were not patentable under Section 3(c) of the Act as the claimed subject matter was a natural substance. The Appellant submitted that the biological process indicator was not a living thing or non-living substance occurring in nature.

The IPAB was of the view that the biological process indicator comprised of a thermostable kinase immobilised directly onto or inside a solid support, which in turn was selected from plastic, ceramic, or metallic surfaces, or an indicator strip, a dip-stick, or a bead, none of which were living things or non-living things occurring in nature. Hence, the biological process indicator comprising the thermostable kinase along with the solid support was not a living thing or non-living substance occurring in nature to attract Section 3(c) of the Act.

The Appellate Board also observed that the biological process indicator was also not a substance that ‘occurred in nature,’ and plastic and ceramic were non-natural substances as were indicator strips, dip-sticks, and beads, which required human intervention to be manufactured. Thus, the biological process indicator with these various components was not a naturally occurring product. The Appellant submitted that the objection was unfounded and unscientific.

Additionally, the thermostable kinases required human intervention to be immobilised onto or inside any solid supports via non-specific adsorption or chemical cross-linking. The kinase had to also be pre-treated to withstand high temperature environments. The biological process indicator was an artificially manufactured product that required substantial human intervention, and thus, the claimed biological process indicator does not occur in nature.

Reference was made to Reynolds v. Herbert Smith & Co. Ltd,[2] wherein the Court had stated that an invention could not be a mere discovery but had to consist of an act that resulted in a new product, result, process, or a new combination for producing an old product or result. On application of this test to the patent application, the subject matter was found to not be a discovery but rather involved several technical steps to prepare the new product.

The IPAB found that the Respondent had neither read nor understood the invention and as such, the refusal of the application was contrary to law and unsustainable.

Objection under Section 3(d)

The Respondent alleged that the biological process indicator was not patentable under Section 3(d) of the Act, which excluded ‘the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance.’

The IPAB however held that the claimed subject matter was not a discovery or a ‘mere’ discovery, rather, it involved various technical steps to be performed in order to prepare the new products with new results.

It held that the claimed biological process indicator was not merely the discovery of a new form of a known substance, and unlike the kinase-based agents described in the prior art, the claimed invention is effective for validating a sterilization treatment or a cleaning process for reducing the amount or activity of a contaminating biological agent in or on a sample.

Objection under Section 3(i)

The Respondent purported that the indicators, kits, and methods claimed in the patent application fell ‘indirectly’ under the exclusion from patentability under Section 3(i) of the Act, which bars patent protection for processes for the medicinal, surgical, curative, diagnostic, therapeutic, or any other treatment of human beings or animals to render them free of disease or to increase their economic value or of their products.

The IPAB however held that invention had absolutely nothing to do with the treatment of any living human being or animal to render them free of disease or increase their economic value. It noted that the indicators and kits claimed in the patent application were for the validation of a treatment process to reduce/eliminate the amount or activity of a biological agent in a sample i.e., to ensure samples were free of contaminants and were safe for use in a healthcare environment.

It noted that the biological agent encompassed infectious and non-infectious agents, and included bacteria, viruses, spores, proteins, peptides, and prions. The treatment process was the exposure of biological agents to high temperature or high pH exposure, under which human/animal survival would be impossible. The sample included any item, instrument, surface, fluid, or material such as surgical and medical instruments, hospital gowns, bedclothes, workbenches, walls and floors, and did not include any living human/animal.

Further, the method claims were for the validation of the treatment process to clean samples specifically defined in the claims, excluding body fluids of any living human/animal, by using the thermostable kinase activity of the claimed indicator. The claimed indicators, kits, validation, and correlating methods did not have any diagnostic or therapeutic purpose.

The Appellate Board also noted that the sole purpose of claims 1-17 was to validate the sterilisation treatment process performed on the samples to reduce the contaminating biological agent; the sole purpose of the methods in claims 18-42 was to validate the sterilisation treatment process; and the sole purpose of the methods in claims 43-48 was to correlate a reduction in the thermostable kinase activity of the biological process indicator.

It also held that the department’s finding that the claimed subject matter ‘indirectly’ fell under Section 3(i) of the Act was wrong, as there is no concept of a claimed method being patentable ‘directly’ or ‘indirectly’ under Section 3(i) of the Act.

