Recent Trends and Developments in Patent Matters in India

Post abolition of the Intellectual Property Appellate Board (IPAB) in India after the enactment of Tribunals Reforms (Rationalisation and Conditions of Service) Ordinance 2021, a separate Intellectual Property Division (IPD) was established in the High Court of Delhi in 2021, and Intellectual Property Division Rules, 2021 were notified. In 2023, the Madras High Court also established a separate IPD and notified the Madras High Court Intellectual Property Rights Division Rules, 2022. Recently, Calcutta High Court has notified its draft IPD rules, and it is expected that separate IPD will also soon be established in the Calcutta High Court.

With the formation of exclusive benches to adjudicate matters related to intellectual property, there have been many significant changes, and key landmark judicial rulings have been passed. A few of such key rulings which have demystified and interpreted key provisions of the Patent Act, 1970, are discussed below.

Inventive Step

On the aspect of inventive step, the Delhi High Court has elaborated in many of the matters, as enlisted below, the key factors that must be considered while assessing the obviousness of the invention in question.

• In Avery Corporation v Controller vide order dated 4 November 2022, the court discussed that various structured tests that are used in other jurisdictions such as Graham factual inquiry/KSR in the United States of America, Pozzoli five-step in the United Kingdom or the Problem-Solution Approach used in Europe might be applied to assess inventive step or non-obviousness. However, the Indian statutory requirement “invention must involve non-obvious technical advancement”, is mandatory. Further, the court also observed that other factors, such as the age of the prior art, long-felt want, etc, may be used to indicate non-obviousness to complement the existing test of inventiveness.
• Novartis v Natco vide order dated 9 January 2023, held that mere cherry-picking to select substitutes out of the myriad substitutions provided in the Markush formula in the prior art to arrive at the claimed compound is hindsight reconstruction and, therefore, not permissible.
• In Astrazeneca v Intas vide order dated 20 July 2021, the Division Bench of the court rejected the appellant’s contentions that the claimed compound was disclosed generally in genus patent, whereas the same was disclosed specifically in species patent and held that one invention could be protected by only one patent.
• In Boehringer v Vee Excel Drugs, the court, in its order dated 29 March 2023, using the prosecution and litigation history of the genus patent, held that the claimed compound (Linagliptin) in species suit patent was found to be “disclosed”, “claimed” and “covered” under the genus patent.
• In Biomoneta Research Pvt Ltd v Controller, the court vide order dated 13 March 2023, held that an invention is patentable if the combination of features as a whole is non-obvious in nature, and if the combination is synergistic (not mere juxtaposition) or if there is a working interrelation that produces a new and improved result, the subject matter is patentable.
• In Pharmacyclics v Hetero, the court, via order dated 21 December 2023, observed that for asserting lack of inventive step, the prior art and the suit patent are required to be analogous. Similarly, in Titan v Controller, the court vide order dated 2 May 2023, observed that if prior art addresses different problems, it would not be plausible for a person skilled in the art to realistically combine the teachings of the referenced prior art. The court further observed that it is inappropriate to combine or “mosaic” two substantially unrelated prior art. In the same case, the court also observed that the mere absence of working examples does not render the subject application liable for rejection. The court emphasised that as per Section 10(4)(b), an applicant is required to disclose the best method of performing the invention known to them for which they are claiming monopoly.
• In AGFA NV v Controller, the court vide order dated 2 June 2023, observed that to rely on common general knowledge as a ground for lack of inventive step, it is essential to specify the source of such knowledge.

Section 3(d)

A requirement under the Indian Patent Act, introduced in 2005 to curb evergreening, Section 3(d) lays down specific requirements. According to Section 3(d) of the Indian Patents Act, the following are not patentable:

• the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance;
• the mere discovery of any new property or new use for a known substance; or
• the mere use of a known process, machine, or apparatus unless such known process results in a new product or employs at least one new reactant.

