In general, it is mandatory for the inventor to give an evidence or information in the patent specification in support of the inventive step. If that is not done, the application is likely to suffer the objection from the IP office that the application is "ab initio implausibility" as the skilled person would have a legitimate reason to doubt that the purported technical effect would have been possible as on the filing date of the patent application. Courts would also disregard post-published evidence to investigate the ‘inventive step’ question if such patent is subjected to invalidation action. In Indian context, the applicant invariably brings up the post published data to cross the therapeutic efficacy objections raised by IPO under section 3(d) or in the pregrant opposition proceedings. The admissibility of such post published data remained unclear as in some cases the Controllers refused the grant of the patent while disallowing the data for consideration of enhanced efficacy requirement under section 3(d). In patent application for “Topical Co-enzyme Q10 Formulations and Methods of Use Thereof”, for example, Controller refused the patent inter-alia ruling that
“ i) Use of liposome as carrier of active drug molecules is already known in the art. The proposed revision of claim, combining the carrier liposome with active drug molecule, Coenzyme Q 10 and evidence for enhancement of activity (as proposed by further documents) are beyond the scope of ‘invention’ as described in the complete specification as on record.
ii) Further technical results or post filing data cannot be included in the descriptive part of the complete specification as it is not allowable as per section 59 of the ‘Act.
iii) Applicant did not incorporate the further experimental results in the specification by way of amendment within stipulated time period. At this stage, inclusion of major technical data and change of direction of the invention is not acceptable and merit of the invention has to be decided based on the disclosure as on record.
iv) As per present disclosure, specification lacks in technical data for enhancement of efficacy or synergism. Therefore, the ‘invention’ cannot be acknowledged to involve inventive step [as per section 2(1)(j)] and also not patentable under section 3(d) of the ’Act.”
When this case came before IPAB on appeal (OA/33/2015/PT/KOL), IPAB first considered whether post published data can be considered for determining efficacy/ inventive step. The IPAB allowed the filing of additional document, data and evidence in support of the invention while overruling controllers order and observed that
“The claims are novel and also inventive in view of the cited documents and completely supported by the specification as originally filed. Filing of additional documents, data and evidence in support of the invention, to overcome the objection raised and to attack a specific objection is something which is allowed under the Patent Law of not only India but also other foreign jurisdictions.”[Emphasis added]
The IPAB find the filing of additional a data to meet the objections is admissible to determine the patent eligibility of the patent application. However, in this case its relevance to determine ‘inventive step’ was not discussed and adjudicated as IPAB found the invention otherwise novel and inventive.
Earliest reported case : USPTO rejection of post filling data
The earliest reported case where the issue of the rejection of post filling evidence by USPTO in re Khelghatian case [53 CCPA 1441, 364 F.2d 870, 876 (1966)] was adjudicated by Federal court. In this case Federal court allowed the appeal and held that the claimed invention is non-obvious in view of post-filing evidence of an unexpected property not disclosed in the specification as the evidence adduced by the applicant was directed to that which ‘would inherently flow’ from what was originally disclosed [with emphasis]“. The court also found the solicitor's contention that the affidavit "is entitled to no weight whatsoever” because it is not directed to an unexpected property "within the ambit of the original disclosure," unpersuasive and observed that “here we think the affidavit is directed to that which "would inherently flow" from what was originally disclosed,”. Considering the post published document along with the disclosure in the specification Court allowed the patent over the cited prior art.
Position in EPO
The relevance of post published data to support inventive step argument is not an easy question to get a straitjacket answer. For example, when the question of admissibility of post published data to support the polynucleotide encoding “Growth differentiation Factor-9 (GDF 9) technical effect in [T1329/04] came before EPO board, it found that demonstration of plausibility only by post-published data is not sufficient. This means that the application as filled must either contain experimental evidence that the desired technical effect is achieved by the claimed subject matter.
