The Intellectual Property Appellate Board (‘IPAB’) recently reaffirmed the interminable role of the principles of natural justice in judicial and/or quasi-judicial decisions, whilst also clarifying aspects of patent law with respect to cited prior art documents and description of the invention[1].
In the instant case, University of Miami (‘Appellant’) filed a national phase patent application in India under Rule 20 of the Patent Rules, 2003 (‘Rules‘), vide Patent Application No. 2090/KOLNP/2006 for an invention titled, ‘TOPICAL CO-ENZYME Q10 FORMULATIONS AND METHODS OF USE THEREOF’. The Appellant claimed priority from a U.S. Patent Application No. 60/538,319, and thereafter filed a PCT Application No. PCT/US2005/001581.
Facts and background
Pursuant to the publication of the Appellant’s patent application, the Controller of Patents (‘Respondent’) issued the first examination report (‘FER’), the response to which was submitted by the Appellant. The objections stated in the hearing notice included that the title of the application was imprecise, the invention was not novel and lacked any inventive step in light of the cited prior art documents, the claims fell under Section 3(d) and 3(e) of the Patents Act, 1970 (‘Act’), claims 47-79 were not supported by the specification, and that the Appellant had failed to pay certain statutory fees.
Subsequent to the hearing and submissions, the Respondent issued a single-page order, rejecting the patent application (‘impugned order’). The Appellant thereafter preferred an appeal under Section 117A of the Act before the IPAB.
Invention claimed
The invention claimed by the Appellant was a pharmaceutical composition comprising Coenzyme Q10 (‘Q10‘) and the method of using Q10 for the treatment of cancer, selective reduction of cancer cell growth, the induction of apoptosis in cancer cells, the inhibition of tumour mediated angiogenesis along with a kit for the same.
The composition described in the patent application consisted of Q10 and a pharmaceutically acceptable carrier, preferably a liposome, which could be administered topically or via intravenous injection. In response to the Respondent’s objections, the claims were amended to narrow the scope, and the claims reciting method of treatment were deleted since they are not permissible in India.
The as filed specification of the Appellant’s patent application included experiments along with analysis of the effects of Q10 on various cell types. It was observed that when Q10 was delivered to normal cells in culture, it did not cause cell death but enhanced their growth, and when Q10 was delivered to cancer cells, it inhibited cell proliferation and caused cell death. Additionally, the specification demonstrated that topical administration of the composition was effective in the treatment of cancer.
In the instant case, crux of the invention lied in the effectiveness of Q10 and that of using a lipid along with Q10 in the treatment of cancer, supported by in-vitro studies and animal-based studies. Owing to the promising results, a patent application covering a lipid composition comprising Q10 and methods of treatment using the lipid composition comprising Q10 was filed in India and several other countries. The results were further confirmed, elaborated, and reinforced in various clinical stages which were performed after the filing of the patent application. Expert affidavits from Niven R. Narain and John P. McCook confirmed the safety and efficacy of intravenous, and topical administration, respectively, of the composition claimed to treat cancer.
Impugned order
The Respondent rejected the Appellant’s patent application on the following grounds –
- The use of liposome as a carrier of active drug molecules was already known in the cited prior art, and the proposed revision of the claim by combining Q10 with a liposome along with the evidence for enhancement of activity was beyond the scope of the invention as described in the specification;
- Further, the technical results or post-filing data could not be included in the specification description as it was not permissible as per Section 59 of the Act;
- The Appellant failed to incorporate the further experimental results in the specification by way of amendments within the stipulated time period; the merit of the invention would thus have to be decided based on the disclosure on record;
- The specification lacked technical data to prove enhancement of efficacy, and thus the invention did not involve any inventive step as per Section 2(1)(j) of the Act and was not patentable under Section 3(d) of the Act; and
- The revised claim fell under Section 3(i) of the Act i.e., method of treatment, and thus could not be allowed.
In response to the impugned order, the Appellant submitted that it had filed Form-3 on several occasions[2] to comply with Section 8 of the Act and filed details regarding the prosecution of its corresponding EP Application No. 5711599 along with its response to the FER.
Violations of principles of natural justice and Section 3(i) objection
The Appellant submitted that the claims in the patent application were regarding a pharmaceutical composition and not a method of treatment, and therefore could not fall within the purview of Section 3(i) of the Act. It also submitted that the Respondent had incorrectly rejected its patent application via the impugned order under Section 3(i) of the Act as it had not raised the objection in the hearing notice and failed to communicate the objection to the Appellant as required under Section 14 of the Act, and hence acted against the principles of natural justice.
The IPAB in its order concurred with the submissions made by the Appellant and held that there had been an error on the part of the Respondent. The IPAB held that the use of the expression, ‘composition for the treatment’ in the claims would not render the claim to fall under Section 3(i) of the Act. The IPAB order further held that the expression used in the claim was only a way of defining the composition, and in no way could the claimed composition be considered as a method of treatment that a physician could adopt and perform to treat a disease.
