This case analysis is written by T.V. Lavanyaa, IV-year B.A.LL. B, Chennai Dr. Ambedkar Government Law College, Pudupakkam.
SUMMARY
While reversing the judgment of denial, the court observed that a claim itself does not become a method of treatment under Section 3(i) merely because the term “treatment” finds a mention in the words used in the claim. The courts can read phrases like “for use” or “in the treatment of” as forming part of the preamble of the claim. Their inclusion or exclusion in the claim text does not alter the scope of the claim. As a result, the Hon’ble Court allowed the applicant to reinsert the phrase “for use in the treatment of” in the claims in addition to allowing the “Composition with Components” claims under section 3(i). The Hon’ble Court also allowed the claims for the composition under section 3(e) after holding that the evidence put forth to establish ingenuity was sufficient.
THE OBSERVATION OF THE COURT:
a. The patent application’s subject matter claims are related to a composition which comprised DGLA, EPA, and DHA instead of a method of treatment to the human body.
b. Section 3(i) of the Act provision does not apply since the subject matter of the patent application does not focus on procedure or method for preventative treatment.
c. The composition is the focus of claim 1 of the subject matter patent at the hearing.
d. Because the applicant’s amended application expanded the scope of the claim, it was denied. But the question was whether the petitioner should be permitted to use the claim that was initially filed.
e. It is observed that the appeal forms an extension of proceedings by the initial court. The Single Judge, under the provisions of Section 15 of the Act, therefore has full authority to approve the revisions. With that, it was held that Section 3(i) of the Act does not bar the claim that was first made.
f. The Court also dismissed the controller’s claim of data inadequacy for the reason that, in the opinion of the Hon’ble High Court of Delhi, the whole specification of the patent application provided sufficient data.
g. The length of the prior art gap is directly related to patentability of an application under obviousness.
h. It is very clear that the subject matter patent in this case is not obvious because the closest prior art identified was 20 years old
INTRODUCTION
The ruling by the Hon’ble High Court of Delhi in an appeal brought under Section 117A of the Patents Act, 1970 (the “Act”) is discussed here. The Controller of Patents and Design (“the Respondent”) rejected the patent application under sections 3(i), 3(e), and 59 of the Act on the grounds of the failure of the patent based on inventive step and ineligible for protection under the law of patent. Societe Des Produits Nestle Sa (“the Appellant”) appealed the decision. On the basis of facts in the case, the High Court concluded that the Respondent’s evaluation of the invention was incorrect and granted the patent application.
For surmounting the complaints in the directions of non-patentability, mainly Section 3(i) of the Act, the High Court re-interpreted the requirements for the parameters of allowable change without disturbing the requirements of Section 59 of the Act. This article essentially explores the judgment on interpretation given by the High Court concerning the meaning of Section 3(i) and Section 59 of the Act.
FACTS OF THE CASE
With application number 201817040811, referred to as the “Application,” the appellant filed a patent application with the title “Composition for use in the Prophylaxis of Allergic Disease.” The Application is a National Phase arising from the international application number PCT/EP2017/055680. The Respondent raised objections to the non-patentability under Sections 3(e) and 3(i) of the Patents Act as well as the lack of novelty and inventive step under Sections 2(1)(j) and 2(1)(ja) in a First Examination Report (FER). Subsequent to receiving a response to the FER from the Appellant along with the revised claims, the Respondent made a hearing notice raising again the objections in the FER. After a hearing, written submissions were filed by the Appellant.
According to Sections 2(1) (ja) and 3 of the Act, the respondent refused the application after scrutiny of the written statement made by the appellant and amendments submitted with the claim. Apart from this, the respondent rejected the application on the ground of Section 59 of the Act. Here, the respondent stated that the appellant has defined a process of “treatment of human body,” and thus, the claims were non-patentable. The Respondent, while arguing that the subject matter protected by the original claim was a “composition, when used in treatment” and thus contained both “composition” and “method features,” made this in rebuttal to the objection put forth under Section 3(i) of the Act.
Respondent pleaded that modified claims filed by the Appellant under Section 59 of the Act were unlawful since an applicant attempted to provide wider scope of protection than that enjoyed by the original claims which is not allowed under Section 59 of the Act. Furthermore, the applicant was arguing that the original claims were protecting only when the compound was in use for the treatment process. But with the proposed amended claims, it would be a case where protection would extend beyond its usage, more so than with the original claims.
In view of the objection made under Section 59 of the Act, the Respondent submitted that the objection under Section 3(i) of the Act was sustained. Appellant, feeling that the decision of respondent was unfair, appealed before the trial court to reverse the order refusing permission.
