Establishment of IPR Divisions in Different High Courts of India

Establishing the Intellectual Property Division (IPD) at the Delhi High Court became an essential step after the abolition of the Intellectual Property Appellate Board (IPAB) under the Tribunals Reforms Act, 2021. In response, the Delhi High Court created the IPD as a solution to manage the increasing caseload, forming a specialised division, albeit without specialised judges initially. The first year of the IPD’s operations showcased the division’s efforts in handling the significant number of cases transferred from the now-dissolved IPAB. In its second year, the IP Division continued to make strides in reducing the backlog of these transferred cases. Between January 2023 and June 2024, the division disposed of 1,217 IPAB-transferred cases. By June 2024, over 60% of the cases received from the IPAB had been successfully resolved. Additionally, the IP Division managed to clear 2,026 fresh cases, contributing to a decrease in the overall pendency of IP cases — from 3,799 cases in 2023 to 3,742 cases by June 2024.

The success of this model was widely recognised, notably by the 169th Report of the Parliamentary Standing Committee on Commerce, which recommended the replication of this model in other High Courts across the country. In response to this, several other High Courts, including those of Madras, Calcutta, and Karnataka, have followed suit, establishing their own dedicated IPR divisions. These divisions serve not only to streamline the adjudication process but also to address the growing complexity and volume of intellectual property litigation in India.

Following the dissolution of the erstwhile IPR tribunals, the Delhi High Court took the lead by setting up a specialised IPR division, an initiative that has proven to be highly successful - in its first year alone, this division resolved over 600 commercial IPR suits, setting a high standard for the expeditious handling of IPR disputes.

At the same time, legislative changes have been introduced to further enhance the functioning of India’s patent system. Amendments to the Patents Rules, 2003, which came into effect in March 2024, aim to reduce procedural delays, simplify compliance for patent applicants, and align India’s patent system with international best practices. This combination of judicial and legislative reforms is set to transform India into a more attractive destination for innovation and IP protection. This paper delves into the establishment of IPR divisions across Indian High Courts, the recent legislative changes, and key judicial rulings that have shaped the landscape of intellectual property law in India.

Legislative Changes

• The Government of India has passed key legislative amendments to the Patents Rules, 2003, effective March 15, 2024. The amendments aim to streamline patent prosecution and implement various court decisions in India, as outlined below.
• Reduced examination timeline: Requests for examination can now be filed within 31 months, down from the previous 48-month period, accelerating the examination process.
• Simplified submission process: Foreign patent submissions must be filed within three months of receiving the first statement of objections, with late submissions allowed if condoned by the Controller.
• Relaxed filing norms: Statements of working under Form 27 need to be filed only once every three financial years, simplifying compliance for patent applicants. Further, on August 26, 2024, the Indian Patent Office clarified the rules for filing the statement of commercial working of patents. The key points are:
1. First statement: Must be filed according to specific due dates.
2. Subsequent Statements: Required every three financial years. For instance, if filed in 2024, the next is due by September 30, 2027.
3. Last statement: Should cover the entire 20-year patent term or until the patent expires. The final statement period may be shorter, depending on the remaining term.
• Extensions: The filing deadline of September 30 can be extended up to three months with a fee of INR10,000 (approximately USD125) per month. A further extension of up to six months can be requested with a fee of INR50,000 (approximately USD600) per month.
• Amendment to pre-grant opposition Rules: The amendment mandates that if a pre-grant representation is filed, the Controller is required to examine if a prima facie case is made out by the opponent. Only upon determination of the prima facie case shall the patent applicant be notified about the representation.

Illustrative List of Case Laws

Interpretation of product-by-process claims

A division bench of the High Court of Delhi has resolved the contentious debate on the interpretation of product-by-process claims in India. In Vifor (International) Limited & Anr v MSN Laboratories Pvt Ltd & Ors, the Court sided with the UK and EP approach while recognising the unique nature of product-by-process claims. The case concerned infringement of Vifor’s patent covering Ferric Carboxymaltose, used to treat iron-deficiency anaemia. The Court held that the claim relates to a novel product, ie, a water-soluble iron carbohydrate complex of iron and an oxidation product comprising one or more maltodextrins. The Court applied the rule of necessity, holding that product by process claims are the ones whose unique attributes are sought to be explained by reference to the manufacturing process. The Court clarified that product and process claims cannot be categorised in watertight compartments. Therefore, the mere fact the patentee chose to describe the invention more exhaustively by reference to process terms does not limit the patent to a specific process.

