Patent

The Section 3(e) Soup: What Makes for Synergistic Effect?


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Earlier this month, Pune-based home maker Shubhangi Patil was granted a patent over her unique ragi walnut soup mix composition (Edit: Application No. 201621034764). The mix claims to combine ragi (finger millet) and walnut to create a nutrient-rich substitute for non-vegetarian foods containing calcium, Omega-3 and Omega-6 fatty acids which can be used to treat Vitamin B12 deficiency. According to the patentee’s statements to The Hindu’s Business Line, she invented the soup out of necessity owing to her husband’s health condition which needed him to consume protein-rich foods such as eggs and meat whereas he preferred only vegetarian diet.

Food Patents and the Section 3(e) Challenge

Since the 2005 amendment to the Patent Act, 1970, the Indian Patent Office has granted patents on food-related inventions. A previous post by Kiran Mary George explains how the threefold requirement of novelty, non obviousness and utility, apply to food-related inventions. Some Indian food patents have been granted on: wheat chocolate bar for sustained energy release (IN 229291), fermentation process for production of tender coconut wine (IN 209015), and fried banana masala chips making process (IN 198069).

When it comes to food-related inventions, Section 3(e) is particularly relevant as it screens claims to ensure that frivolous patents aren’t granted. This section assists the Patent Office in determining whether the food-related claim is an invention in the first place. Section 3(e) disqualifies claims that fail to meet its standard in addition to the threefold test of patentability. It prohibits the grant of patent on substances ‘obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance’ (emphasis added). 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. The invention should be able to show an unforeseen synergistic effect, rather than a mere additive effect. That is, (A) + (B) = (A+B).

This presents a challenge before food-related inventions because usually, food items are simply the expected sum total of their individual components. A new method of cooking rice might not have been previously employed, but if it provides the nutritional value that is expected to be provided through such a method or by use of the chosen ingredients, i.e., it shows nothing more than an additive effect.

The ragi walnut soup applicant, in reply to the 3(e) objection, states that the soup shows ‘enhanced health benefits and nutritional values’. While it does provide the nutritional value of each of the ingredients and that of the soup mix, it is doubtful whether this sufficiently proves synergistic effect. To meet the threshold, experiment results must show the individual values of ingredients as well as their expected sum total value. This sum total would then serve as a reference point to compare with the actual value obtained, in order to prove that the latter is different from what the ‘mere admixture’ would provide. Thus, both the expected (A) + (B) = (A+B), and the invented (A) + (B) = (A+B)’ must be shown and the difference between (A+B) and (A+B)’ be explained through data analysis. Without this, the synergistic effect analysis is incomplete. And yet, this has passed the scrutiny of the Patent Office.

Pharma Patents and Section 3(e) Misses

Nonetheless, all said and done, food is rather innocuous and it would be interesting to see how this patent is enforced in other people’s kitchens. However, let’s turn to a sector that has more noticeable, far-reaching consequences. Section 3(e), along with Sections 3(d) and 3(i), forms a set of anti-evergreening provisions present in the Act that create exceptions from patentability in order to prevent the extension of patent monopoly over variants of existing inventions. Thus, a detailed scrutiny into whether Section 3(e) disqualifies the patent is absolutely necessary for the safeguards in the Patent Act to fully operate. While the soup mix patent does not have significant implications on public health, the Patent Office has faltered in its assessment of synergistic effect in case of other types of patents as well, including pharma patents.

AccessIBSA’s study of 2293 patents granted between 2009 and 2016 shows that nearly 72% of these patents were granted for marginal improvements over previously patented drugs. The study estimates that from this pool, as many as 297 patents are likely in violation of Section 3(e). The complete report can be accessed here.

Let’s look at some other recent examples (and a shoutout to Sandeep Rathod and others who regularly mention such examples on their social media pages). In the proceedings of a recent post-grant opposition filed against Troikaa Pharmaceuticals for IN 231479, one of the grounds for opposition was Section 3(e). The Controller found that there was no data provided to establish or substantiate unexpected synergistic effect between the components used in the formulation when taken individually or in combination. The revocation order emphasized that the data showing that effect must be clearly incorporated in the description by way of comparison. Similarly, a pre-grant opposition against Lincoln Pharmaceuticals’s application for ‘A Pharmaceutical Formulation for Paracetamol Injection’ (Appl. No. 1746/MUM/2008) succeeded in obtaining a rejection on multiple grounds including Section 3(e). The Asst. Controller specifically stated: ‘since Glycofurol and alcohol are individually known to solubilize paracetamol, it was imperative to provide comparative data to show the synergistic effect (enhanced solubility) achieved through the combination of solvents.’