Novelty of claims

It was the Respondent’s submission that the biological process indicator in the patent application lacked novelty over prior cited art viz., WO 2004003226 (D1), WO 0046357 (D2), US 4584272 (D3), Michel P.E. et al. (1998) Analytica Chemica Acta, Vol 360, No. 1-3.89-99 (D4), and Aflalo C. et al. (1987) Biochemistry, Vol-26 No. 13, 3913-3920 (D5).

The IPAB noted that the biological process indicator comprised of a thermostable kinase which retained at least 95% kinase activity after exposure to 70°C for thirty (30) minutes, wherein the kinase was a trimeric adenylate kinase or a monomeric adenylate kinase, and a solid support onto or inside which the thermostable kinase was directly immobilised via non-specific adsorption or chemical cross-linking.

It held that the Respondent failed to identify any passage within the cited prior art, wherein the claimed indicator with the same structural and functional features had been disclosed. The Board noted that in the case of General Tyre & Rubber Co. v. Firestone Tyre Co.,[3] the Court had held that for anticipation to occur, the antecedent documents should contain clear directions to perform what the patentee had claimed in the contested claim.

The IPAB noted that D1 failed to disclose any trimeric or monomeric adenylate kinase and also failed to disclose any thermostable kinase; the only treatment described in D1 was 'thermal processing.’ In D2, the thermostable kinase was attached to an antibody/binding agent and not onto or inside a solid support. D3-D5 only disclosed certain kinases which were different from the kinases used in the Appellant’s invention, and were also from animal muscles and hence, very unstable, and D3-D5 were also silent about a solid support.

It held that the Respondent had erred in refusing the Appellant’s application as none of the cited prior art disclosed all the features as recited in the claims of the Appellant’s invention. The biological process indicator was thus found to be novel over D1-D5, and the Respondent’s impugned order on the ground of novelty was found to be arbitrary and factually incorrect.

Inventive step

With respect to the determination of an inventive step in the Appellant’s patent application, reference was made to Technograph v. Mills and Rockley,[4] wherein the Court stated that in order to establish the ‘obviousness’ of an invention, it was permissible to make a ‘mosaic’ of the relevant documents, but the same should be put together by an unimaginative man with no inventive capacity.

The Appellant submitted that there was no teaching or disclosure of the invention in the prior art documents. There was also no suggestion to modify the inventions in D1-D5 to arrive at the claimed invention. A person skilled in the art would not be motivated to combine the teachings of the prior art documents and arrive at the claimed invention.

The IPAB observed that the claimed indicator was highly effective for the validation of a sterilisation treatment process to reduce/eliminate the amount of contaminating biological agents in or on a sample, and as such, the IPAB found the claimed subject matter to be inventive. Respondent’s refusal of the claims owing to the lack of inventive step was held to be without any merit.

Conclusion

The IPAB noted that the present invention had been granted corresponding patents in major jurisdictions including Australia, Canada, USA, Europe, and Japan, which in turn further established the novelty and inventive step of the claimed invention. Moreover, the EPO and the USPTO after duly considering the documents D1-D5 granted the patent with a broader scope than the claims in the instant amended application. Albeit not binding in nature, these patents should have been taken into account by the Respondent.

The IPAB surmised that the Respondent’s impugned order of refusal on grounds mentioned only in the order, without having given the Appellant the opportunity to be heard in respect of grounds of novelty, inventive step, non-patentable subject matter under Section 3(d) and lack of descriptive support for method claims, was in contravention of the statutory safeguards provided under Sections 14 & 15 of the Act, and against the principles of natural justice.

It noted that the Respondent failed to distinguish a mere discovery of a living or non-living thing occurring in nature from a new and useful invention recited in the claims of the biological process indicator, it overlooked the superior efficacy of the indicator and confused the claimed invention with a treatment for humans/animals. The IPAB accordingly allowed the appeal and directed the grant of the patent.

[1] Health Protection Agency v. The Controller General of Patents & Designs & Anr [OA/40/2015/PT/KOL, decided on 25 August 2020]

[2] (1903) 20 R.P.C. 123.

[3] General Tyre & Rubber Co. v. Firestone Tyre Co., (1972) R.P.C. 4567.

[4] (1972) R.P.C. 346.