In appeal,High Court has the same powers as the Controller, including the power to require amendment

In an order dated February 03, 2023, the Delhi High Court in the case of Societe Des Produits Nestle Sa vs The Controller Of Patents And Designs [C.A.(COMM.IPD-PAT) 22/2022] held that “it is axiomatic that if the Controller has been given the power to direct an amendment to the patent application, the High Court, which is sitting in appeal over the decision of the Controller, should also have similar powers to direct the patent applicant to amend Claims to its satisfaction”.

Background:

The present suit arose out of a PCT application no. PCT/EP2017/055680 that entered the national phase application in India as Indian Patent Application No.201817040811 titled as "Composition for use in the Prophylaxis of Allergic Disease". Pursuant to the submissions filed by the Applicant in support of the arguments advanced during the hearing, the Respondent passed an order (hereinafter referred as "impugned order") refusing the grant of the patent application under Section 15 of the Indian Patents Act (hereinafter referred as "Act").

As per the impugned order, the Respondent held that:

- Claims of the patent application are not patentable under Section 3(i), Section 3(e) and Section 2(1)(ja) of the Act.

- The amended Claims are outside the scope of the originally filed claims and therefore impermissible under Section 59.

Therefore, the Applicant filed the present appeal.

Submissions made by the Parties:

· Permissibility of amended claims under Section 59 of the Act:

The Applicant argued that the amendments were made to the claims to overcome the objections raised by the Respondent in the office action and hearing notices. The Applicant further relied on Nippon A & L Inc v. The Controller of Patents [C.A. (COMM.IPD-PAT) 11/2022] to establish that the amendment ought not to have been rejected as long as the invention was disclosed in the specification and the Claims were restricted to the disclosures made in the specification.

The Respondent, on the other hand, submitted that the claims were amended from being purpose-limited product Claims which conferred limited scope of protection to Claims on a composition. This amendment of Claims from purpose-limited product Claim to pure composition Claims was in contravention of Section 59 of the Act.

· Patentability under Section 3(i) and Section 3(e):

With regard to Section 3(i), the Applicant opined that the originally filed claims were directed towards a “composition” and not towards a “method of treatment”. Therefore, the findings of the Patent Office that the Claims relate to a method of treatment was wholly erroneous. Reliance in this regard was placed on University of Miami v. Controller of Patents [OA/33/2015/PT/KOL].

The Respondent argued that the amended claims were in contravention of Section 3(i) of the Act as the body of the claims defined medicinal use in terms of the method of treatment/prophylaxis.

With respect to Section 3(e), the Applicant opined that an extensive data was provided in support of synergism of the composition claimed in the application. Further, the Applicant relied on Tata Global Beverages Limited v. Hindustan Unilever Limited [TRA/1/2007/PT/MUM] to state that it is a settled position of law that the Applicant is not required to give each and every possible embodiment falling within the scope of the Claims and the Applicant is only required to maintain an illustrative data in support of the Claims.

The Applicant further asserted that the teachings from the documents cited by the Respondent as prior art were not individually or collectively leading any person skilled in the art to the subject matter of the present patent application.

However, the Respondent opined that the Applicant had not submitted sufficient data to demonstrate stabilized synergism as the patent application lacked data on the individual effects of each drug (when each drug is used alone).

Court’s analysis:

· Whether the use of expression “treatment” in the claim render a claim falling under Section 3(i) of the Indian Patents Act.

The Hon’ble Court relied on the judgment in University of Miami v. Controller of Patents [OA/33/2015/PT/KOL], where the IPAB observed that:

"17. ...The use of expression treatment in the claim does not render a claim falling under Section 3(i) of the Indian Patents Act. The expression "composition for the treatment" has been used in the preamble of many claims which have been granted by the office of Respondent No.1 and is only a way of defining the composition and in no way the claimed composition can be a method performed by a physician for treatment of disease. There are plenty of compositions claimed wherein the composition is defined in the preamble with the disease/condition that is being treated with the composition."

The Hon’ble Court noted that the amended claims were directed towards a composition and not a method for treatment. Moreover, the expression “composition comprising DGLA directed towards treatment” in the originally filed claims was used only for defining the composition and not directed towards a method of treatment.

· Whether amendment can be allowed at the stage of appeal or not.

The Hon’ble Court opined that there is no provision in the Act, which specifically bars the amendment of a patent specification at the appellate stage. Only requirement under the Act is that the amendment has to fulfil the requirements under Section 59 of the Act and the consideration that has to be kept in mind is that the amended Claims are not inconsistent with the earlier Claims in the original specification.

The Hon’ble Court asserted that it is axiomatic that if the Controller has been given the power to direct an amendment to the patent application, the High Court, which is sitting in appeal over the decision of the Controller, should also have similar powers to direct the patent applicant to amend Claims to its satisfaction. Further, the Hon’ble Court opined that it is a settled position of law that an appeal is a continuation of the proceedings of the original court. The appellate jurisdiction involves a re-hearing on law as well as on facts. Reference in this regard was made to a recent judgement of the Supreme Court in Ramnath Exports Pvt. Ltd. v. Vinita Mehta & Anr, [(2022) 7 SCC 678].

