Latest Judgements Related to Patents in India: Key Insights and Implications

India’s patent landscape continues to evolve with new judicial pronouncements that shape the enforcement and interpretation of patent laws. This blog explores recent landmark judgments in Indian patent law, highlighting their significance and the impact on patent holders, applicants, and the broader legal community.

1. Novartis AG v. Union of India (2013)

Case Summary:

In the landmark judgment of Novartis AG v. Union of India (2013), the Supreme Court of India addressed the patentability of a drug under Section 3(d) of the Patents Act, 1970. Novartis sought a patent for the beta-crystalline form of imatinib mesylate, an anti-cancer drug. The Court ruled that the modified form did not meet the criteria for patentability, emphasising that mere incremental innovations without significant enhancement in efficacy do not qualify for patent protection.

Key Takeaways:

• The judgment reinforced the application of Section 3(d), which excludes patents on new forms of known substances unless they demonstrate enhanced efficacy.
• It highlighted India’s commitment to balancing patent protection with public health needs, particularly in the context of affordable medicines.

2. Bayer Corporation v. Union of India (2014)

Case Summary:
In Bayer Corporation v. Union of India (2014), the Delhi High Court examined the patent infringement issue and the extent of compulsory licensing under the Patents Act. Bayer had patented the anti-cancer drug sorafenib, but the court upheld the decision of the Controller of Patents to grant a compulsory license to Natco Pharma, citing that the drug was not available at an affordable price.

Key Takeaways:

• The court upheld the principles of compulsory licensing, emphasising that patent rights must be exercised in a manner that serves the public interest and is affordable.
• The decision underscored the importance of balancing intellectual property rights with access to essential medicines.

3.Merck Sharp & Dohme Corp v. Glenmark Pharmaceuticals (2020)

Case Summary:
In the case of Merck Sharp & Dohme Corp v. Glenmark Pharmaceuticals (2020), the Bombay High Court dealt with the issue of patent validity concerning the drug sitagliptin, used in treating diabetes. Merck’s patent claim was challenged by Glenmark, which argued that the patent lacked novelty and inventiveness.

Key Takeaways:

• The Court’s decision highlighted the importance of meeting the requirements of novelty and inventiveness for patent validity.
• It reaffirmed the rigorous standards that patent applicants must meet to secure and enforce their patents in India.

4. Telefonaktiebolaget LM Ericsson v. Competition Commission of India (2021)

Case Summary:
In Telefonaktiebolaget LM Ericsson v. Competition Commission of India (2021), the Supreme Court addressed issues related to patent enforcement and competition law. Ericsson, a major player in telecommunications, faced scrutiny regarding its licensing practices for Standard Essential Patents (SEPs). The Court examined whether Ericsson’s licensing practices violated competition norms.

Key Takeaways:

• The judgment explored the intersection of patent law and competition law, particularly in the context of SEPs.
• It stressed the need for fair, reasonable, and non-discriminatory (FRAND) licensing practices, impacting how patent holders negotiate and enforce their rights.

5. Gilead Sciences Inc. v. Natco Pharma Ltd.(2022)

Case Summary:
In Gilead Sciences Inc. v. Natco Pharma Ltd. (2022), the Delhi High Court reviewed issues related to patent filing procedures and the disclosure requirements under the Patents Act. Gilead challenged Natco’s patent application for a generic version of its antiviral drug, arguing that the application did not meet disclosure norms.

Key Takeaways:

• The Court’s ruling emphasised the importance of compliance with procedural requirements and full disclosure in patent applications.
• It reinforced the principles of transparency and integrity in the patent filing process.

6. Nestle SA v. Controller (February 2023)

• Case Study: 

The Delhi High Court clarified that “composition comprising X directed towards treatment” only defines the composition, not a treatment method, thus not attracting Section 3(i) of the Patents Act. The court emphasised that disclosing the best method known to the patentee suffices for sufficiency requirements.

• Key Takeaway: 

This case clarifies the interpretation of claims and the requirements for disclosure in patent applications​​.

7. Nippon v. Controller (July 2022)

• Case Study: 

The Delhi High Court ruled that pre-grant amendments should be construed liberally, allowing “product-by-process” claims to be amended to “process” claims under Section 59(1).

• Key Takeaway: 

This judgment supports a more flexible approach to amendments during the patent application process​.

8. Allergan Inc v. Controller (January 2023)

• Case Study: 

The Delhi High Court allowed the amendment of “method of treatment” claims to “product” claims, emphasising that amendments should consider the complete specification, not just the pre-amended claims.

• Key Takeaway: 

This decision underscores the importance of the complete specification in determining the scope of permissible amendments​​.

9. Commonwealth Research Organization v. Controller (October 2023)

• Case Study: 

The Madras High Court allowed amendments to claims as long as they fall within the scope of the complete specification.

• Key Takeaway: 

This ruling reinforces the allowance of amendments within the bounds of the complete specification, promoting greater flexibility in patent claim amendments​.