THE INTERSECTION BETWEEN SECTION 59 AND SECTION 3(I) OF THE ACT:
As pointed out during the argument by appellant’s counsel, claim 4 as filed is centered on a “composition” and not a “method of treatment” and thus, description and scope of claims are preserved in the same position. Second, the Appellant claimed that the changes in the claims were made in order to respond to objections from the Patent Office in the FER and the Hearing Notice, and that these changes were within the scope of the claims filed originally, which meant that they were valid under Section 59 of the Act. The body of claims filed in response to the FER was, the counsel for the Respondents argued, as follows: “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.” This definition of medicinal use in terms of the treatment/prophylaxis method is non-patentable under Section 3(i) of the Act. In objection to change of claims, counsel for the Respondents argued that the claims were expanded from “purpose-limited” product claims to “pure composition,” thereby violating Section 59 of the Act. To get over the challenge under Section 3(i) of the Act as mentioned in the Hearing Notice, it was submitted on behalf of the Respondent that upon attending the Hearing, the Appellant had altered and changed the claims with the written submissions to omit the words “for use.” Upon perusal of the case facts, the High Court independently evaluated sections 3(i) and 59 of the Patents Act.
THE HIGH COURT’S ANALYSIS OF SECTION 3(I) OF THE ACT:
The High Court then determined that any claim dealing with preventive treatment or prophylactic procedure is barred by Section 3(i) of the Act. The High Court then refers to the judgment of the lower court in University of Miami v. Controller of Patents, where the former IPAB clarified that while talking about the grounds of rejection under Section 3(i) of the Act that the mere use of the word “treatment” in the claim does not automatically throw it within Section 3(i) of the Act. For similar reasons, the term “treatment composition” is merely used to identify the composition and says nothing whatever to suggest that the subject composition is a course of medical treatment for an ailment. The Manual of Patent Office Practice and Procedure (the “Manual”), which addresses the exclusion of medical, surgical, curative, preventive, diagnostic, therapeutic or other treatments from consideration by way of examination, was relied upon by the High Court.
Having put everything into proper perspective, the High Court made a declaration to the effect that the previous submitted claims described a composition, and not a prophylactic treatment method. To the High Court, “composition comprising. Intended to treat” was only being used in the description of the composition and did not at all refer to a treatment method. The High Court thus concluded that since the claims on record were directed to a composition for use in treatment, the same did not fall under the ambit of Section 3(i) of the Act. Thus, there was no merit in the decision of the Respondent to refuse the application under Section 3(i) of the Act.
THE HIGH COURT’S ANALYSIS OF CLAIM AMENDMENTS:
The High Court mainly held the view that the appellant filed amended claims in response to respondent’s objection under Section 3(i) of the Act along with the Hearing Notice. As a result, the claim was enlarged from its originally framed scope to become one general claim over the said composition rather than a purpose-specific claim. This became the justification for the respondent to make objections to the patent filed under Section 59 of the Act.
Referring to the fact that no provision of the Act provides the courts with discretion to grant permission for any amendment at the stage of appellate proceedings, the Respondent also argued that the Appellant had wrongly relied on purpose-limited composition claims in the course of the proceedings, which were not dissimilar from those in response to the FER. The High Court pointed out some vital factors in considering the present case by referring to the Act and several court judgments to emphasize some basic features of altering a patent specification:
- A request for amendment can be made even after the grant of patent.
The High Court emphasized that there is no explicit clause in the Act that prohibits changing a patent specification throughout the appeals process. It was made abundantly evident in Subsection 3 of Section 57 of the Act that an alteration might be made even after a patent had been granted.
- An amendment to the specification can be allowed in the proceedings before the High Court.
Using sub-section (1) of Section 58 of the Act as authority, the High Court held that it may allow a specification change in a case that was before it at the time of patent revocation. Thus, even at a later time, there is no specified bar for the alteration. The Act merely requires that the revised claims be consistent with the earlier claims in the original specification and that the amendment meet the standards under Section 59 of the Act.
- The High Court has similar powers as those granted by Section 15 of the Act to the Controller.
The High Court held that the Controller has the right to require an application to be modified to his satisfaction under Section 15 of the Act. It follows that if the Controller has the power to direct changes to the patent application, the High Court, hearing an appeal of the Controller’s decision, should have the same power to direct the patent applicant to change claims to its satisfaction. The recent decision of the Supreme Court in Ramnath Exports Pvt. Ltd. v. Vinita Mehta & Anr, (2022), which made it clear that an appeal constitutes a continuation of the original court’s proceedings, was also relied upon by the High Court.
In the case of AGC Flat Glass Europe SA v. Anand Mahajan and Ors. a single judge of the High Court adopted an analogous view, allowing changes in claims of a patent specification while an application for an interim injunction is being considered, if the change satisfies Sections 58 and 59 of the Act. According to this view, the High Court held that it has equal powers with the Controller in a patent grant appeal, including powers to amend the patent application.
For this reason, an indulgent attitude toward amendment of claims is necessary since the appellate process is objecting to denial of a patent, which calls for a comprehensive reappraisal of facts. Accordingly, Section 59 of the Act wholly encompasses the appellant’s application of the earlier filed claims. In addition, justice would not be served by not allowing the change at the appellate level since the objection leading to its filing was reversed.
CONCLUSION
After the judgment passed by the High Court, now it is clear that, keeping all the limitations of Sections 58 and 59 of the Act in mind, applicants would be able to file revised claims to overcome non-patentability issues, especially Section 3(i) of the Act under the Indian Patent Law. Furthermore, since Section 3(i) of the Act applies only to claims relating to a process, this judgment makes it clear that product claims cannot and should not be objected to under that section.