The Hon’ble Court further relied on AGC Flat Glass Europe SA v. Anand Mahajan and Ors., [CS(OS) 593/2007] where the Hon’ble Court had allowed amendments to claims of a patent specification when an interim injunction application was being considered, so long as the amendment was in conformity with Section 58 and 59 of the Act.

Thus, the Hon’ble Court concluded that if the High Court, in appeal is considering the issue of grant of patent, it should necessarily have the same powers as given to the Controller under Section 15 of the Act, which includes power to require amendment. Further, the appellate proceedings challenging the refusal of grant of a patent, questions of facts need to be re- examined comprehensively and therefore, a liberal view has to be taken with regard to amendment of Claims.

The Hon’ble Court noted that in the present case, since the appellant was resorting back to the previously filed claim, the same was fully covered under Section 59 of the Act. Taking into account the fact that the objection due to which the amendment was pursued has itself been set aside, it would be in the interest of justice to allow the amendment at the appellate stage.

· Requirements under Section 3(e):

To analyse the issue of Section 3(e), the Hon’ble Court relied on Lallubhai Chakubhai Jarivala v. Shamaldas Sankalchand Shah, [(1934) 36 BOMLR 881], where the Bombay High Court had given clarity on the aspect of grant of patents with respect to new combinations. The relevant extract from the said judgement reads as:

“The point of a combination patent is that the elements of which the combination consists is to produce one result. The merit depends upon the result produced. Frost in Vol. 1 of his Patent Law and Practice, Edn. 4 observes as follows (P. 74):

The merit, of a new combination very much depends on the result produced. When a very slight alteration turns that which was practically useless into what is useful and important, the Courts consider that, though the invention was apparently small, yet the result being the difference between failure and success, it is a fit subject-matter. Thus, the mere placing of two flat wicks parallel to each other in an oil lamp, two concentric round wicks having been previously combined, and flat wicks being perfectly well-known, has been held sufficient to merit a patent.

The authority cited is Hinks & Son v. Safely Lighting Co., (1876) 4 Ch. D 607. In that case Jessel, M.R., makes the following observation where a slight alteration in a combination turns that which was practically useless before into that which is very useful and very important, Judges have considered that, though the invention was small, yet the result was so great as fairly to be the subject of a patent; and as far as a rough test goes, I know of no better”.

The Hon’ble Court further referred to the IPAB order in Tata Global Beverages Limited (supra). The relevant observations in paragraph 94 are set out below:

"94. So far as the ground of insufficiency is concerned the applicant must prove that information given in the specification is insufficient to work the claimed invention. The sufficiency requirement is met if at least one way of working the invention is clearly indicated enabling the skilled person to carry out the invention…It is not necessary for the purpose of section 10(4) that the disclosure of a patent be adequate to enable the skilled person to carry out all conceivable ways of operating the invention. If the best method known to the patentee is disclosed it satisfies the requirement of sufficiency. Since the appellant has not contested the reproducibility of the example of the patent in question we find it sufficient for the purpose of section 10."

The Hon’ble Court opined that sufficient data had been provided by the Applicant for comparing the individual components and control group and their efficacy with that of the claimed composition. Therefore, the objection taken by the Patent Office under Section 3(e) of the Act is not sustainable and the same is set aside.

· Considerations for finding inventive step:

The Hon’ble Court observed that in F. Hoffmann-La Roche Ltd. and Ors. v. Cipla Ltd., [2016(65) PTC 1 (Del)], the Court had laid down the seminal test to be followed for determining inventive step and lack of obviousness. The steps involved in the said test are as follows:

“Step No.1 To identify an ordinary person skilled in the 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 alleged invention, constituted steps which would have been obvious to the ordinary person skilled in the art and rule out a hindside approach”

Further, the Hon’ble Court observed that in Avery Dennison Corporation v. Controller of Patents and Designs, [202/DHC/004697], the age of the prior art cited was found to be a relevant consideration for determining if the subject matter of the Patent Application would be obvious to a person skilled in the art or not.

The Hon’ble Court noted that the prior arts cited in the subject Patent Application had priority dates in the year 1995 whereas the subject patent application was filed with a priority date of 1st June, 2016 i.e., the prior arts cited were more than 20 years older than the subject Patent Application. Therefore, the Hon’ble Court asserted that, when the subject matter of the patent application is showing technical advancement over the cited prior arts, and when the cited prior arts are considerably old, it is a clear indicator of non-obviousness.

The Hon’ble Court noted that the prior arts cited by the Indian Patent Office were the same as that were cited by the European Patent Office (EPO) when the corresponding European (EU) patent application was being prosecuted. The said EP patent application was granted vide publication EP3463332B1, dated 21st April, 2021 and this, in the view of the Court, would also be a persuasive argument in support of the grant of the Indian Patent Application, especially when the same prior art had been cited.

Finally, the Hon’ble Court found subject Patent Application satisfying the criteria of inventive step and ordered the subject patent application to proceed for grant.