The IPAB order went on to state that there were several claims related to compositions which had been granted in the past by the Indian Patent Office, wherein the composition was defined in the preamble along with the disease/condition that was being treated. Thus, the objection under Section 3(i) of the Act showed non-application of mind by the Respondent, and was on the face, a clear and apparent error.
Additionally, the Appellant stated that the Respondent’s failure to elaborate on its reasons for rejection violated natural justice principles. It also cited the IPAB’s decision in Order No. 8/2014, wherein the IPAB held that it was an established legal principle that a refusal decision in which the Appellant’s rights were refused had to be a speaking order, along with elaborate details regarding the grounds for refusal. The IPAB stated that the Respondent’s refusal was provided only in two paragraphs without any elaboration on the grounds of rejection. Thus, the absence of a speaking order was considered to be a flagrant violation of the principles of natural justice and the principles of law established in the country.
Prior Art Documents vis-à-vis Section 2(1)(j) of the Act
The IPAB noted that the Respondent, in the impugned order, had not indicated which cited prior art documents were considered for refusing the patent application for lack of inventive step. Further, the IPAB observed that the hearing notice issued by the Respondent did not identify the claims that were being objected to for the lack of novelty and inventive step; therefore, the arguments were articulated for all the claims. The experimental data provided by the Appellant demonstrated that the claimed composition was effective in the treatment of cancer by decreasing tumour cell growth and angiogenesis. The advantages of the claimed composition were neither taught nor suggested by the cited prior art.
With respect to D1 US2002/0156302 (‘D1’), it was held that it failed to teach or suggest any element of the claimed invention, and it would not have been possible for a person skilled in the art to have formulated the topical or intravenous administration of the claimed composition. D1 disclosed Q10 to be associated with the treatment of cardiovascular diseases but not for the treatment of cancer. Further, D1 taught that the composition comprising Q10 was to be prepared in vegetable oils. In contrast, the claimed invention was directed to a liposomal composition comprising Q10, and since liposomes are formed in aqueous solutions and not in oils, D1 neither taught nor suggested the claimed composition.
The Appellant argued that D1 disclosed that Q10 was associated with the treatment of several diseases, particularly cardiovascular diseases. D1 further disclosed that amongst the number of pharmacological uses ascribed to Q10, one such use was for ‘anticancer’ activity, and that such activity was related to Q10 being an antioxidant. A skilled person referring to D1 in relation to cancer would not be led to believe that Q10 had a potential therapeutic activity to treat cancer, but rather would be led to believe that the anticancer activity ascribed to Q10 was a preventative activity.
At the time of the invention, a skilled person would neither have had the motivation nor a reasonable expectation to have successfully modified D1 to arrive at the claimed invention. The Appellant accordingly submitted that D1 failed to teach the claimed invention and therefore could not render the claimed invention to lack novelty or any inventive step.
With respect to D2 US2002/0039595 (‘D2’), the document directed to a liposomal composition in a gelatin capsule for oral delivery, and not a topical or intravenous delivery. There was no suggestion that the D2 composition comprising Q10 would be useful to treat any disease or condition. D2 thus failed to destroy the inventiveness of the claimed invention.
With respect to Kokawa et al., (‘D3’), the document provided no teaching with respect to either Q10 compositions or composition comprising Q10 and liposome. Document D3 disclosed that Q10, being a physiological activator of the electron transport system in mitochondria, might promote the metabolism of a chemotherapeutic agent. However, a skilled person on reading D3 would not expect Q10 per se to contain any utility in the treatment of cancer.
With respect to D4 US6582723 (‘D4’) was directed to a composition comprising a combination of specific nutrients that would help prevent, protect, and neutralise cancer cells by boosting the body’s immune system. D4 was directed solely to nutrients and for oral administration only. A skilled person who read D4 would not expect the individual components of a composition to individually produce the effect of the combination i.e., even if D4 taught that Q10 could treat cancer (which it did not), it did not demonstrate that Q10 alone, without the other components, could treat cancer.
None of the cited references, either singularly or collectively, taught or suggested a composition comprising Q10 and a liposome for a topical or intravenous administration as claimed. It was also observed that none of the cited documents suggested the advantage of the topical or intravenous administration of the composition as per the claimed invention, which provided increased cellular uptake of Q10 as compared to non-lipid composition. Additionally, since none of the cited documents suggested the use of solely Q10 for the treatment of cancer, no combination comprising of Q10 for the treatment of cancer could destroy the novelty or inventiveness of the claimed invention. Thus, none of the references destroyed the novelty or inventiveness of the claimed invention.
The IPAB highlighted that the results provided in the as-filed specification and the declarations clearly demonstrated the advantage of the claimed invention in terms of enhanced delivery of Q10 to the cells and for treating cancer, and the said advantage was not obvious in light of the cited documents. With respect to the declaration submitted by Niven R. Narain, results provided in point no. 5 of page no. 2 clearly demonstrated the increased cellular uptake of Q10 when compared to the formulation comprising of Q10 without the presence of lipid. The results also provided a possible mechanism for the efficacy of the claimed composition in treating cancer. The IPAB thus held that the Respondent erred in holding that the invention lacked inventive step by not elaborating how the invention lacked any inventive step in view of the cited documents.