Although IN 231479 was ultimately revoked and 1746/MUM/2008 rejected, their lack of synergistic effect data went unnoticed in the Patent Office’s Examinations. The fact that such a serious issue wholly escaped the scrutiny of the Patent Office and only came to light through Opponents’ intervention is worrying.

Section 2 Justifies Section 3?

Section 2 of the Patents Act lays down the conditions of patentability, whereas Section 3 creates exceptions from patentability. The Supreme Court in Novartis v. Union of India, while discussing therapeutic efficacy under Section 3(d), held that in order to gain a chemical or pharmaceutical patent, a product must pass this test in addition to the requirements of Sections 2(1)(j) and 2(1)(ja) (see para 190-192).

However, pharma companies have been seen to rely on novelty and/or non-obviousness of a claim to bypass the requirements of Section 3(e). In reply to the Patent Office’s Section 3(e) objection in Application No. 4045/DELNP/2014, the applicant stated that since the novelty of the composition was acknowledged, it cannot be deemed a mere admixture of known components. The Controller then proceeded to grant the patent. Similarly, in Application No. 4538/CHENP/2013 filed by Genentech, the Patent Office, after raising aSection 3(e) objection, then went on to accept that the provision would not be attracted because novelty and inventive step are acknowledged. These are not isolated cases. The AccessIBSA report linked above lists 19 pharma patents between 2009-2016 where such an objection has been overcome by citing Section 2(1)(j).

Considering Novartis makes it clear that the Sections 2(1)(j) and 2(1)(ja) and Section 3(d) have to be satisfied separately, the Patent Office’s practice of allowing applicants to circumvent Section 3(e), a similar anti-evergreening provision, by showing novelty and/or inventive step, cannot make for sound legal precedent.

Importance of Synergy Data

The synergistic effect in an invention cannot simply be stated, but needs to be shown through detailed, comparative analysis of data relating to individual and combined results. This would entail not only the statement of the result or technical effect achieved by the claim, but the description and measurement of the improvement from what would have been the expected result. While several errors persist, the Patent Office has also rightly rejected a number of applications which have not shown how synergistic effect is achieved (see for e.g. applications 2641/MUM/2015 and 4670/DELNP/2011). Such an in-depth scrutiny approach needs to be followed for all patent applications.

Unlike the more controversial Section 3(d), so far Section 3(e) has not received equal international attention. However, its importance in preventing evergreening attempts cannot be undermined. AccessIBSA’s report shows that only 12 patents were granted where the order clearly cited the data that proves synergism (see page 27). In many others, either no synergism data was reproduced in the order (it might still have been submitted to the Patent Office) or the order does not provide any clear reasoning as to how the objections were overcome. This, coupled with the estimated 72% error rate in secondary patent grants, makes it evident that the Patent Office needs to be more vigilant and observe stricter scrutiny.

(Note: All comments on the specific patent applications/grants above are after a personal first level analysis and readers are welcome to give in their comments if they have a contrary take or more information on the same).

13 comments.

  1. AvatarAmit Tailor

    on “equal international attention”: To me, one of the reasons why the 3(e) issues not getting highlighted as much as 3(d), is because of them being secondary patents/claims they may not ‘hurt’ much to the follow-on entrants as they do in case of 3(d) issues, and they are able to ‘by-pass’ these claims. So as long as something is not an obstacle for others, nobody bothers to get rid of it and would prefer to jump-over or pass-by it. As soon as something appears a ‘threat’, there would be oppositions and challenges for sure. So, as 3(e) does not get as much ‘resistance’ as 3(d), it may have remained under-noticed.
    And second reason probably is what the author is pointing – claims with a 3(e) ‘element’ are getting allowed more frequently and generously, so again there would not be much noise around the issue.
    On “consistency”: Yes, there is an element of ‘inconsistency’ in the amount and intensity of the scrutiny by the Patent Office when it comes to the 3(e) issues. Some claims are appropriately rejected for lack of synergy, while others are allowed without rigorously ascertaining the synergy.

