Patent on the Menu: Economizing Enzymes Wins at the Appeal Court
Section 2(1)(ja), Section 3(d), Section 3(i)
In Kemin Industries vs Controller of Patents, the Court had to determine whether an invention that helps monogastric animals—such as humans, chickens, and pigs—absorb more energy from their diet was eligible for a patent.
The patent application at hand concerned a method titled “USE OF FERULIC ACID ESTERASE TO IMPROVE PERFORMANCE IN MONOGASTRIC ANIMALS,” (Indian Patent Application No. 201617013577), involved a method to enhance the apparent metabolizable energy (AME) of animal feed. The method uses ferulic acid esterase (FAE) and main chain degrading enzymes (MCDE) to improve the efficiency of energy extraction from the diet of monogastric animals such as pigs and poultry. The application was challenged on the grounds of Section 3(i) and Section 3(d) of the Indian Patents Act, 1970, with the Patent Office initially rejecting the application.
The applicant argued that the method—supplementing animal feed with enzymes—did not constitute a treatment of animals under Section 3(i), as it focused on feed preparation to optimize enzyme usage rather than direct administration to animals. The applicant also maintained that the invention met the criteria for inventiveness under Section 2(1)(ja), and that it did not fall under Section 3(d), since the method employed enzymes not disclosed in prior art, effectively using a new reactant.
In contrast, the Patent Office contended that the method could be viewed as a process enhancing the economic value of animals or their products, thereby qualifying as a treatment under Section 3(i). It further argued that the invention lacked an inventive step (Section 2(1)(ja)) in light of existing prior art and fell within Section 3(d), as it involved a known process without introducing a new product or reactant. Based on these grounds, the Patent Office concluded that the invention was not patentable under Indian patent law
Analysis & Conclusion
The Court reviewed the arguments and clarified that Section 3(i) is limited to methods involving treatment—such as administering drugs or feed to animals. Since the claimed invention related to the preparation of animal feed, rather than its administration, it did not fall under this provision. The Court also found that the Patent Office had not demonstrated that the method was a known process under Section 3(d), and the inclusion of new enzymes in the formulation allowed the applicant to bypass this objection. The final challenge was under Section 2(1)(ja), which concerns inventive step. The Court noted that the distinguishing feature of the invention was the inclusion of MCDE, specifically a combination of ferulic acid esterase (FAE) with four other enzymes. This specific combination was not disclosed in the two cited prior arts. Given the vast number of potential enzyme combinations, the Court held that there was no teaching, suggestion, or motivation in the prior art to arrive at this precise selection. As a result, the invention was deemed non-obvious.
From Rejection to Remand: The PVP-Rotigotine Patent Turnaround
Section 2(1)(j)
This case involves an appeal by UCB Pharma GMBH & Anr. against the refusal of Indian Patent Application No. 1574/KOLNP/2012, which claimed a method and composition for stabilizing non-crystalline rotigotine using polyvinylpyrrolidone (PVP). The invention focused on specific rotigotine: PVP weight ratios within a solid dispersion, its incorporation into a transdermal therapeutic system (TTS), and related preparation methods. Initially comprising 14 claims, the application was later narrowed to 8 claims centred on the stabilized solid dispersion and TTS features.
The patent application was refused under Section 2(1)(ja) of the Patents Act, 1970, on the grounds of lack of inventive step. The Respondent asserted that the use of rotigotine with PVP, specific adhesives, and defined weight ratios was already known in prior art and thus obvious to a skilled person. Key reliance was placed on prior art documents D4 and D5, introduced for the first time during the hearing, which purportedly disclosed similar compositions and transdermal therapeutic systems (TTS). Additional objections included ambiguities in claim scope, redundancy between claims, and allegations that certain claims extended beyond the originally filed scope.
The Appellant contested the refusal by emphasizing the invention’s technical contribution in resolving a real-world stability problem linked to the emergence of Form II rotigotine crystals, which had previously led to the recall and cold chain storage of commercial products. The Appellant highlighted comparative data in the specification showing superior drug release and physical stability at specific rotigotine: PVP ratios. Procedurally, the Appellant argued that introducing new prior art during the hearing without prior notice violated principles of natural justice and deprived them of a fair chance to respond. It further noted that the objection to Claims 4-7 was not mentioned in the hearing notice, and cited case law underscoring the necessity of clear and complete communication of all objections by the Patent Office.
Analysis:
The Calcutta High Court set aside the refusal order, holding that the introduction of new prior art documents D4 and D5 during the hearing without prior notice violated principles of natural justice and denied the Appellant a fair opportunity to respond. Emphasizing the quasi-judicial role of the Patent Office, the Court criticized the lack of procedural transparency and found that the objection under Section 2(1)(j) for Claims 4 to 7 was also improperly raised, as it was not included in the hearing notice. The matter was remanded for fresh consideration by a different officer, with instructions to allow the Appellant to respond to the newly introduced documents and to decide the case afresh on its merits within six months.