The Delhi High Court in DS Biopharma v Controller vide order dated 30 August 2022, held that in case of rejecting a patent application on the ground of Section 3(d), he would have to identify the specific known substance in the hearing notice and clarify how the claimed compounds are “new forms” of the known substance. The Madras High Court in Tony Mon George v Controller vide order dated 20 December 2023, held that to qualify as a “known substance”, the substance should be in the public domain before the priority date of the claimed invention, and if the claimed compound is structurally different from the prior art, then the claimed compound cannot be construed as polymorphic forms of the compound disclosed in the prior art.

Section 3(e)

This section provides that a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance is not patentable. The Madras High Court in Novozymes v Assistant Controller vide its order dated 20 September 2023, rejected the view of erstwhile IPAB’s decision in Stempeutics and adopted a narrower interpretation that the application of Section 3(e) is not limited to a composition claim formed by the aggregation of known ingredients and its applicability is not linked to the novelty of its components. Thus, it was held that Section 3(e) is applicable to all composition claims, even those containing novel ingredients.

Section 3(i)

This section provides that any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products shall not be patentable. The Madras High Court vide order dated 12 October 2023, in Chinese University of Hong Kong And Sequenom, Inc. v The Assistant Controller Of Patents And Designs, passed a first-of-its-kind judgment analysing factors to be kept in mind while looking at an invention of screening test through Section 3(i). The court held that “diagnostic” should neither be interpreted narrowly nor be given a very wide definition. The court took into view the relevant provisions of the TRIPS agreement, the Indian Patent manual and the findings of the EU in the Enlarged Board of Appeal in case No G 0001/04 and held that a test that can detect a disease, even if it requires further confirmation, would be considered as “diagnostic”; thus, there is no distinction between in-vitro or in-vivo diagnosis. However, the court further observed that if the test only provides a sign that prompts additional testing for a diagnosis, it would not be classified as “diagnostic”.

In another case, Nestle SA v Controller, the Delhi High Court vide order dated 3 February 2023, held that the expression “composition comprising X directed towards treatment” was used only for defining the composition and not directed towards a method for treatment of a disease and thus it does not attract Section 3(i). In the same case, the court also observed that 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. The court clarified that if the best method known to the patentee is disclosed, it satisfies the requirement of sufficiency.

Scope of amendments

In India, generally, amendments are not allowed if amended claims do not strictly fall within the literal reading of the pre-amended claims, even if they are disclosed in the complete specification, and the nature and extent of claim amendments are restrictive compared to US and EP jurisdiction. However, recently, the Delhi and Madras High Court both clarified the nature of amendments that may be allowed.

In Nippon v Controller, the Delhi High Court, vide its order dated 5 July 2022, observed that pre-grant amendments ought to be construed more liberally rather than narrowly. The court further held that amendment of “product-by-process” claims to “process” claims is permissible u/s 59(1) of the Act.

In another case, Allergan Inc v Controller, the Delhi High Court vide order dated 20 January 2023, held that for amendments under Section 59(1), one would require taking into consideration the complete specification of a pre-amended claim and not merely a textually cabined reading of a pre-amended claims itself, de hors the complete specification. This case was one of its kind as the originally filed “method of treatment” claims (not patentable in India) were allowed to be amended to “product” claims (implants) since the originally filed claim was for the method of using the “product” and every detail of that “product” was disclosed in the complete specification.

Similarly, in Commonwealth Research Org. v Controller, the Madras High Court, via order dated 4 October 2023, observed that an application for amendment should be allowed provided the amended claims fall in substance within the scope of the complete specification.

The Calcutta High Court recently made a substantive interpretation of section 13(3) in the case of Oppo v The Controller of Patents vide its order dated 13 June 2023, held that when any amendments are made to a claim, then the controller has to carry out a fresh examination and issue an examination report on the basis of such fresh examination.

