Delhi High Court on Patent Suit Against Dr Reddy’s Laboratories

The Delhi High Court rejected a patent infringement suit filed against Dr Reddy’s Laboratories (DRL).
The High Court refused to grant Novo Nordisk, a Danish pharmaceutical company, an interim injunction against DRL.
The dispute concerned the drug semaglutide, which is patented by Novo Nordisk in India.
o Semaglutide is an active pharmaceutical ingredient (API) used for treating Type 2 diabetes.
o Semaglutide is also used for treating obesity.
▪ An Active Pharmaceutical Ingredient (API) is the chemical component of a medicine that produces the intended therapeutic effect.
Novo Nordisk markets its anti-diabetic drug Ozempic using semaglutide.
Novo Nordisk also markets its weight-loss drug Wegovy using semaglutide.
The Court observed that Novo Nordisk’s two patents on minor variations of semaglutide could amount to evergreening.
About Evergreening of Patents
Evergreening of patents is a strategy used to extend patent monopolies beyond the standard period.
The maximum life of a patent is 20 years, after which generic production is allowed.
Evergreening often involves making minor changes to existing patented compounds.
Such modifications may include new forms of the same drug.
o They may include new salts of an existing molecule.
o They may include new isomers, which are molecules with the same formula but different structures.
o They may include new polymorphs, which are different crystalline forms of the same chemical.
o They may include new dosages or delivery systems that do not improve therapeutic value.
Legal Provisions Against Evergreening
Section 3(d) of the Patents Act, 1970 expressly prohibits patents on new forms or derivatives of known substances.
o Section 3(d) allows such patents only when the new form shows significantly enhanced therapeutic efficacy.
o This provision limits unjustified evergreening practices.
Indian patent standards of patentability require strict tests of novelty.
They also require strict tests of inventive step, which prevents protection for trivial modifications.
These standards ensure that obvious variants of existing drugs are not granted new patents.
India’s patent framework remains TRIPS-compliant, meaning it adheres to the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights.
India uses Doha Declaration flexibilities to protect public health.
The Doha Declaration allows countries to curb unjustified secondary patents in the interest of public access.
These flexibilities help ensure access to affordable generic medicines in India.

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