    Reply
  2. AvatarArvind Birajdar

    could you please share patent number of abovesaid post. (Shubhangi Patil was granted a patent over her unique Ragi-walnut Soup Mix Composition)

    Reply
    1. AvatarAdyasha Samal Post author

      Sir, the patent application number is 201621034764. Thanks for pointing this out, I have added it to the post as well.

      Reply
      1. AvatarSriram Kannan

        Thanks for updating the application number. But it is indeed strange to see, despite the granted-reworded claim for this patent, it does not look like an advancement over existing knowledge as the proteins so-derived from the soup can still admixture of individual ingredients that they are made out of. With all due respect for the lady and her agent who has gone the extra mile to protect their IP, this patent should not open a flood-gate for patenting recipes. Even if so happens, it will be interesting to see how IPO handles N-U-N (patent-ability) test for such recipes.

        Reply
      2. AvatarAnonymous

        I have filed for a ‘pre-grant’ opposition. It has been accepted by the Patent Office and uploaded on the Government website.

        Reply
        1. AvatarAnonymous

          I believe, you are a little late to approach the Patent Office – ‘Pre-Grant’, as the patent stands “garnted” u/s 43 by the controller and only awaiting certain formalities by the NBA. [See, the controller’s order dated 2ndDecember,2020 – “it is hereby decided that, the patent application no. 201621034764 with amended claim1 submitted on 24th November, 2020 is IN ORDER OF GRANT u/s 43 of the Act and will be granted after the submission of NBA approval”]

          Reply
  3. AvatarSandeep Kanak Rathod

    Thanks for the shout-out.

    I have found IPO’s stand on S.3(e) very inconsistent and even today, am not able to decipher which way a decision will go only by looking at the Specification and FER query.

    As I wrote on my LinkedIn post, this ragi soup patent is NOT worth the paper its printed on. Borrowing words from a famous Delhi HC case, this seems to be a case of ‘luxury patenting’. Some friends have put interesting comments there – do see those, too:
    https://www.linkedin.com/posts/rathodsandeep_home-maker-shubhangai-patil-receives-patent-activity-6744831541823725568-PvR1

    Reply
    1. AvatarAdyasha Samal Post author

      Indeed sir, while the Soup patent looks unexpected, the IPO has been quite unpredictable in its approach to likely Section 3(e) violations. Thank you for flagging these strange decisions.

      Reply
  4. AvatarSathya

    There appears to be a simple yet logical explanation for the grant of this patentably absurd patent : The granting authority is not experienced and knowledgeable enough to make sense out of facts presented before him/her. Patent granting is a techno-legal task and granting authority is expected to be conversant with the subject matter to ascertain facts from the response provided by applicant. Saying Omega-3-fatty acids will cure Vit B12 deficiency is unscientific on the face of it. Neither of Ragi and Walnut have B12 in them and there’s no way they can act in synergy either to cure B12 deficiency. I went through the decision of granting authority to know the reasons behind the grant but shocked to see that no reasons were recorded for granting the patent. The decision was written in just a couple of lines and it says that the requirements are met and so patent was granted. Reminds me of comments made by Prof. Shamnad Basheer once on a SpicyIP post ( https://spicyip.com/2018/08/sexual-pleasure-is-immoral-so-says-the-indian-patent-office.html) reproduced here verbatim:

    ” Quasi judicial officers are meant to “reason” out their decisions. In clear lucid language so that parties and the public understand why they’ve decided the way they did. Thats the least expected of a public functionary that is authorised to hand out twenty year monopolies. And paid through tax payer money, if I might add. if they fall short on this count, its imperative that this be redressed..through more rigorous selection/promotion procedures and more training programmes. Without using it as a fall back excuse each time: Oh well! they’re science folks. How do you expect them to interpret the law? If they can’t read and interpret the law reasonably decently, they have no business being in a post that vests them with such vast powers.”

    Looks like patent office left the business of ascertaining the validity of patent to public itself than doing its job properly.

    Reply
    1. AvatarAnonymous

      The pre-grant opposition u/s 25(1) I believe isn’t admissible once the controller is done deciding the application. The application was marked as ‘in order for grant’ and hence I believe its late for pre-grant opposition. The document filed by you may have been uploaded in the IPO website but It may not proceed further to the stage of hearing etc. The only way now appears to be a post-grant opposition u/s 25(2)

      Reply
      1. AvatarAnonymous

        There are case laws which consider pre-grant opposition before the grant of patent, till the receival of certificate, before the grant from the Patent Office.

        Reply

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