Infringement of species patent

A single judge of the Delhi High Court delivered an interim injunction in favour of Kudos Pharmaceuticals Ltd and held Natco Pharma Limited liable for patent infringement for unauthorised manufacture and distribution of a compound named Olaparib, an oral poly (ADP-ribose) polymerase (PARP) inhibitor, used for treating various forms of Cancer. The Court rejected the invalidity challenge raised by Natco in light of a genus patent. The Court held that the genus patent failed to provide an enabling disclosure about the claimed compound and was not a valid prior art for prior claiming. It was further held that Natco failed to raise the challenge due to a lack of inventive steps and the absence of any teaching from the genus patent and other prior arts towards the claimed compound, Olaparib. The Court discouraged an attempt by Natco for hindsight reconstruction to attack the validity of the species patent. In another litigation for the same compound, the Court ordered BDR Pharmaceuticals to earmark 20% of the net value from the sale of the infringing drug to protect the financial interest of Kudos, given that an interim injunction was possible due to the expiry of the patent during the case hearing.

Divisional patenting

A division bench of the Delhi High Court in Syngenta Limited v Controller of Patents and Designs clarified the Indian position on divisional patents, holding that a further application can be filed from the subject matter disclosed in provisional or complete specification already filed. The Court held that the divisional claims need not be restricted to the parent application’s claims.

Antibody patenting in India

The Madras High Court in Genmab A/S v Assistant Controller of Patents set aside an order refusing a grant of a patent for antibody claims. The Patent Office had earlier rejected the grant of claims noting that the DNA and protein of claims were from homo sapiens as per the sequence listing. The High Court refused to apply Section 3(c), holding that the said provision is applicable only for the “discovery of a naturally existing molecule/substance” and not for a synthetic version of a non-living substance, especially a monoclonal antibody. The Court held that the claimed invention concerns Daratumubab, a monoclonal antibody that binds to human CD38. It was held that the annotation homo sapiens indicated that the antibody was developed from a transgenic HubMab Mouse platform based on human germline sequence. The High Court also allowed a separate appeal by Immunas Pharma, Inc against the application of Section 3(c) for an invention titled “Antibody Capable of Binding Specifically to A-beta Oligomer and Use Thereof”.

Patents for diagnostic methods

The Madras High Court in The Chinese University of Hong Kong v The Assistant Controller of Patents has clarified the law on patent ineligibility for diagnostic methods in India.The Court held that the patentability prohibition proposed by Section 3(i) of the Patents Act is limited to inventions that are inherently and per se capable of identifying the disease, disorder or condition for treatment of the person. However, if the process cannot per se uncover the pathology, the same would not qualify as “diagnostic”. The Court held that the claimed invention relates to a method for determining a fractional concentration of fetal DNA in a biological sample taken from a pregnant female subject, which per se was incapable of identifying the existence of a disease, a disorder or a condition and further testing is required for such purpose and thus was not barred from patenting.

Determining therapeutic efficacy for patentability

The Madras High Court in Bristol Myers Squibb Company v Deputy Controller of Patents set aside a refusal order by the Patent Controller denying the grant of a patent for a new formulation under Section 3(d) of the Patents Act. The Court held that bioavailability is relevant for therapeutic efficacy but may not be the sole criterion for patentability. Therapeutic efficacy under Section 3(d) is a unique provision for India and has previously been debated.

