The Madras High Court earlier this year rejected a writ petition filed against a patent owned by Kibow Biotech Inc. for a dietary supplement that aids in the carrying out of the kidney function, for reasons, among others, that there was no expert evidence led to support the case. The validity of the patent was challenged primarily under Section 3(e) of the Patents Act, i.e., on grounds that it was "a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance".
Writs in patent cases
The patent had already travelled through the chain of authority in the patent office, and the Intellectual Property Appellate Board (IPAB). Formal charges of revocation had already been examined and decided against the petitioner and in favour of the patent holder by the appropriate forum. The petitioner filed a writ petition (La Renon Health Care Pvt., Ltd. vs. UOI and others, WP 1219 of 2014, decision of the Madras High Court dated 10 January 2019) challenging the order of the IPAB which rejected the revocation application filed by the petitioner.
The petitioner's strategy of using a writ procedure had a fundamental disadvantage. Unlike a straightforward appeal process, a writ procedure is very different. Unless there is some infirmity in the procedure followed by the IPAB, the writ court cannot re-examine the issues. This is important because in a lot of intellectual property matters, the court tends to rehear all the substantial arguments again.
Leading proper expert evidence
The main critical observation made by the court was that the patent revocation attempt had failed because the petitioner had failed to substantiate its case by submitting expert evidence in support of its claims. Specifically, the court said that in order for the court to appreciate the evidence filed in support of revocation, the petitioner should have pro-actively either produced an expert or an expert's affidavit, and where relevant, allowed the expert to be subjected to cross examination.
The IPAB could have, on its part, called for an expert's view as well when it was examining the revocation application filed before it. But, as the court noted, in the proceedings before the IPAB, the petitioner had failed to establish even a prima facie case on the strength of the materials placed by it, and expert evidence was not required.
The Madras High Court was loud and clear in stressing that it was important to lead expert evidence in technical matters, and that one could not rely only on mere documents and arguments. This is something I strongly agree with. Especially in complex patent cases, where we are dealing with good science that is being damaged by inaccurate statements and loose observations, the importance of sound evidence cannot be emphasised enough. One possible outcome of this decision is that it might actually foster more academic involvement in patent litigation. There is of course the challenge of finding good unbiased experts in India, but that is a completely different story.
To the extent that the IPAB concluded that the patent in question aids in the carrying out of the kidney function, the court held that such a finding could not have been given without the help of an scientific adviser and/or technical expert's evidence. At best, the court said that the IPAB could only have held that the materials filed by the petitioner was not sufficient to revoke the patent. To this extent, the observations made by the IPAB in its order were liable to be expunged.
Burden of proof on challenger
The court also concluded that the burden of proof when a patent is challenged lay with the person making the challenge. The court was emphatic that this onus of establishing invalidity on any of the grounds could not be shifted to the patentee or to the IPAB.
Prior art must show anticipation
The IPAB was made a respondent to the case, but the court noted that it was not the IPAB's task to infer invalidity based on the documents filed by the petitioner. This segwayed into the next critical observation made by the court. The court was clear that merely putting forth a host of documents before the adjudicating authority was not sufficient. The prior art must be shown to clearly anticipate the patent.
In this context, two specific practices indulged in by the petitioner came in for criticism: firstly, what the court referred to as "mosaicing", by choosing sentences from different documents to suggest that the patent claims and specification were such that it was liable to be revoked; secondly, the piecing together of various prior art documents so as to construct an anticipation of the invention, which the court held was not permissible to defeat claims.
No local manufacture could lead to compulsory license
The court also made some interesting observations on non-working of patents, which stand out. It said,
- "If the invention that has been patented has not been put to use by way [of] production and manufacture in India, the purpose for which the Patent was granted would stand defeated.
- The intention of the law is not to merely confer monopoly to an inventor to make disclosure in the specification and make claims and to flood the market without actual manufacture in the country.
- If the patented product is manufactured on overseas soil and imported into the country, the monopoly cannot remain. There could be compulsory licensing."
This is fairly strong language saying that not manufacturing locally may in fact lead to not keeping the promise made by the patentee, and would lead to compulsory licensing. In one way, this further strengthens the position on compulsory licensing in the absence of local working that was set out in the compulsory licensing decision of the Bombay High Court in 2014, involving Bayer and Natco (WP 1323/2013, Bombay HC).
The writ was eventually thrown out and the patent grant was held to be valid. The court noted that the scope of the writ petition was limited to whether there was any infirmity in the procedure adopted by the IPAB while deciding the revocation application. While holding that there was no such infirmity, the court also noted that the order against revocation could not be termed to be erroneous due to errors on the face of record.
Disclosure: Kibow Biotech Inc. was advised by Essenese Obhan of the firm
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