In another case T108/09 where the patent was for the use of fluvestrant for the treatment of patient of breast cancer who previously has been treated with an aromatase inhibitors and tamoxifen and has failed such previous treatment. The patent application in this case disclosed protocol for clinical trial but not its results. The results of the trials were provided later (post published). In this case unlike T1329 where there were serious doubt about the fact that polypeptide denominated GDF 9 belonged to the TGF Beta super family and thus solved the problem of the invention, Fluvestrant was known to be effective as second line agent in the treatment of breast cancer. In the patent in question the applicant mentioned the detailed information as to how fluvestrant can be formulated and administered to get the desired results. And the post published data was far from being the only source of information that fluvestrant is useful as third line agent. Therefore, EPO board found that the supporting data may be useful in evaluation of whether the problem underlying the claimed invention has been plausibly solved.
EPO board also considered other situation in T385/08 [Fixed dose association] case, where board allowed submission of post published data to show that a combination of enalapril sodium and micronized nitredipine showed a synergistic effect with regards to the solubility of nitredipine. In this case the application only mentioned the patent achieved good solubility of the enalapril and a good solubility of the nitredipine. The opposition Division in this case considered the synergistic effect in the formulation of the OTP and ruled that patent fulfils the requirement of inventive step. However, board of appeal denied the presence of inventive step as they came to different conclusion in their evaluation of inventive step. Mind you the technical effect may be shown by post publication, but the effect must owe its existence to the originally stated problem in the specification as filled.
Position In UK
In Generics vs Yeda & Teva court of appeal UK (2013) summarized the position of considering post published data in determination of inventive step as under
- A technical effect which is not rendered plausible by the patent specification may not be taken into account in assessing inventive step
- Later evidence may be adduced to support a technical effect made plausible by the specification.
In this decision in the UK Court of Appeal considered the extent to which subsequent evidence can be relied upon for the determination of inventive step. The UK Court in fact, followed the approach adopted by the EPO in the cases discussed ante for the consideration of such evidence. In this case legal issue which the appeal court adjudicated was whether the argument presented by Mylan which relied upon the results of two clinical trials obtained after the priority date of the patent was admissible to determine the technical contribution necessary to disprove inventive step. The First instance Judge in this case rejected this approach stating that where a patent specification made a technical effect ‘plausible’, it was not open to Mylan to mount a challenge to the existence of that effect by the use of later evidence.
The appeal court in this case disagreed with this approach of the first instance judge and held that, it was permissible to consider such evidence so as to assess the true nature of the advance made by the invention. Thus, post-published evidence could be used to determine whether particular technical advance has been achieved by a claimed product or method. The court found evidence adduced by Mylan to attack inventive step to be admissible. It is altogether different thing that the Court of Appeal held that the evidence relied upon did not prove the lack of a technical contribution. The Court of Appeal therefore, upheld the decision of first Instance judge for different reason, dismissing the revocation action and refusing the declaration of non-infringement. Mind you the technical effect may be shown by post publication to support and prove inventive step. Since the appreciation of the evidence is objective, we may find difference of opinion as we have seen in this case. However, courts do agree that such technical effect must owe its existence to the originally stated problem in the specification as filled.
Position in India
When we look at the judgements of the IPAB and Delhi High Court so far, we find that both favors to permit reliance on post-filing data to address objections or to provide evidence for the superior advantages of the invention as required under section 3(d).
However, in certain cases the courts denied the admission of post priority document as we find in AstraZeneca case where Court observed that
“[P]ost priority date evidence …. to show technical advance can only be taken into account to confirm the existence of technical effect which is found embedded in the specification of IN625 and is capable of being understood by a skilled person having common general knowledge and not to rely upon the same to establish its effect for the first time”
If in Co-enzyme Q10 case IPAB rejected the Controller argument to disallow the post priority document applying the limitation under section 59, the court in fact followed current trends as established by precedents in foreign courts on this issue. However, the IPAB ruling in this case remain within the established rules that such post publication would be permissible only where the submitted additional data has some prior basis in the specification already filed. This position of IPAB justifies that as a general principle the scope of the patent monopoly must be justified by the patentee’s contribution to the art.
