Sharad Vadehra and Reena MP Singh

October 6, 2026
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India’s 2026 Draft Pharmaceutical Patent Guidelines: Key Changes and a Critical Analysis

India’s pharmaceutical patent regime has always sought to balance two competing objectives: encouraging genuine innovation and ensuring access to medicines. The Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, 2026, issued by the Office of the Controller General of Patents, Designs and Trade Marks, seek to strengthen that balance through a […]

May 28, 2026
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The Clock That Never Stops: Understanding Patent Term Adjustment and Extension in India, the US, and Europe

September 15, 2025
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Synergy, Obviousness, and Enablement: Key Takeaways from the Madras HC’s Amgen Decision

Introduction In a recent judgment dated August 22, 2025, the Madras High Court in Amgen Inc. v. Assistant Controller of Patents 1overturned the Controller’s decision to reject patent Application No. 5857/CHENP/2008 which had been rejected under Sections 3(d), 3(e), 2(1)(ja) (lack of inventive step), and 10(4) of the Patents Act, 1970 for insufficiency of disclosure. […]

July 25, 2025
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Understanding the Difference between Section 3(d) and 3(e) through Oramed

Introduction In a recent judgment dated July 4, 2025, the Calcutta High Court in Oramed Ltd. vs The Controller General of Patents 1overturned a patent refusal order for Application No. 3996/KOLNP/2010, which the Indian Patent Office had rejected on the grounds of lack of inventiveness under Section 2(1)(ja) and non-patentability under Section 3(e) of the […]

June 20, 2025
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No Patent For Intermediates without Efficacy

Introduction On May 27, 2025, in 1, the Delhi High Court upheld the refusal of divisional patent, affirming that minor structural modifications of known pharmaceutical compounds—especially intermediates—must still demonstrate enhanced therapeutic efficacy to be patentable under Section 3(d) of the Indian Patents Act, 1970. The Court further upheld the refusal on grounds of lack of […]

October 3, 2024
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Sowing the Seeds of Change: Patent Law, Biotechnology, and the Sakata Case

Introduction In a recent judgment in Sakata Seed Corporation v. Deputy Controller of Patents and Designs [1], the Madras High Court set aside a patent refusal order issued by the Controller of Patents for patent application No. 1221/CHENP/2015. The refusal was based on non-compliance with Section 3(j) of the Indian Patents Act, 1970 (“the Act”). […]

September 18, 2024
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Crystallized Control: Unlocking the Secrets to Polymorph Patents

Introduction Polymorphs are compounds that can exist in two or more crystalline structures with the same chemical composition but different molecular arrangements. These variations result in differing physical properties such as solubility, and dissolution rates, making polymorphs especially important in industries like pharmaceuticals, agrochemicals, and pigments. For pharmaceutical companies, securing patents for polymorphs in addition […]

August 27, 2024
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Delhi High Court Temporarily Injuncts Zydus Lifesciences from Selling Breast Cancer Drug

Introduction On July 9, 2024, in F-Hoffmann-La Roche Ag & Anr v. Zydus Lifesciences Limited [1], the Delhi High Court issued a temporary injunction preventing Zydus Lifesciences from selling its breast cancer drug, Sigrima. This biosimilar of Roche’s Pertuzumab (marketed as Perjeta®) became the center of a patent infringement lawsuit initiated by Roche against Zydus […]

August 2, 2024
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Post-Hearing Claim Amendments andSection 59: Key Insights from Recent Judgment

Introduction In a recent judgment dated March 19, 2024, in Genomatica Inc vs Controller of Patents and Designs, the Madras High Court overturned a patent refusal order issued by the Controller in respect of patent application No. 201747013084, in which the Controller had rejected the latest amendments to the pending claims, instead opting to examine […]

June 10, 2024
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Amendments at PCT National Phase Entry: DHC in Mitsui Chemicals

Introduction In a recent judgment dated February 23, 2024, in Mitsui Chemicals Inc. vs Controller of Patents [1], the Delhi High Court set aside a patent refusal order issued by the Controller in respect of patent application No. 3877/DELNP/2009, which had been denied on the grounds of non-compliance with Sections 59 and Section 3(h) of the […]

Author: Sharad Vadehra and Reena MP Singh

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