Breaking News: Madras HC Upholds Kibow’s Probiotic Patent on Renadyl

In a significant development for Indian patent law, the Madras High Court dismissed a writ petition challenging an IPAB order that effectively upheld a probiotic patent. This is one of the rare Indian cases, where a patent has been upheld by the IPAB and that order has effectively been validated by a High Court. Very well-reasoned, this decision by Justices R. Subbiah and C. Saravanan has important propositions for both patent law and administrative law. But first some background.

As we’d blogged earlier, Kibow biotech, a leading biotech company that effectively pioneered the use of probiotics for augmenting kidney function was granted an Indian patent covering its flagship product, Renadyl, a dietary supplement that augments kidney function and often reduces the need for kidney patients to undergo dialysis.

A local Gujarati company La Renon challenged this patent in a revocation proceeding before the IPAB in 2006, on the ground that the patent was obvious and not new etc. After hearing the parties, the IPAB dismissed the challenge. It was against this IPAB order that La Renon approached the Madras High Court in a writ petition arguing that the order of the IPAB was perverse. The Madras High Court, however, ruled against La Renon and effectively upheld the IPAB order. The order was uploaded on the court’s website only today, although the same was delivered on 10th January.

From the vantage point of administrative law, the court makes it very clear there is a clear distinction between the scope of review in a writ jurisdiction and an appeal. The former review is far more limited than the latter. This is what the court rules in this regard:

143. We are not exercising Appellate Court’s Jurisdiction under Article 226 of the Constitution of India. On the other hand, we have to examine the impugned order from the perspective of a Court exercising supervisory jurisdiction under Article 226 of the Constitution of India. The scope of writ petition against an order of the third respondent Appellate Board is limited. We can only examine whether there was any infirmity in the procedure adopted by the third respondent Appellate Tribunal while passing the impugned order.

144. We do not find any infirmity in the procedure adopted by the third respondent Appellate Tribunal while passing the impugned order. The impugned order also cannot be termed to palpably erroneous order on account of error on the face of record. We therefore find no grounds to intervene.”

The court also lays down the following propositions:

  1. Burden of proof: when a patent is challenged, the burden of proof is on the one challenging. To quote from the decision, “[T]hough patent granted by a patent office is revocable under the provisions of the Act under Section 64 of the Act, yet the burden of proof to establish the grounds was with the petitioner…The onus of establishing invalidity on any of the grounds cannot be shifted to the patentee.
  2. A person challenging a patent must produce evidence (prior art) and argue how the prior art anticipates the patent. Merely throwing a ton of prior art is not enough. To quote from the decision,”[T]he third respondent Appellate Board has correctly observed that it is for the applicant to prove the case and it is not sufficient to make bald assertions in the pleadings and mere filing documents is not sufficient in revocation proceeding under Section 64(1)(d)(e) and (f).”
  3. A person who had the opportunity to adduce evidence and make arguments before the IPAB to contest validity of patent and didn’t avail of the opportunity suitably cannot now come and demand a remand.
  4. A person interested (for purpose of challenging a patent) is not just a manufacturer of a product. Therefore, although La Renon only markets and does not manufacture the product, it is still a person interested.

The decision is a significant one for Indian patent law and is lucid and well-reasoned. Hopefully, courts will be more mindful of their limited review powers in future; else proceedings will continue forever leading to wastage of time, resources and leading to more uncertainty for patentees/inventors.

Given that the US is still barking at India’s poor patent record (the latest GIPC report are testament to this), this decision needs to be thrown at them to indicate that Indian courts are not anti-patent! And that they will rule in favour of patentees, when the circumstances so demand.

If time permits, we hope to bring you a more detailed post on this.

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1 thought on “Breaking News: Madras HC Upholds Kibow’s Probiotic Patent on Renadyl”

  1. la renon should have filed an appeal instead of a writ if they believed the IPAB order was flawed on both facts, application of law and appreciation of evidence.

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