Recently Madras High Court added another tale in the litigation scrimmage between US corporate Kibow Biotech and Indian entities La Renon Healthcare Pvt. Ltd. and Stanford Labs Pvt. Ltd. (not to be confused with the American university) by “making absolute” a previously granted interim injunction against the Indian entities, via its order dated 01/04/2021 (pdf).
Back in 2013 we had reported about a rare occurrence in Indian IP litigation where the IPAB’s order against the revocation of a patent was validated by the High Court. Emanating from the same chain of events, Kibow Biotech (Patentee/ Respondent in those proceedings) instituted a suit against La Renon Healthcare Pvt. Ltd. and Stanford Labs Pvt. Ltd. (the applicant seeking the revocation then), for infringement of its patents, via its exclusive licensee Centaur Pharmaceuticals Pvt. Ltd. In course of the proceedings, initially an interim injunction was granted for 14 days and was later modified permitting the Respondents to sell the stock in hand. However, that order was kept in abeyance and by this order the Court reinforced the interim injunction presumably without the additional conditions attached thereby “making absolute” the injunction.
On 28/03/2006, Kibow Biotech applied for registration of its invention “Compositions For Augmenting Kidney Function”. It was specified as “an invention which augments kidney function using a probiotic Streptococcus Thermophilus (the probiotic) so that build up of toxins and metabolic wastes, and overgrowth of undesirable bacteria is reduced in the kidney.” (pdf of the specification). It’s application was based on the priority date 18/03/2004 and was granted patent protection on 29/09/2008 bearing no. 224100. This patent protection was challenged by La Renon by instituting a revocation proceeding before the IPAB under the grounds mentioned in Section 64 (1) (d), (e), (f), (h), (i), (j), (k) and (q). The Board rejected the revocation petition and the rejection was subsequently upheld by the Madras High Court as well.
Cut to 2019, Kibow Biotech and its exclusive licensee Centaur Pharmaceuticals (Applicants) filed a suit against La Renon Healthcare and its manufacturer Stanford Labs (Respondents) seeking permanent injunction, direction to take accounts of the Respondents with regard to alleged infringing use, consequential relief of seizure and forfeiture and destruction of the Respondents’ products and for damages of INR 1,00,00,000. The Applicants alleged that the Respondents via their products “Cudo” “Cudo Forte and/or Probigress” are infringing its patent by using the same strain of the probiotic, which is administered in similar fashion and results in similar effects as their patented product (sold under the name Renadyil). The patentee also sought an ex-parte interim injunction by the Court, which was granted via order dated 29/11/2019, for a period of 14 days i.e. till 13/12/19. The Respondent subsequently sought vacation of this ex-parte order, however, the Patentee alleged that Respondent continued to sell its product in this period, and produced bills of sale as evidence. Owing to this, the Respondents filed an application for contempt of the Court’s ex-parte order. By a chain of subsequent orders, the Court permitted the Respondents to sell off the stock in hand (for Cudo Forte and/or Probigress) and also directed for keeping the ex-parte interim order in abeyance till a clarification by the Division Bench on a specific order. . Finally, the Division Bench asked the single bench to combine these applications and hear them together, in furtherance of which the present order was passed.
Thankfully, the single bench avoided holding a “mini trial” in the interlocutory stage and instead directed the parties to relegate arguments on validity, infringement and application of infringement back to the trial court. However, while holding that the Applicants are able to establish a prima facie case for the interim protection, the Court made some problematic observations on patentability of subject matter.
Section 3(e) of the Patent Act, states that a substance which has been obtained by a mere admixture resulting in aggregation of its properties is not an invention. Thus, as explained by Adyasha here, to avoid attracting Section 3(e), a claim must show that the interaction between the components involved in the invention achieves a combined effect which is different from the sum total of the effects of the individual substances.
In the present case, the patented subject matter is claimed to be a “composition for augmenting kidney function in a subject comprising at least one probiotic bacterium wherein said probiotic bacterium selected from streptococcus thermophiles at about 5 billion to about 20 billion colony forming units of said at least one probiotic bacterium other ingredient being selected from vitamin, mineral, carbohydrate, protein and fats.” (Claim no.1 ) The remaining claims of the invention includes other components (like fats, minerals, carbohydrates in the invention), but the function which the invention seeks to perform is performed by the probiotic as specified in Claim no. 1. However, the Court opined that the Applicant’s efforts in identifying the probiotic among plethora of other bacterium and determining the required quantity for forming the colony requires research; and to identify this probiotic, numerous others would have been tested and rejected. The Court therefore observed that the present invention cannot be regarded as a mere admixture or a “discovery made overnight.”
How do the earlier statements lead to that conclusion? Given that ‘a mere admixture’ of the given statements certainly don’t lead to it – it would’ve been useful for the Court to explain how the ‘combined effect’ was greater than the sum of its parts! (thanks Swaraj for this line) While it was right in not making an in depth assessment of the patentability of the subject matter and left it to be determined during the trial, I feel that it should have completely avoided summarily discussing applicability of Section 3(e) in the present case. The Court on numerous points stressed upon the need of evidence and pleadings to substantiate complicated matters surrounding patentability (see para (s) 58, 63, 64, 69) however, by making the above observation in the order the Court somewhat impresses the validity of the patent, something which by its own admission is to be decided in the trial up ahead.
Furthermore, the Court’s reasoning for dismissing the Respondent’s arguments on the patented subject matter being an admixture is based on the revocation ruling of the IPAB and the Court subsequent order in the Writ petition. However, these two orders have their own set of limitations with regard to determining whether the invention is a mere admixture or not. The IPAB revocation ruling for instance isn’t clear on how the product is not a mere admixture since the “augmenting kidney function” as claimed in Claim number 1 is performed by the probiotic alone whereas compositions Claim 5 onwards assist as mere supplements. The Board hasn’t exactly justified its reasoning on holding that the primary function of the invention i.e. augmenting kidney function is performed by the combined effects of the components of the invention and much of this lack of reasoning can be attributed to the relative absence of substantive pleadings by the Applicant there. Similarly, as pointed out by Pankhuri here, with regard to the order concerning the writ petition, the Court held itself back on adjudicating upon the merits of the IPAB order and rather focused on its “supervisory jurisdiction” under Article 226, thereby taking IPAB’s word on the issue. Thus, on one hand the Court rightly left substantial issues for the trial but on the other hand made a quick assessment of the above said complicated issues anyways. Such an assessment should have been avoided, during the interlocutory hearings (as argued by Prof. Basheer, Jay and Prakruti in their paper here) largely owing to the complexity of the matters and the lack of understanding of our Courts in understanding the technical jargon. Therefore, it would have been better had the Court reserved itself from getting into these intricacies and left adjudication on patentability of the subject matter for the trial.