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Imagine that your client has come up with an invention (a process) that enables animals on your farm to absorb more energy than is usual from their feed/diet. It coincidently might also increase the economic value of the animals, mostly poultry and swine, after consuming the enhanced feed. Would this be a method of treatment for animals that is barred by Section 3(i)? Madras High Court delivered a judgement answering this specific question and more. The Court in Kemin Industries vs Controller of Patents had to decide whether an invention enabling monogastric animals (monogastric means an animal with a single-chambered stomach, for example, humans, chicken, and pigs are monogastric) to absorb more energy from their feed/diet is patentable. The Patent Office had previously rejected the patent application on three grounds: Section 3(i) (method of treatment), Section 3(d) (mere use of a known process), and Section 2(1)(ja) (inventive step or lack thereof). The Madras High Court, sitting on appeal, reversed all the objections and ordered the grant of the patent. In this post, I will briefly explain the single claim that was under consideration. Later, I will discuss the reasoning of the Court with regard to Section 3(i), Section 3(d), and Section 2(1)(ja).
Suit Patent:
The Suit Patent in question is titled “USE OF FERULIC ACID ESTERASE TO IMPROVE PERFORMANCE IN MONOGASTRIC ANIMALS” with the application number (201617013577). The sole claim is a method claim, which is as follows:
In simple words, the method seeks to significantly reduce (by 20-80%) the enzymes required to extract energy from the diet given to animals like pigs, poultry etc.
Apparent Metabolisable Energy (AME) is the amount of energy that the monogastric animal (eg. poultry and swine) can absorb after consuming the feed or diet and not excrete out. Ferulic Acid Esterase (FAE) supplemented with Main Chain Degrading Enzymes (MCDE), when added to a feed or diet, helps extract this AME and, in that process, also economises on the use of MCDE.
When is a “method” hit by Section 3(i)?
The Court first cited Kymab Limited v. Assistant Controller of Patents & Designs (discussed previously by Tejaswini) to explain the structure of Section 3(i). The Court in Kymab had conveniently bifurcated the section into two self-contained limbs separated by an “or”. While the first limb dealt with humans, the second limb dealt with animals.
For our purposes, let’s just focus on the second limb. Section 3(i) analysis under the second limb can be split into two steps:
- Are the claim(s) directed towards a method or process for a “similar treatment” of animals? (i.e. “medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment”)
- Secondly, if the method claimed is a method of treatment, then is it directed towards the purpose of:
i) to eliminate disease in the animal or
ii) to enhance the animal’s economic value or
iii) to improve the economic value of their products.
If one answers both questions in the affirmative, the patent application will be hit by Section 3(i).
Is the suit patent a method of treatment?
The Court analysed the single independent claim and concluded it is a method to economise the use of MCDE to extract a set amount of AME. Then, the Court clarified the scope of Section 3(i). It noted that only a method of administration of a drug or feed to an animal would attract the wrath of Section 3(i), not a method of preparing the feed or the drug. As the Court itself put it:
Section 3(i) cannot be extended to a method of supplementing an animal feed merely because the use of such animal feed may ultimately result in improving the economic value of the animal/poultry to which such feed is administered or that of animal/poultry products such as meat or chicken.
Thus, in this case, the method was directed towards preparing the feed to enhance AME and economise the use of enzymes, not towards the administration of the feed. The method claim is directed towards a step before the administration of the feed and not towards the act of administration; hence, it is not hit by Section 3(i).
Yet it has to be noted that before claim 1 was amended, the preamble (the starting part of the claim) of pre-amended claim 1 had read, “A method of improving the apparent metabolizable energy from a diet and performance in an animal, comprising…” One can only wonder whether the Court would have ruled the same way if the claim had not been amended. Improving performance (increase in weight, better nutritional status and disease resistance) in an animal will fall under one of the purposes discussed above (ii and iii) under Section 3(i). Yet it might be a bit of a stretch to argue that the invention in question would fall under the scope of “similar treatment” as the method is performed on the feed and not on the animal.
Previously, I had highlighted how clever claim drafting can be employed to evade Section 3(d) scrutiny. Similarly, in a WIPO report, Prof Basheer discussed the same in the context of the method of treatment claims and the specific strategies applicants use to avoid getting hit by Section 3(i). To give one example, he notes how applicants try to avoid Section 3(i) by drafting a method of treatment claim as a kit claim.
