The Intellectual Property Appellate Board (‘IPAB’) recently discussed the admissibility of amendments to claims in a patent application as per the provisions of the Patents Act, 1970 (‘Act’), and the need to conduct tests of novelty and inventive step on claims in patent applications. Another important aspect dealt with was the applicability of Section 3(i) of the Act. [1]
FACTS AND BACKGROUND
Tony Mon George (‘Appellant’) filed a patent application vide Application No. 6001/DELNP/2013 as a national phase application in India for its invention titled, ‘STEM CELL FACTOR INHIBITOR,’ on 4 July 2013, claiming priority from U.S. Application No. U.S.A. 61/431246.
The claimed invention eliminated/minimised the side effects that arise from the interference with general intracellular signalling pathways by modulating stem cell factor (SCF) activity, thereby minimizing toxicity. The claimed invention also included a method to prepare an antibody that targeted SCF. In contrast to previous anti-SCF antibodies that targeted SCF without discrimination between the two isoforms (a and b), the claimed antibody attached itself only to SCF isoform b. The results demonstrated the strong binding nature of the claimed antibody to human SCF isoform b and the protection of haematopoiesis. The claimed antibody binding to isoform b further reduced the side effects that are observed when an antibody binds to isoform a.
The patent application was initially filed with 30 claims, which were subsequently amended on 9 January 2015. The Assistant Controller of Patents & Designs (‘Respondent’) issued the first examination report (‘FER‘), wherein it was communicated that the Form-13 filed by the Appellant would not be allowed as no marked-up copy was submitted indicating the amendments as per Section 57, and therefore the originally filed claims (1-30) were examined. The main objections raised in the FER were pertaining to the non-patentability of the invention under Section 3 of the Act, the lack of unity of invention, and the Appellant’s failure to suitably define the scope of the invention.
The FER explicitly stipulated that the examination with respect to novelty and inventive step was restricted only to the first group, viz., claims 1-23 and 29, while the product claims were not examined. It is pertinent to mention that on perusal of the FER, it was noted that novelty and inventive step had not been considered at all in respect of any of the claims.
The Respondent issued the hearing notice on 19 November 2019, and the following objections were communicated to the Appellant
- The amendments to the claims were impermissible as the addition of new claims was beyond the scope of Section 59 of the Act;
- There was no unity of invention as the patent application contained a group of inventions which did not relate to a single inventive concept as per Section 10(5) of the Act;
- The claimed invention was not patentable under Section 3 of the Act;
- The scope of the invention was not clearly defined; and
- The claims lacked clarity and conciseness – the groups of claims related to multiple inventions and also had different intentions i.e., a treatment using the inhibition of SCF, a composition comprising of antibodies against specific sequences, and methods of preparation of isolated monoclonal antibodies that would bind to peptides.
Pursuant to the hearing on 22 January 2020, and in accordance with the Respondent’s directions, the Appellant submitted a set of eight (8) revised claims via Section 57(6) of the Act. It retained the original claims 25-27 as claims 1-3, which recited a composition, and to further define the composition, it added new dependant claims 4-6. Claim 7 recited the kit and was based on original claim 30. Claim 8 recited the method to prepare an isolated monoclonal antibody that targeted SCF and was based on the original claim 28.
The Respondent refused to grant the Appellant’s patent application vide an order dated 13 March 2020 (‘impugned order’), against which the Appellant preferred this present appeal to the IPAB under Section 117A of the Act.
ISSUES, DECISION AND ANALYSIS
As per the impugned order, the amended claims 1-8 were neither in accordance with Section 59(1) of the Act nor were they compliant with the requirements of the hearing notice. The Respondent found the newly added claims to have been added without any explanation and were not in the prescribed manner. Section 59 of the Act does not permit an applicant to amend claims, other than by way of a disclaimer, correction, or explanation. The suo motu amendments of claims 4-6 were found to go beyond the scope of the Act, amended claim 8 was not patentable as per Section 3(i) of the Act, and accordingly, the Respondent refused to grant a patent for the claimed invention.
Novelty and patentability:
The IPAB referred to Novartis v. Union of India,[2] wherein the Supreme Court of India held that for an invention to be patentable, both tests of inventiveness and patentability as per Sections 2(1)(j), (ja), and 3(d) had to be applied. This is equally valid for any other sub-clause of Section 3 as well.
In the instant case, the Respondent only made reference to the prior art documents to substantiate the lack of unity of invention objection, and no analysis for the determination of (or the lack thereof) any inventive step or novelty was undertaken. The IPAB found the absence, on the Respondent’s part, in establishing the novelty and inventive step of the invention to be a case of negligence.
The IPAB also stated that if the report was found to be inadequate or improperly prepared, it was the Respondent’s duty to have directed the examiner to rectify its mistake prior to reporting the objections to the Appellant. It was explicitly clarified by the IPAB that the examiners and Controllers do not have the liberty to merely examine the invention for applicability of Section 3 requirements alone, leaving aside the basic question of patentability as provided in Section 2(1)(j) of the Act.