Post-filing of therapeutic efficacy data

The Delhi High Court in Ischemix LLC v The Controller of Patents has permitted the patent applicants to rely on post-filing of clinical trial data to determine therapeutic efficacy. The decision follows a similar position taken by the Calcutta High Court in  Oyster Point Pharma Inc v The Controller of Patents and Designs and the Delhi High Court in AstraZeneca AB and Ors v Intas Pharmaceuticals. The Court reasoned that in the pharmaceuticals industry, the drug could be undergoing clinical trials for a new form at the time of filing of the patent application. Furthermore, given the complexities and lengthy nature of the process for drug development, empirical evidence may not be readily available to the applicant at the time of filing a patent application. Therefore, the clinical trial data can be filed later only to support the stand taken by the applicant in the complete specification demonstrating enhancement of therapeutic efficacy.

Biochemical patents

A Single of the Madras High Court in Novozymes v Assistant Controller of Patents clarified the efficacy test for a biochemical patent application titled “Phytase Variants with Improved Thermostability”. The Court observed that biochemical derivative forms are distinguishable from the derivatives of synthesised chemicals. It was held that the explanation clause of Section 3(d) is only applicable to synthesised chemicals and not to variants of phytase, ie, an enzyme/biochemical. The Court ruled that the efficacy of biochemicals is to be assessed based on the product’s function, purpose or utility. The Court agreed with the appellant, noting that increased thermostability is a relevant factor that enhances the known efficacy of the enzyme for phytase.

Biosimilar litigations

Indian courts have currently witnessed an exponential rise in biosimilar litigation proceedings. A Single Judge of the Delhi High Court in F Hoffman-La Roche Ltd & Ors v Drugs Controller General of India & Others rejected applications filed by Cadilla Healthcare and Hetero Drugs against Roche’s suit for restraining the said companies to manufacture a biosimilar version of “Trastuzumab” and “Bevacizumab”, respectively. Roche has challenged the validity of marketing approval secured by the said companies and has a restraining order from representing those versions of drugs as biosimilars. Roche had alleged several irregularities in clinical trials carried out by Hetero and Cadilla, which is a mandatory requirement as per Biosimilar Guidelines. The Court held that a substantial part of the cause of action pleaded relates to non-compliance/violation of the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules, 1945 and Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2012, and in any manner, these statutes do not exclude the jurisdiction of the civil courts.

Roche has also filed biosimilar infringement litigation against Zydus Lifesciences Limited for its patented drug Pertuzumab, a monoclonal antibody (MAb) biologic and first in a line of agents called “HER Dimerisation Inhibitors”. In another suit, E.R Squibb and Sons have filed an infringement proceeding against Zydus for infringement of their patent pertaining to the pharmaceutical product “Nivolumab”. These cases are pending adjudication before the Delhi High Court.

Directions for treatment of rare diseases

The High Court of Delhi decided a batch of writ petitions in Master Arnesh Shaw v Union of India & Anr pertaining to the treatment of patients suffering from rare diseases in India. The Court issued a slew of directions for all stakeholders, including the constitution of a National Fund for Rare Diseases (NFRD) with a budgetary allocation of at least INR 974 crores. The Court also directed pharmaceutical companies to ensure a proper distribution network to make available therapies and medicines for rare diseases in India. The companies involved in the import of rare disease therapies were also directed to prepare detailed plans for establishing local manufacturing or distribution facilities. Furthermore, the companies were directed to make the therapies available after reaching a price agreement with the National Rare Diseases Committee.

Maintainability of an infringement suit

The High Court of Delhi in AstraZeneca Ab & Anr v Westcoast Pharmaceutical Limited held that nothing in the Patents Act, 1970 precludes a patentee’s right to institute an infringement suit even if a post-grant opposition proceeding is pending. The Court rejected Westcoast’s argument that the patentee was required to wait for one year to have their patent rights crystallised. It was held that such an interpretation of an orbiter dicta from an earlier decision of the Supreme Court in Alloys Wobben was incorrect.

Ad interim injunctions for pharmaceutical patents

The High Court of Delhi has passed a series of ad-interim restraining orders in lawsuits filed by AstraZeneca AB for infringement of patented compound “Osimertinib”. The orders were passed against several entities, including Westcoast Pharmaceuticals, BDR Pharmaceuticals, Azista Industries, Everest Pharmaceuticals, Beacon Pharmaceuticals, Zee Laboratories and MSN Laboratories.