It’s anyone’s guess whether this is also another instance of clever claim drafting and strategic amendments in response to objections raised by the Controller (as was the case here) carrying the day. Yet this case is a very close call, and cases such as this also reflect the indeterminacy in determining whether an invention falls within the hit list or not.
Identifying a “Known Process”:
More informed readers would be aware of Section 3(d) in the context of secondary patents, evergreening and therapeutic efficacy. However, this case involved a portion of the section that rarely comes up.
The Court in Novozymes v. Asst. Controller of Patents and Designs (previously covered by Amit Tailor) had again bifurcated this section into three limbs; in this case, the Court was concerned with the third limb. Now, the question is whether the method in question was a “known process” and if it is a known process does it result in a “new product” or employ a “new reactant”?
Here again, for the sake of convenience, the analysis can be split into two steps:
- Is the method/process a “known process”? (whether a process is a “known process” is determined in reference to the prior art)
- If yes, does it result in a “new product” or at least employ one “new reactant”?
If a method claimed is a “known process,” it can still escape the clutches of Section 3(d) if it is able to produce a “new product” or employ a “new reactant”.
After reading the order (pdf) of the Patent Office, I could not find where the controller had specifically identified the “known process” from the prior art before asserting that the claimed method is hit by Section 3(d). It has been previously discussed that a “known substance” must be identified from the prior art before the start of a Section 3(d) analysis. It is difficult to see why the same logic would not extend to a “known process” analysis under Section 3(d). The Court concluded that the method claimed was not a “known process” disclosed in the prior arts since the Patent Office was not able to argue that the process was disclosed in the prior arts in the appeal. Even if the method/process was a “known process”, the use of enzymes in the invention not disclosed in the prior art allowed the applicant to escape the clutches of Section 3(d) as it employs at least one new reactant.
Can the “Known process” requirement be gamed?
Unfortunately, the Court did not clarify what it means to “employ at least one new reactant” since if a “known process” employs a “new reactant” would it still be a “known process”? A “reactant” as per the Oxford Dictionary of Chemistry, defines a reactant in the context of a chemical reaction as follows: “A change in which one or more chemical elements or compounds (the reactants) form new compounds (the products).” A similar definition is also provided in Britannica’s dictionary. So if there is a new reactant(s) then it would not be a “known process” anymore isn’t it? Likewise, is it possible for an applicant to simply add additional reactant(s) just so that he can claim that his process is not a “known process”? Previously, I had discussed how applicants draft compositional claims so that they can argue that the claimed product is not a “known substance”. I wonder whether the “known process” portion of Section 3(d) lends itself to such evasion and clever drafting? This is not to argue that this was the case in the present application, but merely a more general question with regards to the Section that more informed readers might be able to answer in the comments.
Did the Court miss a step in Inventive step analysis?
The final objection was on the grounds of Section 2(1)(ja), the major difference between the prior arts (there were two) and the invention was the use of MCDE (the applicant has specifically claimed four different enzymes which will supplement FAE). The prior arts did not disclose the specific combination of FAE plus the four enzymes. After noting the fact that there are thousands of enzymes to choose from, the Court concluded that the prior arts do not contain teaching, suggestion, or motivation to choose the specific four enzymes and thus arrive at the invention. The Madras High Court previously in Rhodia Operations v. Assistant Controller of Patents (para 16) and also the Delhi High Court in AstraZeneca Ab & Anr v. Intas Pharmaceuticals Limited (para 23, 24) on a plain reading of Section 2(1)(ja) have noted that inventive step analysis involves a two-step process of identifying the features of the invention contributing to technical advance or economic significance or both and then whether the invention itself is non-obvious to the person skilled in the art. For some reason, the first step of the analysis is absent in the judgment, and it failed to follow its own precedent in Rhodia.
In the end, one is left with mixed feelings about the judgement. On the one hand, the Court builds on its previous precedents; on the other hand, it ignores them. The judgement also leaves one with a lot of food for thought about the “known process” portion of Section 3(d). If readers have any further thoughts on the case, do drop them in the comments below!