The IPAB also held that the Respondent erred in holding that the claimed composition did not provide any synergistic effect. It noted that the as-filed specification clearly provided the data to support the synergistic effect of the ingredients of the composition. The IPAB pointed out the Respondent’s error in not having considered the data which proved the synergistic effect and non-obviousness of the claimed invention provided by the experts, namely, John Mc. Cook and Niven R. Narain while passing its order. The IPAB stated that similar affidavits had been filed by the Appellant in different jurisdictions, and the affidavits had also been considered by the respective patent offices. Since the Respondent passed the order without consideration of the evidence placed on record by the Appellant, the order was found to be erroneous and a violation of principles of natural justice.
Violation of legal principle laid down by IPAB in terms of Section 3(d)
The Appellant claimed that the Respondent erred in holding that the claims in the patent application fell under Section 3(d) of the Act without providing reasons for the same. The IPAB, in Order No. 173/2013, discussed the applicability of Section 3(d) of the Act in detail, and held that claims directed to a composition do not fall under Section 3(d) of the Act.
In the instant case, the Respondent failed to identify the category of Section 3(d) under which the respective claims were rejected. Neither the hearing notice nor the impugned order explained the ‘known’ substance in relation to which enhanced efficacy was to be shown. The IPAB also stated that there were various precedents wherein the IPAB had made it very clear that an order must clearly state the reasons of refusal of a patent application, and in the absence of such reasons, the order would be considered as vague and accordingly be set aside. The Respondent failed to explain how Section 3(d) would apply, and in the absence of any reasons provided by the Respondent, the impugned order was found to be vague.
Filing of additional data
The IPAB clearly explained the process-flow of drug development. Keeping in view the cumbersome nature of the drug development process, if the drug (composition) provides promising results in the initial phases, the researchers are bound to generate supporting data during the process. The IPAB observed that the Appellant had filed extensive data, including the results from the clinical trials to support the inventiveness of the claimed invention.
The IPAB also acknowledged that the additional data elaborated the already extensive data included in the as-filed specification which clearly exhibited the surprising effect of the claimed composition comprising Q10 in the presence of lipid for treating cancer. The IPAB order held that the Respondent was incorrect in not allowing the additional data and cited previous case laws[3] wherein additional data was taken into account.
Reference was made to Re Khelghatian,[4] wherein it was stated that additional data could be considered to support the non-obviousness of the claimed invention if the data acted as an inherent extension of the property of the claimed invention which was originally disclosed. The IPAB held that the filing of additional data in support of the invention and to overcome the objection raised was permissible under the Patent Law of not only India, but also other foreign jurisdictions.
Support of claims in the specification
The IPAB held that the Appellant’s claims were supported by the as-filed specification and were not beyond the scope of the subject matter as originally disclosed. The composition comprising lipids and Q10 had been clearly defined, the efficacy of the composition had also been studied and demonstrated, and data supporting the invention obtained by further research had been provided as supporting evidence.
The IPAB observed that the original claims were directed to a composition comprising Q10 and excipients, which could also be lipid as per the dependent claims. The preferred composition had been described as comprising Q10 and lipids as per page no. 2 and 12 of the as-filed specification. The preferred composition had also been exemplified in Example 3 of the as-filed specification.
Further, it was observed that the claim had been limited to one of the embodiments, and the data in support of the embodiment had also been provided in the as-filed specification and in the form of affidavits submitted by the experts. Therefore, the IPAB held that the limited scope of the initial claim which had been exemplified could not be held to be beyond the scope of what was originally filed. Hence, the IPAB held that the Respondent was incorrect to have declared that the composition was beyond the scope of what had been originally disclosed.
Conclusion
The IPAB considered the facts and legal issues and concluded that the impugned order had been passed without appropriate application of the law to the facts in the case. The IPAB held that the Respondent failed to consider the facts and evidence produced by the Appellant and passed a vague order. The IPAB further appreciated the claimed invention, which was being studied at the clinical stage, as a breakthrough for the treatment of cancer.
The IPAB upheld the claims to be novel and inventive in view of the cited prior art documents, which were supported by the specification as originally filed. The IPAB criticised the Respondent for having taken a contrary view to the same invention that had been recognised in other countries across the globe, and that the Respondent was bound to provide valid reasons in support of the contrary view, which was missing in the refusal order. Thus, the impugned order was found to be contrary to law and was set aside, and the appeal was allowed and the Respondent was directed to grant the patent.
[1] University of Miami v. The Controller of Patents [OA/33/2015/PT/KOL, decided on 25 August 2020].
[2] 25 July 2006, 20 October 2006, 25 December 2011, 2 September 2013, and 22 July 2013.
[3] Genetics Institute, LLC. v. Novartis Vaccines And Diagnostics 655 F.3d1291, Re Khelghatian, 53 CCPA 1441, 364 F.2d 870, 876 (1966), Knoll Pharmaceuticals Company, Inc. v. Teva Pharmaceuticals USA, Inc., 367F.3d 1381.
[4] Re Khelghatian, 53 CCPA 1441, 364 F.2d 870, 876 (1966).