Conclusion:
The case underscores the importance of procedural fairness in patent prosecution. It affirms that while the substantive assessment of inventive step is crucial, it must be carried out in a manner consistent with natural justice. Applicants must be given clear and timely notice of all grounds of objection and cited prior art to prepare a meaningful defense. The Appellate Court’s intervention in remanding the matter for reconsideration not only protected the Appellant’s right to be heard but also reinforced the duty of the Patent Office to maintain procedural integrity while exercising its quasi-judicial authority.
Abbvie Biotherapeutics Inc & Anr. vs Assistant Controller of Patents
Section 117A, Section 59(1), Section 2(1)(j), section 3(i)
The subject appeal was filed under Section 117A of the Patents Act, 1970, in the Delhi High Court, challenging the refusal of Indian Patent Application No. 201817047767, titled “ANTI-cMet ANTIBODY DRUG CONJUGATES AND METHODS FOR THEIR USE,” by the Assistant Controller of Patents and Designs on 31st July 2023. The application, filed under the Patent Cooperation Treaty (PCT) by Abbvie Biotherapeutics Inc & Anr. on 17th December 2018, faced objections regarding industrial applicability under Section 2(1)(j), patentability under Section 3(i), and broader scope under Section 59(1) of the Act.
The applicant had responded with amended claims and submitted additional arguments after the hearing, but the refusal was upheld. The appellant subsequently filed a review petition on 26th October 2023, which was dismissed as time-barred on 6th March 2024. In the appeal, the appellant’s counsel contended that they were not barred from amending the claims under Section 57(6) and Section 59 of the Patents Act, asserting that amendments can be made at any stage during the patent application’s life. The appellant also argued that since the amended claims for anti-cMet antibody-drug conjugates (ADC) were disclosed in the specification, objections under Sections 2(1)(j) and 3(i) should be waived. The appellant relied on the court decision in Allergan Inc. v. Controller of Patents for support.
In response, the respondent’s counsel argued that under Section 138(4) of the Act, the PCT national phase application in India must mirror the international filing, with some exceptions for deleting claims. The respondent emphasized that the appellant did not amend the claims at the PCT stage and entered the national phase with treatment-related claims. Therefore, the proposed amendments went beyond the scope allowed under Section 59(1). The respondent cited the judgment in Nippon A & L Inc. v. Controller of Patents to argue that the Controller’s decision was justified and should not be overturned.
Analysis:
The central issue in this case revolved around the appellant’s attempt to amend the claims from a method-of-treatment approach to a product claim for the anti-cMet antibody-drug conjugate (ADC). The appellant’s counsel argued that amendments could be made at any stage during the patent process, and they should be allowed to amend the claims to reflect the full scope of the invention as disclosed in the specification. They claimed that the objections under Sections 2(1)(j) and 3(i) should be waived, referencing the decision in Allergan Inc. v. Controller of Patents to support their argument.
However, the respondent’s counsel pointed out that under Section 138(4) of the Patents Act, the national phase application must align with the international filing, with some exceptions. Since the appellant did not amend the claims during the PCT stage, their attempt to amend the claims in the national phase was beyond the scope permitted under Section 59(1), which prohibits enlarging the scope of claims after they have been filed. The respondent also cited Nippon A & L Inc. v. Controller of Patents to reinforce the view that the Controller’s decision was legally sound, emphasizing the importance of maintaining consistency between the PCT and national phase applications.
Judgement:
The Controller’s decision to refuse the proposed amendments was upheld, as it was found that the amendments sought by the appellant would ismproperly enlarge the scope of the claims. The original claims, directed to a method of treating cMet-overexpressing cancers, were found to fall within the exclusions under Section 3(i) of the Indian Patents Act. Furthermore, the amendments would introduce a product claim for the ADC, which was considered impermissible under Section 59(1) due to the risk of expanding the protection conferred by the claims. The appeal failed, and the court concluded that the amendments sought by the appellant were beyond the scope allowed under the Act.
Are Patent Application Amendments Admissible at the Appellate Level?
Section 58(1) and Section59
Background:
The present appeal concerns the refusal of Indian patent application No. 7493/DELNP/2012, titled “Microvesicles (MVs) Derived from Adult Stem Cells for Use in the Therapeutic Treatment of a Tumor Disease.” Filed by Fresenius Medical Care Deutschland. The application was a national phase entry under the Patent Cooperation Treaty (PCT), filed in India on 28 August 2012.
During prosecution, the applicant complied with all procedural and formal requirements for the grant of a patent. Despite this, the Controller of Patents refused the application on the following grounds: Lack of novelty under Section 2(1)(j); Lack of inventive step under Section 2(1)(ja); Insufficient disclosure and lack of clarity; Non-patentability under Section 3(e); and Non-patentability under Section 3(i)
Appeal Under Section 117 of the Patents Act, 1970: Fresenius Medical Care Deutschland, the appellant, challenged the refusal before the High Court under Section 117A of the Patents Act. In support of its position, the appellant submitted that the claimed invention had been granted patents in several major jurisdictions, including China, Europe, Japan, and the United States. In response to the submissions made during the appeal proceedings, the appellant also submitted amended claims, including a revised Claim 1, to clearly highlight the inventive features of the invention.