10. Oppo v. Controller of Patents (June 2023)

• Case Study: 

The Calcutta High Court held that any amendments to claims require a fresh examination by the controller, ensuring that the examination report reflects the amendments.

• Key Takeaway: 

This judgment ensures that amendments to patent claims are thoroughly examined, maintaining the integrity of the patent examination process​​.

11. Boehringer Ingelheim v. Controller of Patents (July 2022)

• Case Study: 

The Delhi High Court ruled that only claims, not specifications, should be considered when assessing unity of invention in divisional applications.

• Key Takeaway: 

This decision clarifies the criteria for divisional applications, focusing on claims rather than specifications​​.

12. Syngenta v. Controller of Patents (October 2023)

• Case Study: 

The Division Bench of the Delhi High Court held that divisional applications require a “plurality of inventions” and can be filed voluntarily or in response to objections.

• Key Takeaway: 

This judgment clarifies the requirements for filing divisional applications, promoting a better understanding of patent application processes​​.

13. Novartis v. Natco (January 2024)

• Case Study: 

The Delhi High Court determined that patent examination and pre-grant opposition are independent processes, with opponents having no right to participate in the examination.

• Key Takeaway: 

This ruling separates the processes of examination and opposition, streamlining patent application procedures​​.

14. Ericsson v. CCI (July 2023)

• Case Study: 

The Delhi High Court limited the powers of the Competition Commission of India, holding that the Patents Act overrides the Competition Act concerning patent licensing and abuse.

• Key Takeaway: 

This decision reinforces the Patents Act as the primary legislation governing patent rights and disputes​ ​.

15. OpenTV v. Controller of Patents (May 2023)

• Case Study: 

The Delhi High Court ruled that narrowing down claims is permissible, but broadening them is not, ensuring that amendments stay within the original scope.

• Key Takeaway: 

This judgment highlights the permissible scope of claim amendments, maintaining the integrity of the original patent application​​.

Conclusion

Recent judgments in Indian patent law have significantly impacted the patenting landscape, reflecting the dynamic nature of intellectual property rights. These cases demonstrate the judiciary’s role in balancing innovation with public interest, ensuring that patent laws evolve in response to emerging challenges and societal needs. Staying informed about these developments is crucial for patent holders and applicants to navigate the complexities of patent enforcement and protection in India.

Frequently Asked Questions on Judgements Related to Patents in India

Q1. What was the Supreme Court’s ruling in Novartis AG v. Union of India?
Ans1: The Supreme Court ruled that Novartis’s modified drug form did not meet the criteria for patentability under Section 3(d) of the Patents Act, emphasising that incremental innovations without significant enhancement in efficacy do not qualify for patent protection.

Q2. How did the Delhi High Court’s decision in Bayer Corporation v. Union of India impact compulsory licensing?
Ans2: The Delhi High Court upheld the compulsory licensing decision, highlighting that patent rights must serve the public interest and be affordable, especially when essential medicines are involved.

Q3. What did the Bombay High Court decide regarding patent validity in Merck Sharp & Dohme Corp v. Glenmark Pharmaceuticals?
Ans3: The Bombay High Court reaffirmed the necessity of novelty and inventiveness for patent validity, emphasising rigorous standards for securing and enforcing patents.

Q4. What was the key takeaway from the Supreme Court’s ruling in Telefonaktiebolaget LM Ericsson v. Competition Commission of India?
Ans4: The Supreme Court stressed the need for fair, reasonable, and non-discriminatory (FRAND) licensing practices for Standard Essential Patents (SEPs), impacting how patent holders enforce their rights.

Q5. How did the Delhi High Court address patent filing procedures in Gilead Sciences Inc. v. Natco Pharma Ltd.?
Ans5: The Delhi High Court emphasised the importance of compliance with procedural requirements and full disclosure in patent applications, reinforcing transparency and integrity.

Q6. What clarification did the Delhi High Court provide in Nestle SA v. Controller regarding patent claims?
Ans6: The court clarified that “composition comprising X directed towards treatment” defines the composition, not a method of treatment, thus not attracting Section 3(i) of the Patents Act.

Q7. What did the Delhi High Court rule about pre-grant amendments in Nippon v. Controller?
Ans7: The Delhi High Court ruled that pre-grant amendments should be construed liberally, allowing “product-by-process” claims to be amended to “process” claims under Section 59(1).

Q8. What was the Delhi High Court’s stance on amendments in method of treatment claims in Allergan Inc v. Controller?
Ans8: The court allowed amendments from “method of treatment” claims to “product” claims, emphasising that amendments should consider the complete specification.

Q9. How did the Madras High Court rule on claim amendments in Commonwealth Research Organization v. Controller?
Ans9: The Madras High Court allowed amendments as long as they fall within the scope of the complete specification, reinforcing flexibility in patent claim amendments.

Q10. What did the Delhi High Court determine about the separation of patent examination and pre-grant opposition in Novartis v. Natco?
Ans10: The Delhi High Court ruled that patent examination and pre-grant opposition are independent processes, with opponents having no right to participate in the examination.