Novartis AG v. Union of India & Others
Whether a beta crystalline form of a known molecule could be patented in India despite the bar on new forms of known substances.
What the court held
The Court dismissed the appeal. It read section 3(d) as a second and stricter filter that applies after the usual tests of novelty and inventive step have been met. For a new form of a known substance, the applicant must show a real improvement in therapeutic efficacy over the known substance itself. Better flow properties, stability or solubility were held not to be enough on their own in the case of a medicine. On the facts, the claimed form was a new form of a known substance whose efficacy had not been shown to improve.
Why it matters to a reader of this provision
Section 3(d) is the provision raised most often against pharmaceutical and chemical applications in India. This judgment is the leading explanation of what it asks for, and of the gap between a substance being new and a substance working better. Anyone reading section 3(d), or considering a fresh form of a known compound, will meet this decision again in examination reports, oppositions and revocation petitions.
Provisions this judgment interprets
Open a provision for the plain-language explanation, the worked example and the forms and deadlines it touches.
Does this judgment affect your matter?
Whether a decision helps or hurts depends entirely on your facts and your claims. A patent professional can tell you which.