Legal Analysis:
The High Court exercised its appellate jurisdiction under the Patents Act, 1970, which empowers it with the same authority as the Controller under Section 15 of the Act. Accordingly, the Court had the jurisdiction to permit amendments to the complete specification, including the claims, at the appellate stage.
This legal position has been affirmed in previous judicial decisions, including Opentv Inc. v. Controller of Patents and Nestlé SA v. Controller of Patents, which established that such amendments are permissible under Section 59 of the Act, provided they meet the following conditions:
- The amendment must be by way of disclaimer, correction, or explanation.
- It must incorporate factual material already disclosed in the original specification.
- The amended claims must fall entirely within the scope of the originally filed claims.
Applying these principles to the present case, the Court found that the proposed amendments constituted both a disclaimer and an explanation. It held that the amendments did not expand the scope of the originally filed claims and that the subject matter of the amendments was already disclosed in the original specification. Consequently, the Court concluded that the amendments were compliant with Section 59 and admitted them into the record.
Conclusion:
Based on the above findings, the Court allowed Fresenius Medical Care Deutschland to file the amended complete specification with the Patent Office. It further directed the Patent Office to re-examine the application de novo, taking into account the amended claims. As a result, the original refusal order was set aside, and the matter was remanded to the Patent Office for reconsideration.
The Court also directed the Patent Office to issue a fresh hearing notice and emphasized the need for expeditious processing, given that the application was originally filed on 28 August 2012. A final decision was ordered to be issued within three months from the date of the Court’s order.
Is a Biological Invention Created Through Human Intervention Eligible for a Patent?
Section 3 and Section 13(3)
In a present judgment, the Calcutta High Court upheld the appeal of BTS Research International Pty Ltd against the refusal order of the Controller of Patents, which was based on Section 3(j) of the Patents Act. The Court directed the Controller to conduct a fresh review of the application.
Facts:
This appeal was filed under Section 117 of the Patents Act, 1970, against an order dated 16 June 2020, related to Patent Application No. 41/KOLMP/2012, titled “Method of Generating Hybrid/Chimeric Cells and Uses Thereof.” The invention concerns a tri-hybrid cell and the method for preparing it; consisting of tri-hybrid cell is produced through an artificial process involving the fusion of three somatic cells wherein at least two of which are of different types, including potentially human and mouse cells. These cells are fused using genetic engineering techniques.
The appellant contended that the invention does not involve an organism or any part of a plant or animal, nor does it involve any essentially biological process for the production or propagation of plants or animals. Moreover, the appellant raised the concern that the Patent Office failed to issue a Second Examination Report (SER) after examining the applicant’s response to the First Examination Report (FER), which is a mandatory procedural step. Instead, it directly issued a refusal order, skipping the required step under Section 13(3) of the Act.
Moreover, the appellant raised the concern that the Patent Office failed to issue a Second Examination Report (SER) after examining the applicant’s response to the First Examination Report (FER), which is a mandatory procedural step. Instead, it directly issued a refusal order, skipping the required step under Section 13(3) of the Act.
However, the patent application was refused on the grounds that it fell within the scope of Section 3(j) of the Act, making it non-patentable. The reasoning provided was that the resulting hybrid cell is a structural and functional unit of the organism from which the cells are derived. Therefore, it was concluded that the method of preparing tri-hybrid cells from stem cells constitutes a biological process, and such cells cannot be considered artificially produced. Additionally, the invention was deemed to fall under Section 3(c) of the Act, which excludes the “discovery of any living thing or non-living substance occurring in nature.”
Court’s Analysis:
The Court first noted that the respondents were negligent in issuing the SER. Citing Oyster Point Pharma Inc. vs. The Controller of Patents and Designs & Anr. [MANU/WB/1544/2023], the Court emphasized that the issuance of an SER is a statutory mandate under Section 13(3), and must be followed irrespective of the application’s outcome. The Assistant Controller, therefore, erred by failing to comply with this requirement.
Next, the Court also observed that five prior arts cited in the FER had already been reviewed by the European Patent Office, which eventually granted the corresponding patent. The Assistant Controller, however, failed to acknowledge or assess these international proceedings and rejected the application without due consideration.
With respect to Section 3(j), the Court adopted a liberal interpretation. It pointed out that the impugned order failed to consider the artificial process involved in the subject invention. This was a significant flaw, as it overlooked the key argument that the tri-hybrid cell is not produced through an essentially biological process for the propagation or production of any plant or animal. The Court stressed the need to assess the degree of human intervention and the resulting outcomes when determining whether a process is essentially biological.
Conclusion:
After considering all relevant aspects, the Court held that the impugned refusal order was unsustainable and set it aside. The matter was remanded to the Controller for a fresh adjudication. The Court further directed that the case be heard by a different hearing officer, who must dispose of the application within 12 weeks from the date of receipt of the Court’s order.
The Court made it clear that it had not adjudicated on the merits of the case and left all substantive issues open for reconsideration in accordance with the law. Additionally, liberty was granted to the appellant to make amendments and submit additional documents, if any, in accordance with applicable legal provisions.