The Respondent further refused claim 8, which recited ‘a method of preparing an isolated monoclonal antibody…’ on the grounds of non-patentability as per Section 3(i) of the Act by specifically referring to the steps of ‘immunizing a host with the peptide, isolating an immune cell from the host,’ in the method. The IPAB referred to Section 3(i) of the Act and clarified that inventions which related to a ‘method of treatment of human beings or similar treatment of animal which renders them free of disease, their economic value or that of their product’ were not patentable as per the teachings of the Act.
It observed that there was no process or method defined in the instant patent application that would help in the treatment of humans or animals, and that the claimed invention defined a method to prepare an isolated monoclonal antibody. It further clarified that the particular step, identified by the Respondent to attract the provisions of Section 3(i) of the Act, i.e., ‘immunizing a host with the peptide, isolating an immune cell from the host,’, was in relation to the preparation of monoclonal antibody using an animal model rather than treating any human being or animal per se. The IPAB concluded that Claim 8 reciting ‘a method of preparing an isolated monoclonal antibody’ did not attract the provisions of Section 3(i) of Act and was, therefore, allowable.
Amendments to claims:
Another major point that was clarified in the instant IPAB order was the provisions and limitations of Section 57 and 59 of the Act. The Appellant had deleted the original claims 1-24 and renumbered the remaining claims. It retained the original claims 25-27 as claims 1-3, which recited a composition, and to further define the composition, it added new dependant claims 4-6. Claim 7 recited the kit and was based on original claim 30, and claim 8 was the method to prepare an isolated monoclonal antibody that targeted SCF and was based on the original claim 28.
The Respondent objected to the claims under Section 59(1) of the Act, stating that the claims 4-6 were new claims that had been added and therefore not allowable as per the provisions of Section 59(1) of the Act. Reference was made to Electric and Musical Industries Ltd v. Lissen Ltd,[3] in the present order, which held that the function of claims was to define the monopoly claimed in the invention so that others would know the boundaries within which they would-be trespassers. The intent of patent law is to limit and not extend the monopoly, and what is not claimed is disclaimed.[4] The language used in a specification cannot change a claim which claims for a different subject matter.
Further, Justice Ayyangar, in his report,[5] drew parallels between the scope of amendments before and after the acceptance of a patent. He stated that the scope of an amendment prior to acceptance should be wider than after acceptance, since, before its acceptance, the specifications of the invention would be undisclosed to the public. He also suggested two limitations to be imposed after the acceptance of the complete specification –
- Where a complete specification has been advertised, it should be presumed that all claims not made before acceptance will be considered as abandoned, except if due to a mistake;
- The invention before and after the amendment must be identical viz., the applicant should not be able to make a claim for any other invention by way of amendments.
The IPAB also noted that following the 2002 and 2005 amendments to the Patents Act in India, Section 11A was amended whereby the concept of publication after acceptance was removed, and publication would precede examination. Section 57(3) of the Act was also amended, and it now allows for the amendment of a patent application after the grant of a patent rather than after acceptance.
In the present case, the Respondent’s objections were with respect to claims 4, 5, and 6. The IPAB found that the contents of claims 4 and 6 narrowed the scope of the composition of claim 1 (which was allowed by the Respondent during the course of the hearing) and further defined the features of an isolated antibody or antigen-binding fragment thereof, as recited in the composition. This narrowing of the scope was essential as per the teachings of Patent Law. The claims merely prevented the principal claim from being vague and qualified the scope of the subject matter. However, the IPAB found claim 5 to go beyond the scope of claim 1.
In light of its findings and the settled law of, ‘no new claim may be allowed by way of amendment,’ the IPAB found the dependant claims 4 and 6 to be permissible as it only further defined the features already covered in the principal claim and had sufficient basis in the description. However, it refused to allow claim 5 as it was beyond the scope of the principal claim, and lastly, it found claim 8 to be patentable under the Act.
CONCLUSION
The IPAB directed the Appellant to file fresh, renumbered claims. It warned the Respondent regarding the determination of novelty and inventive step of an invention and advised it to be more cautious in the future when communicating its objections to applicants under Section 14 of the Act. The IPAB directed the Respondent to examine the novelty and inventiveness of the amended patent application in accordance with the Act and the principles of natural justice.
[1] Tony Mon George – The Regents of the University of Michigan v. The Controller General of Patents, Designs & Trademarks & Anr. [OA/48/2020/PT/DEL, decided on 27 October 2020].
[2] Novartis, Civil Appeal Nos. 2706-2716 of 2013.
[3] Electric & Musical Industries Ltd., 56 R.P.C. 23.
[4] Also reiterated in The Manual of the Patent Office: Practice & Procedure, available at http://www.ipindia.nic.in/writereaddata/Portal/Images/pdf/Manual_for_Patent_Office_Practice_and_Procedure_.pdf.
[5] Shri Justice N. Rajagopala Ayyangar, Report on the Revision of the Patents Law, pg. 131, (Sep., 1959),
http://www.ipindia.nic.in/writereaddata/Portal/Images/pdf/1959-_Justice_N_R_Ayyangar_committee_report.pdf.