Divisional application

The Delhi High Court gave much-needed clarity regarding divisional patent applications. In an earlier case, Boehringer Ingelheim v Controller of Patents, the court vide order dated 12 July 2022, had declared that only the claims must be considered when assessing whether there is unity of invention or plurality of inventions and that a divisional application is not maintainable if plurality resides in the specification and not in the claims. The recent order dated 13 October 2023 of Division Bench in Syngenta v Controller held as follows.

• A divisional application can be filed suo moto by the applicant or in response to an objection by the controller. In both cases, a “plurality of inventions” is required to file a divisional application.
• A divisional application is maintainable provided the “plurality of inventions” is disclosed in the provisional or complete specification filed with respect to the parent application.

Pre-grant opposition v examination

In a landmark judgment, the Division Bench of Delhi High Court, vide its order dated 9 January 2024, in Novartis v Natco, held that patent examination and pre-grant opposition are independent and separate processes. The court observed that while pre-grant representation aids the controller while carrying out a holistic examination of a patent application, the pre-grant opponents do not get any right to participate in the examination process, independent of the grounds of opposition. The court clarified that opponents do get the right to respond and be heard only with respect to the grounds of opposition and held that if the controller directs amendments, pre-grant opponents do not get any right of hearing to oppose the amendments. In other words, the controller need not keep the opponents in the loop with respect to amendments carried out in response to their direction or requirement for the grant of a patent. However, if a patent applicant voluntarily makes any amendments, the opponents get an appropriate opportunity to be heard.

Abuse of patent rights

In another landmark decision in the case of Ericsson v CCI, the division bench of the Delhi High Court vide its order dated 13 July 2023, limited the powers of the Competition Commission of India (CCI), holding that the Patents Act is a complete code in itself. It overrides the Competition Act, 2002. The court took the legislative intent behind the Patents Act into consideration and observed that the Act is specifically designed to deal with matters concerning allegations of unreasonable conditions in licensing, abuse of one’s patent rights and eventually, the relief that can be granted. With this judgment, the court set aside the single-judge orders in Ericsson v. CCI and Monsanto v CCI.

Interim injunctions

Interim injunctions are a major relief in a patent infringement matter. They help protect the rights of the patent holders from further infringement until the pendency of the proceedings. Interim injunctions that are granted to an IP holder are based on a three-factor test, that is the prima facie case, the balance of convenience, and irreparable harm. The person claiming an injunction has to make out a prima facie case in their favour, show that the balance of convenience lies towards them, and non-granting of the injunction would cause irreparable harm to their reputation or rights. The courts adopt a cautious approach while granting such orders in technical patent disputes. Recently, the Delhi High Court in Intex v Ericsson vide order dated 29 March 2023, has held that interim injunctions can be granted in Standard Essential Patents (SEP) disputes against an unwilling implementer, and the conduct of the party during a negotiation is a major factor in determining its willingness. The court held that interim injunctions could be granted on a prima facie level, setting aside the four-factor test set out in the Nokia v Oppo (2022) matter.

The Division Bench of the Bombay High Court in the case of Tri-Parulex Fire Protection System v M/S. Ctr Manufacturing Industries Private Limited vide order dated 25 April 2023, overturned a decision of a single judge after analysing the risk of unreasoned injunction orders and the caution that the courts need to apply. The single judge had passed an interim order without substantially finding on the prima facie case, even though an interim injunction should be granted only in exceptional cases where all three factors are fulfilled.

Performance of IPD

The Delhi High Court’s IPD performance in its first year itself is very encouraging, and as per the IPD report published by Delhi High Court, it was reported that out of patent appeals transferred, more than 45% of all patent appeals were disposed of in 2022, while 68% of original revocation petitions were disposed of.

Conclusion

With the recent developments and the establishment of IPD, faster adjudication of patent cases has started taking place, and much-needed clarity on many aspects has been achieved that is helping both in prosecution as well as enforcement of patents.