Notably, AstraZeneca was also successful in post-grant oppositions filed by Natco Pharma Ltd and Sunshine Organics Pvt Ltd against the grant of a patent for Osimertinib. The claimed compound is an oral, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) approved for the treatment of non-small cell lung cancer (NSCLC). The drug is being marketed under the brand Tagrisso in India and several other countries across the world.

The Delhi High Court also passed an ad interim injunction in Helsinn Healthcare SA v Hetero Healthcare Limited, restraining Hetero from infringing a formulation patent for an oral dosage of “Netupitant” and “Palonosetron hydrochloride”. The infringing drug was being sold in an integrated combination of both salts.

Imposition of cost for causing delay in determining infringement

The Delhi High Court in Bristol Myers Squibb Holdings v KM Swarnlatha imposed a cost on one of the defendants who had launched the infringing drug but failed to appear before the Court, causing a delay in suit proceedings. Earlier, the Court issued an ex parte restraining order as the defendant launched a generic version of Dasatinib before the expiry of the patent.

Relevance of Opposition Board Recommendations

The Madras High Court in Ashok Leyland Limited vs. The Controller of Patents has ruled that while dealing with post-grant opposition, the Controller is duty-bound to decide on the qualitative merit of the Opposition Board Recommendations (OBR). The Court held that OBR is a foundational document during the post-grant stage, and the patent applicant shall be given an opportunity to illustrate the inadequacies of the OBR during the hearing.

Writ proceedings against pre-grant opposition decisions

A Division bench of the Delhi High Court in Rich Products Corporation v The Controller of Patents & Anr examined the issue of maintainability of a writ petition against the Controller’s dismissal of a pre-grant opposition. The Court held that remedy under Article 226 of the Constitution is discretionary and shall not be used if there is an efficacious, alternate and statutory recourse available. The Court upheld the single judge’s refusal to entertain a writ petition in view of the post-grant opposition remedy available for the opponent.

Territorial jurisdiction to adjudicate patent appeals

The High Court of Delhi in Filo Edtech Inc v Union of India ruled that an appeal arising from the Patent Office would lie with the appropriate High Court on the basis of the appropriate office having dominion over the patent application. The Court reaffirmed the decision of a coordinate bench in Dr. Reddy’s Laboratories, stating that an appeal is a continuation of the original proceeding. Once the patent applicant has chosen the appropriate office when filing the application, it cannot be allowed to approach a different High Court to decide the appeal arising from the refusal of the patent application.

Conclusion

The establishment of IPR divisions in India’s High Courts is a landmark development in the country’s approach to intellectual property enforcement, signifying a move toward more efficient, specialised, and accessible IPR adjudication. These divisions not only expedite the resolution of IPR disputes but also create a focused platform for addressing the unique challenges associated with intellectual property law.

Complementing the judicial reforms are significant legislative changes, particularly the amendments to the Patents Rules, 2003, which aim to streamline the patent prosecution process, reduce delays, and enhance compliance. These changes reflect the government’s commitment to creating a more efficient and transparent system for intellectual property rights in India, fostering innovation, and encouraging international collaborations. Judicial rulings have clarified and refined key areas of patent law, such as the patentability of antibody claims, divisional patents, diagnostic methods, and therapeutic efficacy. These rulings reflect an increasingly sophisticated approach to IPR issues, demonstrating India’s readiness to address complex challenges in a globalised economy.

In sum, establishing IPR divisions across High Courts, along with the legislative amendments and key case law developments, positions India as a growing hub for innovation and intellectual property protection. These reforms not only enhance the legal landscape for domestic and international patent applicants but also provide a more streamlined and specialised system for enforcing and adjudicating IPR matters. As India continues to modernise its IPR regime, these initiatives promise to contribute significantly to protecting intellectual property, ultimately fostering an environment conducive to growth, innovation, and global competitiveness.