In another case Delhi High Court reaffirmed the acceptance of post-filing data in its decision in AstraZeneca vs Intas Pharma (MANU/DE/1939/2020):
“The plaintiffs’ argument that post filing data relating to the invention is admissible is based on two grounds: (i) First and foremost, the applicant may not be fully aware of the advances and properties of the subject invention, in this case, the compound DAPA, on the priority date. In this behalf, it is stated that DAPA’s properties for treatment of heart failure came to be known only subsequently. (ii) Second, there is no requirement in law that all properties, advantages, and characteristics should be stated on the filing date of the patent application “.
Post published data filed to meet objections
It is interesting to note that in these reported cases applicants filed affidavits, declarations, or clinical trial data to support and establish the technical advance under section 2(1) (ja) and enhanced efficacy data undersection 3(d) to overcome inventive step or patentability objections raised by Controller. In the coenzyme Q10 case, IPAB found the additional data along with the data in the specification was sufficient to meet the objections raised by the Controller and allowed the grant of the patent overruling its refusal by the Controller. In the Astrazeneca case , the Delhi High Court disallowed the submission of additional data to prove “inventive step” in view of the fact such data was not disclosed in the original specification.
This indicates that post-filing efficacy data should be within the scope of the originally filed specification. In another case (TRA/7/2007/PT/KOL), IPAB observed that “If a synergistic effect is to be relied on, it must be possessed by everything covered by the claim, and it must be described in the specification.” Thus rejected the consideration of post published data to establish inventive step.
When this issue came before IPAB again in an appeal case (OA/6/2015/PT/MUM), IPAB considered efficacy data submitted under Section 3(d) assessment even when claimed properties of the compounds in question were not disclosed in the specification. Interestingly, in this case IPAB considered the compounds were novel and observed that objection under Section 3(d) was unwarranted.
The IPO guidelines issued in para 09.03.05.04 of Manual Of Patent Office Practice And Procedure March 2019 do provide some direction on the issue of allowability of the submission of post published data as follows
“the complete specification shall bring out clearly and categorically in the description, as to how the subject matter differs significantly in properties with regard to efficacy from the known substance at the time of filing of the application or subsequently by way of an
However, this seeks applicant to file amendments in the specification and that gives an opportunity to the Controller to question its admissibility under section 59. If we see the position of the post published data from the point of view of admissibility, it is merely a supporting document and in no way seeks to amend the specification. A relook at this guideline may help to resolve this point in future in view of the IPAB ruling in coenzyme Q10 case.
The question of determination of inventive step in certain cases is not only complex but also tricky. The court rulings in India and other jurisdictions do provide a pointer towards the circumstances under which the post published data may be considered to support the invention step statement. However, Co-enzyme Q10 case requires CGPDTM to issue clear guidelines to clearly spell out the circumstances under which such post-filing data can be taken into consideration for determination of the inventive step. The reported cases discussed above may clear some mist surrounding the admissibility of the post filling data in general. It may also be noted that admissibility such data is not tool to expand the scope of the monopoly as stated in the claims as filed. Curiously speaking, the recent case does provide an opportunity to the applicants to support and rather substantiate disclosure of some data relating to technical effect already stated in the specification. The later experimental data on efficacy with comparative data in fact is extension of what has been already stated in the specification. Therefore, if the applicant anticipate delay in obtaining such experimental data at the time of filing the specification, he should at least draft the specification in manner to clearly infer claimed technical effect from the disclosure. This will help him to find support for the post published experimental data based on explicit or implied disclosure in the specification. The Co-enzyme Q10 decision raised the hope of the applicant’s facing objections under section 3(d) on the likelihood of acceptance of such post-filing data in support of the enhanced efficacy. Later allowability of such post published data rests on the discretion of the Controller. Therefore, an expert advice in drafting specification, where the need to file supporting data later may arise, would be beneficial to save the application from the stigma of being refused where the admissibility of post published data filing is likely to be denied or questioned by the Controller.