The Appeal:
The Subject Matter Appeal has been filed against order dated 29.12.2021 passed by the Controller of Patents and Designs, Patent , refusing the Patent Application of the Appellant.

The Parties:
The Appellant is the Applicant for the Patent while the Respondent is the controller of the Patent which has passed the Order of refusal.

The Patent Application:
On 29.10.2018, the Appellant filed patent application No.201817040811 for an invention title "Composition for use in the Prophylaxis of Allergic Disease claiming priority date from European Patent Application, i.e., EP16172431.5 dated 1st June, 2016.

The Reason For Refusal Of The Patent Application:

1. The Patent Application is a method for treatment of the human body‟ and hence barred under the provisions of Section 3(i) of the Patent Act.
2. The amendments sought were not permissible as they were enlarging the scope of invention, hence barred under Section 59 of the Act.
3. In the complete specification, there is insufficient data, hence barred under 2(1)(ja) and Section 3(e) of the Act.

The Judgement:
The subject matter Patent Application was ordered to proceed for grant.

The Observation Of The Court:

1. The subject matter claims of the Patent Application was not a method for treatment of the human body but rather it was directed towards a composition comprising DGLA, EPA and DHA.
2. The Ld. Controller was wrong in observing that the subject matter Patent Application is barred under Section 3 (i) of the Patent Act. As the subject matter Patent Application is not directed towards a method or process for prophylactic treatment, the provision of Section 3 (i) of the Act is not Applicable.
3. At the time of hearing, the claim 1 of the subject matter Patent is mainly focused on the composition. The relevant portion of claim 1 of the subject matter Patent was:
   
   1. A composition comprising DGLA for use in the prophylaxis of allergic disease in an offspring of a mammalian subject, comprising administration of the composition to said subject pre-pregnancy and/or during pregnancy and/or during lactation and preferably wherein said composition is a composition enriched in DGLA wherein said composition also contains an omega-3 polyunsaturated fatty acid, selected from the group consisting of DHA and EPA or a combination of DHA and EPA....".
      
      It is apparent that claim 1 of the subject matter Patent was directed towards the composition comprising of DGLA , DHA and EPA. It was not focused on the method of treatment, rather it was focused on a composition comprising of DGLA , DHA and EPA which is used in relation to of allergic disease in an offspring of a mammalian subject.
       
4. The Applicant's application for amendment was enlarging the scope of claim , hence it was not allowed. However, the question was this, whether the applicant should be allowed to resort the originally filed Claim.
    
5. The Court observed that the Appeal is a continuation of the proceedings of the original court. Hence, the Single Judge is fully entitled to allow the amendments under Section 15 of the Act. Accordingly, the originally filed claim was held not to be barred under the provision of Section 3 (i) of the Act.
    
6. The Court also rejected the argument of the controller regarding inefficiency of data as , according to the Hon'ble High Court of Delhi, there was sufficient data in the complete specification of the Patent Application.
    
7. For evaluating the inventive steps, the Hon'ble Single Judge followed the 5 layers of test of this as laid down in F. Hoffmann-La Roche Ltd. and Ors. Vs. Cipla Ltd., 2016(65) PTC 1 (Del). These tests are as:
   
   Step No.1 To identify an ordinary person skilled in art.
   
   Step No.2 To identify the inventive concept embodied in the patent.
   
   Step No.3 To impute to a normal skilled but unimaginative ordinary person skilled in the art what was common general knowledge in the art at the priority date.
   
   Step No.4 To identify the differences, if any, between the matter cited and the alleged invention and ascertain whether the differences are ordinary application of law or involve various different steps requiring multiple, theoretical and practical applications.
   
   Step No.5 To decide whether those differences, viewed in the knowledge of an alleged invention, constitute steps which would have been obvious to the ordinary person skilled in the art and rule out a hindside approach.
    
8. Another fact for evaluating the inventive steps as laid down in Avery Dennison Corporation v. Controller of Patents and Designs, 202/DHC/004697 is the time gap between the prior art document and the invention under consideration. If a long time has passed since the prior art was published and a simple change resulted in unpredictable advantages which no one had thought of for a long time, the Court would tilt in favour of holding that the invention is not obvious.
    
9. In the present case, the closest prior art cited was 20 years old, hence it is a clear indicator that the subject matter patent is non obvious.
    
10. It is submitted that the idea behind this concept is that there has been a long gap between the prior art and the patent application. By passage of time , there has been technical advancement , still inventive steps have not been envisaged by the field. Hence, the law says, the older a prior art is, the less amount of inventiveness is required. Hence, the wide gap of prior art is directly proportional to the inventiveness of patents.

Important Note:

1. To attract the provision of Section 3 (i) of the Patent Act, a composition for treatment of the human body is not enough. To attract the provision of Section 3 (i) of the Act, a method for prophylactic treatment is required to be shown.
    
2. In the subject matter case, the Patent was focused on composition , used for treatment and not on the method of treatment. Hence the same was held not be barred under the provisions of Section 3 (i) of the Act.
    
3. Appeal is a continuation of the proceedings of the original court.
    
4. While evaluating the patent application on the parameter of lacking inventive step, the relevant criteria is how long the time gap between the subject matter patent application and the prior art. If the time gap is longer, then even less amount of enhancement may result into inventive step.
    
5. The long gap of prior art is directly proportional to a Patent Application being non obvious.

Case Law Discussed:
Case Title: Societe Des Produits Nestle SA Vs The Controller of Patent
Judgment date: 03.02.2023
Neutral Citation No. 2023/DHC/000774
Case No: C.A. (COMM.IPD-PAT) 22/2022
Name of Court: High Court of Delhi
Name of Hon'ble Justice: Amit Bansal, H.J.

Disclaimer:
This information is being shared in the public interest. It should not be treated as a substitute for legal advice as there may be possibility of error in perception, presentation and interpretation of facts and the law involved therein.

Written By: Ajay Amitabh Suman, IPR Advocate, Hon'ble High Court of Delhi.
Email: [email protected], Ph No: 9990389539